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Follica Announces Positive Feedback From End of Phase 2 Meeting With FDA for Its Lead Program to Treat Male Androgenetic Alopecia – BioSpace

By daniellenierenberg

BOSTON--(BUSINESS WIRE)-- Follica, Inc. (Follica), a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial aging and other related conditions, today announced positive feedback from a meeting with the U.S. Food and Drug Administration (FDA) as the company prepares to advance its lead program into Phase 3 development following a successful safety and efficacy optimization study for the treatment of hair loss in male androgenetic alopecia announced in December 2019.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200603005934/en/

Follicas approach, which is designed to stimulate the growth of new follicles and new hair, is being developed as a potential new option for the millions of people seeking treatments to grow new hair. (Graphic: Business Wire)

Follica plans to launch its Phase 3 program this year. Overall, approximately 280 patients will be enrolled, with efficacy assessed against two co-primary endpoints: visible (non-vellus) hair count and patient-reported outcomes on a pre-established scale. The randomized, controlled, double-blinded studies will be conducted in multiple centers across the U.S. A maximal use study to further understand the pharmacokinetics of the treatment will be conducted in parallel. The trial design is consistent with feedback from the FDA during the End of Phase 2 meeting.

In the U.S. alone, 47 million men are affected by progressive hair loss caused by androgenetic alopecia, a condition that is largely unresolved today, leaving many dissatisfied with the current available treatments and looking for a new alternative. Our recent safety and optimization study points to a new level of effect, enabled by our proprietary approach, which stimulates the growth of new follicles and new hair, said Jason Bhardwaj, chief executive officer of Follica. Were grateful to the FDA for their guidance as we prepare for our pivotal program, and we look forward to advancing the development of our treatment regimen, which has demonstrated strong potential to address the current need for those who seek treatment for androgenetic alopecia.

Follicas approach is based on generating an embryonic window in adult scalp cells via a series of short office-based treatments with its proprietary Hair Follicle Neogenesis (HFN) device. The scalp treatments, which last just a few minutes, stimulate stem cells and enable the growth of new hair follicles. A topical drug is then applied to enhance efficacy by growing and thickening new hair follicles and hair on the scalp.

Follica reported topline results from its safety and optimization study in December 2019. That trial was designed to select the optimal treatment regimen using Follicas proprietary HFN device in combination with a topical drug and successfully met its primary endpoint. The selected treatment regimen demonstrated a statistically significant 44% improvement of visible (non-vellus) hair count after three months of treatment compared to baseline (p < 0.001, n = 19). Across all three treatment arms, the overall improvement of visible (non-vellus) hair count after three months of treatment was 29% compared to baseline (p < 0.001, n = 48), reflecting a clinical benefit across the entire trial population and a substantially improved outcome with the optimal treatment regimen. Additionally, a prespecified analysis comparing the 44% change in visible (non-vellus) hair count to a 12% historical benchmark set by approved pharmaceutical products established statistical significance (p = 0.005).

In addition to the safety and optimization study, Follica has validated its approach in prior clinical studies using prototype HFN devices with different treatment parameters and therapeutic compounds. Follicas translational work builds on research by George Cotsarelis, M.D., who isolated and characterized the expression pattern of stem cells from a critical region of the follicle. An expert in epithelial stem cell biology, Dr. Cotsarelis is chair of the department of dermatology at the University of Pennsylvania and a co-founder of Follica.

About Androgenetic Alopecia Androgenetic alopecia represents the most common form of hair loss in men and women, with an estimated 90 million people who are eligible for treatment in the United States alone. Only two drugs, both of which have demonstrated a 12% increase of non-vellus hair count over baseline for their primary endpoints, are currently approved for the treatment of androgenetic alopecia1. The most effective current approach for the treatment of hair loss is hair transplant surgery, comprising a range of invasive, expensive procedures for a subset of patients who have enough donor hair to be eligible. As a result, there remains a significant need for safe, effective, non-surgical treatments to grow new hair.

About Follica Follica is a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial aging and other related conditions. Founded by PureTech (LSE:PRTC), a co-inventor of the current platform, and a group of world-renowned experts in hair follicle biology and regenerative medicine, Follicas experimental treatment platform has been shown to stimulate the development of new hair follicles and hair in three previously conducted clinical studies. The companys proprietary treatment is designed to induce an embryonic window via a device with optimized parameters to initiate hair follicle neogenesis, the formation of new hair follicles from epithelial (skin) stem cells. This process is enhanced through the application of a topical compound. Follica completed a safety and efficacy optimization study in 2019, and its Phase 3 program in male androgenetic alopecia is expected to begin in 2020. Follicas technology is based on work originating from the University of Pennsylvania that has been further developed by Follicas internal program. Follicas extensive IP portfolio includes IP exclusively licensed from the University of Pennsylvania as well as Follica-owned IP.

1 Olsen EA et al, J Am Acad Dermatol. 2002 Sep;47(3):377-85Olsen EA et al, J Am Acad Dermatol. 2007 Nov;57(5):767-74. Epub 2007 Aug 29Price VH et al, J Am Acad Dermatol. 2002 Apr;46(4):517-23Kaufman et al, J Am Acad Dermatol. 1998 Oct; 39(4):578-589

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Follica Announces Positive Feedback From End of Phase 2 Meeting With FDA for Its Lead Program to Treat Male Androgenetic Alopecia - BioSpace

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Dermal Regeneration Matrix Device Market to Exhibit Increased Demand in the Coming Years – Lake Shore Gazette

By daniellenierenberg

Skin is the largest organ of the human body. It is composed of three layers: epidermis-the outermost layer; dermis-contains sweat glands, hair follicles and connective tissue and hypodermis-made up of fat and connective tissue. The main functions of the skin includes protection, sensation and regulation. The skin acts as a barrier and provides protection against harmful chemicals, radiation, microorganism and changing environmental conditions. It also helps regulate body temperature and maintain fluid balance. Skin is an extensive network of nerve cells and contains various receptors to detect changes in the environment such as touch, pain, heat and cold. Damage to skin due to burn or trauma can disrupt all the vital functions performed by the skin.

Currently, topical antibiotics, skin grafting, wound dressings and tissue-engineered substitutes are available in the market that are used to treat skin-related disorders. A skin graft can be done by natural substitute such as amniotic membrane, potato peel or artificial material that includes synthetic polymer sheet, polymer foam or spray. These substitute helps in the healing process. Skin regeneration refers to the regrowth of the damaged skin from the remaining tissue. Stem cell therapy has a vital application in skin regeneration.

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Dermal regeneration matrix device provides an appropriate environment that is necessary for the proliferation and differentiation of skin cells. It helps in triggering the bodys own repair mechanism by cell signaling, that drive the matrix environment in wound healing process. Dermal regeneration matrix device is used to treat skin burns and is also finds application in reconstructive surgery for contractures (scars). The dermal regeneration matrix device is placed over the damaged skin which provides an environment for regeneration of new skin and tissue. The matrix is made of cow collagen, silicone and shark cartilage.

In 1996, the U.S. Food and Drug Administration (FDA) first approved integra dermal regeneration matrix device for treatment of burn injuries. In 2002, dermal regeneration matrix device was approved for use in reconstructive surgery for burn scars. About 30 million people in the U.S. are suffering from diabetes, of which 15% experience a diabetic foot ulcer in their lifetime. In January 2016, FDA approved the use of dermal regeneration matrix for treatment of chronic diabetic foot ulcers (DFU). The usage of dermal regeneration matrix device is expected to expand the growth of dermal regeneration matrix device owing to increase usage in chronic foot ulcer.

Technological advancement and continued research in the development of artificial skin promises to bring more products to the marketplace. Increasing adoption of the device and long-term benefits associated with its application are some of the factors expected to fuel growth of the global dermal regeneration matrix device market over the forecast period. However, less awareness among the consumers and high cost of device are some of the key factors that could hamper growth of the market.

The global dermal regeneration matrix device is segmented on the basis of source, application, end user and geography.

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On the basis of source, the global dermal regeneration matrix device market is segmented into cow collagen, silicone and shark cartilage. On the basis of end user, the global dermal regeneration matrix device market is segmented into hospitals and dermatology centers. The hospital segment is expected to contribute significantly to the total market in terms of market share. According to World Health Organization, over 265,000 deaths are caused due to burns each year. The majority of the burn cases occur in low and middle-income countries. Injuries such as traffic collisions, falls, burns, drowning, poisoning and others are expected to kills around five million people worldwide. Thus, the demand for dermal regeneration growth matrix is expected to be high in the low and middle-income countries over the forecast period.

On the basis of region, the global dermal regeneration matrix device market is segmented into five key regions: North America, Latin America, Europe, Asia Pacific and Middle East & Africa.

Some of the major players in the global dermal regeneration matrix device market include Integra LifeSciences Corporation, Platelet BioGenesis, Avita Medical, Stratatech, Organogenesis Inc., Smith & Nephew, Inc., ACell Inc., Symatese and others.

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PureTech Founded Entity Follica Announces Positive Feedback from FDA as it Prepares to Advance its Lead Programme in Male Androgenetic Alopecia into P…

By daniellenierenberg

Follica plans to initiate its Phase 3 programme this year

PureTech Health plc (LSE: PRTC) (PureTech), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, is pleased to note that its Founded Entity, Follica, today announced positive feedback from an End of Phase 2 meeting with the US Food and Drug Administration (FDA) for its lead programme to treat male androgenetic alopecia. The company plans to advance the programme into Phase 3 development this year following the successful safety and efficacy optimisation study announced in December 2019.

Bharatt Chowrira, JD, PhD, president and chief of business and strategy at PureTech, said: This positive feedback from FDA enables Follica to move forward with its pivotal trial this year. Current treatments for the progressive hair loss caused by androgenetic alopecia are inadequate, and we are pleased with Follicas progress towards Phase 3 development, bringing us another step closer to a potential new treatment for the millions of people seeking safe, effective, non-surgical treatments to grow new hair.

The full text of the announcement from Follica is as follows:

Follica Announces Positive Feedback from End of Phase 2 Meeting with FDA for its Lead Programme to Treat Male Androgenetic Alopecia

Company plans to initiate its Phase 3 programme this year

BOSTON, June 4, 2020 -- Follica, Inc.(Follica), a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial ageing and other related conditions, today announced positive feedback from a meeting with the US Food and Drug Administration (FDA) as the company prepares to advance its lead programme into Phase 3 development following a successful safety and efficacy optimisation study for the treatment of hair loss in male androgenetic alopecia announced in December 2019.

Follica plans to launch its Phase 3 programme this year. Overall, approximately 280 patients will be enroled, with efficacy assessed against two co-primary endpoints: visible (non-vellus) hair count and patient-reported outcomes on a pre-established scale. The randomised, controlled, double-blinded studies will be conducted in multiple centers across the US. A maximal use study to further understand the pharmacokinetics of the treatment will be conducted in parallel. The trial design is consistent with feedback from the FDA during the End of Phase 2 meeting.

In the US alone, 47 million men are affected by progressive hair loss caused by androgenetic alopecia, a condition that is largely unresolved today, leaving many dissatisfied with the current available treatments and looking for a new alternative. Our recent safety and optimisation study points to a new level of effect, enabled by our proprietary approach, which stimulates the growth of new follicles and new hair, said Jason Bhardwaj, chief executive officer of Follica. Were grateful to the FDA for their guidance as we prepare for our pivotal programme, and we look forward to advancing the development of our treatment regimen, which has demonstrated strong potential to address the current need for those who seek treatment for androgenetic alopecia.

Follicas approach is based on generating an embryonic window in adult scalp cells via a series of short office-based treatments with its proprietary Hair Follicle Neogenesis (HFN) device. The scalp treatments, which last just a few minutes, stimulate stem cells and enable the growth of new hair follicles. A topical drug is then applied to enhance efficacy by growing and thickening new hair follicles and hair on the scalp.

Follica reported topline results from its safety and optimisation study in December 2019. That trial was designed to select the optimal treatment regimen using Follicas proprietary HFN device in combination with a topical drug and successfully met its primary endpoint. The selected treatment regimen demonstrated a statistically significant 44% improvement of visible (non-vellus) hair count after three months of treatment compared to baseline (p < 0.001, n = 19). Across all three treatment arms, the overall improvement of visible (non-vellus) hair count after three months of treatment was 29% compared to baseline (p < 0.001, n = 48), reflecting a clinical benefit across the entire trial population and a substantially improved outcome with the optimal treatment regimen. Additionally, a prespecified analysis comparing the 44% change in visible (non-vellus) hair count to a 12% historical benchmark set by approved pharmaceutical productsestablished statistical significance (p = 0.005).

In addition to the safety and optimisation study, Follica has validated its approach in prior clinical studies using prototype HFN devices with different treatment parameters and therapeutic compounds. Follicas translational work builds on research by George Cotsarelis, MD, who isolated and characterised the expression pattern of stem cells from a critical region of the follicle. An expert in epithelial stem cell biology, Dr Cotsarelis is chair of the department of dermatology at the University of Pennsylvania and a co-founder of Follica.

About Androgenetic Alopecia

Androgenetic alopecia represents the most common form of hair loss in men and women, with an estimated 90 million people who are eligible for treatment in the United States alone. Only two drugs, both of which have demonstrated a 12% increase of non-vellus hair count over baseline for their primary endpoints, are currently approved for the treatment of androgenetic alopecia1. The most effective current approach for the treatment of hair loss is hair transplant surgery, comprising a range of invasive, expensive procedures for a subset of patients who have enough donor hair to be eligible. As a result, there remains a significant need for safe, effective, non-surgical treatments to grow new hair.

About Follica

Follica is a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial ageing and other related conditions. Founded by PureTech (LSE: PRTC), a co-inventor of the current platform, and a group of world-renowned experts in hair follicle biology and regenerative medicine, Follicas experimental treatment platform has been shown to stimulate the development of new hair follicles and hair in three previously conducted clinical studies. The companys proprietary treatment is designed to induce an embryonic window via a device with optimised parameters to initiate hair follicle neogenesis, the formation of new hair follicles from epithelial (skin) stem cells. This process is enhanced through the application of a topical compound. Follica completed a safety and efficacy optimisation study in 2019, and its Phase 3 programme in male androgenetic alopecia is expected to begin in 2020. Follicas technology is based on work originating from the University of Pennsylvania that has been further developed by Follicas internal programme. Follicas extensive IP portfolio includes IP exclusively licensed from the University of Pennsylvania as well as Follica-owned IP.

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, including intractable cancers, lymphatic and gastrointestinal diseases, central nervous system disorders and inflammatory and immunological diseases, among others. The Company has created a broad and deep pipeline through the expertise of its experienced research and development team and its extensive network of scientists, clinicians and industry leaders. This pipeline, which is being advanced both internally and through PureTechs Founded Entities, is comprised of 23 product candidates and one product that has been cleared by the US Food and Drug Administration (FDA). All of the underlying programmes and platforms that resulted in this pipeline of product candidates were initially identified or discovered and then advanced by the PureTech team through key validation points based on the Companys unique insights into the biology of the brain, immune and gut, or BIG, systems and the interface between those systems, referred to as the BIG Axis.

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Follica Announces Positive Feedback From End of Phase 2 Meeting With FDA for Its Lead Program to Treat Male Androgenetic Alopecia – Business Wire

By daniellenierenberg

BOSTON--(BUSINESS WIRE)--Follica, Inc. (Follica), a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial aging and other related conditions, today announced positive feedback from a meeting with the U.S. Food and Drug Administration (FDA) as the company prepares to advance its lead program into Phase 3 development following a successful safety and efficacy optimization study for the treatment of hair loss in male androgenetic alopecia announced in December 2019.

Follica plans to launch its Phase 3 program this year. Overall, approximately 280 patients will be enrolled, with efficacy assessed against two co-primary endpoints: visible (non-vellus) hair count and patient-reported outcomes on a pre-established scale. The randomized, controlled, double-blinded studies will be conducted in multiple centers across the U.S. A maximal use study to further understand the pharmacokinetics of the treatment will be conducted in parallel. The trial design is consistent with feedback from the FDA during the End of Phase 2 meeting.

In the U.S. alone, 47 million men are affected by progressive hair loss caused by androgenetic alopecia, a condition that is largely unresolved today, leaving many dissatisfied with the current available treatments and looking for a new alternative. Our recent safety and optimization study points to a new level of effect, enabled by our proprietary approach, which stimulates the growth of new follicles and new hair, said Jason Bhardwaj, chief executive officer of Follica. Were grateful to the FDA for their guidance as we prepare for our pivotal program, and we look forward to advancing the development of our treatment regimen, which has demonstrated strong potential to address the current need for those who seek treatment for androgenetic alopecia.

Follicas approach is based on generating an embryonic window in adult scalp cells via a series of short office-based treatments with its proprietary Hair Follicle Neogenesis (HFN) device. The scalp treatments, which last just a few minutes, stimulate stem cells and enable the growth of new hair follicles. A topical drug is then applied to enhance efficacy by growing and thickening new hair follicles and hair on the scalp.

Follica reported topline results from its safety and optimization study in December 2019. That trial was designed to select the optimal treatment regimen using Follicas proprietary HFN device in combination with a topical drug and successfully met its primary endpoint. The selected treatment regimen demonstrated a statistically significant 44% improvement of visible (non-vellus) hair count after three months of treatment compared to baseline (p < 0.001, n = 19). Across all three treatment arms, the overall improvement of visible (non-vellus) hair count after three months of treatment was 29% compared to baseline (p < 0.001, n = 48), reflecting a clinical benefit across the entire trial population and a substantially improved outcome with the optimal treatment regimen. Additionally, a prespecified analysis comparing the 44% change in visible (non-vellus) hair count to a 12% historical benchmark set by approved pharmaceutical products established statistical significance (p = 0.005).

In addition to the safety and optimization study, Follica has validated its approach in prior clinical studies using prototype HFN devices with different treatment parameters and therapeutic compounds. Follicas translational work builds on research by George Cotsarelis, M.D., who isolated and characterized the expression pattern of stem cells from a critical region of the follicle. An expert in epithelial stem cell biology, Dr. Cotsarelis is chair of the department of dermatology at the University of Pennsylvania and a co-founder of Follica.

About Androgenetic AlopeciaAndrogenetic alopecia represents the most common form of hair loss in men and women, with an estimated 90 million people who are eligible for treatment in the United States alone. Only two drugs, both of which have demonstrated a 12% increase of non-vellus hair count over baseline for their primary endpoints, are currently approved for the treatment of androgenetic alopecia1. The most effective current approach for the treatment of hair loss is hair transplant surgery, comprising a range of invasive, expensive procedures for a subset of patients who have enough donor hair to be eligible. As a result, there remains a significant need for safe, effective, non-surgical treatments to grow new hair.

About FollicaFollica is a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial aging and other related conditions. Founded by PureTech (LSE:PRTC), a co-inventor of the current platform, and a group of world-renowned experts in hair follicle biology and regenerative medicine, Follicas experimental treatment platform has been shown to stimulate the development of new hair follicles and hair in three previously conducted clinical studies. The companys proprietary treatment is designed to induce an embryonic window via a device with optimized parameters to initiate hair follicle neogenesis, the formation of new hair follicles from epithelial (skin) stem cells. This process is enhanced through the application of a topical compound. Follica completed a safety and efficacy optimization study in 2019, and its Phase 3 program in male androgenetic alopecia is expected to begin in 2020. Follicas technology is based on work originating from the University of Pennsylvania that has been further developed by Follicas internal program. Follicas extensive IP portfolio includes IP exclusively licensed from the University of Pennsylvania as well as Follica-owned IP.

1 Olsen EA et al, J Am Acad Dermatol. 2002 Sep;47(3):377-85Olsen EA et al, J Am Acad Dermatol. 2007 Nov;57(5):767-74. Epub 2007 Aug 29Price VH et al, J Am Acad Dermatol. 2002 Apr;46(4):517-23Kaufman et al, J Am Acad Dermatol. 1998 Oct; 39(4):578-589

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Eradicating balding a step closer with new procedure in the cross hairs – The New Daily

By daniellenierenberg

For Australias balding community, letting your hair down is just an idiom.

But soon, it may be a reality.

In a breakthrough in the battle against baldness, researchers from the University of Pennsylvania have managed to grow skin that develops distinct layers, including hair follicles,from stem cells.

Scientists were already able to grow skin cells, but recreating the complex, multi-layered skin structure has been a major challenge.

As the largest human organ, the skin has multiple functions including temperature regulation and bodily fluid retention to the sensing of touch and pain that increases the difficulty of synthesising it, researchers say.

But over a four-to-five month period, researchers succeeded in growing complex skin cells and hair follicles, which were grafted onto mice.

More than half of the mice sprouted hair from the process.

Its a development that may also affect those with genetic skin disorders and cancers, as well as those with burns or wounds.

But those who are a little thin on the top shouldnt get excited too fast.

There are several major questions that remain before this approach can become a reality, researchers Leo Wang and George Cotsarelis say.

Several other aspects of the authors approach will also need to be optimised before it can move to the clinic.

The hairs that grew in the current study were small; in future, furtheroptimisation of culture conditions will be needed to form large scalp hairs.

However, the authors conclude: The work holds great promise of clinical translation we are confident that research will eventually see this promise realised.

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Future Growth of Cosmetic Skin Care Market by New Business Developments, Top Companies and Forecast to 2026 – Bulletin Line

By daniellenierenberg

Cosmetic Skin CareMarketBusiness Insights and Updates:

The latest Marketreport by a Data Bridge Market Researchwith the title[Global Cosmetic Skin CareMarket Industry Trends and Forecast to 2026].The new report on the worldwide Cosmetic Skin CareMarketis committed to fulfilling the necessities of the clients by giving them thorough insights into the Market. The various providers involved in the value chain of the product include manufacturers, suppliers, distributors, intermediaries, and customers.The reports provide Insightful information to the clients enhancing their basic leadership capacity identified.Exclusive information offered in this report is collected by analysis and trade consultants.

Global cosmetic skin care market is set to witness a substantial CAGR of 5.5% in the forecast period of 2019- 2026.

Cosmetic skin care is a variety of products which are used to improve the skins appearance and alleviate skin conditions. It consists different products such as anti- aging cosmetic products, sensitive skin care products, anti- scar solution products, warts removal products, infant skin care products and other. They contain various ingredients which are beneficial for the skin such as phytochemicals, vitamins, essential oils, and other. Their main function is to make the skin healthy and repair the skin damages.Get PDF Samplecopy(including TOC, Tables, and Figures) @https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-cosmetic-skin-care-market

Thestudy considers the Cosmetic Skin CareMarketvalue and volume generated from the sales of the following segments:Major Marketmanufacturerscovered in the Cosmetic Skin CareMarketare:LOral, Unilever, New Avon Company, Este Lauder Companies, Espa, Kao Corporation, Johnson & Johnson Services, Inc., Procter & Gamble, Beiersdorf, THE BODY SHOP INTERNATIONAL LIMITED, Shiseido Co.,Ltd., Coty Inc., Bo International, A One Cosmetics Products, Lancme, Clinique Laboratories, llc., Galderma Laboratories, L.P., AVON Beauty Products India Pvt Ltd, Nutriglow Cosmetics Pvt. Ltd, Shree Cosmetics Ltd

Segmentation:Global Cosmetic Skin Care Market

By Product

By Application

By Gender

By Distribution Channel

Get Table of Contents with Charts, Figures & Tables @https://www.databridgemarketresearch.com/toc/?dbmr=global-cosmetic-skin-care-market

Based on regions, the Cosmetic Skin CareMarketis classified into North America, Europe, Asia- Pacific, Middle East & Africa, and Latin AmericaMiddle East and Africa (GCC Countries and Egypt)North America (United States, Mexico, and Canada)South America(Brazil, Argentina etc.)Europe(Turkey, Germany, Russia UK, Italy, France, etc.)Asia-Pacific(Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

Market Drivers:

Market Restraints:

Key Developments in the Market:

Key Benefits for Cosmetic Skin CareMarket:

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About Us:Data Bridge Marketresearch endeavors to provide appropriate solutions to the complex business challenges and initiates an effortless decision-making process Data Bridge set forth itself as an unconventional and neoteric Marketresearch and consulting firm with unparalleled level of resilience and integrated approaches. We are determined to unearth the best Marketopportunities and foster efficient information for your business to thrive in the Market.We ponder into the heterogeneous Markets in accord with our clients needs and scoop out the best possible solutions and detailed information about the Markettrends. Data Bridge delves into the Markets across Asia, North America, South America, Africa to name few.

Contact Us:Data Bridge MarketResearchUS: +1-888-387-2818UK: +44 208 089 1725Hong Kong: +852 819+2 7475Email: [emailprotected]

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Future Growth of Cosmetic Skin Care Market by New Business Developments, Top Companies and Forecast to 2026 - Bulletin Line

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Best Retinol Creams: Best Retinol Eye Creams, Night Creams and More – Parade

By daniellenierenberg

Retinol, sometimes referred to collectively as retinoids (the group name for everything in the retinol family) are powerful enough to fade hyper-pigmentation, soften wrinkles and give your skin some of that youthful glow back. Depending on the formulation, retinol formulations might even prevent future wrinkles. Since retinols have a reputation for being strong, some people are scared to actually start using them, or dont know how to begin choosing thebest retinol creamsfor their skin.

But with Google searches for retinol at an all-time high, we have a hunch that people are looking to improve the quality of their skinso weasked Austin-based dermatologist Dr. Adam Mamelak for a primer on all these ingredients starting with r (retinol, retinoids and retinoic acid) which all serve the same purpose.

According to Dr. Mamelak, in its most basic form, retinol is a form of vitamin A and has been used to treat acne, but it has also been shown to help decrease wrinkles and fine lines. More than that, retinol allows the skin to repair any damage already inflicted. And since its all powered by vitamin A, retinol helps turn over the skin, exfoliating it naturally, and also helps stimulate collagen production in the deeper layers.

As you begin your search for the right retinol for your skin, consider starting with one of these 10 options.

Unlike many retinol-based products, First Aid Beauty FAB Skin Lab Retinol Eye Cream With Triple Hyaluronic Acidis a light and creamy formula that doesnt sting. Its active ingredient is microencapsulated retinol, which means its surrounded by a protective layer that helps stimulate natural collagen production to minimize the appearance of crows feet, fine lines and and wrinkles without the irritation. ($42, Sephora.com).

No7 ADVANCED Retinol 1.5% Complex Night Concentrate was so eagerly anticipated in the UK that 100,000 people signed up for the waiting list. In addition to a high concentration of retinol, this product also has a retinol optimizer, which ensures that the product works throughout the night, along with a retinol soother to keep skin calm. ($36.99, us.no7beauty.com)

InstaNaturals Retinol Moisturizercontains a robust blend of ingredients designed to address multiple signs of aging. Combined with vitamin C, Hyaluronic Acid, nourishing oils and extracts, this moisturizer aims to smooth lines and wrinkles while reducing discoloration and blemishes on the skin. It works to fight breakouts by clearing away dead skin cells that can clog the pores, and brightens the appearance of discoloration. For best results, apply this product nightly and follow with an SPF during the day. ($24.00, InstaNaturals Retinol Moisturizer, Amazon.com)

Related: Your 10-Minute Makeup Guide to Looking Great on Your Next Zoom Work Call

This past year, Olay launched their Regenerist Retinol24 Night Collection, which hydrates, minimizes pores and evens your skin tone without irritation. The formulation combines retinol and the popular skincare ingredient Niacinamide (vitamin B3), which is used as a soothing ingredient in many acne and rosacea treatments. ($28.99,Olay.com).

If youre looking for a vegan option, Drunk ElephantsA-Passioni Retinol Anti-Wrinkle Creamis a good place to start. It combines 1.0% vegan retinol with other natural, soothing ingredientskale leaf extract and winter cherry juice make the list. ($78, Amazon.com)

If youve tried retinol in the past and had bad side effects including skin irritation,DefenAgemay be a good option for you. Its a clean beauty line, meaning there are no animal or human-originated ingredients, parabens, sulfates, mineral oils, or phthalates. This retinol substitute works by activating dormant LGR6+ stem cells in the body to create fresh new skin, meaning its active ingredients (which include a safe retinol substitute) encourage cell turnover in skin cells that have become sluggish due to the natural aging process. ($28.50 for the 24-Hour Fast Starter Kit, defenage.com)

RoC Skincares new Retinol Correxion Line Smoothing Night Serum Capsules. This overnight renewal treatment comes in single-use capsules (30 per jar), that are sealed for optimal ingredient freshness. Theyre also biodegradable, so you dont have to worry about extra waste. ($33.00, Ulta/Ulta.com)

SeneGence Advanced SenePlex+ Renewal Serum with Retinolcontains incredibly gentle ingredients, including meadowfoam seed oil, aloe vera and hyaluronic acid, so your skin isnt dry or irritated like with typical retinoids. Use two pumps at night for best results. ($75.00, seneweb.senegence.com)

Related: Your Guide to Buying Prescription Glasses Online

Recently, theres been a lot of buzz around an ingredient called bakuchiol (pronounced buh-koo-chee-all) which is derived from an Indian plant and is deeply hydrating.Ole Henriksen Goodnight Glow Retin-ALT Sleeping Creme uses bakuchiol, along with other gentle ingredients, that will leave your skin with a glowy look without redness or inflammation. ($55.00, Sephora.com)

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If youre a bit worried about trying retinol, you can always use a product once a week until your skin gets used to it. Or, ease yourself in with a body lotion instead. Advanced Clinicals Retinol Cream is great for elbows, feet, or other rough body parts in need of some extra attention. ($27.95, Walmart.com)

As Dr. Mamelak explains it, the reason retinol works so well is because it increases the blood flow to the skin which will ultimately improve collagen production.

He adds that when retinol is applied directly to the skin, the basal cells (the ones at the lowest level of the skin) will start to divide. This division activates new epidermal cells to migrate to the skin surface, he says. In more basic terms, this means that newer cells appear on the surface of skin, while older cells are shed causing the exfoliation process to occur.

All this improved collagen production and increased exfoliation comes with a bit of a priceyou might notice, for example, that your skin is more sensitive. As Dr. Mamelak explains it, Because the skin cells are rapidly producing, they lack the adhesion and lipid production to protect the skin. Without these layers of protection, your skin becomes more sensitive when using retinol. Your skin also becomes much more sensitive to sunlight, so Dr. Mamelak says using products containing SPF is mandatory when using retinol.

Next up, how to do your eyebrows.

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Sick bees social distance, but only within their own colony – Massive Science

By daniellenierenberg

Our relationship to Neanderthals has been a point of contention for over a century. It all began with an inaccurate reconstruction of the first Neanderthal ever found, which portrayed them as brutish, stooped-over cavemen (turns out, that Neanderthal was an injured old man with arthritis).

But within the last half century, scientists have noticed the many biological and behavioral similarities that show just how close our species are. While these similarities are clear from hard objects like bones and tools, perishable objects, which comprise the majority of material culture items in humans, have been lacking.

Now, scientists have discovered a Neanderthal feat that hammers another nail in the coffin of supposed Neanderthal inferiority. Last month, an international team of researchers found a small section of a twisted cord attached to a stone flake in Neanderthal site in southeastern France, dated to over 40,000 years old. This constitutes the oldest direct evidence of fiber technology ever found.

A stone flake with three distinct twisted fibers preserved (indicated by the box).

M.-H. Moncel

When artifacts are recovered from archaeological sites, they are generally imaged using high powered microscopes to zoom in on tiny marks and details on the stones. Previously, plant fibers had been found on stones at this site, but they were too poorly preserved to be interpreted. When the team examined this particular flake, they were surprised to find three distinct twisted fibers, which were then twisted together in the opposite direction to form a 3-ply cord.

While it may not sound like much, this piece of string hints at something much more significant. For one, extracting and manipulating plant fibers requires working memory, as well as understanding plant seasonality and the concept of numbers. Also, such cords are the building blocks for creating other textiles, such as baskets, fabrics, and nets. Once adopted, these objects would have been indispensable in daily life.

This little piece of string provides unprecedented insight into the lives of our extinct relatives, which, despite an abundance of genetic, archaeological, and skeletal data, have been extremely difficult to interpret. It seems as though we humans arent as unique as we like to think.

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Impacts of COVID 19 on the Global Regenerative Medicine Market Size: Global Industry Analysis, Growth, Top Companies Revenue, MRFR Reveals Insights…

By daniellenierenberg

(MENAFN - GetNews) Market Research Future (MRFR) collected data on several factors including implications of COVID 19 Impact on Regenerative Medicine Market and demographic challenges, showed how it could move forward in the coming years.

Regenerative Medicine Market Outlook

Global regenerative medicine market is growing continually, witnessing a massive uptake. Market growth primarily attributes to the increasing advancement in healthcare technology and the growing prevalence of chronic diseases. Besides, improvements in the field of regenerative medicine and stem cell technology drive the growth of the market excellently.

Moreover, the rising uptake of therapeutics such as stem cell biology, cellular therapy, tissue engineering in applications, including cord blood, oncology, urology, orthopedics, neurology, dermatology, and others accelerate the market growth. According to Market Research Future (MRFR), the global regenerative medicine market is poised to grow at 25.4% CAGR throughout the forecast period (2016 2022).

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Additionally, the rising uptake of stem cell & tissue engineering processes in the treatment of health issues ranging from orthopedics, musculoskeletal & spine, dental, and skin/integumentary to cancer, neurology, and cardiology substantiate the market growth. Furthermore, the increasing rate of road accidents, injuries, and trauma cases drive the market exponentially, driving the demand for transplants & surgical reconstruction procedures.

On the other hand, factors such as the lack of awareness, skilled professionals, and stringent regulatory policies are projected to act as significant impeders for market growth. Nevertheless, funding support for the development of regenerative medicines would support the growth of the market throughout the predicted period. Also, widening application areas of regenerative medicines in the field of stem cell reconstructive and skin grafting would increase the market growth.

Global Regenerative Medicine Market Segments

The analysis is segmented into four dynamics;

By Material : Synthetic Materials, Genetically Engineered Materials, Pharmaceuticals, and others.

By Therapy : Stem Cell Biology, Cellular Therapy, Tissue Engineering, and others.

By Application : Cord Blood, Oncology, Urology, Orthopedics, Neurology, Dermatology, and others.

By Regions : Americas, Europe, Asia Pacific, Middle East & Africa, and Rest-of-the-World.

Regenerative Medicine Market Regional Analysis

North America is projected to continue dominating the global regenerative medicine market throughout the forecast period. In 2015, North America accounted for more than 44% of the overall market share. This huge market growth attributes to the presence of a large number of major players and pharma & biotechnology companies. Moreover, huge investments made by public & private organizations drive the regenerative medicine industry in the region.

Besides, the rising prevalence of chronic diseases and orthopedic issues and increasing clinical trials to evaluate the therapeutic potential of products foster regional market growth. Also, the well-spread awareness towards the therapeutic potency of regenerative medicines impacts the market growth positively. The North American regenerative medicine market is expected to grow at a robust CAGR of 22.3% over the review period.

Europe stands second in the global regenerative medicine market. Factors such as the increasing per capita healthcare expenses and penetration of healthcare sectors in the region boost the market growth. Additionally, the rising government support and R & D funding in the life science developments substantiate the regional market growth. Markets in the UK, Germany, and France, contribute to the regional market majorly. The European regenerative medicine market is estimated to grow at 22.5% CAGR during the assessment period.

The Asia Pacific regenerative medicine market has emerged as a rapidly growing market. Factors such as the large advances in biotechnology and increasing government support for R & D are fostering the growth of the regional market. Regenerative medicine markets in highly populated countries such as China, India, and Japan support the regional market growth excellently, heading with huge technological advances. The APAC Regenerative Medicine market is predicted to demonstrate huge growth potential.

Global Regenerative Medicine Market - Competitive Analysis

The well-established regenerative medicine market appears to be highly competitive with the presence of several notable players. To gain a larger competitive advantage, market players incorporate strategic initiatives such as mergers & acquisitions, expansions, and product/technology launch. Also, they make substantial investments to drive R & D to develop their capabilities and to expand their global footprints. Simultaneously, R & D funding programs initiated by the governments to enhance regenerative medicine capabilities are offering high growth potential. This is further going to attract several new entrants to the market and intensify the market competition further.

Regenerative Medicine Market Major Players:

Players active in the global regenerative medicine market include Osiris Therapeutics, Cook Biotech, Organogenesis, Baxter International, Inc., Stryker and RTI surgical, LifeSciences, CryoLife, Advanced Cell Technology, Sanofi, BioMimetic Therapeutics, Medtronic, StemCellsInc, and LifeCell Kinetic Concepts, among others.

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Regenerative Medicine Industry/Innovations/Related News:

March 15, 2020 - Research team at the University of Sheffield published their study on stem cell mutations that could improve regenerative medicine in the magazine Stem Cell Reports.' Their study gives new insights into the cause of mutations in pluripotent stem cells and potential ways of stopping these mutations from occurring. It also suggests ways to reduce the likelihood of variations occurring in these cells when cultured.There is considerable interest in using Pluripotent stem cells to produce cells that can replace diseased or damaged tissues in applications referred to as regenerative medicine.

Pharmaceutical Industry Related Reports

Global Anti-viral drugs Market Information, by application (hepatitis, HIV/AIDS, herpes, influenza and others) and by mechanism of action (nucleotide polymerase inhibitors, reverse transcriptase inhibitors, protease inhibitors and others) - Forecast to 2022: https://www.marketresearchfuture.com/reports/anti-viral-drugs-market-2454

Drug allergy market information: by type (immunologic, nonimmunologic, and others), diagnosis (skin tests, blood tests, and others), by treatment (antihistamines, corticosteroids, and others), by end user- global forecast till 2023: https://www.marketresearchfuture.com/reports/drug-allergy-market-4033

About Market Research Future:

At Market Research Future (MRFR) , we enable our customers to unravel the complexity of various industries through our Cooked Research Report (CRR), Half-Cooked Research Reports (HCRR), Raw Research Reports (3R), Continuous-Feed Research (CFR), and Market Research & Consulting Services.

MRFR team have supreme objective to provide the optimum quality market research and intelligence services to our clients. Our market research studies by Components, Application, Logistics and market players for global, regional, and country level market segments, enable our clients to see more, know more, and do more, which help to answer all their most important questions.

In order to stay updated with technology and work process of the industry, MRFR often plans & conducts meet with the industry experts and industrial visits for its research analyst members.

NOTE: Our team of researchers are studying Covid-19 and its impact on various industry verticals and wherever required we will be considering covid-19 footprints for a better analysis of markets and industries. Cordially get in touch for more details.

Media Contact Company Name: Market Research Future Contact Person: Abhishek Sawant Email: Send Email Phone: +1 646 845 9312 Address: Market Research Future Office No. 528, Amanora Chambers Magarpatta Road, Hadapsar City: Pune State: Maharashtra Country: India Website: http://www.marketresearchfuture.com/reports/regenerative-medicine-market-2220

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Hope Realized – CU Anschutz Today

By daniellenierenberg

Not anymore.

Thanks to significant philanthropic support from The Sprout Foundation, a Denver-area foundation funded by Suzanne and Bob Fanch, and gifts from others including Wag and Annalee Schorr, the Ehlers-Danlos Syndrome Center of Excellence was launched in 2019. The goal of the center is to eventually develop a cure for EDS at the Gates Center for Regenerative Medicine, while better addressing the clinical needs of patients today through specialty care at Childrens Hospital Colorado. The clinical components of this new center address the critical need for patient-centered, coordinated EDS care where physicians come together to agree on the treatment plan, rather than leaving the patient and their family to determine the course of action.

Calla Winchell, left, with her grandfather, Dr. Wag Schorr, and her mother, Dr. Kate Schorr.

Simultaneously, the Gates Center for Regenerative Medicine scientists are conducting leading-edge research with the ultimate goal of finding a cure. Today, this research is aimed at discovering the genetic underpinnings of hypermobile EDS and leveraging this information to develop future therapies for patients like Calla.

The Fanches said, Sprout Foundation has funded research and the outstanding staff at the Gates Center for Regenerative Medicine to accelerate the cure for this life-changing disorder and also for clinical care to patients through the EDS Center of Excellence.

Joining in this effort are Callas own grandparents, Wag Schorr, an accomplished nephrologist and 1963 CU School of Medicine alumnus, and his wife, Annalee.

An essential component of the EDS Center of Excellence is a translational research program, which leverages existing campus resources and partnerships, including the Gates Center for Regenerative Medicine and the Colorado Center for Personalized Medicine.

The research program at the Gates Center is led by Dennis Roop, PhD, director of the Gates Center, in partnership with Ganna Bilousova, PhD, and Igor Kogut, PhD. The program brings EDS patients genetic information from clinical visits to the Gates Center where researchers are working on future treatments for the condition. In this virtuous cycle, patients inform future therapies in the lab that, in turn, could ultimately change lives back in the clinic.

Calla is one of those patients. She is motivated by the possibility of improving EDS research.

In preclinical models, scientists are collecting stem cells from Calla and other patients that indicate a possible mutation. These studies, using multiple patients, allow for a more accurate portrait of the errors in DNA. Early findings at the Gates Center suggest that a possible mutation for the hypermobile form of EDS may have been identified. The hope is that this research will lead to a potential treatment in the coming years.

Scientists are growing skin cells in the lab using Callas stem cells, with the EDS gene mutations removed. If successful, the modified stem cells will hook onto sites of inflammation and grow new cells restoring function to damaged tissues and organs. It sounds like science fiction, but it could be a reality at the CU Anschutz Medical Campus in the years to come.

The research advances taking place at the Gates Center will ultimately mean incredible hope and healing for people like Calla, and others with rare genetic disorders, who are eager to regain their health and their independence.

Im thrilled, she said. Im excited to receive coordinated care and treatments that will help me get back to my life. What if I could go to the grocery store and not have to use a wheelchair anymore?

By bringing research together with clinical care, the EDS Center of Excellence is helping turn such possibilities into realities.

Callas care plan is coordinated by a team of experts at the EDS multidisciplinary clinic at Childrens Hospital Colorado, led by the Medical Director of the Special Care Clinic Ellen Roy Elias, MD, in close collaboration with Kourtney Santucci, MD.

The clinic places the patient at the center of care, and brings forward all of the right health professionals required to determine a comprehensive care plan. In this model, the patient is seen by a team of specialists in a single day, with the goal of having a treatment plan at the end of the visit.

Callas grandfather, Dr. Schorr, says no more will Calla and others like her have to create a center of excellence for themselves as they traverse a complex and fragmented healthcare system to ensure their needs are met.

The pioneering work taking place at the EDS Center of Excellence began with Dr. Schorrs vision. In 2016, as a member of the Gates Center for Regenerative Medicine Advisory Board, Dr. Schorr approached director Dennis Roop and began laying the groundwork for research efforts in EDS, which he and Annalee funded later that year. Dr. Schorrs vision and commitment made it possible to develop the EDS Center of Excellence as a place to realize scientific advances in EDS research.

CU is poised for another breakthrough in medicine, said Dr. Schorr. I believe that EDS patients will soon have access to effective treatments, and possibly even a cure. If we are precise with our research and resources, we can resume our place at the forefront of the medical world. Thats our responsibility.

Another must, said Dr. Schorr, is to empower visionaries in their fields to pave the path toward new discoveries and major medical advances.

Leading this charge is CU School of Medicine Dean and Vice Chancellor for Health Affairs John Reilly, Jr., MD. Dean Reilly said, One of the great advantages of having our pediatric hospital partner, Childrens Hospital Colorado, and a research entity like the Gates Center on campus is the opportunity to collaborate. By bringing some of the best minds together to lead the next generation in EDS research, we get remarkable innovation, and leading-edge treatments and care. What our philanthropic partners have built here is inspiring, and together we are determined to bring hope to patients and their families. It has been exciting to see two families with a long friendship come together with a shared goal to create a center that will have a positive effect on so many patients and families.

With each new discovery at the EDS Center of Excellence, lives will improve through better care and better health. Each new discovery brings new opportunity for people with EDS to live lives they never knew they could have.

Guest Contributor: Courtney Keener, CU Anschutz Office of Advancement.

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Buckeye butterflies get their color from their scales – Massive Science

By daniellenierenberg

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Study reveals birth defects caused by flame retardant – University of Georgia

By daniellenierenberg

Research focuses on mans exposure prior to conception

A new study from the University of Georgia has shown that exposure to a now-banned flame retardant can alter the genetic code in sperm, leading to major health defects in children of exposed parents.

Published recently in Scientific Reports, the study is the first to investigate how polybrominated biphenyl-153 (PBB153), the primary chemical component of the flame retardant FireMaster, impacts paternal reproduction.

In 1973, an estimated 6.5 million Michigan residents were exposed to PBB153 when FireMaster was accidentally sent to state grain mills where it made its way into the food supply. In the decades since, a range of health problems including skin discoloration, headache, dizziness, joint pain and even some cancers have been linked to the exposure.

More striking, the children of those who were exposed seemed to experience a host of health issues as well, including reports of hernia or buildup in the scrotum for newborn sons and a higher chance of stillbirth or miscarriage among adult daughters.

Yet, little work has been done to understand how the chemical exposure could have impacted genes passed from an exposed father, said study author Katherine Greeson.

It is still a relatively new idea that a mans exposures prior to conception can impact the health of his children, said Greeson, an environmental health science doctoral student in Charles Easleys lab at UGAs College of Public Health and Regenerative Bioscience Center.

Most studies where a toxic effect is observed in children look only to the mothers and the same has been true of studies conducted on PBB153, she said.

Greeson and a team of researchers from UGA and Emory University used a unique combination of observational and laboratory approaches to demonstrate how PBB153 acted on sperm cells.

Typically, scientific studies are either epidemiological in nature and inherently observational or focus on bench science, but in this study, we did both, said Greeson.

This approach allowed the researchers to mimic the known blood exposure levels of PBB153 in a lab environment.

We were uniquely able to recreate this effect using our previously characterized human stem cell model for spermatogenesis, she said, which allowed us to study the mechanism that causes this effect in humans.

The team looked at the expression of different genes in their human spermatogenesis model after dosing with PBB153 and found marked alterations in gene expression between dosed and undosed cells, specifically at genes important to development, such as embryonic organ, limb, muscle, and nervous system development.

PBB153 causes changes to the DNA in sperm in a way that changes how the genes are turned on and off, said Greeson. PBB153 seems to turn on these genes in sperm which should be turned off, said Greeson, which may explain some of the endocrine-related health issues observed in the children of exposed parents.

Though the study used this model to directly replicate exposure to PBB153, Greeson says this approach could be used to better understand the impact of other environmental exposures on reproduction, including large-scale accidental exposures to toxic chemicals or everyday exposures.

Hopefully this work will lead to more studies combining epidemiology and bench science in the future, which will tell us more about why were seeing an effect from an environmental exposure in human populations and encourage experimental studies to more closely mimic human exposures, she said.

The study, Detrimental Effects of Flame Retardant, PBB153, Exposure on Sperm and Future Generations, published May 22. It is available online.

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The 15 Best New Products to Try in Isolation This Month – InStyle

By daniellenierenberg

My summer countdown usually starts on the first day of fall. However, with social distancing still in place and travel completely off the cards for the foreseeable future, it's tough to get excited about what's arguably the best time of year.

Throughout quarantine, beauty products have given me a little bit of comfort and madethe stressand challenges of our current reality seem more manageable.

But even though everyone'sdaily routines have changed and the beauty industry has been greatly impacted by COVID-19, brands haven't stopped launching new products.

RELATED:Shopping for Makeup Post COVID-19 Lockdown Will Never Be the Same

This month's just-launched and soon-to-launch makeup, skincare, and haircare products include a number of treatments that are perfect for taking a time out and indulging in a little TLC in isolation. Briogeo's repairing hair mask, HoliFrog's glow-boosting cleanser, and Gucci Westman'svelvety eyeshadows are just a few examples.

Ahead, 15 new beauty products to give yourself some extra self-care while stuck at home.

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Genetic features pave way for targeted BPDCN therapies – Dermatology Times

By daniellenierenberg

Researchers are learning more about genetic aberrations common in the rare but clinically aggressive hematological cancer blastic plasmacytoid dendritic cell neoplasm. There is one targeted therapy approved by the U.S. Food and Drug Administration: Elzonris (tagraxofusp-erzs, Stemline). However, more treatment options are needed to improve the cancers clinical outcome, according to a review published May 2020 in Critical Reviews Oncology/Hematology.1

Dermatologists might be the first providers to encounter patients with blastic plasmacytoid dendritic cell neoplasm because more than 70% of these patients have cutaneous lesions. Those lesions often are asymptomatic and vary in size. The skin lesions tend to have nodules, plaques or bruise-like areas, a brown to violet color and might be solitary or multifocal, according to the authors.

Blastic plasmacytoid dendritic cell neoplasm often originates from type 2 myeloid-derived resting plasmacytoid dendritic cell precursors. Recent research suggests providers can diagnose the cancer when patients express at least four of five plasmacytoid dendritic cell specific markers, CD4, CD56, CD123, TCL1 and BDCA-2, without expressing myeloid, T-cell or B-cell lineage markers.

Commonly, [blastic plasmacytoid dendritic cell neoplasm] is characterized by high CD123 expression, aberrant NF-B [nuclear factor-B] activation, dependence on TCF4-/BRD4-network, and deregulated cholesterol metabolism, they wrote.

Despite advancing knowledge about the cancer type, patients median overall survival remains at 12 to 14 months, according to the paper. Conventional treatment approaches include chemotherapy, radiotherapy and ultimately hematopoietic stem cell transplantation. The challenges with conventional therapies are while blastic plasmacytoid dendritic cell neoplasm is sensitive to some chemotherapy regimens, patient relapse is high at more than 60%. And many patients with blastic plasmacytoid dendritic cell neoplasm are too old or frail to have intensive chemotherapy or hematopoietic stem cell transplantation, according to the authors.

Recently, the most attractive agent for [blastic plasmacytoid dendritic cell neoplasm] is tagraxofusp, which is composed of the catalytic and translocation domains of diphtheria toxin (DT) fused to interleukin-3 (IL-3), the authors wrote.

Blastic plasmacytoid dendritic cell neoplasm cells overexpress interleukin-3 receptor subunit alpha (IL3RA, also called CD123). Elzonris, or tagraxofusp-erzs, is a CD123-directed cytotoxin given intravenously, which is used to treat blastic plasmacytoid dendritic cell neoplasm in adults and in pediatric patients 2 years and older.

Researchers reported in a study of 47 blastic plasmacytoid dendritic cell neoplasm patients published in 2019 in the New England Journal of Medicine that tagraxofusp led to clinical responses in untreated and relapsed patients.2 The overall response rate with tagraxofusp was 90% and the primary outcome of complete response and clinical complete response was 72% among the previously untreated patients. Overall response was 67% in the previously treated patients. Serious adverse events including capillary leak syndrome, hepatic dysfunction and thrombocytopenia were common, according to the NEJM paper.

More targeted therapies are needed to treat blastic plasmacytoid dendritic cell neoplasm, but many potential therapeutic agents are not advancing to clinical trials, according to authors of the paper in Critical Reviews Oncology/Hematology.

Common blastic plasmacytoid dendritic cell neoplasm characteristics are genetically heterogeneous and provide valuable drug targets, according to the authors.

Apart from aberrant activation of NF-B signaling pathway, which is highly dependent on TCF4- and BRD4- transcriptional networks, cholesterol metabolism deregulation and CD123 expression, defects of DNA damage repair and mitosis are new, potential common features of the cancer. Corresponding therapies might be promising, the authors wrote.

Venetoclax, anti-CD123 CAR-T, XmAb14045 and IMGN632 are in clinical trials for blastic plasmacytoid dendritic cell neoplasm. But the authors noted that bortezomib, lenalidomide, 5-aza and pralatrexate could easily be pushed to the front line of the cancers treatment.

Disclosures:

The authors report no relevant disclosures.

References:

1. Zhang X, Sun J, Yang M, Wang L, Jin J. New perspectives in genetics and targeted therapy for blastic plasmacytoid dendritic cell neoplasm. Crit Rev Oncol Hematol. 2020 May;149:102928.2. Pemmaraju N, Lane AA, Sweet KL, et al. Tagraxofusp in Blastic Plasmacytoid Dendritic-Cell Neoplasm. N Engl J Med. 2019;380(17):1628-1637.

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Ageing: An expos on what really causes us to show our age – The South African

By daniellenierenberg

Most people are seeking the secret to anti-ageing, but did you ever wonder how the skin actually ages or how you could slow the process down?

Ageing is a natural process accompanied by a continuous alteration of the body. Your body produces visible changes in its structure, function and vulnerability to environmental stress and disease. Genetics, as well as the lifestyle we lead, play a big role in the ageing process.

Your skin is an organ, and its function is to regulate the excretion of metabolic waste products, regulate the bodies temperature as well as containing receptors for pain, tactile sensation, and pressure. Therefore, the health and appearance of your skin, like the health of your other organs correspond with your lifestyle and dietary habits, as well as with age-related factors such as the imbalance of hormones.

Ageing of the skin can be influenced by many factors including ultraviolet radiation, excess alcohol consumption, tobacco abuse, and environmental pollution.

What a lot of people dont realise is that as their body weight increases and their blood sugar levels rise, biochemical reactions interrupt the structural framework of their skin. With all these factors combined they lead to cumulative deterioration in the appearance of the skin as well as the function of the skin.

Within the skin ageing is associated with a loss of fibrous tissue, a slower rate of cellular renewal, and a reduced vascular and glandular network. The barrier function that maintains cellular hydration also becomes impaired. The subcutaneous tissue (known as the hypodermis or the third layer of the skin) flattens.

The rate at which these functions decline can be more than 50% by middle age depending upon ones genetic makeup, lifestyle and normal physiological functions within the skin. If we dont take action to support our skins intrinsic defence systems, the youthful qualities of our skin will deteriorate rapidly. Luckily for us, we can harness insights gathered through the latest scientific innovations and slow or potentially reverse the signs and symptoms of accelerated skin ageing.

Intrinsic skin ageing is primarily determined by genetic factors, hormonal imbalances and metabolic reactions like oxidative stress. Signs of intrinsic ageing include skin sagging, thinning and cracking, and the appearance of fine lines and wrinkles.

There are numerous external factors that affect the skin and cause signs and symptoms of premature ageing. Generally, most premature ageing is caused by over-exposure to the suns UV rays. However, there are other contributing factors, for example, atmospheric factors such as air pollution, visible light and infrared radiation. Lifestyle choices such as smoking, chronic stress and excessive alcohol consumption can lead to older-looking skin.

The most common signs of extrinsic ageing are thinning of the skin, laxity, fragility and the increased appearance of wrinkles.

As the skin is a visual organ, the beauty industrys main objective is to improve the appearance of skin with extensive topical treatments and products. However, often overlooked is the need to support the health and beauty of the skin from within.

Ideally one should centre their diet upon fruits, vegetables, whole grains, legumes, monounsaturated fats (like those found in olive oil), and a healthy ratio of omega-3 to omega-6 polyunsaturated fatty acids. Generally, consumption of shellfish, fish rich in omega 3 fatty acids, regular tea drinking, and greater consumption of fruits and vegetables have been known to be associated with improved skin health.

Gut health is crucial to healthy skin. The human skin hosts a variety of microorganisms, collectively known as the skin microbiota. Within the skin, there is a complex network of interactions between the microbes and cells. Friendly bacteria, such as Lactobacillus and Bifidobacteria are well researched for effectively treating infections, promoting healthy immunity, and reducing inflammation in the skin. Oral pre- and probiotics help to rebalance the skin microbiota and optimise the skin barrier function.

In addition, oral probiotics boost cellular antioxidant capacity and combat inflammation in general. Probiotics also help to neutralise toxic byproducts, defend the lining of the intestine, increase the bioavailability of some nutrients and reinforce the intestinal barrier against infectious microbes that may harm healthy skin.

Cosmeceuticals are topical products that exert both cosmetic and therapeutic benefits which have continued to evolve in order to ward off the signs of skin ageing. Some of the most popular topicals include exfoliating and depigmenting agents, antioxidants and regenerating products, such as peptides and stem cells.

Sunscreens (with dual protection against UVA and UVB in a photostable complex) are the most important topical as they protect us from the UV damage caused by the sun. Sun exposure is definitely one of the biggest contributing factors to premature ageing and is actually known as photo-ageing.

Another phenomenal topical is retinoids which have proven their safety and efficacy in reducing photo-damaged skin and are a popular treatment for anti-ageing. Retinoids help combat and reverse the visual effects of ageing, such as wrinkles, laxity, and discolouration. Retinoids accelerate cell turnover and can also improve blemishes and the appearance of pores.

The use of alpha-hydroxy acids (AHAs) has also been known to improve skin texture and reduce the signs of ageing by promoting the shedding of our superficial dead skin cells which in turn helps to restore hydration and a smoother texture. Whats nice about alpha-hydroxy acids is that they can pretty much treat any skin condition or concern because there are so many different types of acids. Theres literally something for everything. The most common ingredients used in product formulations and peels include citric acid, glycolic acid, lactic acid, malic acid, pyruvic acid as well as tartaric acid.

Antioxidants are being increasingly used in anti-ageing skincare. Topical antioxidants are effective in fending off damaging free radicals and reducing inflammation within the skin. A few popular ones used are ascorbic acid (vitamin C,) tocopherols (vitamin E,) alpha-lipoic acid and coenzyme Q10. Emerging natural antioxidants proving effective include EGCG (from green tea), resveratrol, Centella Asiatica (Gotu Kola,) proanthocyanidins (grapeseed,) curcumin, pomegranate, silymarin/silibinin (milk thistle), coffeeberry, melatonin, and marine-based ingredients.

Within the skin, the deterioration of collagen results in the formation of protein fragments, called peptides. These peptides are then recognised by collagen-producing cells, which respond by increasing collagen production in order to repair the damaged skin. However, as we age this positive feedback between skin breakdown and the initiation of new collagen formation becomes inefficient. Therefore by applying specialised peptides to your skin topically you can effectively trick collagen-producing cells into boosting collagen production. There are many other active ingredients used in topical products that are focused on anti-ageing among other things.

So basically all we need to do is protect the skin from the inside by consuming nutrient-packed foods as well as reducing our exposure to extrinsic factors that cause premature ageing along with using topical skincare products. Not as difficult as we may have thought, hey?

This content has been created as part of our freelancer relief programme. We are supporting journalists and freelance writers impacted by the economic slowdown caused by #lockdownlife.

If you are a freelancer looking to contribute to The South African,read more here.

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Ageing: An expos on what really causes us to show our age - The South African

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Stem cell therapy: a potential approach for treatment of influenza virus and coronavirus-induced acute lung injury – BMC Blogs Network

By daniellenierenberg

Acute lung injury (ALI) is a devastating disease process involving pulmonary edema and atelectasis caused by capillary membrane injury [1]. The main clinical manifestation is the acute onset of hypoxic respiratory failure, which can subsequently trigger a cascade of serious complications and even death [2]. Thus, ALI causes a considerable financial burden for health care systems throughout the world. ALI can result from various causes, including multiple traumas, large-volume blood transfusions, and bacterial and viral infections [2, 3]. A variety of viruses, including influenza virus, coronavirus (CoV), adenovirus, cytomegalovirus (CMV), and respiratory syncytial virus (RSV), are associated with ALI [4]. Importantly, most viruses, whose hosts are various animal species, can cause severe and rapidly spreading human infections. In the early 2000s, several outbreaks of influenza virus and CoV emerged, causing human respiratory and intestinal diseases worldwide, including the more recent SARS-CoV-2 infection [5,6,7]. To date, SARS-CoV-2 has affected more than 80,000 people, causing nearly 3300 deaths in China and more than 1,800,000 people, causing nearly 110,000 deaths all over the world (http://2019ncov.chinacdc.cn/2019-nCoV/).

Infectious respiratory diseases caused by different viruses are associated with similar respiratory symptoms ranging from the common cold to severe acute respiratory syndrome [8]. This makes the clinical distinction between different agents involved in infection very difficult [8, 9]. Currently, the clinical experience mainly includes antibacterial and antiviral drug treatment derived from handling several outbreaks of influenza virus and human CoVs. Numerous agents have been identified to inhibit the entry and/or replication of these viruses in cell culture or animal models [10]. Although these antiviral drugs can effectively prevent and eliminate the virus, the full recovery from pneumonia and ALI depends on the resistance of the patient. Recently, stem cell-based therapy has become a potential approved tool for the treatment of virus-induced lung injury [11,12,13]. Here, we will give a brief overview of influenza virus and CoVs and then present the cell-based therapeutic options for lung injury caused by different kinds of viruses.

Influenza virus and human CoV are the two most threatening viruses for infectious lung injury [14]. These pathogens can be transmitted through direct or indirect physical contact, droplets, or aerosols, with increasing evidence suggesting that airborne transmission, including via droplets or aerosols, enhances the efficiency of viral transmission among humans and causes uncontrolled infectious disease [15]. Throughout human history, outbreaks and occasional pandemics caused by influenza virus and CoV have led to approximately hundreds of millions of deaths worldwide [16].

Influenza virus is a well-known human pathogen that has a negative-sense RNA genome [17]. According to its distinct antigenic properties, the influenza virus can be divided into 4 subtypes, types A, B, C, and D. Influenza A virus (IAV) lineages in animal populations cause economically important respiratory disease. Little is known about the other human influenza virus types B, C, and D [18]. Further subtypes are characterized by the genetic and antigenic properties of the hemagglutinin (HA) and neuraminidase (NA) glycoproteins [19]. Sporadic and seasonal infections in swine with avian influenza viruses of various subtypes have been reported. The most recent human pandemic virusesH1N1 from swine and H5N1 from aviancause severe respiratory tract disease and lung injury in humans [20, 21].

CoVs, a large family of single-stranded RNA viruses, typically affect the respiratory tract of mammals, including humans. CoVs are further divided into four genera: alpha-, beta-, gamma-, and delta-CoVs. Alpha- and beta-CoVs can infect mammals, and gamma- and delta-CoVs tend to infect birds, but some of these viruses can also be transmitted to mammals [22]. Human CoVs were considered relatively harmless respiratory pathogens in the past. Infections with the human CoV strains 229E, OC43, NL63, and HKU1 usually result in mild respiratory illness, such as the common cold [23]. In contrast, the CoV responsible for the 2002 severe acute respiratory syndrome (SARS-CoV), the 2012 Middle East respiratory syndrome CoV (MERS-CoV), and, more recently, the SARS-CoV-2 have received global attention owing to their genetic variation and rapid spread in human populations [5,6,7].

Usually, the influenza virus can enter the columnar epithelial cells of the respiratory tract, such as the trachea, bronchi, and bronchioles. Subsequently, the influenza virus begins to replicate for an asymptomatic period of time and then migrate to the lung tissue to cause acute lung and respiratory injury [24]. Similar to those with influenza virus infection, patients with SARS, MERS, or SARS-CoV-2 present with various clinical features, ranging from asymptomatic or mild respiratory illness to severe ALI, even with multiple organ failure [5,6,7]. The pathogenesis of ALI caused by influenza virus and human CoV is often associated with rapid viral replication, marked inflammatory cell infiltration, and elevated proinflammatory cytokine/chemokine responses [25]. Interestingly, in IAV- and human CoV-infected individuals, the pulmonary pathology always involves diffuse alveolar damage, but viral RNA is present in only a subset of patients [26]. Some studies suggest that an overly exaggerated immune response, rather than uncontrolled viral spread, is the primary cause in fatal cases caused by virus infection [27]. Several immune cell types have been found to contribute to damaging host responses, providing novel approaches for therapeutic intervention [28].

IAV infection, the most common cause of viral pneumonia, causes substantial seasonal and pandemic morbidity and mortality [29]. Currently, antiviral drugs are the primary treatment strategy for influenza-induced pneumonia. However, antiviral drugs cannot repair damaged lung cells. Here, we summarize the present studies of stem cell therapy for influenza virus-induced lung injury.

Mesenchymal stem/stromal cells (MSCs) constitute a heterogeneous subset of stromal regenerative cells that can be harvested from several adult tissue types, including bone marrow, umbilical cord, adipose, and endometrium [30]. They retain the expression of the markers CD29, CD73, CD90, and CD105 and have a rapid proliferation rate, low immunogenicity, and low tumorigenicity [30]. MSCs also have self-renewal and multidifferentiation capabilities and exert immunomodulatory and tissue repair effects by secreting trophic factors, cytokines, and chemokines [31]. Due to these beneficial biological properties, MSCs and their derivatives are attractive as cellular therapies for various inflammatory diseases, including virus-induced lung injury.

Several studies on IAV-infected animal models have shown the beneficial effects of the administration of different tissue-derived MSCs [32,33,34,35]. H5N1 virus infection reduces alveolar fluid clearance (AFC) and enhances alveolar protein permeability (APP) in human alveolar epithelial cells, which can be inhibited by coculture with human bone marrow-derived MSCs (BMSCs) [32]. Mechanistically, this process can be mediated by human BMSC secreted angiopoietin-1 (Ang1) and keratinocyte growth factor (KGF) [32]. Moreover, in vivo experiments have shown that human BMSCs have a significant anti-inflammatory effect by increasing the number of M2 macrophages and releasing various cytokines and chemokines, such as interleukin (IL)-1, IL-4, IL-6, IL-8, and IL-17 [32]. Similar anti-inflammatory effects have been achieved in another virus-induced lung injury model. The intravenous injection of mouse BMSCs into H9N2 virus-infected mice significantly attenuates H9N2 virus-induced pulmonary inflammation by reducing chemokine (GM-CSF, MCP-1, KC, MIP-1, and MIG) and proinflammatory cytokine (IL-1, IL-6, TNF-, and IFN-) levels, as well as reducing inflammatory cell recruitment into the lungs [33]. Another study on human BMSCs cocultured with CD8+ T cells showed that MSCs inhibit the proliferation of virus-specific CD8+ T cells and the release of IFN- by specific CD8+ T cells [36].

In addition, human umbilical cord-derived MSCs (UC-MSCs) were found to have a similar effect as BMSCs on AFC, APP, and inflammation by secreting growth factors, including Ang1 and hepatocyte growth factor (HGF), in an in vitro lung injury model induced by H5N1 virus [34]. UC-MSCs also promote lung injury mouse survival, increase the body weight, and decreased the APP levels and inflammation in vivo [34]. Unlike Ang1, KGF, and HGF mentioned above, basic fibroblast growth factor 2 (FGF2) plays an important role in lung injury therapy via immunoregulation. The administration of the recombinant FGF2 protein improves H1N1-induced mouse lung injury and promotes the survival of infected mice by recruiting and activating neutrophils via the FGFR2-PI3K-AKT-NFB signaling pathway [37]. FGF2-overexpressing MSCs have an enhanced therapeutic effect on lipopolysaccharide-induced ALI, as assessed by the proinflammatory factor level, neutrophil quantity, and histopathological index of the lung [38].

MSCs secrete various soluble factors and extracellular vesicles (EVs), which carry lipids, proteins, DNA, mRNA, microRNAs, small RNAs, and organelles. These biologically active components can be transferred to recipient cells to exert anti-inflammatory, antiapoptotic, and tissue regeneration functions [39]. EVs isolated from conditioned medium of pig BMSCs have been demonstrated to have anti-apoptosis, anti-inflammation, and antiviral replication functions in H1N1-affected lung epithelial cells and alleviate H1N1-induced lung injury in pigs [35]. Moreover, the preincubation of EVs with RNase abrogates their anti-influenza activity, suggesting that the anti-influenza activity of EVs is due to the transfer of RNAs from EVs to epithelial cells [35]. Exosomes are a subset of EVs that are 50200nm in diameter and positive for CD63 and CD81 [40]. Exosomes isolated from the conditioned medium of UC-MSCs restore the impaired AFC and decreased APP in alveolar epithelial cells affected by H5N1 virus [34]. In addition, the ability of UC-MSCs to increase AFC is superior to that of exosomes, which indicates that other components secreted by UC-MSCs have synergistic effects with exosomes [34].

Despite accumulating evidence demonstrating the therapeutic effects of MSC administration in various preclinical models of lung injury, some studies have shown contrasting results. Darwish and colleagues proved that neither the prophylactic nor therapeutic administration of murine or human BMSCs could decrease pulmonary inflammation or prevent the progression of ALI in H1N1 virus-infected mice [41]. In addition, combining MSC administration with the antiviral agent oseltamivir was also found to be ineffective [41]. Similar negative results were obtained in another preclinical study. Murine or human BMSCs were administered intravenously to H1N1-induced ARDS mice [42]. Although murine BMSCs prevented influenza-induced thrombocytosis and caused a modest reduction in lung viral load, murine or human BMSCs failed to improve influenza-mediated lung injury as assessed by weight loss, the lung water content, and bronchoalveolar lavage inflammation and histology, which is consistent with Darwishs findings [42]. However, the mild reduction in viral load observed in response to murine BMSC treatment suggests that, on balance, MSCs are mildly immunostimulatory in this model [42]. Although there are some controversial incidents in preclinical research, the transplant of menstrual-blood-derived MSCs into patients with H7N9-induced ARDS was conducted at a single center through an open-label clinical trial (http://www.chictr.org.cn/). MSC transplantation significantly lowered the mortality and did not result in harmful effects in the bodies of the patients [43]. This clinic study suggests that MSCs significantly improve the survival rate of influenza virus-induced lung injury.

The effects of exogenous MSCs are exerted through their isolation and injection into test animals. There are also some stem/progenitor cells that can be activated to proliferate when various tissues are injured. Basal cells (BCs), distributed throughout the pseudostratified epithelium from the trachea to the bronchioles, are a class of multipotent tissue-specific stem cells from various organs, including the skin, esophagus, and olfactory and airway epithelia [44, 45]. Previously, TPR63+/KRT5+ BCs were shown to self-renew and divide into club cells and ciliated cells to maintain the pseudostratified epithelium of proximal airways [46]. Several studies have shown that TPR63+/KRT5+ BCs play a key role in lung repair and regeneration after influenza virus infection. When animals typically recover from H1N1 influenza infection, TPR63+/KRT5+ BCs accumulate robustly in the lung parenchyma and initiate an injury repair process to maintain normal lung function by differentiating into mature epithelium [47]. Lineage-negative epithelial stem/progenitor (LNEP) cells, present in the normal distal lung, can activate a TPR63+/KRT5+ remodeling program through Notch signaling after H1N1 influenza infection [48]. Moreover, a population of SOX2+/SCGB1A/KRT5 progenitor cells can generate nascent KRT5+ cells as an early response to airway injury upon H1N1 influenza virus infection [49]. In addition, a rare p63+Krt5 progenitor cell population also responds to H1N1 virus-induced severe injury [50]. This evidence suggests that these endogenous lung stem/progenitor cells (LSCs) play a critical role in the repopulation of damaged lung tissue following severe influenza virus infection (Table2).

Taken together, the present in vitro (Table1) and in vivo (Table2) results show that MSCs and LSCs are potential cell sources to treat influenza virus-induced lung injury.

Lung injury caused by SARS, MERS, or SARS-CoV-2 poses major clinical management challenges because there is no specific treatment that has been proven to be effective for each infection. Currently, virus- and host-based therapies are the main methods of treatment for spreading CoV infections. Virus- and host-based therapies include monoclonal antibodies and antiviral drugs that target the key proteins and pathways that mediate viral entry and replication [51].The major challenges in the clinical development of novel drugs include a limited number of suitable animal models for SARS-CoV, MERS-CoV, and SARS-CoV-2 infections and the current absence of new SARS and MERS cases [51]. Although the number of cases of SARS-CoV-2-induced pneumonia patients is continuously increasing, antibiotic and antiviral drugs are the primary methods to treat SARS-CoV-2-infected patients. Similar to that of IAV, human CoV-mediated damage to the respiratory epithelium results from both intrinsic viral pathogenicity and a robust host immune response. The excessive immune response contributes to viral clearance and can also worsen the severity of lung injury, including the demise of lung cells [52]. However, the present treatment approaches have a limited effect on lung inflammation and regeneration.

Stem cell therapy for influenza virus-induced lung injury shows promise in preclinical models. Although it is difficult to establish preclinical models of CoV-induced lung injury, we consider stem cell therapies to be effective approaches to improve human CoV-induced lung injury. Acute inflammatory responses are one of the major underlying mechanisms for virus-induced lung injury. Innate immune cells, including neutrophils and inflammatory monocytes-macrophages (IMMs), are major innate leukocyte subsets that protect against viral lung infections [53]. Both neutrophils and IMMs are rapidly recruited to the site of infection and play crucial roles in the host defense against viruses. Neutrophils and IMMs can activate Toll-like receptors (TLRs) and produce interferons (IFNs) and other cytokines/chemokines [54]. There are two functional effects produced by the recruitment of neutrophils and IMMs: the orchestration of effective adaptive T cell responses and the secretion of inflammatory cytokines/chemokines [55]. However, excessive inflammatory cytokine and chemokine secretion impairs antiviral T cell responses, leading to ineffective viral clearance and reduced survival [56].

MSCs are known to suppress both innate and adaptive immune responses. MSCs have been suggested to inhibit many kinds of immune cells, including T cells, B cells, dendritic cells (DCs), and natural killer (NK) cells in vitro and in vivo [57] (Fig.1). Several molecules, including IL-1, TNF-, and INF-, most of which are produced by inflammatory cells, are reported to be involved in MSC-mediated immunosuppression [58]. Furthermore, MSCs can produce numerous immunosuppressive molecules, such as IL-6, PGE2, IDO, and IL-10, in response to inflammatory stimuli. PGE2 has been reported to mediate the MSC-mediated suppression of T cells, NK cells, and macrophages. Moreover, PGE2 has been found to act with IDO to alter the proliferation of T cells and NK cells [59]. In contrast, MSCs have come to be recognized as one type of adult stem cell actively participating in tissue repair by closely interacting with inflammatory cells and various other cell types [60]. Numerous reports have demonstrated that MSCs can release an array of growth and inhibitory factors, such as EGF, FGF, PDGF, and VEGF, and express several leukocyte chemokines, such as CXCL9, CCL2, CXCL10, and CXCL11. These factors provide an important microenvironment to activate adaptive immunity for lung repair [61]. Thus, the dual functions of MSCs may improve lung recovery after human CoV-induced ALI. Recently, MSCs was transplanted intravenously to enrolled patients with COVID-19 pneumonia. After treatment, the pulmonary function and symptoms of these patients were significantly improved. Meanwhile, the peripheral lymphocytes were increased, the C-reactive protein decreased, the level of TNF- was significantly decreased, and the overactivated cytokine-secreting immune cells disappeared. In addition, a group of regulatory DC cell population dramatically increased. Thus, the intravenous transplantation of MSCs was effective for treatment in patients with COVID-19 pneumonia [62, 63].

Stem cell therapies for treatment of influenza virus and coronavirus-induced lung injury. CoVs, coronavirus; MSCs, mesenchymal stem/stromal cells; LSCs, lung stem/progenitor cells; NK cells, natural killer cells; DC cells, dendritic cells

In addition, endogenous LSCs also play an important role in lung cell reconstitution after virus-induced ALI. In particular, TPR63+/KRT5+ airway BCs comprise approximately equal numbers of stem cells and committed precursors and give rise to differentiated luminal cells during steady state and epithelial repair after lung injury [44, 64]. Research has shown that KRT5+ cells repopulate damaged alveolar parenchyma following influenza virus infection [47]. However, there is still little evidence for the role of altered TPR63+/KRT5+ stem cells during lung injury repair caused by human CoVs.

In summary, exogenous MSCs may modulate human CoV-induced lung injury repair and regeneration through their immunoregulatory properties. These cells are capable of interacting with various types of immune cell, including neutrophils, macrophages, T cells, B cells, NK cells, and DCs. Furthermore, viral infections can activate endogenous LSCs to produce new lung cells and maintain lung function (Fig.1). Thus, we propose that MSCs and LSCs are two potential cell sources for treating human CoV-induced lung injury.

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AUGUSTMAN Grooming Awards 2020 Part IV: Best Head-To-Toe Treatment Services For Gentlemen – AUGUSTMAN

By daniellenierenberg

Introducing the best in mens grooming for the year. The fourth and final segment in this series is a compilation of trusted head-to-toe treatment services every gentleman should indulge in to look and feel your best.Sometimes its better to leave things to an experts hands.

Treatment: CO2 Skin Renewal Facial Treatment, Porcelain

This treatment helps to deal with adult skin issues ranging from acne to ageing. To address the latter, a combination of a C02 mask and cryoprobes work to promote collagen production, boost blood circulation and tighten sagging skin. A hydrating enzyme mask then restores moisture and dissolves acne-causing grime and debris. Theres nothing to complain about when we left the compound with improved skin.Available at Porcelain for $298.50

Treatment: The Ultimate Shave Experience, Truefitt + Hill

We found out why people say its better to leave things to the experts. At this salon, the barber put us through an aromatic hot towel treatment to both soften our facial hair and help us relax. Swift and gentle strokes of the straight razor gave us a close shave, leaving our skin baby smooth and looking dapper fresh. We also appreciate the massage, which made us forget our worries and feel good to be alive.Available at Truefitt + Hill for $80

Treatment: Miracle Stem Cell Treatment, PHS Hairscience

This may not be as effective as a hair transplant, but it is a much less painful alternative to revive dormant hair follicles. The treatment uses the brands potent Miracle Stem Cell Solution, which contains a blend of growth factors, botanical stem cells and nutrients that nourish the scalp and encourage hair growth. DHT blockers neutralise the effects of androgen, the hormonal culprit behind hair loss.Available at PHS Hairscience for $297

Treatment: Rescue & Release Massage, Raffles Spa

Whether you pick the 60- or 90- minute option, this massage provides soothing relief from the tensions that city life inflicts. Swedish techniques were used to loosen tight knots, and this release of built-up tension left us feeling calmer and more in touch with our senses. The luxurious oils used in the treatment also left our skin feeling moisturised and nourished. Make time to use the baths to reap fuller relaxation benefits.Available at Raffles Hotel from $245

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Minoxidil Market will witness over 100 million units demand by 2024 – Cole of Duty

By daniellenierenberg

According to the latest research report by Global Market Insights, Inc., minoxidil market size is projected to surpass US$ 1 billion by 2024.

Frontrunners in the Minoxidil industry:

Nanz Med Science Pharma Private Limited, Bakul Group of companies, Kumar Organic Products Limited, Changzhou Tianhua Pharmaceutical Co. Ltd., Par Pharmaceuticals, Provizer Pharma, Metapharmaceutical Ind. S.L., Pharhome International Limited, LOY Pharma Lab, Inc., Maruti Futuristic Pharma Pvt. Ltd., Dr. R. Pfleger Chemical Factory GmbH, Renata Limited, McNeil Consumer Healthcare

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https://www.gminsights.com/request-sample/detail/750

2% product segment is likely to provide a positive impetus to the industry forecast as it is believed to bolster effectiveness and enhance quality of hair growth. Apparently, 2% formulation triggers the hair growth via dermal papilla and epithelial cells. Given it seemingly has minimal side effects to the skin, the product is said to be apt for patients with sensitive skin.

2% solution tends to reduce baldness at the receding hairline and at the front as the product offsets hair thinning and boosts hair growth. Prominently, soaring adoption of topical supplementation to improve hair density is expected to spur demand for 2% solution.

5% product is also expected to impel minoxidil market size as demand for high dosage medicines with minimal side effects continues to rise unabated. 5% solution is said to be highly efficacious in hair growth, thereby spurring growth of adipose-derived stem cells (ASCs) and reducing hair thinning. Stakeholders are increasingly being involved in product development to negate irritation and burning sensation.

According to the American Hair Loss Association, more than 80% of men suffer from hair loss by the age of 50. Strikingly, 40% of the 21 million women who are inflicted with hair loss problems opt for active treatments. As it pans out, North America minoxidil market size is expected to expand substantially. Prevalence of oral medication and skepticism towards surgical procedures are anticipated to bolster North America minoxidil market share.

Growth Drivers:

Pitfalls & Challenges:

Make an inquiry for purchasing this report @ https://www.gminsights.com/inquiry-before-buying/750

Geographies covered:

U.S., Canada, Germany, UK, France, Italy, Spain, Russia, Poland, China, India, Japan, South Korea, Indonesia, Thailand, Malaysia, Australia, Brazil, Mexico, Argentina, Saudi Arabia, UAE, South Africa

Stakeholders will continue to invest in APAC minoxidil market as number of people with thin hair line problem has soared drastically in the region. According to reports from United Nations Economic & Social Commission for Asia and the Pacific (ESCAP) in North & Central Asia, population ratio aged 60 or above will rise to 24% by 2050up 8% from 2016. As regions such as APAC and Europe witness an uptick in middle-age population, minoxidil market value will rise significantly in the next half a decade.

New product roll outs and mergers & acquisitions are expected to grab headlines among leading companies such as Renata Ltd., Kumar Organic Products, McNeil PPC, Par Pharmaceuticals, and Dr. R.P Fletcher Chemical Factory, among others. For instance, Kumar Organic Products Ltd. inaugurated a new office in Switzerland in February 2018 to expand market footprints.

Browse Related News, May You Also Like:

https://www.openpr.com/news/2008806/what-s-driving-the-bitumen-market-size-leading-players-exxon

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KEYTRUDA (pembrolizumab) plus LENVIMA (lenvatinib) Combination Demonstrated Clinically Meaningful Tumor Response Rates in Unresectable Hepatocellular…

By daniellenierenberg

KENILWORTH, N.J. & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced new data from analyses of two trials evaluating KEYTRUDA, Mercks anti-PD-1 therapy, plus LENVIMA, an orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. In the KEYNOTE-524/Study 116 and KEYNOTE-146/Study 111 trials, the KEYTRUDA plus LENVIMA combination demonstrated clinically meaningful objective response rates (ORR) in patients with unresectable hepatocellular carcinoma (HCC) with no prior systemic therapy and in patients with metastatic clear cell renal cell carcinoma (ccRCC) who progressed following immune checkpoint inhibitor therapy, respectively.

The tumor response rates demonstrated with KEYTRUDA plus LENVIMA in these studies underscore the potential of this combination regimen in certain types of hepatocellular and renal cell carcinoma, said Dr. Jonathan Cheng, Vice President, Oncology Clinical Research, Merck Research Laboratories. KEYTRUDA plus LENVIMA is an important pillar of our broad oncology research program, and we continue to advance the study of the combination across multiple types of cancers and stages of disease.

As data from our combination trials continue to read out, our enthusiasm for and belief in the potential of KEYTRUDA plus LENVIMA are strengthened by the growing body of evidence observed in multiple advanced cancers, said Dr. Takashi Owa, Chief Medicine Creation and Chief Discovery Officer, Oncology Business Group at Eisai. Our ongoing clinical study efforts on this combination exemplify our commitment to following the science and exploring possible solutions for patients affected by difficult-to-treat cancers.

Results from KEYNOTE-524/Study 116 (Abstract #4519) are being presented in a poster discussion session, and results from KEYNOTE-146/Study 111 (Abstract #5008) are being presented in an oral abstract session of the Virtual Scientific Program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting.

KEYNOTE-524/Study 116 Trial Design and Data (Abstract #4519)

KEYNOTE-524/Study 116 (ClinicalTrials.gov, NCT03006926) is a Phase 1b, open-label, single-arm trial evaluating the KEYTRUDA plus LENVIMA combination in 100 patients with unresectable HCC with no prior systemic therapy. Patients were treated with KEYTRUDA 200 mg intravenously every three weeks in combination with LENVIMA 8 or 12 mg (based on baseline body weight 60 kilograms or 60 kilograms, respectively) orally once daily. The primary endpoints are ORR and duration of response (DOR) by modified Response Evaluation Criteria in Solid Tumors (mRECIST) and RECIST v1.1 per independent imaging review (IIR). Secondary endpoints include progression-free survival (PFS), time to progression (TTP) and overall survival (OS). At data cutoff (Oct. 31, 2019) and a median duration of follow-up of 10.6 months (95% CI: 9.2-11.5), 37 patients were still on study treatment (KEYTRUDA plus LENVIMA: n=34; LENVIMA only: n=3), and median duration of treatment exposure to the KEYTRUDA plus LENVIMA combination was 7.9 months (range: 0.2-31.1).

The final analysis of the studys primary endpoints showed the KEYTRUDA plus LENVIMA combination demonstrated an ORR of 36% (n=36) (95% CI: 26.6-46.2), with a complete response rate of 1% (n=1) and a partial response rate of 35% (n=35), and a median DOR of 12.6 months (95% CI: 6.9-not estimable [NE]), using RECIST v1.1 criteria per IIR. As assessed using mRECIST criteria per IIR, the KEYTRUDA plus LENVIMA combination demonstrated an ORR of 46% (n=46) (95% CI: 36.0-56.3), with a complete response rate of 11% (n=11) and a partial response rate of 35% (n=35), and a median DOR of 8.6 months (95% CI: 6.9-NE).

Treatment-related adverse events (TRAEs) led to discontinuation of KEYTRUDA and LENVIMA in 6% of patients, discontinuation of KEYTRUDA in 10% of patients, and discontinuation of LENVIMA in 14% of patients. Grade 3 TRAEs occurred in 67% of patients (Grade 3: 63%; Grade 4: 1%; Grade 5: 3%). There was one Grade 4 TRAE (leukopenia/neutropenia), and there were three Grade 5 treatment-related deaths (acute respiratory failure/acute respiratory distress syndrome, intestinal perforation and abnormal hepatic function; n=1 for each). The most common TRAEs of any grade (20%) were hypertension (36%), diarrhea (35%), fatigue (30%), decreased appetite (28%), hypothyroidism (25%), palmar-plantar erythrodysesthesia syndrome (23%), decreased weight (22%), dysphonia (21%), increased aspartate aminotransferase (20%) and proteinuria (20%).

KEYNOTE-146/Study 111 Trial Design and Data from the RCC Cohort (Abstract #5008)

KEYNOTE-146/Study 111 (ClinicalTrials.gov, NCT02501096) is a Phase 1b/2, open-label, single-arm trial evaluating the KEYTRUDA plus LENVIMA combination in patients with selected solid tumors. Results from the RCC cohort of the Phase 2 part of the study are based on 104 patients with metastatic ccRCC with disease progression following PD-1/PD-L1 immune checkpoint inhibitor therapy using RECIST v1.1 criteria. Patients were treated with KEYTRUDA 200 mg intravenously every three weeks in combination with LENVIMA 20 mg orally once daily until unacceptable toxicity or disease progression. The primary endpoint is ORR at week 24 by immune-related RECIST (irRECIST) per investigator review. Secondary endpoints include ORR, PFS, OS, safety and tolerability for a maximum of 35 cycles/treatments (approximately two years).

At data cutoff (Apr. 9, 2020), results from the Phase 2 part of the study showed the KEYTRUDA plus LENVIMA combination demonstrated an ORR at week 24 of 51% (95% CI: 41-61) by irRECIST per investigator review. As assessed by irRECIST per investigator review, ORR was 55% (95% CI: 45-65), with a partial response rate of 55%, a stable disease rate of 36% and a progressive disease rate of 5% (5% were not evaluable). Median DOR was 12 months (95% CI: 9-18). Median PFS was 11.7 months (95% CI: 9.4-17.7), and the 12-month PFS rate was 45% (95% CI: 32-57). Median OS was not reached (NR) (95% CI:16.7-NR), and the 12-month OS rate was 77% (95% CI: 67-85).

As assessed by RECIST v1.1 per investigator review, ORR was 52% (95% CI: 42-62), with a partial response rate of 52%, a stable disease rate of 38% and a progressive disease rate of 6% (5% were not evaluable). Median DOR was 12 months (95% CI: 9-18). Median PFS was 11.3 months (95% CI: 7.6-17.7), and the 12-month PFS rate was 44% (95% CI: 31-55).

TRAEs led to discontinuation of KEYTRUDA and LENVIMA in 15% of patients, discontinuation of KEYTRUDA in 12% of patients, and discontinuation of LENVIMA in 12% of patients (2% due to proteinuria). The most common TRAEs that led to dose reduction of LENVIMA were fatigue (14%), diarrhea (10%) and proteinuria (9%). Grade 4 TRAEs included lipase increased, diverticulitis, large intestine perforation and myocardial infarction, and there were two Grade 5 treatment-related deaths of upper gastrointestinal hemorrhage and sudden death. The most common TRAEs of any grade (20%) were fatigue (53%), diarrhea (46%), proteinuria (39%), dysphonia (35%), hypertension (34%), nausea (32%), stomatitis (32%), arthralgia (29%), decreased appetite (28%), palmar-plantar erythrodysesthesia syndrome (25%), hypothyroidism (23%) and headache (22%).

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Endometrial Carcinoma

KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those 1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

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Research at MDI Biological Laboratory explores novel pathways of regeneration and tumorigenesis – Bangor Daily News

By daniellenierenberg

BAR HARBOR Research by scientists at the MDI Biological Laboratoryis opening up new approaches to promoting tissue regeneration in organs damaged by disease or injury.

In recent years, research in regenerative biology has focused on stem cell therapies that reprogram the bodys own cells to replace damaged tissue, which is a complicated process because it involves turning genes in the cells nucleus on and off.

A recent paper in the journal Genetics by MDI Biological Laboratory scientist Elisabeth Marnik, Ph.D., a postdoctoral fellow in the laboratory of Dustin Updike, Ph.D., offers insight into an alternate pathway to regeneration: by recreating the properties of germ cells.

Germ cells, which are the precursors to the sperm and egg, are considered immortal because they are the only cells in the body with the potential to create an entirely new organism. The stem cell-like ability of germ cells to turn into any type of cell is called totipotency.

By getting a handle on what makes germ cells totipotent, we can promote regeneration by unlocking the stem cell-like properties of other cell types, said Updike. Our research shows that such cells can be reprogrammed by manipulating their cytoplasmic composition and chemistry, which would seem to be safer and easier than changing the DNA within a cells nucleus.

Using the tiny, soil-dwelling nematode worm, C. elegans, as a model, the Updike lab studies organelles called germ granules that reside in the cytoplasm (the contents of the cell outside of the nucleus) of germ cells. These organelles, which are conserved from nematodes to humans, are one of the keys to the remarkable attributes of germ cells, including the ability to differentiate into other types of cells.

In their recent paper entitled Germline Maintenance Through the Multifaceted Activities of GLH/Vasa in Caenorhabditis elegans P Granules, Updike and his team describe the intriguing and elusive role of Vasa proteins within germ granules in determining whether a cell is destined to become a germ cell with totipotent capabilities or a specific type of cell, like those that comprise muscle, nerves or skin.

Because of the role of Vasa proteins in preserving totipotency, an increased understanding of how such proteins work could lead to unprecedented approaches to de-differentiating cell types to promote regeneration; or alternatively, to new methods to turn off totipotency when it is no longer desirable, as in the case of cancer.

The increase in chronic and degenerative diseases caused by the aging of the population is driving demand for new therapies, said MDI Biological Laboratory President Hermann Haller, M.D. Dustins research on germ granules offers another route to repairing damaged tissues and organs in cases where therapeutic options are limited or non-existent, as well as an increased understanding of cancer.

Because of the complexity of the cellular chemistry, research on Vasa and other proteins found in germ granules is often overlooked, but that is rapidly changing especially among pharmaceutical companies as more scientists realize the impact and potential of such research, not only for regenerative medicine but also for an understanding of tumorigenesis, or cancer development, Updike said.

Recent research has found that some cancers are accompanied by the mis-expression of germ granule proteins, which are normally found only in germ cells. The mis-expression of these germ-granule proteins seems to promote the immortal properties of germ cells, and consequently tumorigenesis, with some germ-granule proteins now serving as prognosis markers for different types of cancer, Updike said.

Updike is a former postdoctoral researcher in the laboratory of Susan Strome, Ph.D., at University of California, Santa Cruz. Strome, who was inducted into the National Academy of Sciences last year, first discovered P granules more than 30 years ago. She credits Updike, who has published several seminal papers on the subject, with great imagination, determination and excellent technical skill in the pursuit of his goal of elucidating the function and biochemistry of these tiny organelles.

The lead author of the new study from the Updike laboratory, Elisabeth A. Marnik, Ph.D., will be launching her own laboratory at Husson University in Bangor, Maine, this fall. Other contributors include J. Heath Fuqua, Catherine S. Sharp, Jesse D. Rochester, Emily L. Xu and Sarah E. Holbrook. Their research was conducted at the Kathryn W. Davis Center for Regenerative Biology and Medicine at the MDI Biological Laboratory.

Updikes research is supported by a grant (R01 GM-113933) from the National Institute of General Medical Sciences (NIGMS), an institute of the National Institutes of Health (NIH). The equipment and cores used for part of the study were supported by NIGMS-NIH Centers of Biomedical Research Excellence and IDeA Networks of Biomedical Research Excellence grants P20 GM-104318 and P20 GM-203423, respectively.

We aim to improve human health and healthspan by uncovering basic mechanisms of tissue repair, aging and regeneration, translating our discoveries for the benefit of society and developing the next generation of scientific leaders. For more information, please visitmdibl.org.

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Research at MDI Biological Laboratory explores novel pathways of regeneration and tumorigenesis - Bangor Daily News

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