Operational Highlights and Financial Results for the Year Ended June 30, 2021 – GlobeNewswire
By daniellenierenberg
NEW YORK, Aug. 30, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reported operational highlights and financial results for the fourth quarter and full-year ended June 30, 2021 (FY2021).
During this calendar year we made significant progress in both regulatory and clinical outcomes for our lead product candidate, remestemcel-L, after experiencing a disappointing set-back last year said Silviu Itescu, Chief Executive of Mesoblast. We are pleased with recent recommendations by FDAs CBER to meet with the review team and address remaining CMC items for remestemcel-L in the treatment of steroid-refractory acute graft versus host disease in children. Additionally, our most recent meeting with the FDA has provided clarity on the pathway towards an emergency use authorization for remestemcel-L in the treatment of COVID ARDS.
Operational Highlights
Remestemcel-L Outcome of recent meeting with FDA on regulatory pathway for emergency use authorization in the treatment of COVID-19 ARDS:
Remestemcel-L in the treatment of steroid-refractory acute graft versus host disease (SR-aGVHD) in children:
Rexlemestrocel-L in the treatment of chronic heart failure and chronic low back pain:
Manufacturing
Financial Highlights
DETAILED CLINICAL ACTIVITIES FOR THE FISCAL YEAR FY2021
Remestemcel-L
Acute Respiratory Distress Syndrome due to COVID-19
Mesoblast recently presented results from the randomized controlled trial of remestemcel-L in 222 ventilator-dependent COVID-19 patients with moderate/severe acute respiratory distress syndrome (ARDS) at the biennial Stem Cells, Cell Therapies, and Bioengineering in Lung Biology and Diseases conference hosted by the University of Vermont, Burlington, VT, and at the International Society for Cell & Gene Therapy (ISCT) Scientific Signatures Series event on Cell and Gene-Based Therapies in Lung Diseases and Critical Illnesses.
The presented data included improved respiratory function in patients treated with remestemcel-L, as well as 90-day survival outcomes showing remestemcel-L significantly reduced mortality by 48% at 90 days compared to controls in a pre-specified exploratory analysis of 123 treated patients under 65 years old. The trial had been halted after the third interim analysis since the 30-day primary endpoint would not be attained.
Key presentation findings were:
Mesoblast plans to move forward with an additional Phase 3 trial in COVID-19 ARDS with the next step being to agree with the FDA the final protocol and potency assay.
Inflammatory Bowel Disease Crohns Disease and Ulcerative Colitis
A randomized, controlled study of remestemcel-L delivered by an endoscope directly to areas of inflammation and tissue injury in up to 48 patients with medically refractory Crohns disease and ulcerative colitis commenced at Cleveland Clinic in October 2020. The investigator-initiated study is the first in humans using local cell delivery in the gut and will enable Mesoblast to compare clinical outcomes using this delivery method with results from an ongoing randomized, placebo-controlled trial in patients with biologic-refractory Crohns disease where remestemcel-L was administered intravenously.
Rexlemestrocel-L
Chronic Heart Failure
The results from the landmark DREAM-HF randomized controlled trial in 537 treated patients with chronic heart failure with reduced left ventricular ejection fraction (HFrEF) who received rexlemestrocel-L (REVASCOR) or control sham, demonstrated that a single dose of rexlemestrocel-L resulted in substantial and durable reductions in heart attacks, strokes, and cardiac deaths. The trials primary endpoint of reduction in volume overload related hospitalizations was not achieved. The results of this trial identify New York Heart Association (NYHA) class II HFrEF patients as the optimal target population for greatest rexlemestrocel-L treatment effect, and therefore a focus for developing rexlemestrocel-L in the largest market in heart failure.
The incidence of heart attacks and strokes were reduced by 60% over a median follow-up period of 30 months following a single dose of rexlemestrocel-L in the entire population of 537 treated patients. The incidence of death from cardiovascular causes was reduced by 60% in the 206 patients with NYHA class II disease, a significant reduction which was evident in both ischemic and non-ischemic subgroups as well as diabetic and nondiabetic patients.
The results also show that the NYHA class II patients in the control group, following an initial period of approximately 20 months of disease stability, progressed to cardiac death rates in-line with NYHA class III patients. NYHA class II patients treated with a single dose of rexlemestrocel-L did not show such cardiac death progression.
The combination of the three pre-specified outcomes of cardiac death, heart attack or stroke into a single composite outcome - called the three-point major adverse cardiovascular events (MACE) is a well-established endpoint used by the FDA to determine cardiovascular risk. Rexlemestrocel-L reduced this three-point MACE by 30% compared to controls across the entire population of 537 treated patients. In the NYHA class II subgroup of 206 patients, rexlemestrocel-L reduced the three-point MACE by 55% compared to controls.
Mesoblast expects feedback from the FDA in the next quarter on the potential pathway to US regulatory approval for rexlemestrocel-L in patients with chronic heart failure.
Chronic Low Back Pain due to Degenerative Disc Disease
The results from the randomized controlled trial of its allogeneic mesenchymal precursor cell (MPC) therapy rexlemestrocel-L in 404 enrolled patients with chronic low back pain (CLBP) due to degenerative disc disease (DDD) refractory to conventional treatments indicate that a single injection of rexlemestrocel-L+hyaluronic acid (HA) carrier may provide a safe, durable, and effective opioid-sparing therapy for patients with chronic inflammatory back pain due to degenerative disc disease, and that greatest benefits are seen when administered earlier in the disease process before irreversible fibrosis of the intervertebral disc has occurred. The trial's composite outcomes of pain reduction together with functional responses to treatment were not met by either MPC group.
The rexlemestrocel-L+HA treatment group achieved substantial and durable reductions in CLBP compared to control through 24 months across the entire evaluable study population (n=391) compared with saline controls. Greatest pain reduction was observed in the pre-specified population with CLBP of shorter duration than the study median of 68 months (n=194) and subjects using opioids at baseline (n=168) with the rexlemestrocel-L+HA group having substantially greater reduction at all time points (1, 3, 6, 12, 18 and 24 months) compared with saline controls. There was no appreciable difference in the safety of MPC groups compared to saline control over the 24-month period of follow-up in the entire study population. In subjects using opioids at baseline, the MPC+HA demonstrated a reduction in the average opioid dose over 24 months, while saline control subjects had essentially no change.
There is a significant need for a safe, efficacious, and durable opioid-sparing treatment in patients with chronic low back pain due to severely inflamed degenerative disc disease. Mesoblast has filed a request and expects to receive feedback from the FDA on the pathway to US regulatory approval in patients with chronic low back pain due to degenerative disc disease.
Intellectual Property
Mesoblast has an extensive patent portfolio with over 1,000 patents and patent applications across 77 patent families, and patent terms extending through 2041. These patents cover composition of matter, manufacturing, and therapeutic applications of mesenchymal lineage cells, and provide strong commercial protection for our products in all major markets, including the United States, Europe, Japan and China. During the fiscal year Mesoblast has significantly expanded its patent portfolio, focusing on areas of its strategic commercial interests.
Licensing agreements with JCR, Grnenthal, Tasly and Takeda highlight the strength of Mesoblast's extensive intellectual property portfolio covering mesenchymal lineage cells. Mesoblast will continue to use its patents to prosecute its commercial rights as they relate to its core strategic product portfolio. When consistent with the Companys strategic objectives, it may consider providing third parties with commercial access to its patent portfolio.
DETAILED FINANCIAL RESULTS
Financial Results for the Year Ended June 30, 2021 (FY2021)
In August we entered into a contractual amendment to extend the interest-only period of its current senior debt facility to at least January 2022 and as a result no loan repayments will be required prior to January 2022. Mesoblast is in active discussions to refinance the facility.
We expect to recognize the existing US$21.9 million of remestemcel-L pre-launch inventory on the balance sheet if we receive FDA approval.
As a result of the above and other remeasurements on revaluation of assets and liabilities, the loss after tax for FY2021 was US$98.8 million compared to US$77.9 million for FY2020. The net loss attributable to ordinary shareholders was 16.33 US cents per share for FY2021, compared with 14.74 US cents per share for FY2020.
Conference Call
There will be a webcast today, beginning at 7.00pm EDT (Monday, August 30, 2021); 9.00am AEST (Tuesday, August 31). It can be accessed via:https://webcast.boardroom.media/mesoblast-limited/20210826/NaN61036c41df5665001c97fc67
The archived webcast will be available on the Investor page of the Companys website: http://www.mesoblast.com
About Mesoblast
Mesoblast is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of late-stage product candidates which respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.
Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2041 in all major markets. The Companys proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.
Mesoblast has completed Phase 3 trials of rexlemestrocel-L for advanced chronic heart failure and chronic low back pain. Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid refractory acute graft versus host disease and moderate to severe acute respiratory distress syndrome. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.
Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast
References / Footnotes
Forward-Looking Statements
This announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of Mesoblasts preclinical and clinical studies, and Mesoblasts research and development programs; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblasts ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblasts product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblasts product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblasts ability to enter into and maintain established strategic collaborations; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblasts expenses, future revenues, capital requirements and its needs for additional financing; Mesoblasts financial performance; developments relating to Mesoblasts competitors and industry; and the pricing and reimbursement of Mesoblasts product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.
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Operational Highlights and Financial Results for the Year Ended June 30, 2021 - GlobeNewswire
Hematopoietic Stem Cell Transplantation (HSCT) Market by Sales, Revenue, Price and Gross Margin (2021-2027) UNLV The Rebel Yell – UNLV The Rebel Yell
By daniellenierenberg
Hematopoietic somatic cell Transplantation (HSCT) may be a specialized sort of blood somatic cell transplant therapy. The term hematopoietic refers to the function of the stem cells in citizenry . Stem cell refers to specialized somatic cell types which are capable of developing into specific cells like bone, muscle, blood, and nerve cells.
The PDF for the study can be requested using the following link: https://www.coherentmarketinsights.com/insight/request-pdf/1250
Hematopoietic somatic cell transplantation are often utilized in the treatment of certain cancers of the blood or bone marrow, like myeloma or leukemia. High prevalence of such diseases is predicted to assist in growth of the hematopoietic somatic cell transplantation (HSCT) market. consistent with Leukemia and Lymphoma Society, 176,200 people within the US are expected to be diagnosed with leukemia, lymphoma or myeloma in 2019.
The hematopoietic somatic cell transplantation (HSCT) market in North America is witnessing high growth, due to high adoption of allogeneic hematopoietic somatic cell transplant. Around 30,000 patients undergo allogeneic hematopoietic somatic cell transplant annually within the us .
Hematopoietic cell transplantation is that the transplantation of stem cells, generally derived from bone marrow, duct , or peripheral blood. It also can be allogenic, autologous or syngeneic. the foremost common sort of somatic cell transplant is that the allogenic transplant, which is actually the method of harvesting such stem cells that have the power to become many various specialized cell types, like bone, kidney, heart, liver, lungs, pancreas, nervous, and immune cells. However, approximately 20% to 85% of the patients develop acute Graft Versus Host Disease that affects the skin, gut, or liver. Such scenario hinders the expansion of hematopoietic somatic cell transplantation (HSCT) market.
There are different methods of transplant. just in case of a basic transplant, the stem cells are directly transplanted into an individuals veins, while a minimal invasive procedure also referred to as a micro-implantation requires the injection of the cells into the patients veins. supported the precise needs of the patient, the precise sort of transplant is completed . for instance , a toddler who has undergone bone marrow transplantation can continue to possess other somatic cell types utilized for an equivalent purpose. this is often one among the foremost commonly performed sorts of transplants.
High prevalence of red blood cell anemia is additionally expected to assist in growth of the hematopoietic somatic cell transplantation (HSCT) market. Specially created somatic cell therapies are often utilized in the treatment of red blood cell anemia. These cells are basically taken from the bone marrow of the person then induced to make a thick, jelly like substance. The patient will got to take medicine for a couple of days after the procedure to assist his bodily process the cells.
Hematopoietic cell transplantation has its own set of complications, which limit the expansion of the hematopoietic somatic cell transplantation (HSCT) market. a number of these include infection, allergies , bleeding, and scarring. Infection can occur if theres a severe immune deficiency. The patient also will need to take antibiotics to clear up the infections. If the stem cells are used, they need to be grown under very strict conditions to avoid rejection. Most surgeons attempt to perform this transplant first on those people that suffer from serious diseases like leukemia or cancer as these are the people that stand the simplest chance to achieve success .
Competitive Landscape
Key players operating in the Hematopoietic Stem Cell Transplantation (HSCT) Market are Pluristem Therapeutics Inc., CellGenix GmbH, Regen Biopharma Inc., Lonza Group, Kiadis Pharma, Taiga Biotechnologies, Inc., Takeda Pharmaceutical Company Limited, Escape Therapeutics, Inc., Bluebird Bio, Talaris Therapeutics, Inc., Marker Therapeutics Inc., and Stempeutics Research Pvt Ltd.
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Hematopoietic Stem Cell Transplantation (HSCT) Market by Sales, Revenue, Price and Gross Margin (2021-2027) UNLV The Rebel Yell - UNLV The Rebel Yell
Vitro Biopharma Acquires Fitore Nutrition and Infinivive MD, Adding Revenues from Innovative Stem Cell Activation Products and Topical Cosmetic Stem…
By daniellenierenberg
GOLDEN, CO / ACCESSWIRE / August 31, 2021 / Vitro Biopharma, Inc. (Vitro) announced the acquisition of Fitore Nutrition (Fitore) and Infinivive MD (Infinivive). Fitore, a private company headquartered in Denver, Colorado creates clinically validated supplements and sells them direct to consumers (D2C) via their unique digital marketing platform and SEO expertise.
Infinivive, located in Cherry Creek, Colorado developed the worlds first topical cosmetic stem cell serum and is a nationally recognized company led by one of the top industry pioneers in the area of cosmetic surgery, Dr. Jack Zamora M.D.
These two acquisitions will drive significant new revenues to Vitro, funding its therapeutic pipeline and expanding Vitros overall stem cell regenerative capabilities. Vitro acquired Fitore Nutrition for $2,300,000 in a combination of notes and stock and Infinivive MD for $5,750,000 in an all-stock deal.
The acquisition of Fitore & Infinivive gives us the opportunity to leverage the revenues of both companies, increase market awareness for Vitro, and cross sell the regenerative therapies of AlloRx Stem Cells said Jack Zamora C.E.O. of Vitro Biopharma.
Vitros acquisition of Fitore and Infinivive brands makes strategic sense for Vitro as it helps to (1) leverage synergies across therapeutic outcomes and bio-supplements, (2) is consistent with managements M&A growth strategy of high growth and high margin acquisitions with a focus on ecommerce capabilities, (3) provides Vitro with a significant online presence thereby expanding Vitros branding footprint.
The integration of Fitores direct to consumer (D2C) technology platform will accelerate Vitros product penetration and brand recognition into the marketplace for all its products. To date we have had an incredibly successful partnership with Vitro with the joint development of Stemulife formerly known as STEMulize, and Spectrum +. Partnering with Vitro Biopharma only accelerates our mission as we continue to develop more life-changing products based on Vitros scientific capabilities and the expanding market demands for natural health products. said Tanner Haas C.E.O. of Fitore Inc.
Fitore and Infinivive will allow Vitro deeper access into the direct-to-consumer market channels and complement Vitros existing revenue drivers. The consolidated results of all operations are expected to drive $3-$5M in revenue over the next 12 to 18 months, a 300% plus increase in our pre-pandemic revenues. said John Evans C.F.O. and Chairman of the Board of Vitro Biopharma.
ABOUT VITRO BIOPHARMA
Vitro Biopharma is a clinical-stage biotechnology company focused on developing novel and proprietary best-in-class natural regenerative products. Vitro develops and commercializes adult stem cell technology for applications in stem cell research and drug development for the treatment of a vast variety of diseases and conditions. The companys innovative and proprietary technology platform manufactures umbilical cord derived stem cells, AlloRx Stem Cells, used in regenerative clinics to treat a variety of disease indications.
The companies partnered clinics continue to expand and these wellness clinics utilize our cosmetic and nutraceutical products in conjunction with their regenerative therapies. A patient enjoys a beautiful foreign destination experiencing a regenerative treatment with AlloRx Stem Cells along with a spa backdrop featuring a topical cosmetic facial and supporting long term nutraceutical stem cell activator.
The offshore revenues support our clinical work in the US market. Authorization of our recent IND for COVID-19 now positions the company to move forward with Phase I and Phase II clinical trials for disease indications that have shown safety and efficacy in our offshore trials.https://www.vitrobiopharma.com/pages/pipeline
ABOUT FITORE NUTRITION
Fitore Nutrition is a direct to consumer (D2C) and SEO technology platform that creates clinically validated supplements that are formulated by world-leading doctors and stem cell scientists from Vitro Biopharma. Each Fitore nutrition ingredient is all-natural, sustainably-sourced, and of the highest-quality, manufactured in a GMP and FDA Registered facility in Commak New York. In 2021, Fitore sells its products direct to consumers through its unique digital marketing platform. Fitore Nutritions novel formulations include: Stemulife, Thought Calmer, Easy Sleep, and Spectrum +.
ABOUT INFINIVIVE MD
InfiniVive MD has created the highest quality cGMP-grade cosmetic stem cell and exosomes product line. InfiniVive MD cosmetic stem cell products contain ultra-pure mesenchymal stem cells and exosomes to be used topically by plastic surgeons, cosmetic surgeons, and aestheticians throughout the United States and internationally. Infinivive is looking to disrupt the cosmetic industry through next level skin quality results.
Forward-Looking Statements
Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Companys auditors. Certain statements contained herein, and subsequent statements made by and on behalf of the Company, whether oral or written may contain forward-looking statements. Such forward-looking statements are identified by words such as intends, anticipates, believes, expects and hopes and include, without limitation, statements regarding the Companys plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues, and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Companys products in the marketplace, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Companys filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT:
Dr. Jack Zamora, MDChief Executive Officer Vitro Biopharma, Inc.(303) 999-2130 x1www.vitrobiopharma
SOURCE: Vitro Biopharma, Inc.
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Vitro Biopharma Acquires Fitore Nutrition and Infinivive MD, Adding Revenues from Innovative Stem Cell Activation Products and Topical Cosmetic Stem...
Senescent immune cells spread damage throughout the aging body – National Institute on Aging
By daniellenierenberg
Senescent immune system cells are potentially among the most harmful of all senescent cells because they spread tissue damage and rapid aging across other body organs and systems. That is what a team of NIA-supported scientists at the University of Minnesota Medical School discovered through research using a mouse model that accelerated immune system aging by hindering DNA repair. The team recently published these findings in Nature.
Cellular senescence is defined as a condition in which a cell no longer has the ability to proliferate. These damaged cells resist the bodys usual system of disposal and then linger, excreting chemicals that spread inflammation and damage to neighboring normal cells.
For this study, the team made a cell-specific knockout of the gene Ercc1, which controls a protein crucial for DNA repair. Ercc1 was removed in blood-based young stem cells that normally develop into white blood cells cells important for immunity but the gene was expressed normally in all other tissues. This enabled the research team to understand whether senescence in the immune system affects other cells in the body. The engineered mice seemed healthy up until their adulthood (around three months) but then aged rapidly. At age five months, they biologically resembled 2-year-old mice, which is approximately equivalent to an 80-year-old human.
The prematurely older mice had a host of age-related conditions such as osteoporosis; visual and hearing impairment; and high blood pressure, even though the change was limited to cells of the immune system. The senescent immune system cells also spread age-related damage to other organs and tissues in the body, including the liver, lungs, and kidneys. Without the Ercc1 gene, the mice had lost much of their ability to repair DNA in these immune cells and thus experienced a build-up of inflammation and damage in other tissues.
The scientists saw this rapid aging and spread of damage throughout the body as evidence that senescent immune system cells are potentially among the most dangerous of all senescent cell types in the aging body. Because immune cells circulate throughout the body, when they become senescent, they can easily expose a wider range of organs and tissues to inflammation and other damaging factors, unlike more stationary senescent cells such as those in the skin.
The team also studied and confirmed some mechanisms that contribute to senescence in the immune system. First, they showed that senescent immune cells trigger and drive senescence elsewhere in the body by observing senescence triggered across systems in young mice after transplanting spleen cells from old mice into them. Next, they observed that when immune cells from young healthy mice were transplanted into older mice, senescence was reduced, providing further evidence that old immune cells lose function. The scientists also used the drug rapamycin, which tamps down the inflammatory secretions from senescent cells, to show that reducing senescence improved immune function.
While the field of senescence is still very far from any reliable application for humans, the investigators aim to pursue follow-up efforts to pinpoint a precise type of senolytic a drug that selectively clears senescent cells from the body to target reducing immune system senescence as a potential future intervention to aid healthy aging. They hope to conduct additional studies in this realm to find new immune system biomarkers to help gauge which people are at the highest risk for senescence-related tissue damage and faster aging, and thus would be candidates to benefit from senolytic therapies.
This work was supported by NIH grants P01 AG043376, RO1 AG063543, R56 AG059676, U19 AG056278, P01 AG062413, R56 AG058543 and R01 AG044376.
Reference: Yousefzadeh, Matthew J et al. An aged immune system drives senescence and ageing of solid organs. Nature vol. 594,7861 (2021): 100-105. doi:10.1038/s41586-021-03547-7
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Senescent immune cells spread damage throughout the aging body - National Institute on Aging
Prolymphocytic Leukemia: What Is It and How Is It Treated? – Healthline
By daniellenierenberg
Prolymphocytic leukemia (PLL) is a very rare subtype of chronic leukemia. Although most forms of chronic leukemia progress slowly, PPL is often aggressive and can be difficult to treat.
Well walk you through what you need to know about PLL, including the symptoms, how its diagnosed, current treatment options, and more.
PLL is a rare and aggressive type of chronic leukemia.
The American Cancer Society estimates that more than 60,000 people will receive a diagnosis of leukemia in the United States in 2021.
Less than 1 percent of all people with chronic leukemia have PLL. Its most often diagnosed in people between ages 65 and 70 and is slightly more common in men than in women.
Like all types of leukemia, PLL affects blood cells. PLL is caused by the overgrowth of cells called lymphocytes. These cells usually help your body fight infection. In PLL, large immature lymphocyte cells called prolymphocytes are produced too quickly and overwhelm the other blood cells.
There are two subtypes of PLL:
PLL, like other chronic leukemias, is often found on lab work before any symptoms develop. When symptoms develop, they might include:
There are a few additional symptoms that are specific to T-PLL, which include:
Many of these are general leukemia symptoms and are also found in less serious conditions. The presence of any of these symptoms doesnt always indicate PLL.
In fact, since PLL is rare, its unlikely that its causing your symptoms.
However, its a good idea to see a healthcare professional if youve been experiencing any of these symptoms for more than a week or two.
Because PLL is very rare, it can be hard to diagnose. PLL sometimes develops from existing chronic lymphocytic leukemia (CLL) and is found during lab work when monitoring CLL.
PLL is diagnosed when more than 55 percent of the lymphocytes in your blood sample are prolymphocytes. Blood work can also be checked for antibodies and antigens that can signal PLL.
If PLL isnt found during routine blood work, a healthcare professional will order more tests if you have symptoms that might indicate PLL. These tests may include:
Currently, theres no one specific treatment for either type of PLL. Your treatment will depend on how fast your PLL progresses, the type you have, your age, and your symptoms.
Since PLL is rare, your doctor will likely come up with a treatment plan specific to your case. Healthcare professionals may often encourage people with PLL to sign up for clinical trials to try new medications.
Treatments you might receive for PLL include:
PLL is an aggressive form of chronic leukemia. Therefore, the outlook is generally poor due to how quickly it may spread. But outcomes and survival rates can vary greatly between people.
As mentioned earlier, one potential cure for PLL is a stem cell transplant, although not all people with PLL are eligible to receive stem cell transplants.
Newer treatments have improved survival rates in recent years, and research into new therapies is ongoing.
PLL is a rare type of chronic leukemia. Its most commonly diagnosed in people between 65 and 70 years old. It often progresses more quickly and is treatment-resistant than other forms of chronic leukemia.
Treatment options depend on your overall health, age, symptoms, and the type of PLL you have. People are often encouraged to take part in clinical trials to take advantage of new therapies.
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Prolymphocytic Leukemia: What Is It and How Is It Treated? - Healthline
Poison ivy can work itchy evil on your skin here’s how – The Conversation US
By daniellenierenberg
A patient recently came in to our dermatology clinic with a rash and a story similar to so many others. He had been out camping with friends a few days earlier and helped carry some logs to stoke the fire. Little did he know he was going to pay for lending a helping hand. A couple days later, red patches appeared on his forearms and chest, which soon began to itch miserably and form water blisters.
If you have ever spent any time outdoors in the woods, working in the yard, even at the edges of a playground maybe youve experienced something similar after encountering poison ivy. Its not easy to forget.
Poison ivy is found everywhere in the continental U.S., mostly in Eastern and Midwestern states. Unfortunately for us humans, it is a hardy plant that can grow under many different conditions. Its favorite places are in wooded areas, gardens and roadsides with partial shade or full sunlight.
And despite being a nuisance to people, poison ivy is an important member of the ecosystem. Its leaves, stems and berries are food for animals, and its vines can be shelter for small animals like toads and mice, even helping them climb trees. Climate change is turning out to benefit poison ivy, allowing for larger and more irritating plants.
You can usually spot poison ivy by its infamous three dull or glossy green leaves coming off a red stem. Sometimes there are flowers or fruits coming off the end of a branch.
Despite its name, poison ivy is not poisonous. It carries an oily sap on its leaves and stems called urushiol, which is irritating to most peoples skin. In fact, 85% to 90% of people are allergic to poison ivys urushiol to some degree, while the rest lack sensitivity to this oil. You can occasionally see the urushiol oil as black spots on poison ivy leaves. Urushiol is what gives poison oak and poison sumac their evil power, too.
Touching poison ivy directly is obviously a bad idea. You can even get into trouble by touching clothing, pets or anything else that has brushed against the plant and picked up some of the urushiol. If a contaminated object isnt cleaned, the urushiol will remain lying in wait it can still cause a rash after hours, days or even years. Another danger is smoke from burning poison ivy, which can also affect your skin, as well as your nose, mouth, windpipe and lungs if you breathe it in.
Poison ivys rash can come in many forms, from small, red bumps to blisters or red patches. Whichever way it shows up, it is almost always mindbogglingly itchy.
When you get poisoned, you wont know right away. It can take anywhere from four hours to 10 days for the rash to appear, depending on how much urushiol gets on your skin, how sensitive you are to it and how many times you have been exposed to poison ivy previously.
Between exposure and itchy anguish, your body goes through a complex identification and reaction process. When the oil gets into your skin, your immune systems sensor cells recognize urushiol as foreign to your body. These sensor cells then call in protector cells to the area, warning them of the invasion. The protector cells defend your body against the intruder by attacking the urushiol in the skin. Unfortunately, some of your bodys normal skin cells are casualties of this war, which is what leads to the itchiness and swelling of a poison ivy rash.
Your protector cells will then sit near the skin for many years and stand guard for urushiol if it ever shows up again. If it does, they remember having encountered this bad guy before, and their response is often faster and more powerful than the first time.
This rash is a type of allergic contact dermatitis in the same family as the rashes some people get from wearing jewelry or metal belt buckles or from using certain fragrances or cosmetics.
The saying leaves of three; leave them be highlights the best strategy to prevent poison ivy: avoidance. But if you do happen to come into contact with poison ivy, the first step should always be to remove and wash any clothing that has touched the plant. Gently but thoroughly wash your skin immediately with soap and water. It can also help to clean under your fingernails and cut your nails short to prevent the urushiol from spreading if you scratch your skin.
Allergic contact dermatitis from poison ivy almost always results in a rash that usually lasts two to three weeks before it completely goes away.
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It will eventually clear up on its own, but you can try some over-the-counter and home remedies to keep the itchiness and spread of the rash at bay. The blisters that form are not infected and do not normally require antibiotics. If you scratch though and it can be very hard to resist open skin can get infected.
To reduce itchiness, cool, wet compresses can help, as can a soak in a cool bath with baking soda or oatmeal bath products. Calamine lotions or creams containing menthol can also cut the itch a bit. Over-the-counter cortisone cream or ointment can be used for the first several days after contact with poison ivy to quiet down your bodys reaction and keep the rash from getting severe. Taking antihistamines like diphenhydramine at night can slightly reduce itchiness and it has the benefit of helping you sleep better.
Seeing your doctor usually is not necessary for a poison ivy rash unless it spreads over large areas, becomes infected, lasts more than three weeks or is a rare extreme case that affects your breathing.
The best offense is a good defense. When youre in the great outdoors, be careful what you touch and, when in doubt, if it has leaves of three, leave them be.
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Poison ivy can work itchy evil on your skin here's how - The Conversation US
Pyxis Oncology Appoints Pamela Yanchik Connealy as Chief Financial Officer
By Dr. Matthew Watson
– Veteran biotech executive adds financial and operational expertise to growing Pyxis team – – Veteran biotech executive adds financial and operational expertise to growing Pyxis team –
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Pyxis Oncology Appoints Pamela Yanchik Connealy as Chief Financial Officer
STEM Animal Health completes first shipment of bluestem™ oral care products to PetSmart® Canada
By Dr. Matthew Watson
WINNIPEG, Manitoba, Aug. 31, 2021 (GLOBE NEWSWIRE) -- Kane Biotech Inc. announces that STEM Animal Health Inc., has shipped its first order of bluestem™ products to PetSmart® Canada, Canada largest specialty pet retailer of services and solutions for the lifetime needs of pets. Bluestem™ oral care products will be distributed to all 150 stores and will be available via PetSmart®’s online store.
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STEM Animal Health completes first shipment of bluestem™ oral care products to PetSmart® Canada
Immutep’s Chinese Partner, Eoc Pharma, Expands Efti Trial Pipeline
By Dr. Matthew Watson
Sydney, Aug. 31, 2021 (GLOBE NEWSWIRE) -- SYDNEY, AUSTRALIA – 31 August 2021 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or the “Company”) is pleased to advise its Chinese partner for eftilagimod alpha (“efti” or “IMP321”), EOC Pharma (“EOC”) is planning to expand its clinical trial pipeline for efti (designated EOC202 in China) in China.
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Immutep’s Chinese Partner, Eoc Pharma, Expands Efti Trial Pipeline
Tauriga Sciences, Inc. Initiates Clinical Trial to Examine the Effects of Cannabidiol Doses on Pregnant Women with Diagnosis of Hyperemesis Gravidarum
By Dr. Matthew Watson
The Company’s Proposed Cannabidiol Delivery System Utilizes its Proprietary Cannabidiol (“CBD”) Infused Chewing Gum Platform
Quanta to Present at the 2021 Wells Fargo Virtual Healthcare Conference on September 10, 2021
By Dr. Matthew Watson
ALCESTER, United Kingdom and BEVERLY, Mass., Aug. 31, 2021 (GLOBE NEWSWIRE) -- Quanta Dialysis Technologies Ltd (“Quanta” or the “Company”), a medical technology leader delivering on its vision for more flexible and accessible dialysis care, announced today John E. Milad, Chief Executive Officer, will present at the 2021 Wells Fargo Virtual Healthcare Conference on Friday, September 10, 2021, at 9:20 a.m. Eastern Time.
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Quanta to Present at the 2021 Wells Fargo Virtual Healthcare Conference on September 10, 2021
Akoya Biosciences to Present at the Morgan Stanley 19th Annual Global Healthcare Conference
By Dr. Matthew Watson
MARLBOROUGH, Mass., Aug. 31, 2021 (GLOBE NEWSWIRE) -- Akoya Biosciences, Inc. (Nasdaq: AKYA) (“Akoya”), The Spatial Biology Company®, today announced that it will be virtually participating in the Morgan Stanley 19th Annual Global Healthcare Conference.
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Akoya Biosciences to Present at the Morgan Stanley 19th Annual Global Healthcare Conference
ECMOHO Limited Announces Second Quarter 2021 Unaudited Financial Results
By Dr. Matthew Watson
SHANGHAI, China, Aug. 31, 2021 (GLOBE NEWSWIRE) -- ECMOHO Limited (Nasdaq: MOHO) (“ECMOHO”, “we” or the “Company”), a leading integrated solutions provider in the health and wellness market in China, today announced its unaudited financial results for the second quarter ended June 30, 2021.
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ECMOHO Limited Announces Second Quarter 2021 Unaudited Financial Results
Longboard Pharmaceuticals to Present at Two Upcoming Investor Conferences
By Dr. Matthew Watson
SAN DIEGO, Aug. 31, 2021 (GLOBE NEWSWIRE) -- Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today announced that Kevin R. Lind, Longboard’s President & Chief Executive Officer, will present virtually in a fireside chat format at two upcoming investor conferences: Citi’s 16th Annual BioPharma Virtual Conference and H.C. Wainwright’s 23rd Annual Global Investment Conference.
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Longboard Pharmaceuticals to Present at Two Upcoming Investor Conferences
Healthy Extracts Introduces Ultimate Brain Nutrients RELIEF™ for Migraine Sufferers, a Breakthrough Natural Treatment Clinically Shown to Reduce…
By Dr. Matthew Watson
LAS VEGAS, Aug. 31, 2021 (GLOBE NEWSWIRE) -- Healthy Extracts Inc. (OTCQB: HYEX), a leading innovator of clinically proven plant-based products for heart and brain health, has launched Ultimate Brain Nutrients RELIEF™, a proprietary, patent-pending natural formulation that provides relief from symptoms often associated with migraine headaches, while increasing brain and cognitive activation.
Genetic Technologies Reports FY21 Results as it Turns the Corner on its Commercialization Strategy
By Dr. Matthew Watson
Company to present at H.C. Wainwright 23rd Annual Global Investment Conference taking place virtually September 13-15, 2021 Company to present at H.C. Wainwright 23rd Annual Global Investment Conference taking place virtually September 13-15, 2021
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Genetic Technologies Reports FY21 Results as it Turns the Corner on its Commercialization Strategy
XORTX Announces New Clinical Advisory Board Member
By Dr. Matthew Watson
CALGARY, Alberta, Aug. 31, 2021 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (CSE:XRX) (OTCQB:XRTXF), a biotechnology company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce the addition of one new member to the Company’s clinical advisory board, Dr. Charles Edelstein.
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XORTX Announces New Clinical Advisory Board Member
Total number of shares and voting rights in Zealand Pharma at August 31, 2021
By Dr. Matthew Watson
Company announcement – No. 54 / 2021
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Total number of shares and voting rights in Zealand Pharma at August 31, 2021
Nabriva Therapeutics to Present at the H.C. Wainwright 23rd Annual Global Investment Conference
By Dr. Matthew Watson
DUBLIN, Ireland and FORT WASHINGTON, Pa., Aug. 31, 2021 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced that Ted Schroeder, Chief Executive Officer at Nabriva, will provide a company overview and business update at the H.C. Wainwright 23rd Annual Virtual Global Investment Conference. The presentation will be available on-demand starting Monday, September 13, at 7:00 A.M. (ET).
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Nabriva Therapeutics to Present at the H.C. Wainwright 23rd Annual Global Investment Conference
Zealand Pharma to Participate in Goldman Sachs 11th Annual Biotech Symposium
By Dr. Matthew Watson
Company announcement – No. 55 / 2021
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Zealand Pharma to Participate in Goldman Sachs 11th Annual Biotech Symposium