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BREAKTHROUGH: Her vision was getting worse, then animal research made things clear – Speaking of Research

By daniellenierenberg

By Justin A. Varholick, Ph.D.

As we grow older theres an impending fear that we will slowly, but surely, begin to lose our vision. This slow loss of vision is clinically dubbed low vision and impacts more than 39 million Americans, costs $68 billion annually in direct health care costs, and is only growing in our population as baby boomers enter the at-risk age of 65 and older. Magnifiers can often be used to help people with acute issues of low vision, but are often inconvenient and frustrating. More serious issues of low vision such as cataracts, age-related macular degeneration, glaucoma, and diabetic retinopathy require advanced treatment and surgery. For example, cataracts can be improved or reversed by removing the cloudy lens and replacing it with an artificial one. Such surgeries are not always ideal, or convenient, and further contribute to the already hefty direct health care costs. But, a recent breakthrough by Japanese scientists, in correcting blurry vision, might reverse this bleak future.

Old cells can become new againOur story begins around the mid-20th century, in 1958. A young and aspiring scientist, named John Gurdon, was studying frogs at the University of Oxford in England. Not everyone thought Gurdon would end up actually becoming a scientist. In his early days his school master thought such a career was far-fetched for Gurdon. Indeed, he ranked last in his Biology class out of 250 students. Yet despite such poor grades, Gurdon found himself studying frogs at Oxford and earning a doctoral degree in Biology. And his studies would surprisingly lead to a breakthrough in vision, and likely many other issues in human health, like Parkinsons Disease, heart disease, and spinal cord injury.

At the time Gurdon was trying to test an age-old theory on cell development. Many scientists before him discovered that cells the smallest unit of life begin without a clear fate in the early stages of an embryo. Then as the cell develops, their fate becomes more clear. They become cells of the heart, of the brain, the kidneys, the stomach, the spinal cord, or the eyes. But they cannot go back to a time when they had no fate, or specialization. The cells can only develop in one direction, from no destiny, to a clear path, then to a mature adult cell; like one found in the heart. But you just cant take a heart cell and start the process over, maybe turning it into a brain cell.

In disagreement with this theory, Gurdon did a simple experiment. He knew that a tadpole has more adult cells than a frog egg. A tadpole has gills, a heart, eyes, etc., while a frog egg simply does not. So, he cut open the tadpole and removed a single cell from the intestine; an intestinal cell. He then cut open the intestinal cell and removed its nucleus; the seed of the cell carrying all the DNA. Very carefully, he did the same with the frog egg, and finally replaced the nucleus of the frog egg with the nucleus of the intestinal cell. According to the age-old theory, the intestinal nucleus should stop normal development of the frog egg. But thats not what happened.

Instead, the new frog egg continued to develop normally, becoming a tadpole that later became an adult frog. Gurdon thought this was unbelievably odd, and so did everyone else in science. After many more experiments doing the exact same procedure (i.e., replication), it seemed that what he saw was a real, replicable fact. For some reason the nucleus of the intestinal cell was able to reverse itself to have no fate and slowly develop into any other adult cell. The seed from the intestine somehow could become the seed of a heart, brain, kidney, or even an eye cell and of course, an intestinal cell too.

After many more experiments testing the same theory, on many more animals, it seemed the theory was true, but it just didnt work for mammals. Given that the same effect could not be repeated in a mammal, some believed this discovery did not apply to humans. But they were wrong.

The discovery of induced pluripotent stem cellsAlmost 45 years later, around the start of the millennium, Shinya Yamanaka and Kazutoshi Takahashi began running experiments that would translate Gurdons findings to humans. Born after Gurdons findings were already published and well known, Yamanaka and Takahashi grew up in a world in which the fact that old cells can become new again was widely knowna solid foundation for further hypotheses, experiments, and discovery. So, the scientists set out to do what no one had before: turn adult skin cells of mice into new cells without a clear fate.

Yamanaka, the lead investigator of the study, shared a similar early history with Gurdon. He first became a medical doctor in Japan but was frustrated by his inability to quickly remove small human tumors taking over an hour rather than the typical 10 minutes. Senior doctors gave him the nickname Jamanaka, a Japanese pun for the word jama meaning obstacle. He then found himself earning a PhD in pharmacology and becoming a post-doctoral scientist, but spent more time caring for mice than doing actual research. Frustrated again, his wife suggested he just become a practicing physician. Despite her advice, Yamanaka applied to become an Assistant Professor at Nara Institute of Science and Technology, in Japan, and won everyone over with his fantastical ideas of investigating embryonic stem cells; the cells without a clear fate.

Then the persistence paid off when Yamanaka with his assistant, Takahashi discovered how to induce adult skin cells from mice to return to an embryonic, or stem cell, state without a clear fate. They began their experiments knowing that gene transcription factors proteins that turn genes on and off were responsible for keeping embryonic cells in a state without a clear fate. They thought that by turning specific genes on and off with these factors, they could turn back time and make an adult cell embryonic again. So, they tried many different combinations of gene transcription factors and ultimately discovered that 4 specific ones were enough to induce an adult skin cell to a mouse to become an embryonic cell. Because these re-newed embryonic cells, or stem cells, originally came from adult cells they came up with a new name, induced pluripotent stem cell. Broken down, induced pluripotent stem cells means that the cell was induced to become pluripotent pluri meaning several, like plural, and potent meaning very powerful (and stem meaning to have the ability to turn into any cell in the body).

These induced pluripotent cells were thought to be very powerful indeed and scientists across the globe were excited by this great discovery. They had visions of taking a persons skin or blood, forming them into induced pluripotent cells, and then using them to grow a new liver or new parts of the brain. Laboratories across the world confirmed the results by repeating the experiment.

Human stem cells Just repeating the experiments in mice, or frogs, was not enough. They needed to begin making induced pluripotent stem cells from humans. Enter scientists from the University of Wisconsin-Madison. The lead scientist, James Thomson was already well known for deriving primate embryonic cells from rhesus monkeys in 1995 and the first human embryonic cell line in 1998. In fact, Thomsons accomplishment of isolating embryonic cells from monkeys was the first sound evidence that it was possible to do the same for humans. Such discoveries placed him on the forefront in ethical considerations for research using human embryos and the most obvious scientist to lead the path toward making induced pluripotent stem cells from humans.

Thomsons team made the first human derived induced pluripotent stem cells from adult skin, with Yamanaka as a co-scientist. They followed the same general principles set by Yamanaka, who did the procedure with mouse skin cells. Importantly to Thomson, this discovery helped to relieve some ethical controversy with using human embryos to make human stem cells. By being able to induce adult human skin to become pluripotent stem cells, much research on human stem cells could be done without human embryos albeit research with human embryos remains necessary.

Yet more important to the discussion at hand, the ability to induce human skin to become pluripotent stem cells placed us on the edge of a breakthrough. With some clinical trials in humans, the fantasy of growing a new liver, heart, or eye was more a reality than ever before.

The start of human trials In 2012, around the time both Gurdon and Yamanaka were presented with the Nobel Prize in Physiology and Medicine for their work leading to induced pluripotent stem cells, human clinical trials were beginning in Japan. The first clinical trial was for age-related macular degeneration, an eye condition leading to blindness. Unfortunately, this trial was quickly terminated when Yamanaka and his team identified small gene mutations in the transplanted induced pluripotent stem cells from the first patient. Although the procedure did cure the patient of macular degeneration, these small gene mutations worried the scientists because they could lead to tumor development.

But recently with the introduction of an inducible suicide gene that can signal cells with abnormal growth to die, human trials are starting up again. In October of 2018, Japanese scientists began trials with Parkinsons disease, a brain disease related to a shortage of neurons producing dopamine. Scientists took cells from the patients, made them into induced pluripotent stem cells, guided them to develop into dopamine producing cells, and then deposited them in the dopamine centers of the brain through surgery. The outcome is promising since similar procedures in monkeys have been successful.

Other trials in Japan have also started, including spinal cord injury and one for replacing the cornea of the eye. Early results replacing damaged corneas with induced pluripotent stem cells, thereby correcting blurry vision, were just announced at the end of August. Although it will take more patients and safety checks before all humans can get induced pluripotent cells to correct their damaged eyes, malfunctioning brains, or broken spinal cords, Takahashi the post-doctoral scientist working with Yamanaka thinks it might happen as early as 2023. So, it looks like that in our lifetime we just might be able to stay young and enjoy retirement because of great breakthroughs in animal research.Note, EuroStemCell is a great resource for learning more about the ethics and research currently being done with stem cells derived from human embryos.

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Defensins and the dermis – Dermatology Times

By daniellenierenberg

Wound healing is complex. Injured tissues undergo a multi-phase process from hemostasis to tissue remodeling. And defensin plays a role.

Basically, it's your natural mechanism for healing a wound, and it stimulates a specific stem cell, the LGR6+ stem cell, according to Greg Keller, M.D., who presented Clinical Data with Defensins at the Global Aesthetic Conference in Miami earlier this month.

After activation, LGR6+ stem cells physically migrate into the basal layer of the skin and create a new epidermis, and eventually, new, younger-acting skin, says Dr. Keller.

In her Cosmeceutical Critique of The role of defensins in treating skin aging, Leslie Baumann, M.D., writes, LGR6+ stem cells, which are dormant until they are activated to respond to damage, are stimulated by defensins.1

She effectively summarizes their role in anti-aging as:

Old fibroblast and keratinocytes are sluggish and lazy. Old cells do not hear signals as well as younger cells. LGR6+ stem cells repopulate the epidermis with new, young keratinocytes. Defensin stimulates LGR6+ stem cells. The defensin/LGR6+ pathway plays a role in keratinization. Using topical defensin can improve the skins appearance.

Theoretically, says Dr. Keller, hair follicles provide a way for defensins to enter the skin to activate the LGR6+ pathway, but We wanted to actually measure wrinkles and quantify how much better the skin was in terms of pore size, oiliness, wrinkles, and the like.

So he, Amy Taub, M.D., Vivian Bucay, M.D., Jay Williams, Ph.D, and Darius Mehregan, M.D., conducted a participant- and investigator-blinded, placebo-controlled, multi-center study with the defensin-containing DefenAge 3-step system (Progenitor Biologics) that includes the 2-Minute Reveal Masque, 24/7 Barrier Balance Cream and 8-in-1 BioSerum, on 44 women, 41-71 years of age with skin types I to V.2


1. Taub A, Bucay V, Keller G, Williams J, Mehregan D. Multi-Center, Double-Blind, Vehicle-Controlled Clinical Trial of an Alpha and Beta Defensin-Containing Anti-Aging Skin Care Regimen With Clinical, Histopathologic, Immunohistochemical, Photographic, and Ultrasound Evaluation. J Drugs Dermatol. 2018;17(4):426-441.2. Bauman L. The role of defensins in treating skin aging. Cosmeceutical Critique. MDedge Dermatology. April 1, 2018. Accessed November 13, 2019. Available at:

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What to do in Macau: The 66th Grand Prix, $28888 wine dinners and more – Lifestyle Asia

By daniellenierenberg

Macau is the ultimate setting for some high octane fun this weekend with the return of the annual Macau Grand Prix, now heading into its 66th year. As the city is pulsing with adrenaline, there are plenty of gastronomic highlights as well as the creme de la creme of lifestyle experiences to keep on your radar. Here are all the best events to check out in Macau this month.

When: 16 November

Price: MOP501,000 from Macau Grand Prix

The annual mecca for motorsports is back: Macau opens its venerated 6.2km Guia Circuit as the annual Macau Grand Prix edges into its 66th edition. Veteran and young drivers alike are descending on the SAR for the ultimate glory across three headlining races the Formula 3 Macau Grand Prix, the FIA GT World Cup, and the FIA WTCR, also known as the Macau Guia Race. Sundays Grand Prix finale will have all eyes on some of the worlds best racers such as F3 world champion Dan Ticktum as he returns to the spotlight to vie for his third consecutive win at Macau; alongside newcomers such as David Schumacher, nephew of seven-time Formula 1 winner Michael.

If youre not watching from the Grand Stand or the thrilling Lisboa Bend Stand, for a vantage point to catch all the action in comfort, youll want to head to the Grand Lapa for its annual Grand Prix Live BBQ Buffet all weekend from 1617 November, which will also be broadcasting live on mega screens.

More info here.

When: 30 November1 December

Price: HK$5881,688 from MGM

Actor-turned-chef Nicholas Tse is lending both sides of his talents to this unique food and music festival held for the very first time in Macau. MGM is hosting two nights of unmissable concerts by Tse and fellow Canto-pop stars JW, Joey Yung, rock group Mr., Angela Hui, Chinese singer Liu Junge, Singaporean songstress Joanna Dong, and Macanese band MFM. Alongside two nights of performances, Chef Nic has also partnered with MGMs most eminent chefs to deliver mouthwatering menus of local delicacies, as well as live demonstrations featuring popular chef collaborations from his TV show brought to life. Dont miss this rare chance for dinner and a show.

MGM COTAI, 1/F Roof Terrace, Avenida Da Nave Desportiva, Cotai, Macau, +853 8806 8888

When: Through 29 February, 2020

Theres nothing better than a steamy hot pot dinner during the cooler months: Head to Broadway Macau for a foodie extravaganza of Macanese delicacies for its fourth Hot Pot Street promotion for an eclectic taste of the Cantonese winter tradition. The hotels flagship food street introduces 20 authentic varieties of hot pots showcasing a full spectrum of broths, casseroles and winter warmers from an array of international cuisines, paired with spreads of fresh seafood, organic produce, and premium beef from all over the world.

Broadway Macau, Avenida Marginal Flor de Lotus, Cotai, Macau, +853 8883 3338

The latest hot opening adding to the epicurean haven that is Taipa Village is none other than Barcelona, an innovative new Spanish restaurant and bar by chef Hector Costa Fernandez. Dishing up modern tapas and refreshed Spanish classics, Barcelona is a three-storey venue with a stylish ground floor bar and chefs table overlooking an open kitchen, a first-floor dining room inspired by its eponymous city, and an exotic rooftop bar offering views over the vibrant entertainment area below.

Barcelona, 47 Rua dos Clerigos, Taipa, Macau, +853 2845 5168

Facialist to the stars Margie Lombard, founder of Margys of Monte-Carlo brings an exclusive spa experience to Morpheus this autumn. Famed for her gold mask facial, Margys upgrades her ultimate skin rejuvenating treatment with a new platinum mask treatment that is solely available at Morpheus Spa. Book into one of only six suites for an exalted 110-minute session of pampering with the Prestige Facial with Platinum Mask (MOP3,980), and watch as the chainmail-like platinum mask does its work to retexturise skin for an unbeatable lasting radiance. The Platinum mask is also available as a 20-minute add-on (MOP2,500) together with Margys prized bespoke Stem Cell Illuminating Facial (MOP3,800), which uses a new serum featuring the regenerating power of Swiss Apple stem cells.

Morpheus Spa, 35/F, Morpheus, City of Dreams, Estrada do Istmo, Macau, +853 8868 3098

When: 16 November and 25 January, 2020

Price: MOP28,888 + 10 percent service charge

City of Dreams two-Michelin-starred Alain Ducasse by the eponymous legend is home to some of the most exclusive French haute cuisine menus in this part of the world as it is, but this autumn the restaurant is presenting two unprecedented wine-pairing dinners, billed as featuring some of the greatest vintages of all time. On 16 November, guests can look forward to five rare vintages from Domaine de la Romane-Conti, as well as a prize draw to win a bottle of 1997 Grands-chzeaux. On 25 January next year, guests can also book in as they celebrate Bordeauxs landmark 1982 vintage with a horizontal tasting of Chteau Pichon Longueville Comtesse de Lalande, Chteau Mouton Rothschild, Chteau Margaux, Chteau Cheval Blanc and Chteau Lafite Rothschild and have the opportunity to win a bottle of 1982 Chteau Margaux. Priced at MOP28,888 per person, these exclusive wine dinners will feature a tailor-made seven course menu and kick off with a glass of Dom Prignon 2009, followed by five rare vintages and Grand Crus. Make your reservation by email to or call +853 8868 3432.

Alain Ducasse, Level 3, Morpheus, City of Dreams, Estrada do Istmo, Macau, +853 8868 3432

Price: MOP7801,280

The St. Regis Macaos Iridium Spa has unveiled its newest treatment, a session that combines both mindful and physical therapy by allowing guests to create their own blended diffuser scents and body scrubs. After spending time learning more about the healing powers of aromatherapy, the guest is given a 45-minute massage and body treatment thats sure to melt away all the tensions of the mind and body.

Iridium Spa, 38/F, St. Regis Macao, S/N, Estrada do Istmo, Macau, +853 8113 4949

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Todos and Amarantus JV Announces Full Enrollment for Clinical Trial of LymPro Alzheimers Blood Test Relationship with Amyloid PET – Yahoo Finance

By daniellenierenberg

REHOVOT, Israel and NEW YORK, Nov. 14, 2019 (GLOBE NEWSWIRE) -- Todos Medical Ltd. (TOMDF), a clinical-stage in-vitro diagnostics company focused on the development of blood tests for the early detection of cancer and neurodegenerative disorders, and Amarantus Bioscience Holdings, Inc. a US-based JLABS-alumnus biotechnology holding company developing proprietary orphan neurologic, regenerative medicine and ophthalmic therapies and diagnostics through its subsidiaries, today announced that their joint venture company, Breakthrough Diagnostics, Inc. has completed enrollment of its ongoing clinical trial evaluating the relationship of Alzheimers blood diagnostic Lymphocyte Proliferation Test (LymPro Test) with amyloid PET neuroimaging at Leipzig University in Germany (the LymPro PET 2). Topline results are expected before the end of the first quarter of 2020.

Breakthrough completed a 20-subject clinical study (LymPro PET 1) in 2018 evaluating the correlation between LymPro scores and the diagnosis of Alzheimers disease, as confirmed with amyloid PET neuroimaging and other Alzheimers disease biomarkers. LymPro measures cell cycle dysregulation in peripheral lymphocytes. The top-line data, announced in July 2019, revealed a strong and statistically significant correlation between LymPro scores and amyloid PET neuroimaging cSUVR scores (r = -0.849; p = 0.00000216). Breakthroughs academic collaborators at the Leipzig University then expanded enrollment of that study to include an additional cohort of 20 subjects (LymPro PET 2) to confirm the strong relationship seen from LymPro PET 1. The data from both LymPro 1 and LymPro 2 will be published together in a peer-reviewed journal in 2020.

LymPro is a unique immune system-based Alzheimers blood test, said Dr. Herman Weiss, President & CEO of Todos. LymPro could prove to be a major breakthrough for Alzheimers disease diagnosis by measuring cell cycle dysregulation and amyloid, together, conveniently as part of a blood workup in routine clinical practice. The therapeutic field in Alzheimers has begun to see some renewed hope based upon recent Aducanumab data announced by Biogen that is directly related to the amyloid hypothesis, as well as conditional approval by the National Medical Products Administration in China for the first new Alzheimers drug in over 20 years, called Oligomannate from Shanghai Green Valley Pharmaceuticals, that is based on gut-brain biology of the microbiome and its effects on the immune system. We believe this renewed optimism and broadening of pathophysiological hypotheses relevant to Alzheimers disease being evaluated in the clinic significantly increases the scope for LymPro pharma services collaborations and begins to refine LymPros clinical utility profile for primary care physicians as strategies to correct cell cycle dysregulation emerge.

About Alzheimer's DiseaseAccording to the Alzheimer's Association, it is estimated that over 5.4 million people in the United States suffer from Alzheimer's disease. Over 500,000 patients are diagnosed annually, with nearly one-in-eight older Americans affected by the disease. Alzheimer's disease is the third leading cause of death in the United States. The cost of unpaid care in the United States is estimated at over $210 billion annually.Total payments for care are estimated at over $200 billion annually, including $140 billion in cost to Medicare and Medicaid. Alzheimer's expenditures in the United States are expected to exceed $1.2 trillion by 2050. There is no cure or effective treatment for Alzheimer's disease. Worldwide, about 35.6 million individuals have the disease and, according to the World Health Organization, the number will double every 20 years to 115.4 million people with Alzheimer's by 2050.

About Dr. Arendt's Research at Leipzig UniversityDr. Thomas Arendt is Professor of Neuroscience at Leipzig University where he runs the Paul Flechsig Institute of Brain Research. He has a 30-year record in R&D of therapeutic and diagnostic strategies of neurodegenerative disorders and made several seminal contributions to therapeutic concepts of Alzheimer's disease, including stem cell therapy and modulating tumor suppressor genes. In the early 1980's, he was involved in identifying the degeneration of the cholinergic system in Alzheimer's disease laying the basis for today's only available treatment. He is one of the pioneers of the "cell-cycle theory" of Alzheimer's disease, which he developed towards a diagnostic and therapeutic concept.

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About Breakthrough Diagnostics, Inc.Breakthrough Diagnostics, Inc. is a joint venture owned by Amarantus Bioscience Holdings, Inc. (AMBS) (80.01%) and Todos Medical Ltd. (19.99%). Breakthrough has been assigned the intellectual property and other rights to the LymPro Test, a diagnostic blood test for Alzheimers disease, as well as rights to other neurological diagnostics testing intellectual property. Todos Medical has provided Amarantus with notice of Todos decision to exercise its exclusive option to acquire the 80.01% of Breakthrough Diagnostics that it currently does not own.

The Lymphocyte Proliferation Test (LymPro Test) determines the ability of peripheral blood lymphocytes (PBLs) and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle. It is believed that certain diseases, most notably Alzheimer's disease, are the result of compromised cellular machinery that leads to aberrant cell cycle re-entry by neurons, which then leads to apoptosis. LymPro is unique in the use of peripheral blood lymphocytes as surrogates for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain.

About Todos Medical Ltd.Todos Medical Ltd. is an in-vitro diagnostic company engaged in the development of blood tests for the early detection of a variety of cancers, and also has initiated the development of blood tests for neurodegenerative disorders such as Alzheimer's disease through Breakthrough Diagnostics, Inc., its joint venture with Amarantus Bioscience Holdings, Inc. Todos has developed two cancer screening tests based on TBIA (Todos Biochemical Infrared Analyses), a method for cancer screening using peripheral blood analysis. The TBIA screening method is based on the cancers influence on the immune system, which triggers biochemical changes in peripheral blood mononuclear cells and plasma. This proprietary and patented method incorporates biochemistry, physics and signal processing. The companys two cancer screening tests, TM-B1 and TM-B2, have received the CE mark. Breakthrough Diagnostics is developing the LymPro Test, a blood test for diagnosing Alzheimers disease.

For more information, the content of which is not part of this press release, please visit

About Amarantus Bioscience Holdings, Inc.Amarantus Bioscience Holdings (AMBS) is a JLABS alumnus biotechnology company developing treatments and diagnostics for diseases in the areas of neurology, regenerative medicine and orphan diseases through its subsidiaries. The Companys 80.01%-owned subsidiaryBreakthrough Diagnostics, Inc.,currently a joint venture with Todos Medical, Ltd., has licensed intellectual property rights to the Alzheimers blood diagnostic LymPro Test from Leipzig University that was originally developed by Dr. Thomas Arendt, as well as certain rights to multiple sclerosis diagnostic MSPrecise and Parkinsons diagnostic NuroPro. Amarantus entered into a joint venture agreement withTodos Medical, Ltd. to advance diagnostic screening assets and Todos has exercised its exclusive option to acquire Amarantus remaining ownership in Breakthrough in exchange for approximately 50% ownership of Todos. The transaction is expected close before the end of the first quarter of 2020. Amarantus also owns approximately 30% of the common shares of Avant Diagnostics, Inc., a healthcare data-generating technology company that specializes in biomarker assay services that target multiple areas of oncology. Avant provides precision oncology data through its TheraLink assays to assist the biopharmaceutical industry and clinical oncologists in identifying likely responders, initially for breast cancer, to over 70 FDA-approved drug treatments.

AMBS 50%-owned subsidiaryElto Pharma, Inc. has development rights to eltoprazine, a Phase 2b-ready small molecule indicated for Parkinson's disease levodopa-induced dyskinesia, Alzheimers aggression and adult attention deficit hyperactivity disorder, commonly known as ADHD. AMBS acquiredCutanogen Corporationfrom Lonza Group in 2015. Cutanogen is preparing for pivotal studies with Engineered Skin Substitute (ESS) for the treatment of pediatric life-threatening severe burns. ESS is a regenerative medicine-based, autologous full-thickness skin graft technology originally developed by the Shriners Hospital that can be used to treat severe burns, as well as several other catastrophic and cosmetic dermatological indications. AMBS wholly-owned subsidiary,MANF Therapeutics Inc.owns key intellectual property rights and licenses from a number of prominent universities related to the development of the therapeutic protein known as mesencephalic astrocyte-derived neurotrophic factor (MANF). MANF Therapeutics is developing MANF-based products as treatments for ophthalmological disorders such as Wolfram Syndrome, Retinitis Pigmentosa and Glaucoma, as well as neurodegenerative diseases such as Parkinsons disease. MANF was discovered by the Companys Chief Scientific Officer John Commissiong, PhD. Dr. Commissiong discovered MANF from AMBS proprietary discovery engine PhenoGuard, and believes several other neurotrophic factors remain to be discovered. Amarantus has entered into a binding letter of intent to license the therapeutic assets from Elto Pharma, Cutanogen and MANF Therapeutics to Emerald Organic Products.

Forward-looking StatementsCertain statements contained in this press release may constitute forward-looking statements. For example, forward-looking statements are used when discussing our expected clinical development programs and clinical trials. These forward-looking statements are based only on current expectations of management, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for product candidates; competition from other biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; and laboratory results that do not translate to equally good results in real settings, all of which could cause the actual results or performance to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Todos Medical does not undertake any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Todos Medical, please refer to its reports filed from time to time with the U.S. Securities and Exchange Commission.

Todos Investor and Corporate Contact:Kim Sutton GolodetzLHA Investor RelationsSenior Vice President (212)

Todos Corporate ContactDaniel HirschTodos MedicalInvestor RelationsEmail:Dan.h@todosmedical.comPhone: (347) 699-0029

Amarantus Investor and Media Contact:Gerald CommissiongPresident & CEOOffice: 650-862-5391Email:

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New Weill Neurohub will unite UCSF, UC Berkeley, UW in race to find new treatments for brain diseases – UW Today

By daniellenierenberg

Engineering | Health and medicine | News releases | Population Health | Research | Science | Technology

November 12, 2019

Microscopy image showing the cytoskeleton within neurons, which are differentiating from induced pluripotent stem cells.UC San Francisco

With a $106 million gift from the Weill Family Foundation, UC Berkeley, UC San Francisco and the University of Washington have launched the Weill Neurohub, an innovative research network that will forge and nurture new collaborations between neuroscientists and researchers working in an array of other disciplines including engineering, computer science, physics, chemistry and mathematics to speed the development of new therapies for diseases and disorders that affect the brain and nervous system.

A 2016 study by the Information Technology & Innovation Foundation estimated that, in the U.S. alone, neurological and psychiatric disorders and diseases including Alzheimers; Parkinsons; anxiety and depression; traumatic brain injury and spinal cord injury; multiple sclerosis; ALS; and schizophrenia carry an economic cost of more than $1.5 trillion per year, nearly 9 percent of GDP.

The gains in knowledge amassed by neuroscientists over the past few decades can now be brought to the next level with supercomputers, electronic braincomputer interfaces, nanotechnology, robotics and powerful imaging tools, said philanthropist Sanford I. Sandy Weill, chairman of the Weill Family Foundation. The Neurohub will seize this opportunity by building bridges between people with diverse talents and training and bringing them together in a common cause: discovering new treatments to help the millions of patients with such conditions as Alzheimers disease and mental illness.

Complementing the strengths of UCSF, Berkeley and the UW, the Weill Neurohub will draw on the expertise and resources of the 17 National Laboratories overseen by the Department of Energy, which excel in bioengineering, imaging, and data science. In August 2019, the Weill Family Foundation and the DOE signed a Memorandum of Understanding creating a new publicprivate partnership. The partnership is exploring the use of the Departments artificial intelligence and supercomputing capabilities, in conjunction with Bay Area universities and the private sector, to advance the study of traumatic brain injury, or TBI, and neurodegenerative diseases.

Secretary of Energy Rick Perry, who has spearheaded the creation of an AI and Technology Office during his tenure at DOE, said that the vision for the Weill Neurohub dovetails with his own mission to make publicly funded AI and supercomputing resources more widely accessible to advance scientific discovery. We are on the cusp of great discoveries that could transform our approach to TBI, Alzheimers disease and other neurological and psychiatric disorders, and easing access to the world-class computational power of our National Laboratories to initiatives like the Weill Neurohub is a win-win for science and the public sector and, eventually, for patients.

As many neurological disorders, such as dementia, are associated with aging, the costs of these unmet medical needs are expected to increase significantly in the coming years. California, with the largest aging population in the U.S., with one in five residents reaching age 65 or older in the next decade, faces particularly formidable challenges, said Gov. Gavin Newsom.

Every day, millions of people in California, the nation, and the world are facing the uncertainty of neuro-related diseases, mental illness and brain injuries, and collaboration between different disciplines in science, academia, government and philanthropy is critical to meet this challenge. Together, we must accelerate the development and use cutting-edge technology, innovation and tools that will advance research and practical application that will benefit people across the world and for generations to come, said Newsom. I want to thank Sandy Weill and his wife, Joan, for their amazing work, kindness, dedication and commitment to philanthropic causes, especially when they open doors, bridge gaps, and make innovation and collaboration possible to advance causes that can truly have an impact on peoples quality of life.

Sanford and Joan Weill.UC San Francisco

The Weill Neurohub will enable the three universities to work together on these pressing problems. For example, the UW and UCSF, renowned research universities with long traditions of excellence in basic neuroscience research, also have federally sponsored Alzheimers Disease Research Centers, or ADRCs. Through the Weill Neurohub, members of the UWs ARDC, part of the UW Medicine Memory and Brain Wellness Center, and UCSFs ADRC, led by the UCSF Memory and Aging Center, will collaborate with top neurodegeneration researchers at Berkeley.

The Weill Neurohub will provide funding for faculty, postdoctoral fellows, and graduate students at the UW, Berkeley and UCSF working on cross-disciplinary projects, including funding for high-risk/high-reward proposals that are particularly innovative and less likely to find support through conventional funding sources. But the bulk of the Weill Neurohubs funding will support highly novel cross-institutional projects built on one or more of four scientific pillars that Weill Neurohub leaders have deemed priority areas for answering the toughest questions about the brain and discovering new approaches to disease: imaging; engineering; genomics and molecular therapeutics; and computation and data analytics.

The Weill Neurohub may seek additional academic, corporate and philanthropic partners to harness resources collaboratively, better scale research and development efforts, share information and data and create partnerships to make breakthroughs faster and at a lower cost than the current paradigm allows.

Relevant examples of interdisciplinary or cross-institutional neuroscience projects now underway at UCSF, Berkeley and/or the UW include:

This gift expands on the unique vision and mission of the UCSF Weill Institute for Neurosciences, established in 2016 with a $185 million gift from the Weill Family Foundation and Joan and Sandy Weill whose giving to the neuroscience community now exceeds $300 million said UCSFs Dr. Stephen Hauser, the Robert A. Fishman Distinguished Professor of Neurology and Weill Institute director.

The UCSF Weill Institute set out to break down walls between the clinical disciplines of neurology, neurosurgery and psychiatry, and also bring these clinical specialties together with the basic neurosciences, said Hauser. Now, with the Weill Neurohub, were going even further: eliminating institutional boundaries between three great public research universities, and also other disciplinary walls between traditional neuroscience and non-traditional approaches to understanding the brain. By embracing engineering, data analysis and imaging science at this dramatically higher level areas in which both Berkeley and the UW are among the best in the world neuroscientists on all three campuses will gain crucial tools and insights that will bring us closer to our shared goal of reducing suffering from brain diseases.

Hauser will serve as one of two co-directors of the new Weill Neurohub along with Berkeleys Ehud Udi Isacoff, the Evan Rauch Chair of Neuroscience. Together with Tom Daniel, the Joan and Richard Komen Endowed Chair and professor of biology at the UW, they will serve on the Weill Neurohubs Leadership Committee.

In the Weill Neurohub, the emphasis will be on technology to enable discovery of disease mechanisms, and thus development of novel treatments and early detection of neurologic diseases, to allow intervention before conditions become severe, said Isacoff, who heads Berkeleys Helen Wills Neuroscience Institute. The technologies include next-generation neuroimaging and therapeutic manipulations ranging from brain implants to CRISPR gene editing, with major efforts in machine learning and high-speed computation. I think these three campuses can succeed in this joint mission in a way that no others can the combined expertise this group brings to the table, especially when you bring in the National Labs, really is unparalleled.

Tom Daniel, the Joan and Richard Komen Endowed Chair and professor of biology at the University of Washington.University of Washington

The UWs Daniel added, The Weill Neurohub brings together three outstanding public institutions, each with a deep commitment to bridge boundaries between science, engineering, computer science and data science to address fundamental problems in neuroscience and neural disorders. To my knowledge, this is a nationally unique enterprise drawing on diverse approaches to accomplish goals no single institution could reach alone, as well as seeding and accelerating research and discovery.

Neuroscientists have made huge strides in understanding the brain in the 30 years since President George H. W. Bush designated the 1990s as the Decade of the Brain, and subsequently through the National Institute of Healths ongoing BRAIN Initiative, first announced by President Obama in 2013. But treatments for neurological and psychiatric diseases have lagged far behind those for other common afflictions, such as cardiovascular disease and cancer.

Much of the lack of progress on neurological and psychiatric disease is due to the unparalleled complexity of the nervous system, in which hundreds of billions of nerve cells and support cells form as many as 100 trillion connections in intricate three-dimensional networks throughout the brain and spinal cord. The Weill Neurohubs leaders believe reaching beyond conventional approaches is essential to grappling with this complexity.

Despite amazing advances in neuroscience, new therapies are not reaching patients with mental illness and neurological disorders nearly as quickly as they have for heart disease and cancer. And in addition to the terrible personal toll these illnesses exact on patients and their families, they also have a massive impact on our healthcare system and on the global economy, said Joan Weill, president of the Weill Family Foundation. Our goal, through the broad and multifaceted approach of the Weill Neurohub, is to begin to change that.

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Humanigen Announces Two Abstracts Accepted at the 2019 Annual Meeting of the Society for Neuro-Oncology, including Oral Presentation on its Next…

By daniellenierenberg

BURLINGAME, CA / ACCESSWIRE / November 12, 2019 / Humanigen, Inc., (OTC PINK:HGEN) ("Humanigen"), a clinical stage biopharmaceutical company focused on the development of next generation chimeric antigen receptor T cell (CAR-T) and other cell therapies, today announced that two abstracts supporting development of its next generation EphA3-CAR-T program, built on the backbone of ifabotuzumab, the company's proprietary Humaneered anti-EphA3 monoclonal antibody, have been accepted for presentation at the 2019 annual meeting of the Society for Neuro-Oncology (SNO) being held November 20-24, 2019 in Phoenix, AZ.

While CAR-T therapy has revolutionized the treatment landscape for hematological malignancies, its efficacy remains limited in solid tumors. The majority of CAR-T therapies targeting solid tumors have focused on cell surface receptors expressed on tumor cells. However, given the heterogeneity of surface receptor expression on solid tumors and the difficulty of navigating the immunosuppressive stromal microenvironment, strategies to target tumor neovasculature and tumor stromal cells are emerging. Targeting non-transformed, tumor neovasculature and tumor stroma cells may overcome antigen loss and may modulate the suppressive TME. EphA3, an oncofetal antigen, is selectively expressed in tumor neovasculature and tumor stromal cells in brain cancers and other solid tumors making it a novel target for CAR-T development.

The phase I clinical study, led by Prof. Hui Gan and Prof. Andrew Scott from the Olivia Newton-John Cancer Research Institute in Melbourne, Australia, was funded by the Cure Brain Cancer Foundation. The study used radiolabeled ifabotuzumab followed by sequential positron emission tomography (PET) imaging to determine biodistribution, frequency of in situ EphA3 expression and quantitative tumor uptake of ifabotuzumab. The preliminary results include data from eight patients who have been enrolled to date. PET/computed tomography (CT) imaging showed that ifabotuzumab is effectively delivered across the blood-tumor barrier and accumulates specifically at the tumor site in all patients treated to date with no observed normal tissue uptake. Magnetic resonance imaging (MRI) scans showed predominant T2/FLAIR changes, consistent with the treatment effect of ifabotuzumab on tumor vasculature. Treatment emergent adverse events were readily managed with increased premedications after the first occurrence. The abstract is available online at:

Professors Gan and Scott stated "Our results show that ifabotuzumab is safe and very effective at targeting the tumor. We are also excited that there are early indications that ifabotuzumab may help to control disease growth in some patients."

Using a single chain variable region fragment of ifabotuzumab, a second generation CD28 co-stimulated CAR construct was developed. Using primary patient derived GBM cell lines, the EphA3 CAR-T demonstrated specific and potent anti-tumor activity. Data from in vivo and combinatorial CAR-T experiments will be reported during the oral presentation scheduled on Friday, November 22, 2019 at 4:40pm. The abstract is available online at:

"These results indicate for the first time that targeting EphA3 with CAR-T cells is feasible, efficacious, and represents a novel therapeutic strategy for solid tumors" stated Dr. Cameron Durrant, CEO of Humanigen. "Our EphA3-CAR-T program as another pillar in our developing cell therapy pipeline. While we continue to develop our GM-CSF neutralization platform with Kite, we are also busy building next generation CAR-T therapies with our combinatorial GM-CSF gene-editing platform and our other CAR-T programs focused on novel tumor targets", Dr. Durrant continued.

About Humanigen, Inc.

Humanigen, Inc. is developing its portfolio of next-generation cell and gene therapies for the treatment of cancers via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. There is a direct correlation between the efficacy of CAR-T therapy and the incidence of life-threatening toxicities (referred to as the efficacy/toxicity linkage). We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with serious and potentially life-threatening CAR-T therapy-related side effects while preserving and potentially improving the efficacy of the CAR-T therapy itself, thereby breaking the efficacy/toxicity linkage. The company's immediate focus is combining FDA-approved and development stage CAR-T therapies with lenzilumab, the company's proprietary Humaneered anti-human-GM-CSF immunotherapy, which is its lead product candidate. A clinical collaboration with Kite, a Gilead Company, was recently announced to evaluate the sequential use of lenzilumab with Yescarta, axicabtagene ciloleucel, in a multicenter clinical trial in adults with relapsed or refractory large B-cell lymphoma. The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, the company is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). The company has established several partnerships with leading institutions to advance its innovative cell and gene therapy pipeline. For more information, visit

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About the Olivia Newton-John Cancer Research Institute

The Olivia Newton-John Cancer Research Institute is a leader in the development of experimental and breakthrough cancer treatments. We investigate and develop treatments for cancers of the breast, lung, skin, prostate, liver, gastrointestinal tract and brain. Our researchers and clinicians are running more than 120 clinical trials, giving patients access to potential new treatments including immunotherapies and personalized medicine.

Located in Heidelberg, Victoria, Australia, the Institute is integrated within the ONJ Centre, with research laboratories only metres away from where patients are cared for and receive treatment. This inspires and enables the rapid translation of scientific discovery into clinical trial of new, better, cancer treatments.

Forward-Looking Statements

This release contains forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding our expectations for future development of lenzilumab to help CAR-T reach its full potential or to deliver benefit in preventing GvHD. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in Black Horse Capital and its affiliates owning more than 50% of our outstanding common stock, including their ability to control the company; our lack of profitability and need for additional capital to operate our business as a going concern; the uncertainties inherent in the development and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in the Company's periodic and other filings with the Securities and Exchange Commission.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.


Media:Chris Bowe(646)

SOURCE: Humanigen, Inc.

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How to stop throwing away your veggies and fruit – CNN International

By daniellenierenberg

One tweetfest tapped into our pervasive shame over store-bought salad: "Almost left the grocery store without buying a bag of spring mix to throw, unopened, into the garbage in two weeks."

It doesn't have to be that way. You can learn to choose the freshest fruits and veggies, clean and store them properly and be assured at least a few more days of usable life.

Let's start with our "universal" waste disgrace -- store-bought spring mix. First, check out the best-by or expiration date (it may help to pull from the bottom or back of the stack to get a date further in the future). Then before you buy, inspect. Are any wet or bruised leaves visible? If so, keep looking.

Once you've bought the freshest and driest salad you can find, you'll want to open it as soon as you get home and, with freshly washed hands, transfer the leaves into a large bowl. As you put those leaves back into the plastic container, remove any bruised or spoiled pieces and discard. Just as a bad apple will more quickly rot the barrel, those leaves will shorten the life of the rest of your salad greens.

Trouble keeping spinach fresh in those large, cheap containers? The same trick applies.

Greens by the bunch

If you buy lettuce by the head or greens by the bunch from the farmer's market or grow your own, they may contain sand or dirt as well as bacteria.

Immersing the leaves in a bowl of tap water for a few minutes can loosen up any dirt. Again, don't use the dirty sink to soak.

But be careful with the water temperature -- and this applies to all vegetables and fruits -- it should be about the same temperature as the produce you are washing.

If immersed in water more than 10 degrees Fahrenheit colder than the produce, it will create a vacuum -- due to air cells contracting within the produce -- and pull in wash water, Ghimire said.

"If the wash water is contaminated, anything in that water, including foodborne pathogens, will be internalized or sucked into the produce," he explained, adding that it's likely to happen at the weak points of the stem and blossoms.

"Hot water is not desired as it would increase the temperature of the produce and decrease shelf-life," Ghimire said.

After washing, spin the leaves in a salad spinner. If you're storing, pat dry with paper towels before putting them into perforated or vented plastic bags and putting them into the crisper section of your refrigerator.

"I rinse and dry lettuce leaves or raw veggies, such as celery, broccoli, and cauliflower, wrap them in paper towels, and store them in plastic bags or in plastic containers lined with paper towels," Drayer added.

And don't forget to wash your salad spinner after about three uses -- if it will fit into the dishwasher, that's a great option to sanitize it.


"Select veggies in season for maximum freshness, flavor, and nutritional value," said Drayer. And they cost less when in season, an extra bonus.

"Firmness, shape, color, texture of skin, and aroma are keys to selecting the freshest produce," Ghimire said. "For example, a fresh broccoli would be firm, closed, dark-green florets, and tender stalks. Yellowing green-colored heads of broccoli are over mature."

Once they are home, you'll want to take them out of the plastic bags if the bags aren't breathable or perforated.

"Produce are alive even after harvest and they continue to breath and transpire even on your counter top," Ghimire said.

Brush off any loose dirt before storing.

Storing veggies depends on the type. Many do fine in vented plastic bags or plastic containers. Others may fare better in brown paper bags.

"As brown paper bags absorb moisture and are breathable, they would better work for produce like mushrooms and strawberries that have a short shelf-life," Ghimire said.

Potatoes and onions are also good choices for paper bags, Ghimire said. Because brown paper restricts the ability of light to penetrate, onions and potatoes won't turn as green as they would in clear plastic bags; it also reduces the chance of "hollow heart" in potatoes -- the black center you sometimes see which is caused by a lack of oxygen.

Some vegetables need to be kept out of the 40-degree Fahrenheit refrigerator to stay fresh and tasty. You probably know that tomatoes should be stored on the countertop.

But did you know the same is true for basil, cucumbers, eggplants, onions, peppers, potatoes, pumpkins, squash and sweet potatoes?

Cucumbers, for example, "may develop chilling injury if stored below 50 degrees Fahrenheit for more than two or three days," Ghimire said. "Produce kept outside the fridge should be stored in a cool, dry and well ventilated space."

Wash before eating, of course, by using a vegetable brush on hard varieties like potatoes and carrots before peeling; more sensitive veggies can be rubbed briskly between your hands under running water.


Again, selecting fruits that are in season will allow you to buy them at the height of their freshness, flavor, and nutritional value.

"Look for fruits that are firm, don't have soft brown spots or bruises, and are not overly ripe," Al Bochi said, adding that they should not have an odor.

Pears, peaches, plums and other soft fruits should be washed under slightly cool running water and dried with a paper towel before storing or eating.

"You should also wash the peels of bananas, oranges, avocados, and grapefruit with cool tap water as bacteria can transfer from the peel to the edible flesh," Drayer said.

Melons, especially the type that have rough, pocked surfaces such as cantaloupes, should be washed with a vegetable brush under running water and patted dry before storing or eating. Why? Bacteria and other microorganisms can hide in those pits and be transferred to the inside flesh while cutting, or to other veggies and fruits while storing.

The exception to the rule are grapes, cherries and berries.

"Berries should be washed just prior to eating because the moisture can cause them to spoil earlier," Drayer said.

And here's a wrinkle: Some veggies and fruits don't play nicely together. That's because some release ethylene gas as they ripen, which can hurt some other produce.

"For example, apples, avocados, unripe bananas, peaches, nectarines, plums and tomatoes release ethylene gas -- and should not be stored with ethylene-sensitive produce, such as broccoli, Brussels sprouts, ripe bananas, lettuce, peppers, cucumber, eggplant, carrots, cauliflower, and sweet potatoes, as this can speed the decay of the sensitive produce," Dryer said.

Fresh herbs

Look for bright green foliage that isn't wilted. Once home, rinse them under cool water and then lay on paper towels in a single layer to dry. Some suggest using a salad spinner -- but gently.

Storage will depend on whether the herb has a soft or woody stem.

Soft herbs: Treat soft herbs like tarragon, parsley, cilantro, dill and mint like they are fresh flowers. Cut a half-inch off the ends and put the ends down in a jar of water. Cover the jar loosely with a plastic wrap and store in the fridge, changing the water every few days.

Do the same with basil, but store it uncovered on the counter where it can get a bit of light.

Woody herbs: Wrap herbs such as rosemary, thyme, oregano, sage, and chives in wet paper towels and store them in an air-tight container or sealed plastic bag to keep the oxygen out.

Plan ahead

There's one more tip you need to be a star at getting the most out of your produce dollar: Plan your menus for the week in advance.

"Having a general plan of the meals you plan on cooking for the week will help you know what fruits and veggies to buy at the grocery store and help you use up your produce efficiently," Al Bochi said. "You'll reduce food waste and ultimately save money."

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Serving those who serve – The Hub at Johns Hopkins

By daniellenierenberg

ByKristin Hanson

This article was originally published on Nov. 8 on

Between 2001 and the beginning of 2018, more than 1,500 U.S. military service members lost limbs in the line of duty. Although technology has improved the prosthetic devices these people can use, a stubborn obstacle remains: the fragility of human skin.

"Skin was never meant to hold this kind of pressure," says Lee Childers, the senior scientist for the Extremity Trauma and Amputation Center of Excellence at Brooke Army Medical Center in San Antonio, Texas.

"Think about it like a blister on your foot. It's painful, but you can still get by," he continues. "In an amputation, it's a blister on your residual limb. You can't use your prosthesis until the blister is completely healed. If it's your leg [that is affected], you can't walk for two or three weeks. Think about how that would impact your life."

What if there were a way to make the skin at an amputation site tougher, like the palm of your hand or the sole of your foot? Luis Garza, an associate professor of dermatology at Johns Hopkins and leader of the Veteran Amputee Skin Regeneration Program, is developing a cell therapy that could enable prosthetics wearers to use their devices longer.

"This is an example of personalized medicine," Garza says. "We're taking each person's own cells, growing them up, and inserting them back in."

Garza's postdoctoral research focused on skin stem cells. In 2009, he and his department chair, Sewon Kang, began having conversations about how that work could help the increasing numbers of veterans coming back from war with amputations. Garza and his team received grants from the U.S. Department of Defense, National Institutes of Health, and Maryland Stem Cell Fund that have moved the program forward in the past decade.

Garza's team spent the summer of 2019 testing "normal" subjectsthose without amputationsto perfect the procedure, including the dose, content, method, and frequency of the injections. During one appointment, members of Garza's team took biopsies of skin from a subject's scalp and sole. The cells went to a lab where they were grown under an FDA-approved protocol and passed through quality control tests.

In a second appointment, subjects completed a questionnaire and underwent baseline measurements of their skin's thickness and strength. Garza's team then injected a site on the subjects' skin with the stem cells grown from their cells in the lab.

Image caption: Luis Garza, associate professor of dermatology at Johns Hopkins, leads the Veteran Amputee Skin Regeneration Program.

"We're hoping that these stem cell populations will engraft in the new skin," Garza says.

The subjects returned to Hopkins several months later to go through the questionnaire and measurements once more, and Garza's team documented changes.

Confident in the results they gleaned from the normal subjects, Garza's team enrolled its first subject with an amputation in August. Moving from the normal population to the amputation-affected population quickly unearthed some aspects of the therapy Garza didn't anticipate.

"When we talked with him, he said 'I don't want to mess with my one remaining footdo you have to take skin from there?' And we said, 'Actually, no, we could do your palm,'" Garza says.

His team then tested the biopsy and growth of palm cells from subjects in the normal population. "We're moving away from having our product informed purely by biology to letting our therapy development be shaped by the user."

Although federal grants have supported much of the program's progress, private philanthropy has played a role, too. Corporations like Northrop Grumman, foundations like the Alliance for Veteran Support, and grateful patients with and without ties to the armed forces have contributed nearly $300,000. Those gifts have enabled the program to persevere through gaps between federal grants.

Private funds will be increasingly important as the project enters its next phase: extension to military medical centers around the country. Garza's team must prove that the safeguards to protect cells on their round-trip voyage from a test site to Hopkins are effective. They also must secure approval by local institutional review boards for clinical studies.

"Soldiers are used to getting orders, but you can't order someone to be part of a [medical] study," Garza says. "There are hard medical ethics questions around how to make this open to them but ensure they don't feel obligated. We've been working on that for a year, and we probably have another six months or so to go."

Childers stands ready for whenever the program's extension is a go. He will lead the study at Brooke Army Medical Center and feels motivated by the prospect of helping many of the veterans he works with every day.

"We do everything we can to serve those who serve us. This can enable people to return to duty and be redeployed if they choose," he says. "This is game-changing technology that will have an impact for our service members, but also others who live with amputation."

That population includes the hundreds of thousands of Americans who've undergone amputations for complications of diabetes, who must use a wheelchair, or who wear ankle or foot orthoses for help with walking, among others.

"Having the ability to transform skin anywhere you want to target on the body will have gigantic implications across the entire spectrum of our society in many ways," Childers says.

There's a lot of work to be done before such benefits reach the public, Garza cautions. With continued support from donors and the military community, though, he's optimistic about the program's future.

"The challenges are pretty big, but I think within five years, it could happen," he says. "That's the hope."

Disclaimer: The view(s) expressed herein are those of the author(s) and do not reflect the official policy or position of the Brooke Army Medical Center, the U.S. Army Medical Department, the U.S. Army Office of the Surgeon General, the Department of the Army, the Department of the Air Force and Department of Defense or the U.S. Government.

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Hair regrowth depends on lymphatic system, finds study giving hope to find way to cure baldness – International Business Times, Singapore Edition

By daniellenierenberg

Even though your skin goes through unlimited wear and tear, it is able to repair itself. How does it undertake these regrowth factory activities? There are reservoirs of stem cells within supportive micro-environments, also called niches, throughout the skin. They can keep a tight leash on this repairing process. Too much tissue can lead to complications such as cancer, even though too less may enhance ageing.

Can stem cells direct other stem cells to reform into new skin when they reshape their niches? A study published in Science, led by Prof. Elaine Fuchs actually shows that stem cells have an effect on tissue regeneration. It marks out a molecular coordination tool that can be leveraged by stem cells to convey signals across niches.

The scientists wrote in the abstract of their article, published in Science: "Tissues rely on stem cells (SCs) for homeostasis and wound-repair. SCs reside in specialized microenvironments (niches) whose complexities and roles in orchestrating tissue growth are still unfolding. Here, we identify lymphatic capillaries as critical SC-niche components. In skin, lymphatics form intimate networks around hair follicle (HF) SCs."

Hence, another component of the niche that was revealed was the lymphatic capillaries, specialized types of vessels. They transport immune cells and also drain out excess fluids and toxins from tissues. As the capillaries integrate into a close network around the stem cell niche inside every hair follicle, all the niches get interconnected.

"By turning the skin completely transparent," says postdoctoral fellow Shiri Gur-Cohen, "we were able to reveal the complex architecture of this network of tubes." Researchers identified that the hair-follicle stem cells manage the behavior of lymphatic capillaries. They do this by secreting molecules acting as on-off switches for drainage. They enabled them to monitor the compositions of fluids and cells around them and finally synchronize regeneration across the tissues.

"The involvement of the lymphatic system in this process is a new concept," says Fuchs, "and might potentially provide new therapeutic targets for lymph-related conditions such as wound-healing defects and hair loss." The scientists summarized their findings in Science: "When lymphatics are perturbed or the secretome switch is disrupted, HFs cycle precociously and tissue regeneration becomes asynchronous. In unearthing lymphatic capillaries as a critical SC-niche element, we have learned how SCs coordinate their activity across a tissue."

Hence, to those who haven't understood why they are losing hair in tufts, checking out the scientific experiments on your lymphatic systems can go a long way in figuring out how it can be regrown.

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Kadmon Announces that KD025 Met Primary Endpoint at Interim Analysis of Pivotal Trial in Chronic Graft-Versus-Host Disease – Yahoo Finance

By daniellenierenberg

NEW YORK / ACCESSWIRE / November 11, 2019 / Kadmon Holdings, Inc. (KDMN) today announced positive topline results from the planned interim analysis of ROCKstar (KD025-213), the fully enrolled pivotal trial evaluating KD025 in patients with chronic graft-versus-host disease (cGVHD) who have received at least two prior lines of systemic therapy. The trial met the primary endpoint of Overall Response Rate (ORR) at the interim analysis, which was conducted as scheduled two months after completion of enrollment.

KD025 showed statistically significant ORRs of 64% with KD025 200 mg once daily (QD) (95% Confidence Interval (CI): 51%, 75%; p<0.0001) and 67% with KD025 200 mg twice daily (BID) (95% CI: 54%, 78%; p<0.0001). KD025 has been well tolerated and adverse events have been consistent with those expected in the patient population.

"We are extremely pleased with the outcomes of the interim analysis, which showed that KD025 has already greatly exceeded the threshold for success in this pivotal trial," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "We look forward to sharing these results with the FDA at a pre-NDA meeting, where we will also discuss the timing for a regulatory filing for KD025 in cGVHD, which we expect to occur in 2020, subject to FDA input."

"KD025 was shown to be a highly active and well-tolerated therapy across the spectrum of this complex, multi-organ disease," said Corey Cutler, MD, MPH, FRCPC, Associate Professor of Medicine, Harvard Medical School; Medical Director, Adult Stem Cell Transplantation Program, Dana-Farber Cancer Institute and a KD025-213 study investigator and Steering Committee member. "The response rates observed are particularly impressive since this study is being conducted in a real-world population with severe disease, supporting the potential role of KD025 in cGVHD patients who are in need of effective and well-tolerated therapies."

"It is highly encouraging to see the positive results from the pivotal trial are in line with those observed in the earlier Phase 2 study of KD025 in this difficult-to-treat disease," said Madan Jagasia, MD, Vanderbilt University, an investigator of the KD025-208 and KD025-213 studies and the KD025-213 Steering Committee chair. "These latest KD025 data continue to underscore the value that KD025 may offer to cGVHD patients."

KD025-213 is an ongoing open-label trial of KD025 in adults and adolescents with cGVHD who have received at least two prior lines of systemic therapy. Patients were randomized to receive KD025 200 mg QD or KD025 200 mg BID, enrolling 66 patients per arm. Statistical significance is achieved if the lower bound of the 95% CI of ORR exceeds 30%, which was achieved in both arms of the trial at the interim analysis.

While the ORR endpoint was met at the interim analysis, the primary analysis of the KD025-213 study will occur in the first quarter of 2020, six months after completion of enrollment. This analysis will include updated safety data and efficacy data, including ORRs and secondary endpoints, such as duration of response, changes in corticosteroid dose and changes in quality of life. Kadmon plans to submit results from the KD025-213 study for presentation at an upcoming scientific meeting.

Conference Call and Webcast

Kadmon will host a conference call and webcast on Monday, November 11, 2019, at 5:00 p.m., Eastern time, to discuss the topline results of the interim analysis of the KD025-213 study.

To participate in the conference call, please dial (866) 762-3021 (domestic) or (703) 925-2661 (international) and reference the conference ID: 6468498. The accompanying slides will be available for download on Kadmon's website beginning at 5:00 p.m. Eastern time.

To listen online via webcast, please visit: The webcast will be archived and will be available at

About KD025

KD025 is a selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response. In addition to cGVHD, KD025 is being studied in an ongoing Phase 2 clinical trial in adults with diffuse cutaneous systemic sclerosis (KD025-209). KD025 was granted Breakthrough Therapy Designation and Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of patients with cGVHD who have received at least two prior lines of systemic therapy.

Story continues

About cGVHD

cGVHD is a common and often fatal complication following hematopoietic stem cell transplantation. In cGVHD, transplanted immune cells (graft) attack the patient's cells (host), leading to inflammation and fibrosis in multiple tissues, including skin, mouth, eye, joints, liver, lung, esophagus and gastrointestinal tract. Approximately 14,000 patients in the United States are currently living with cGVHD, and approximately 5,000 new patients are diagnosed with cGVHD per year.

About Kadmon

Kadmon is a biopharmaceutical company developing innovative products for significant unmet medical needs. Our product pipeline is focused on inflammatory and fibrotic diseases as well as immuno-oncology.

Forward Looking Statements

This press release contains forward-looking statements. Such statements may be preceded by the words "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "targets," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We believe that these factors include, but are not limited to, (i) the initiation, timing, progress and results of our preclinical studies and clinical trials, including KD025-213, and our research and development programs; (ii) our ability to advance product candidates into, and successfully complete, clinical trials; (iii) our reliance on the success of our product candidates, including KD025; (iv) the timing or likelihood of regulatory filings and approvals, including in connection with KD025-213; (v) our ability to expand our sales and marketing capabilities; (vi) the commercialization of our product candidates, if approved; (vii) the pricing and reimbursement of our product candidates, if approved; (viii) the implementation of our business model, strategic plans for our business, product candidates and technology; (ix) the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; (x) our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; (xi) costs associated with defending intellectual property infringement, product liability and other claims; (xii) regulatory developments in the United States, Europe and other jurisdictions; (xiii) estimates of our expenses, future revenues, capital requirements and our needs for additional financing; (xiv) the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; (xv) our ability to maintain and establish collaborations or obtain additional grant funding; (xvi) the rate and degree of market acceptance of our product candidates; (xvii) developments relating to our competitors and our industry, including competing therapies; (xviii) our ability to effectively manage our anticipated growth; (xix) our ability to attract and retain qualified employees and key personnel; (xx) our ability to achieve cost savings and other benefits from our efforts to streamline our operations and to not harm our business with such efforts; (xxi) the use of proceeds from our recent public offerings; (xxii) the potential benefits of any of our product candidates being granted orphan drug designation; (xxiii) the future trading price of the shares of our common stock and impact of securities analysts' reports on these prices; and/or (xxiv) other risks and uncertainties. More detailed information about Kadmon and the risk factors that may affect the realization of forward-looking statements is set forth in Kadmon's filings with the U.S. Securities and Exchange Commission (the "SEC"), including Kadmon's Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and subsequent Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC's website at Kadmon assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Contact Information

Ellen Cavaleri, Investor

SOURCE: Kadmon Holdings, Inc.

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Kadmon Announces that KD025 Met Primary Endpoint at Interim Analysis of Pivotal Trial in Chronic Graft-Versus-Host Disease - Yahoo Finance

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The one make-up product you need for youthful, radiant-looking skin this winter –

By daniellenierenberg

All summer and early Autumn, Ive been foundation free - and the thought of wearing it ever again is as appealing as putting on a pair of tights. Partly I just dont want all those chemicals on my skin. Partly Ive never liked the look or feel of it - that airbrushed, airtight finish (usually involving a lot of silicones) has never done it for me. It just makes complexions look as though theyve been stored in Tupperware.

But come this time of year, most of us could do with a little help from our friends. Im talking about the latest generation of concealers, highlighters and - never thought Id be won round - tinted moisturisers, or CCs (colour correctors) as they became known.

CCs are not...

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Oct4, Considered Vital for Creating iPSCs, Actually Isnt Needed – The Scientist

By daniellenierenberg

Since 2006, when Shinya Yamanaka, now the director of the Center for iPS Cell Research and Application at Kyoto University, discovered a method that could guide fully differentiated cells back to their pluripotent state, scientists have been using his recipe to produce induced pluripotent stem cells. The protocol relies on overexpressing the so-called Yamanaka factors, which are four transcription factors: Oct4, Sox2, Klf4, and cMyc (OSKM). While the technique reliably creates iPS cells, it can cause unintended effects, some of which can lead to cells to become cancerous. So researchers have worked to adjust the cocktail and understand the function of each factor.

No one had succeeded in creating iPS cells without forcing the overexpression of Oct4. It was thought that this was the most crucial factor of the four. At least until now.

If this works in adult human cells, it will be a huge advantage for the clinical applications of iPS cells.

Shinya Yamanaka, Kyoto University

Four years ago, Sergiy Velychko, a graduate student at the Max Planck Institute for Molecular Biomedicine in Hans Schlers lab, and his team were studying the role of Oct4 in creating iPS cells from mouse embryonic fibroblasts. He used vectors to introduce various mutations of the gene coding for Oct4 to the cells he was studying, along with a negative controlone that didnt deliver any Oct4. He was shocked to discover that even using his negative control, he was able to generate iPS cells.

Velychkos experiment was suggesting that it is possible to develop iPS cells with only SKM.

We just wanted to publish this observation, Velychko tells The Scientist, but he knew hed need to replicate it first because reviewers wouldnt believe it.

He and his colleagues, including Guangming Wu, a senior scientist in the lab, repeated the experiment several times, engineering vectors with different combinations of the four factors. SKMthe combination that didnt include Oct4was able to induce pluripotency in the cells with about 30 percent of the efficiency of OSKM, but the cells were of higher quality, meaning that the researchers didnt see evidence of common off-target epigenetic effects. They reported their results yesterday (November 7) in Cell Stem Cell.

Efficiency is not important. Efficiency means how many colonies do you get, explains Yossi Buganim, a stem cell researcher at the Hebrew University of Jerusalem, who was not involved in the study. If the colony is of low quality, the chances that eventually the differentiated cells will become cancerous is very high.

Finally, the team employed the ultimate test, the tetraploid complementation assay, in which iPS cells are aggregated with early embryos that otherwise would not have been able to form a fully functional embryo on their own. These embryos grew into mouse pups, meaning that the iPS cells the team created were capable of maturing into every type of cell in the animal.

Whats more is they found that the SKM iPS cells could develop into normal mouse pups 20 times more often than the OSKM iPS cells, suggesting that the pluripotency of iPS cells can be greatly improved by omitting Oct4 from the reprogramming factor cocktail.

The results will need to be verified in human cells, Buganim cautions. His team has developed methods for creating iPSCs that worked well in mouse cells only to be completely ineffective in humans.

Yamanaka himself was enthusiastic about the results, telling The Scientist in an email that his team would definitely try the method in other cell types, especially adult human blood cells and skin fibroblasts. If this works in adult human cells, it will be a huge advantage for the clinical applications of iPS cells.

S.Velychkoet al.,Excluding Oct4 from Yamanaka cocktail unleashes the developmental potential of iPSCs,Cell Stem Cell,doi:10.1016/j.stem.2019.10.002,2019.

Emma Yasinski is a Florida-based freelance reporter. Follow her on Twitter@EmmaYas24.

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Ambrosia Is Back to Selling Transfusions of Young People’s Blood – Futurism

By daniellenierenberg

Ambrosia Health is back.

Following a brief shuttering and then a rebranding effort during which it was known as Ivy Plasma the young blood clinic has gone back to its roots: selling plasma sourced from the blood of 16- to 25- year-olds to healthy patients who believe the transfusions can give them ill-defined health benefits.

People really like the Ambrosia name and brand, so Ambrosia is going to continue, Ambrosia founder and young blood advocate Jesse Karmazin told OneZero. The resounding response from people wanting to sign up was, keep things the same. So thats what were going to do.

With the return to its original branding, Ambrosia is also embracing a new business model.

When it was Ivy Plasma, the clinic offered transfusions in San Francisco and Tampa. It since shuttered the clinic in Tampa, but Karmazin told Futurism that Ambrosia will ship plasma directly to any customers doctor so they can get their dose of young blood without having to fly to California.

We use overnight shipping to deliver the plasma to patients doctors offices, and provide training for the doctors to infuse it, Karmazin told Futurism last month. This way, the number of patients we are able to serve has increased dramatically. I dont operate a blood bank.

Ambrosias checkered, on-again-off-again status was spurred by an FDA statement issued in February in which the regulatory agency warned that transfusions of young blood didnt have any of the health benefits especially enhanced youthfulness, improved longevity, or reversedmemory loss that advocates claimed it did.

In slightly more words, the FDA essentially called young blood transfusions dangerous scams.

Because of the FDA warning, Karmazins clinic offered off-label treatments when it resurfaced as Ivy Plasma. That meant that customers could get their treatments if they desired, but they did so at their own risk and then-Ivy Plasma wasnt legally permitted to claim it would do them any good.

That practice continues today in the newly rebranded Ambrosia, according to OneZero. But the clinics updated website includes more details about the treatment.

Our treatment has been found to produce statistically significant improvements in biomarkers related to Alzheimers disease, cancer, inflammation, and stem cells in our clinical trial, the website reads. Patients have reported subjective improvements in athletics, memory, skin quality, sleep, and other areas.

When asked whether the FDAs rules had grown more lenient, Karmazin told Futurism he had consulted with the agency as well as a number of lawyers and wasnt worried about the claims made on his website.

Im comfortable with going ahead and offering this treatment commercially to patients, he told OneZero.

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Doctor explains what happens to your skin during the menopause and the best products to treat it – RSVP Live

By daniellenierenberg

Hormonal changes can play havoc with our skin as we get older, especially in the perimenopause and menopause years.

These changes aren't the same for every woman, and they don't all begin at once.

During the perimenopause and menopause, the most notable hormonal change is a decline of oestrogen levels.

Oestrogen affects every tissue and organ of the human body, skin included, so the decline of oestrogen in perimenopause and menopause can cause the following symptoms:

Dermatologist and founder of Meder Beauty Science Dr Tiina Meder explained the best way to look after your skin during perimenopause and menopause is a "considered daily skincare routine".

"Using a gentle cleanser will help preserve the skins barrier function and prevent dryness and sensitivity," she said.

"Antioxidant-rich moisturisers, packed with prebiotics, will help keep skin hydrated and protected, simultaneously restoring and preserving the skins microbiome.

"Facial oils will also help to compensate lipid deficiency, while weekly exfoliation will help stimulate skin renewal.

Perimenopausal and menopausal skin is more sensitive to sun exposure.

"The maintenance of melanocytes the cells that manufacture the pigment melanin - is controlled by oestrogen," said Dr Meder.

"During the perimenopause and menopause, the number of melanocytes in your skin reduces andoestrogenlevels decline. As a result, less protective melanin is produced, making the skin appear lighter.

"As melanin helps protect the skin from the environmental damage and sun exposure, a decline in the production of melanin results in skin that is more prone to damage from sun exposure.

"As a consequence, it is very important to protect the skin regularly and correctly the second these hormonal changes appear."

When choosing skincare products thatll protect and repair skin during the perimenopause and menopause, Dr Meder recommends looking out for the following ingredients:

Moisturisers- hyaluronic acid, glycerine, carrageenan, chondrus crispus extract, gluconolactone and others.

Fatty acids and lipids- primrose, apricot, olive, macadamia, sweet almond, argan, borago, canola, meadowfoam, sunflowers, and sesame oil, as well as shea butter, squalane, cacao and, in some cases, coconut butter.

Prebiotics and probiotics- alpha-glucan oligosaccharide, inulin, and others, including some bacterial ferments and lysates (alteromonas filtrate, lactobacillus lysate, and saccharomyces).

Antioxidants- resveratrol, green tea, aloe barbadensis, rosemary and wild carrot extracts, vitamin E and C, and beta-carotene.

Remodelers- EGF (Epidermal Growth Factor) and others growth factors, plant stem cells, and peptides (Matrixyl-3000, Rigin, Syn-Tack and others).

Anti-inflammatories- centella asiatica, aloe barbadensis, green tea, calendula officinalis and chamomilla recutita extracts, panthenol, peptide skinasensyl, and albatrellus ovinus.

Microcirculation and capillary strengtheners- niacinamide (vitamin B3), caffeine, horse chestnut extract, and escin.

"Some ingredients - such as retinol or hydroxyl acids - can potentially increase the sensitivity of the skin, cause dryness, or increase ultraviolet sensitivity during the perimenopause and menopause," she went on.

"Sadly, many of these ingredients can actually help perimenopausal andmenopausal skin in many ways by improving the renewal process, lightening pigmentation, decreasing the appearance of wrinkles, and helping restore skin elasticity.

"Luckily, there are some great alternatives to these more aggressive ingredients. For example, retinol and retinol derivatives can be replaced with bakuchiol a natural ingredient that acts in a similar way to retinol - promoting the same benefits but with no side effects."

"Studies have found that HRT can provide several benefits to the skin. The reduction of oestrogen levels during the menopause has a detrimental effect on the skin, so it can be corrected, at least in part, through the early use of HRT in perimenopause.

"When HRT is introduced in the perimenopause period, skin dryness and sensitivity have been shown to be prevented. In addition, long-term use of HRT has been shown to restore the skins water-holding capacity and barrier function of the epidermis.

"Some studies have also found that HRT can control, in part, the dermal thickness and laxity, collagen content and density, as well as the skins mechanical properties and stress reaction."

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Humanity is well on its way to a real-life Terminator uprising – Yahoo Lifestyle

By daniellenierenberg

The recent release of Terminator: Dark Fate saw both Arnold Schwarzenegger and Linda Hamilton reprise their iconic roles and James Cameron's return as a writer and producer. While the sentient killing machines depicted in the Terminator franchise are comprised of CGI and Hollywood special effects, plenty of real world research is going into developing robots with similar capabilities, just without the murderous intent (we hope).

This research spans academia, militaries (though it can be difficult to suss out the actual breakthroughs from government propaganda), and private enterprise. Perhaps the most well known privately-owned robotics developer is Boston Dynamics, makers of the Atlas. You may remember this bipedal robot from September when it showed off its uncanny parkour abilities, which the robot can pull off 80 percent of the time. The Atlas is able to move so fluidly thanks to a novel optimization algorithm that breaks down complex movements into smaller reference motions for its arms, torso, and legs. The Atlas then utilizes a model predictive controller to chain each appendages movements into smoothly flowing movements. However, while Boston Dynamics' Big Dog was developed as a quadrupedal cargo carrier for military operations, the Atlas is strictly for use as an emergency first responder.

But for all of Atlas' fancy footwork, it doesn't look or work very much like the humans it aims to imitate. But, then again, neither did the T-800 from The Terminator and T2: Judgement Day -- at least once stripped of its biological covering. As you can see in the clip below, the T-800's muscles don't operate like a human's. Instead of bundles of contracting fibers, it utilized a complex series of delicate pneumatic compressors to manipulate its movements.

However, building bundles of synthetic muscles is exactly what a number of researchers are currently attempting. These fibers can be made from a variety of materials, from carbon fiber to nylon to exotic polyethylenes. When activated, these materials are capable of lifting up to 1,000 times their own mass (far more than we can) as well as retain a "memory" of their previous shape.

For example, a team of researchers from MIT developed a polymer that can expand 1,000 times its original length and pick up 650 times its own mass. It does this by bonding high-density polyethylene (the stuff used to make recyclable soda bottles) and a stretchy elastomer. This bonded pair naturally coils, like a bedspring. But when heat or cold is applied, the HDPE expands or contracts at five times the rate of the elastomer which lengthens or shortens the coil by as much as 50 percent of its original length.

Similarly, a team from Columbia Engineering recently developed a 3D printed synthetic muscle that not only expands and contracts but also bends, and even twists, on command -- while hauling 1000 times its own mass. This is a big deal because, like the T-800, today's robots are mostly driven by pneumatics, which severely restricts their applications and their overall size. This material, however, can be activated with just 8V of current.

"We've been making great strides toward making robots minds, but robot bodies are still primitive," lead scientist Hod Lipson said in a 2017 statement. "This is a big piece of the puzzle and, like biology, the new actuator can be shaped and reshaped a thousand ways. We've overcome one of the final barriers to making lifelike robots."

Electricity isn't the only potential source of power for these synthetic fibers. Human muscles run on glucose and oxygen, so why not a robot's as well? A research team from Linkping University, Sweden recently did just that and published their findings in the journal, Advanced Materials, this past June.

Their muscle consists of two electroactive polymer sheets sandwiching a non-conductive central membrane. When a positive current is applied to one side (causing it to contract) and a negative current is applied to the other (causing it to expand), the entire thing bends towards the positive charge. But rather than use an electrical current, the Linkping team integrated a naturally occurring enzyme capable of converting chemical energy into electrical energy.

"These enzymes convert glucose and oxygen, in the same way as in the body, to produce the electrons required to power motion in an artificial muscle made from an electroactive polymer. No source of voltage is required: it's enough simply to immerse the actuator into a solution of glucose in water", Edwin Jager, senior lecturer at Linkping University, said in a June statement.

Skin is another sticking point for the T-800 -- it can't travel back in time without an "Edgar Suit" after all -- but modern research is already hard at work on growing human skin in the lab. Don't worry, we're not bringing back Leatherface. It's actually to help eliminate the need for animal testing in the cosmetics industry.

In 2015, cosmetics giant L'Oreal teamed up with 3D printing startup Organovo to begin bioprinting human skin, in half-centimeter square patches. Similarly in 2016, the RIKEN Center for Developmental Biology paired with Tokyo University to grow a nearly complete epidermis -- down to the hair follicles -- that could be transplanted onto live subjects and actually work. The team took cells from the gums of mice and reset them to their stem cell-like iPS state before culturing and then implanting them on other mice, where they grew into integumentary tissue -- that's the layer of cells between the outer and inner skin layers where hairs are developed.

But the skin suit does not make the man -- sit down, Buffalo Bill -- at least when it comes to Terminators. It's their big beautiful AI brains. Obviously, we don't have anything as capable as what sits between the T-800's audio inputs, but that doesn't mean we're not trying. Many of the biggest names in Silicon Valley, including Apple, Huawei, Qualcomm and Alphabet, are racing to develop a new generation of processors specifically designed to handle machine learning tasks. Similar to ARM chips, which pair slower-performing but less energy-intensive cores with more powerful cores with a bigger current draw, the latest generation of "AI chips" integrate cores dedicated to machine learning functions. Image recognition and those sorts of applications -- looking at you Apple Face ID -- are instead routed to the GPU's neural engine.

The T-1000 (portrayed by Robert Patrick in T2 and Byung-hun Lee in Genisys) conveniently didn't require a flesh jacket to get back through time on account of its mimetic poly-alloy "liquid metal" construction. In the movies, these poly-alloys enabled the T-1000 to shrug off immense amounts of damage and change its shape at will. Real-life liquid metals like gallium offer some unique properties of their own like high electrical conductivity and deformability. But there are drawbacks. Most magnetic liquid metals suffer from a high surface tension, limiting their stretchiness to just the horizontal plane. Plus, they typically have to be submerged lest they become a sticky paste when exposed to atmosphere.

To get around these issues, a team of researchers submerged a droplet of gallium-indium-tin alloy in a hydrochloric acid bath. The gallium alloy reacted to the acid, forming a gallium oxide skin on the droplet, which drastically lowered its surface tension and allowed the droplet to be stretched both horizontally and vertically. The results of the team's experiments were published in the journal Applied Materials & Interfaces this past March. But don't worry about getting a finger needle through the eye anytime soon. This research is still in very early development, though it could one day find use in flexible electronics and soft robots.

We're also not likely to see robots melting through gates in the near future, but plenty of robots can already modify their shapes in response to environmental changes. NASA, for example, is working on the Shapeshifter ahead of a proposed expedition to Saturn's moon, Titan.

"We have very limited information about the composition of the surface. Rocky terrain, methane lakes, cryovolcanoes - we potentially have all of these, but we don't know for certain," JPL Principal Investigator Ali Agha said in a statement. "So we thought about how to create a system that is versatile and capable of traversing different types of terrain but also compact enough to launch on a rocket."

The team's answer is a gang of up to 12 small robots, dubbed "cobots," that can Voltron themselves into various configurations depending on the challenge at hand. Each would be capable of autonomous flight. Together they'd be able to daisy chain themselves across gaps or combine into a large wheel for faster overland travel. The team plans to submit their proposal in 2020 for consideration ahead of the next scheduled mission to Titan in 2026.

It may not be able to fully recombine on the other side of a security gate, this tendril-like robot developed by UCSB and Stanford researchers can easily make it between the bars. Taking inspiration from the movements of plant and fungal roots, the inflatable robot can extend up to 72 meters in length. Think of it as one of those balloons that clowns twist into animals, just 236 feet long. By incorporating specialized "control chambers" the robo-tube can also change direction, manipulate objects and even form its own tools, like hooks.

In the third Terminator, T3, Skynet has improved upon the T-1000's poly-alloy design -- this time using it as a protective coating over a super strong endoskeleton -- to create the T-X model. It doesn't just hunt humans, the T-X is a Terminator-killer to boot.

Unfortunately, plenty of research has already been sunk into developing autonomous war machines. In 2016 the US Navy and DARPA collaborated on the Sea Hunter, an autonomous anti-sub system, the US Army is currently accepting proposals for its Advanced Targeting and Lethality Automated System (ATLAS), an AI-powered system able to "acquire, identify, and engage targets at least 3X faster than the current manual process," per the solicitation notice. The Air Force is also exploring the idea of fully autonomous drones as part of its Skyborg project. And those are just a few of the programs we know about.

Whether these systems ever see the light of day -- at least publicly -- remains to be seen given the tremendous public outcry against autonomous weapons. Human Rights Watch is a founding member of the Campaign to Stop Killer Robots and calls for a "preemptive ban on the development, production, and use of fully autonomous weapons." In 2015, robotics researchers and tech luminaries like Steve Wozniak and Stephen Hawking penned an open letter arguing against their development.

"You can't have machines deciding whether humans live or die," Toby Walsh, a professor at the University of New South Wales, told the NYT in July. "It crosses new territory. Machines don't have our moral compass, our compassion and our emotions. Machines are not moral beings."

These pleas have not gone unnoticed. Earlier this month, the Pentagon released draft guidelines regarding AI development. The guidelines demand that AI systems be accountable, avoid bias and be "governable." That is, the systems use an inhibitor function to stop themselves before causing unnecessary harm or damage. Then again, on November 5th, the bipartisan National Security Commission on Artificial Intelligence called for the rapid development and deployment of autonomous weapon systems -- ethical concerns be damned.

"In light of the choices being made by our strategic competitors, the United States must also examine AI through a military lens, including concepts for AI-enabled autonomous operations," the commission's interim report reads.

What could possibly be more terrifying than an unstoppable killing machine? An unstoppable killing machine that can step out of its own skin to become a pair of unstoppable killing machines, that's what. And that's exactly what Sarah Connor has to defeat in Dark Fate. The Rev-9 Terminator builds off of the T-X's endoskeleton-wrapped-in-liquid-metal design except it can separate its halves and fight like those freaky blonde twins from Matrix Reloaded. Our current state of the art swarm technology can't coordinate at that level just yet, but it's getting close.

Drone swarms can actually be quite useful by splitting sensory and processing functions across a group of robots. Lady Gaga would never have been able to pull off her 2017 Super Bowl Halftime Show were it not for a swarm of 300 Intel drones.

This technology has also caught the attention of the US military. The Army, for example, has developed the Perdix system, a hoard of more than 100 microdrones which are launched from a trio of F/A-18 Super Hornets and provide low-altitude surveillance for troops on the ground. The US Navy is developing a similar system, dubbed "swarmbots." These autonomous patrol boats coordinate with one another to investigate suspicious vessels that enter their domain (in this case Chesapeake Harbor) and then relay that information back to a human supervisor. But not all drone swarms wear capes. In 2018, a kidnapping ring leveraged a swarm of drones to buzz an FBI hostage team in the middle of their operation and keep tabs on the Feds' movements.

So even as the military and private enterprises continue to slog towards a future filled with autonomous weapons of war, we can take comfort in knowing that at the current rate of development, we likely won't face a Terminator uprising in our lifetimes. Then again, those maniacal mechanical bastards can time travel.

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Beyond the genome: RNA control of stem cells – Science Magazine

By daniellenierenberg

Tissue-resident stem cells are important for maintaining proper organ and tissue function throughout the lifetime of mammals. Although some types of stem cells constantly proliferate and give rise to committed progeny, such as intestine and skin, others reside mainly in a quiescent (noncycling) state, such as skeletal muscle. How stem cells maintain their quiescence while contributing to homeostatic tissue turnover is not well understood and is an active topic of investigation because of the potential of stem cell biology in regenerative medicine and healthy aging (1). On page 734 of this issue, de Morree et al. (2) characterize the underlying mechanisms that control muscle stem cell (MuSC) behavior in mice. Unexpectedly, they show that multiple species of RNAs coordinately confer precise regulation of quiescence and proliferation in MuSCs under homeostatic conditions.

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Human heart cells change during spaceflight, say scientists in study that could have far-reaching effects on c – MEAWW

By daniellenierenberg

Human heart cells are changed by spaceflight but return to mostly normal on Earth, according to a study that examined how the human heart functions in spaceflight. The scientists were surprised as to how quickly human heart muscle cells could adapt to the environment in which they are placed.

The research team examined the cell-level cardiac function and gene expression in human heart cells that were cultured aboard the International Space Station (ISS) for 5.5 weeks. They found that heart muscle cells -- derived from stem cells -- adapted well to their environment during and after spaceflight.

The analysis, says the team, shows that exposure to microgravity altered the expression of thousands of genes, but largely normal patterns of gene expression reappeared within 10 days after returning to Earth.

These findings provide insight into how the human heart functions at the cellular level in spaceflight. This study suggests that the human heart muscle cells are very adaptable to the environment in which they are placed, including microgravity. Microgravity is an environment that is not very well understood in terms of its overall effect on the human body, and studies like this will be able to help shed light on how the cells of the body behave in space," Dr. Joseph C. Wu, Director, Stanford Cardiovascular Institute at Stanford University School of Medicine, told MEA WorldWide (MEAWW).

The researchers explain that human heart muscle cells, like the whole heart, change their functional properties in spaceflight and compensate for the apparent loss of gravity by changing their gene expression patterns at the cellular level.

"This study does not tell us how the heart as a whole changes in microgravity. There are several other types of cells in the heart that were not included in this study. We also do not know how the cells might react if they were exposed to microgravity for a longer period of time. However, these are both things we can test in the future. The results we observed in this study will allow us to focus those future studies on characteristics of the heart muscle cells we know are strongly affected by microgravity," Dr. Wu told MEAWW.

With extended stays aboard the ISS becoming commonplace, there is a need to better understand the effects of microgravity on cardiac function, say experts. Past studies have shown that spaceflight induces physiological changes in cardiac function. Astronauts on space shuttle missions have experienced reduced heart rate, lowered arterial pressure, and increased cardiac output. But to date, most cardiovascular microgravity physiology studies have been conducted either in non-human models or at tissue, organ, or systemic levels, says the team.

"The National Aeronautics and Space Administration [NASA] Twin Study demonstrated that long-term exposure to microgravity reduces mean arterial pressure and increases cardiac output. However, little is known about the role of microgravity in influencing human cardiac function at the cellular level," says the study published in 'Stem Cell Reports'.

Accordingly, the research team used human induced pluripotent stem cells to study the effects of spaceflight on human heart function.

"We studied human-induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs). We generated hiPSC lines from three individuals by reprogramming blood cells and then differentiated them into hiPSC-CMs," says the study.

Dr. Wu explains that human induced pluripotent stem cells (hiPSCs) are stem cells that can be produced from a small sample of blood or skin through a process called "reprogamming".

"These hiPSCs can be then turned into almost any cell type of interest, including beating human heart muscle cells, or cardiomyocytes. Since these hiPSC-derived cardiomyocytes mimic the function of true adult human heart cells, we can use them as a model for how the cells of the human heart respond to microgravity," Dr. Wu told MEAWW.

Beating hiPSC-CMs were launched to the International Space Station aboard a SpaceX spacecraft, as part of a commercial resupply service mission. Simultaneously, ground control hiPSC-CMs were cultured on Earth for comparison.

"Upon return to Earth, space-flown hiPSC-CMs showed normal structure and morphology. However, they did adapt by modifying their beating patterns and calcium recycling patterns," the findings state.

The researchers performed RNA sequencing. "These results showed that 2,635 genes were differentially expressed among flight, post-flight, and ground control samples. A comparison of the samples revealed that hiPSC-CMs adopt a unique gene expression pattern during spaceflight, which reverts to one that is similar to groundside controls upon return to normal gravity," says the study.

The findings, according to the researchers, could provide insight into cellular mechanisms that could benefit astronaut health during long-duration spaceflight, or potentially lay the foundation for new insights into improving heart health on Earth.

"We know that humans can spend months and years in space. Through decades of analyses, we know that the human heart as a whole organ changes its shape, size, and function in spaceflight. These changes are one reason why astronauts must exercise in space for hours every day to keep their heart muscles strong. While our cell-based experiments were able to confirm that changes also occur on the cellular level, we cannot directly translate this to the organ-level without further studies. The changes in our hiPSC-cardiomyocytes are not adverse effects, but rather adaptations to microgravity. The changes reflect how the cells of the human body can quickly adapt to a low gravity environment," Dr. Wu told MEAWW.

The research team now plans to test different treatments on the human heart cells to determine if they can prevent some of the changes the heart cells undergo during spaceflight.

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The Third Generation of PRP Is Here – Jewish Link of New Jersey

By daniellenierenberg

PRP, or platelet-rich plasma, is part of a revolution in medicine. PRP contains an abundance of growth factors that play a valuable role in healing many ailments. The PRP technology has been developing for the benefit of patients, resulting in improved outcome and great results.

Platelet-rich plasma has evolved over the past 15 years from an experimental treatment and an idea that concentrated platelets can heal injuries to an everyday treatment that benefits so many. Platelets are concentrated by taking your blood in a tube or syringe and spinning the blood in a high-speed centrifuge that causes the components of blood to separate, including the red blood cells, white blood cells and platelets. The first generation of platelets involved one or two spins to separate the platelets, often including an anticoagulant to prevent clotting and solidifying of the platelets so it can be spread as a liquid around the target. This PRP has been effective for a range of musculoskeletal conditions. The second generation of PRP involves formation of a platelet-rich fibrin matrix (PRFM) that is valuable as a gel that can be applied to wounds, surgical sites and for dental conditions.

The third generation of PRP, also called CGF or concentrated growth factors,

was first developed and described in 2006 by an Italian physician (Dr. Sacco) and has recently become widely available in the United States with the Medifuge centrifuge. With a single spin, the blood is spun at multiple speeds, which concentrates the platelets while also isolating cells that express CD34+. This is a type of stem cell that greatly enhances the effectiveness of the platelets. The other advantage of this third-generation PRP is that without anticoagulants the platelets can be applied quickly as a liquid to apply to injured tendons and ligaments or for cosmetic benefit. By waiting a few minutes the platelets solidify, which is great for applying to wounds. Even when applied as a liquid, the third generation platelets solidify soon after injected, which helps attach the platelets to the area injected. This allows the platelets to provide growth factors for a longer duration to increase effectiveness.

There are many applications for this advanced PRP. Ligament and tendon injuries respond very well to PRP. These injuries often do not heal spontaneously because the ligaments and tendons do not get good blood flow. With PRP and its accompanying growth factors, the tendon and ligament is able to finally heal, providing long-term relief. In contrast to a steroid injection, which provides short-term relief and may contribute to tissue degeneration, PRP helps build and strengthen tissue and provides long-term relief.

To clarify, tennis elbow, golfers elbow, rotator cuff tendonitis, wrist tendonitis, iliotibial band syndrome, Osgood-Schlatters and Achilles tendonitis are all examples of tendon injuries characterized by weakening of the tendon fibers or even partial tears. PRP strengthen the tendon and heals all of these conditions.

Ligament injuries include all joint sprains and strains such as ankle sprains, shoulder strains, etc. The hallmark of joint arthritis is weakening of the ligaments that leads to wear and tear of the joint, with a cascade of cartilage erosion that leads to bone spurs, then joint space narrowing and eventually bone on bone. Any time you see a bone spur, chances are that there is a loose ligament that created the conditions that led to that spur. Platelets heal the ligaments so that the joint is more stable and the arthritic pain is relieved and recurrent ankle sprains stop recurring.

Thus, PRP is very effective for arthritic joints, including knee arthritis, hip arthritis and shoulder arthritis among others. The PRP is effective at strengthening the joint capsule that is comprised of ligaments and can provide support for the joint cartilage. Even with severe bone-on-bone arthritis, PRP can help strengthen the ligaments around the joint, which helps reduce pain.

PRP can also help you improve your appearance. With the vampire facial you get the benefit of the healing growth factors, which lead to increased collagen and blood flow for skin rejuvenation. The great aspect of this treatment is that this is a very natural way to naturally enhance your skin. Without undergoing surgery you can achieve a youthful appearance. So while stars such as Bar Rafaeli and Kim Kardashian have used platelets to enhance their appearance, the vampire facial is accessible to you and will give your skin a healthy, revitalized feeling. Everyone has an inner beauty. PRP helps your outer beauty so it is in sync with your inner beauty.

There are other cosmetic benefits to platelets. The growth factors that the platelets release can heal scars. This includes unsightly scars after a surgery or a laceration. Growing collagen within the scar will usually improve its appearance. Acne scars, which are tiny holes along the skin surface, are filled in with platelets. Burn scars may not be totally eliminated with PRP, but the growth factors can have dramatic effects on the appearance of these scars.

Another cosmetic benefit of PRP is hair growth. PRP leads to increased hair follicle formation increasing the hair density. While not practical for total hair loss, PRP is excellent for treating thinning hair in men and women. The best part is that you are stimulating the follicle growth with your own platelets without the use of medications or other invasive procedures. So if you run your hand through your hair and you feel it is thinner than you would like, PRP may be for you.

PRP is abundant, safe and the worlds most sophisticated repair system. Nothing else comes close to its amazing properties. PRP is a powerful source of growth factors. Whats best is that it comes from your own body so you are healing your own body with your own platelets. Whether you have an injury that needs the healing benefit of platelets, or if you want to enhance your appearance, promote hair growth or improve a scar, or for other challenges that can be enhanced with platelets, you should consider PRP to improve your quality of life. The success of PRP has been enhanced with the new technology of third-generation PRP. The concentrated growth factors (CGF) optimize platelets that are enhanced by stem cells for maximal benefit.

Dr. Slaten is a pain wellness physician in Ridgewood. For more than 20 years he has been practicing regenerative techniques with great skill and an open mind. Check out his website at for more information.

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Medical Skin Care Products Market to Witness a Pronounce Growth During 2017 2025 – Zebvo

By daniellenierenberg

Medical skin care products are used for beautifying or to address some other skin care problems. The cosmetic industry is booming and skin care forms a very huge part of this industry. The aesthetic appearance is so important that people spend a lot on skin care products and treatment. People being more technologically aware of the various new skin care products trending in the market. In addition to the aesthetic application, the medical skin care products are also used to address issues such as acne, pimples or scars.

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Medical Skin Care Products Market: Drivers and Restraints

The medical skin care products is primarily driven by the need of natural based active ingredients products which are now trending in the market. Consumers demand medical skin care products which favor health and environment. Moreover, the consumers are updated with the trends so that various companies end up providing such products to satisfy the customers. For instance, a single product face mask has thousands of different variants. This offers consumers different options to select the product depending on the skin type. Moreover, the market players catering to the medical skin care products are offering products with advanced technologies. For instance, Santinov launched the CICABEL mask using stem cell material based on advanced technologies. The stem cells used in the skin care product helps to to protect and activate the cells and promote the proliferation of skin epidermal cells and the anagenesis of skin fibrosis.

Medical Skin Care Products Market: Segmentation

On the basis of product type the medical skin care products market can be segmented as:

On the basis of application, the medical skin care products market can be segment as:

On the basis of distribution channel, the medical skin care products market can be segment as:

Medical Skin Care Products Market: Overview

Medical skin care products are used to address basic skin problems ranging from acne to scars. There are various advancements in the ingredients used to offer skin care products to the consumers. For instance, the use of hyaluronic acid and retinoids is the latest development in the industry. The anti-aging creams are at the forefront as the help treating issues such as wrinkles, scars, acne, and sun damage. Another, product in demand is the probiotic skincare which include lactobacillus and bifidobacterium.

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Medical Skin Care Products Market: Region-wise Outlook

In terms of geography, medical skin care products market has been divided into five regions including North- America, Asia- Pacific, Middle-East & Africa, Latin America and Europe. North America dominated the global medical skin care products market as international players are acquiring domestic companies to make their hold strong in the U.S. LOral is accelerating its U.S. market by signing a definitive agreement with Valeant Pharmaceuticals International Inc. to acquire CeraVe, AcneFree and Ambi skin-care brands for US$ 1.3 billion. The acquisition is expected LOreal to get hold of the brands in the price-accessible segment. Asia Pacific is expected to be the fastest growing region owing to the increasing disposable income and rising awareness towards the skin care products.

Medical Skin Care Products Market: Key Market Participants

Some of the medical skin care products market participants are Avon Products Inc., Beiersdorf AG, Colgate-Palmolive Company, Kao Corporation, LOral S.A., Procter & Gamble, Shiseido Company, The Estee Lauder Companies Inc., Unilever PLC, Revlon, Clinique Laboratories, llc., Murad, LLC., SkinCeuticals, RMS Beauty, J.R. Watkins and 100% PURE.

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AVROBIO, Inc. Reports Third Quarter 2019 Financial Results and Provides Business Update – Business Wire

By daniellenierenberg

CAMBRIDGE, Mass.--(BUSINESS WIRE)--AVROBIO, Inc. (NASDAQ: AVRO) (the Company), a Phase 2 clinical-stage gene therapy company, today reported financial results for the third quarter ended September 30, 2019 and provided a business update.

We are thrilled with the progress across our pipeline, including the dosing of the first patient in our cystinosis program and receipt of orphan drug designation for our investigational gene therapy for Gaucher disease, commented Geoff MacKay, President and Chief Executive Officer of AVROBIO. In our Fabry program, we have now dosed eight patients across two clinical trials and we are on track to use our optimized lentiviral vector and a conditioning regimen utilizing therapeutic drug monitoring for the first time to dose a patient in our Phase 2 clinical trial for Fabry disease by the end of 2019. While our rapid expansion and early data have been exciting, we are humbled by the needs of the rare disease communities with whom we engage. They impress a sense of urgency on our work to deliver a new paradigm that we believe can supersede current treatment options and potentially provide patients freedom from a lifetime of disease.

Program Updates and Milestones

Third Quarter 2019 Financial Results

AVROBIO reported a net loss of $17.1 million for the third quarter of 2019 as compared to a net loss of $11.6 million for the comparable period in 2018. This increase was due to increased research and development expenses, as well as increased general and administrative expenses.

Research and development expenses were $13.0 million for the third quarter of 2019 as compared to $9.2 million for the comparable period in 2018. This increase was driven by increased program development activities related to the advancement of the Companys pipeline, as well as increased personnel-related costs resulting from an increase in employee headcount.

General and administrative expenses were $5.0 million for the third quarter of 2019 as compared to $3.0 million for the comparable period in 2018. This increase was primarily due to an increase in employee headcount, expenses associated with being a publicly traded company, including consulting expenses, and the impact of non-cash stock-based compensation.

As of September 30, 2019, AVROBIO had $206.4 million in cash and cash equivalents, as compared to $126.3 million in cash and cash equivalents as of December 31, 2018. The cash balance as of September 30, 2019 reflects the receipt of net proceeds of $129.5 million from the Companys July 2019 follow-on equity offering. Based on the Companys current operating plan, AVROBIO expects its cash and cash equivalents as of September 30, 2019 will enable the Company to fund its operating expenses and capital expenditure requirements into the second half of 2021.

About AVROBIO, Inc.

AVROBIO, Inc. is a leading, Phase 2 gene therapy company focused on the development of its investigational gene therapy, AVR-RD-01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, cystinosis and Pompe disease. The Companys plato platform includes a proprietary vector system, automated cell manufacturing solution and refined conditioning regimen deploying therapeutic drug monitoring. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON. For additional information, visit

Forward-Looking Statements

This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as aims, anticipates, believes, could, estimates, expects, forecasts, goal, intends, may, plans, possible, potential, seeks, will, and variations of these words or similar expressions that are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding our business strategy, prospective products and goals, the therapeutic potential of our product candidates, the design, commencement, enrollment and timing of ongoing or planned clinical trials, clinical trial results, product approvals and regulatory pathways, the intended incentives conferred by orphan-drug designation, potential regulatory approvals and the timing thereof, expected benefits from the appointment of Ms. Verdin to the position of Chief Human Resources Officer and Ms. May to the position of Chief Commercial Officer, anticipated benefits of our gene therapy platform including potential impact on our commercialization activities, timing and likelihood of success, plans and objectives of management for future operations, future results of anticipated products, and the market opportunity for and anticipated commercial activities relating to our product candidates, and statements regarding the Companys financial and cash position and expected cash runway. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Results in preclinical or early stage clinical trials may not be indicative of results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.

Any forward-looking statements in this press release are based on AVROBIOs current expectations, estimates and projections about our industry as well as managements current beliefs and expectations of future events only as of today and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that any one or more of AVROBIOs product candidates will not be successfully developed or commercialized, the risk of cessation or delay of any ongoing or planned clinical trials of AVROBIO or our collaborators, the risk that AVROBIO may not realize the intended benefits of our gene therapy platform, including the features of our plato platform, the risk that our product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that we anticipate, the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or trials involving AVROBIOs product candidates, the risk that we will be unable to obtain and maintain regulatory approval for our product candidates, the risk that the size and growth potential of the market for our product candidates will not materialize as expected, risks associated with our dependence on third-party suppliers and manufacturers, risks regarding the accuracy of our estimates of expenses and future revenue, risks relating to our capital requirements and needs for additional financing, and risks relating to our ability to obtain and maintain intellectual property protection for our product candidates. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause AVROBIOs actual results to differ materially and adversely from those contained in the forward-looking statements, see the section entitled Risk Factors in AVROBIOs Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, as well as discussions of potential risks, uncertainties and other important factors in AVROBIOs subsequent filings with the Securities and Exchange Commission. AVROBIO explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.


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