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Pembrolizumab Approved for First-Line Treatment of Patients With Colorectal Cancer and Key Mutations – AJMC.com Managed Markets Network

Posted: June 30, 2020 at 10:53 am

The decision comes almost exactly a month after results from KEYNOTE-177 were presented at the annual meeting of the American Society of Clinical Oncology.

Merck, which makes pembrolizumab, sold as Keytruda, announced the approval in a statement.

The approval covers patients who have microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer and is based on results of KEYNOTE-177, a phase 3 trial of 307 patients that found the programmed cell death-1 (PD-1) inhibitor trimmed the risk of death of disease progression 40% compared with chemotherapy, which is the current standard of care (HR = 0.60, 95% CI: 0.45-0.80, P = .0004).

Results presented at ASCO showed that pembrolizumab doubled progression-free survival in these colorectal cancer patients, from 8.2 months to 16.5 months. Lead study author Thierry Andr MD, of the Sorbonne Universit and Hpital Saint Antoine in Paris, said at the time that the findings would change the standard of care. No medical treatment has shown such an improvement, Andr said.

Discussant Michael Overman, MD, of The University of Texas MD Anderson Cancer Center, agreed and said the tumors treated in the study were particularly good candidates for immunotherapy. From now on, he said, It is critical that we test all colorectal cancer patients for mismatch repair or microsatellite status.

The approval came less than a month after Merck submitted a supplemental Biologics License Application, which was handled through FDAs Real-Time Oncology Review pilot program. According to the Merck statement, the approval was reviewed under Project Orbis, an initiative of the FDA Oncology Center of Excellence that allows for concurrent submission and review of oncology drugs among its international partnersin this case, regulators in Australia, Canada, and Switzerland.

Todays approval has the potential to change the treatment paradigm for the first-line treatment of patients with MSI-H colorectal cancer, based on the important findings from KEYNOTE-177 that showed Keytruda monotherapy demonstrated superior progression-free survival compared to standard of care chemotherapy, Roy Baynes, MD, PhD, senior vice president and head of global clinical development, chief medical officer for Merck Research Laboratories, said in the statement.

At ASCO, Andr trumpeted the value of biomarker-driven research, and Baynes did the same today. Our commitment to pursuing biomarker research continues to help us bring new treatments to patients, he said, particularly for those who have few available options.

Immune-related adverse events can include pneumonitis, colitis, hepatitis, skin reactions, renal dysfunction, and endocrinological abnormalities. Patients taking the PD-1 inhibitor may experience solid organ transplant rejection or complications from stem cell transplant.

Luis A. Diaz, MD, head of the division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center. said in the statement that patients with colorectal cancer and the genetic mutations in the study have historically faced poor outcomes, and until today, chemotherapy-containing regimens were the only FDA-approved first-line treatment options.

About 5% of metastatic colorectal cancer patients have MSI-H/dMMR. Pembrolizumabs effectiveness when this mutation is present is well-recognized, and led to FDAs firsttissue-agnostic approvalin May 2017.

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Autologous Stem Cell Transplantation Market 2020 | Incredible Possibilities, Growth With Detailed Analysis and Forecast to 2027: ANTRIA (CRO),…

Posted: June 30, 2020 at 10:53 am

The Global Autologous Stem Cell Transplantation Market Research Report provides customers with a complete analytical study that provides all the details of key players such as company profile, product portfolio, capacity, price, cost, and revenue during the forecast period from 2020 to 2027. The report provides a full assessment. Autologous Stem Cell Transplantation market with future trends, current growth factors, meticulous opinions, facts, historical data and statistically supported and industry-validated market data.

This Autologous Stem Cell Transplantation market research provides a clear explanation of how this market will impress growth during the mentioned period. This study report scanned specific data for specific characteristics such as Type, Size, Application and End User. There are basic segments included in the segmentation analysis that are the result of SWOT analysis and PESTEL analysis.

To Learn More About This Report, Request a Sample Copy:https://www.worldwidemarketreports.com/sample/285423* The sample copy includes: Report Summary, Table of Contents, Segmentation, Competitive Landscape, Report Structure, Methodology.

ANTRIA (CRO), BIOHEART, BRAINSTORM CELL THERAPEUTICS, CYTORI, DENDREON CORPORATION, FIBROCELL, GENESIS BIOPHARMA, GEORGIA HEALTH SCIENCES UNIVERSITY, NEOSTEM, OPEXA THERAPEUTICS, ORGENESIS, REGENEXX, REGENEUS, TENGION, TIGENIX, VIRXSYS are some of the major organizations dominating the global market.(*Note: Other Players Can be Added per Request)

Key players in the Autologous Stem Cell Transplantation market were identified through a second survey, and their market share was determined through a primary and second survey. All measurement sharing, splitting, and analysis were solved using a secondary source and a validated primary source. The Autologous Stem Cell Transplantation market report starts with a basic overview of the Industry Life Cycle, Definitions, Classifications, Applications, and Industry Chain Structure, and when used together, how key players can meet market coverage, offered characteristics, and customer needs It helps to understand.

The report also makes some important suggestions for new Autologous Stem Cell Transplantation market projects before evaluating their feasibility. Overall, this report covers Autologous Stem Cell Transplantation market Sales, Price, Sales, Gross Profit, Historical Growth,and Future Prospects. It provides facts related to the widespread merger, acquisition, partnership, and joint venture activities on the market.

This report includes market size estimates of value (million US $) and trading volume (K MT). The top-down and bottom-up approaches are used to estimate and validate the market size of the Autologous Stem Cell Transplantation market, estimating the size of various other subordinate markets in the overall market. All ratio sharing, splitting, and analysis were determined using the secondary source and the identified primary source.

What Autologous Stem Cell Transplantation Market report offers:

Remarkable Attributes of Autologous Stem Cell Transplantation Market Report:

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Michael Schumacher is reportedly getting another stem-cell surgery; Journalist alleged it will be an experimental procedure – EconoTimes

Posted: June 30, 2020 at 10:53 am

Michael Schumacher is still surviving as he continues to battle complications from the near-fatal head injury he sustained while skiing in 2013. It was reported that the F1 legend is set to undergo another round of stem cell procedure that will help regenerate his nervous system.

Facts about the reported new operation on Schumi

With this surgery, his family and doctors are hoping that he will be able to recover functions in parts of his body. This is because it is aimed at his sensory system that was affected by his injuries.

The Daily Mail reported that currently, Michael Schumacher is being treated and cared for by French cardiologist Dr. Philippe Menasche, a medical expert specializing in stem cell research. It was revealed that a series of surgeries are needed for this treatment, so this is just one of the racing champs operations for his recovery.

In an article that appeared in an Italian publication Le Dauphine, it was reported that Dr. Menasche will do seminal heart surgery on Schumi in his next surgery schedule. It was added that this will take place soon, but the exact date was not revealed.

It is also believed that this will be the second time that the said doctor is operating on Michael Schumacher. The first procedure was said to have been done in September 2019, and Schumi was in the hospital for about three days. At any rate, in this operation, his damaged cells will be replaced with healthy ones that will be taken from his bone marrow.

An experimental stem-cell surgery?

Michael Schumacher has not recovered from his accident that happened more than six years ago. He is currently being treated in his own home in Switzerland, but his exact condition is still a mystery since his family continues to keep everything related to his health a secret.

Dr. Nicola Acciari, a leading neurosurgeon, previously claimed that Michael Schumacher has osteoporosis and suffering from muscle atrophy since he is unable to move for years. The goal is to regenerate Michaels nervous system, The Sun quoted him as saying in connection to the stem cell therapy.

However, Jean-Michel Dcugis, a French journalist, shared to British daily national newspaper, The Times, that the procedure is experimental at this point since Dr. Menasche is actually a cardiologist.

"Our sources say that Michael Schumacher is receiving stem cell perfusions that produce a systemic anti-inflammatory effect, The Sun quoted Dcugis as saying. "It's quite mysterious as Menasch works only on the heart. He is carrying out experiments with secretome that is made by a laboratory from new stem cells and injected into veins, until now only on animals.

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Stem Cell Therapy Market Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2020 2025 – Owned

Posted: June 30, 2020 at 10:53 am

A report on Stem Cell Therapy market compiled by Brand Essence Market Research provides a succinct analysis regarding the values and trends existing in the current business scenario. The study also offers a brief summary of market valuation, market size, regional outlook and profit estimations of the industry. Furthermore, the report examines the competitive sphere and growth strategies of leading players in the Stem Cell Therapy market.

In 2018, the GlobalStem Cell Therapy Marketsize was xx million US$ and it is expected to reach xx million US$ by the end of 2025, with a CAGR of xx% during 2019-2025.

Download Premium Sample of the Report:https://industrystatsreport.com/Request/Sample?ResearchPostId=595&RequestType=Sample

Key playersof the Stem Cell Therapy market are Gilead, Novartis, Organogenesis, Vericel, Others

Stem Cell Therapy Market Segmentation:

Reports include the following segmentation: By Product TypeAdult Stem CellsHuman Embryonic Stem Cells (hESC)Induced Pluripotent Stem CellsVery Small Embryonic Like Stem CellsBy Applications TypeRegenerative MedicineDrug Discovery and DevelopmentBy TechnologyCell AcquisitionCell ProductionCryopreservationExpansion and Sub-CultureBy Cell TherapyAutologousAllogeneicBy RegionNorth Americao U.S.o Canadao MexicoEuropeo UKo Franceo Germanyo Russiao Rest of EuropeAsia-Pacifico Chinao South Koreao Indiao Japano Rest of Asia-PacificLAMEAo Latin Americao Middle Easto Africa

Region Coverage (Regional Production, Demand & Forecast by Countries etc.):North America (U.S., Canada, Mexico)Europe (Germany, U.K., France, Italy, Russia, Spain etc.)Asia-Pacific (China, India, Japan, Southeast Asia etc.)South America (Brazil, Argentina etc.)Middle East & Africa (Saudi Arabia, South Africa etc.)

Table of Contents

1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered1.4 Market Analysis by Type1.4.1 Global Stem Cell Therapy Market Size Growth Rate by Type (2014-2025)1.4.2 Topical Products1.4.3 Botulinum1.4.4 Dermal Fillers1.4.5 Chemical Peels1.4.6 Microabrasion Equipment1.4.7 Laser Surfacing Treatments1.5 Market by Application1.5.1 Global Stem Cell Therapy Market Share by Application (2014-2025)1.5.2 Hospitals1.5.3 Dermatology Clinics1.6 Study Objectives1.7 Years Considered

2 Global Growth Trends2.1 Stem Cell Therapy Market Size2.2 Stem Cell Therapy Growth Trends by Regions2.2.1 Stem Cell Therapy Market Size by Regions (2014-2025)2.2.2 Stem Cell Therapy Market Share by Regions (2014-2019)2.3 Industry Trends2.3.1 Market Top Trends2.3.2 Market Drivers2.3.3 Market Opportunities

3 Market Share by Key Players3.1 Stem Cell Therapy Market Size by Manufacturers3.1.1 Global Stem Cell Therapy Revenue by Manufacturers (2014-2019)3.1.2 Global Stem Cell Therapy Revenue Market Share by Manufacturers (2014-2019)3.1.3 Global Stem Cell Therapy Market Concentration Ratio (CR5 and HHI)3.2 Stem Cell Therapy Key Players Head office and Area Served3.3 Key Players Stem Cell Therapy Product/Solution/Service3.4 Date of Enter into Stem Cell Therapy Market3.5 Mergers & Acquisitions, Expansion Plans

Read More:https://industrystatsreport.com/Semiconductor-and-Electronics/Stem-Cell-Therapy-Market-Share/Summary

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Brandessence market research publishes market research reports & business insights produced by highly qualified and experienced industry analysts. Our research reports are available in a wide range of industry verticals including aviation, food & beverage, healthcare, ICT, Construction, Chemicals and lot more. Brand Essence Market Research report will be best fit for senior executives, business development managers, marketing managers, consultants, CEOs, CIOs, COOs, and Directors, governments, agencies, organizations and Ph.D. Students. We have a delivery center in Pune, India and our sales office is in London.

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Stem Cell Therapy Market Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2020 2025 - Owned

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Vitro Bio-Pharma 2nd Quarter Ended April 30th 2020 Financial Results of Operations and Shareholder Letter – Stockhouse

Posted: June 30, 2020 at 10:53 am

GOLDEN, COLO / ACCESSWIRE / June 29, 2020 / Vitro Diagnostics, Inc. (OTCQB:VODG), dba Vitro Biopharma, announced its 2nd quarter ended April 30th 2020 financial results of operations.

Vitro Diagnostics Inc. ("Vitro Biopharma") announced a reduction in 2nd quarter revenues across all its revenue categories. Vitro Biopharma recorded 2nd quarter revenues of $128,631 vs $211,900 a decrease of 39% over the same comparative quarter last year. Prior to the lockdowns which began at different times for different jurisdictions Vitro had reported increasing revenues across all its revenue categories for 13 consecutive quarters. We expect to see revenue returning in the 4th quarter of 2020 and into the first half of 2021. Preliminary feedback from our customers indicates that patients awaiting treatments at our partner clinic in the Cayman Islands http://www.DVCstem.com are not dropping off but merely postponing their treatments and as such a backlog is building rather than customer cancellations. The cosmetic clinics http://www.Infinivive.com have started to open up but only with reduced occupancy and variations by state and hence reduced revenue into the 3rd quarter with expectations of a revival of revenue in the 4th quarter of 2020 and into the first half of 2021.

Overall operating expenses increased in the quarter by $114,178 to $281,485 from $167,307 in the prior year's comparative quarter. The increase in expenses reflects the increased costs of FDA regulatory, legal, consulting, business and product development expenses. The company added extra resources to turn its attention to the world wide challenge of finding therapies to fight the Covid-19. Vitro filed an Investigational New Drug ("IND") application and also received emergency use authorization from the FDA for use of AlloRx Stem Cells ® in the treatment of COVID-19 patients. A patient was treated subsequent to the end of the second quarter. There were no adverse events demonstrating safety and the patient showed evidence of efficacy including improved lung and kidney function. We also entered into an MOU with GIOSTAR, a leading global stem cell research operating multiple international stem cell clinics.

During and subsequent to the quarter the company achieved and pursed the following objectives:

During the quarter and subsequent to the quarter the company continued with its Series A Convertible Preferred Stock offering to accredited investors under the SEC Regulation D exemption. The preferred Stock is priced at $25 per share which is convertible at $0.25 cents per share for a total of 100 shares. The minimum investment is $50,000 per unit. The company sold $550,000 of the Series A Convertible Preferred Stock during and subsequent to the quarter. The offering was sold out at $1,000,000 and the company is considering expanding it to ensure sufficient working capital during the Coronavirus pandemic and to start the regulatory process of current reporting audits and funding for its expanded clinical trial activities with the FDA.

As a part of our overall strategy to target both global and US stem cell markets, Vitro submitted a Phase I IND application to the FDA https://vitrobiopharma.com/vitro-biopharma-submits-ind-application-to-fda-for-allorx-stem-cellr-therapy-of-covid-19/) to assess safety of AlloRx Stem Cells® in the treatment of COVID-19 patients in the US. Recent umbilical cord stem cell therapies in China to fight the Coronavirus has produced encouraging safety and efficacy results. We are establishing strong communication channels with FDA officials to facilitate and expedite review of our application as well as subsequent steps to gain full FDA approval of AlloRx Stem Cells®. The application is presently under review and we are working closely with FDA reviewers to gain authorization to enroll patients. Several clinical centers have expressed interest in our stem cell therapy. We are also pursuing other avenues for Emergency Use Authorization (EUA). The FDA has thus far authorized three separate EUA applications for compassionate use of AlloRx Stem Cells® in COVID-19 patients. Unfortunately, two patients died prior to treatment. A single patient has been treated by three separate dosages of AlloRx Stem Cells® through an authorized EUA by GIOSTAR. There were no adverse events and the patient who has various comorbidities stabilized and exhibited enhanced pulmonary and renal functions during the six weeks following AlloRx Stem Cell® Therapy. While presently intubated and hospitalized in the ICU, this patient is exhibiting gradual improvement. We are presently pursuing additional EUA applications through our collaboration with GIOSTAR https://vitrobiopharma.com/vitro-biopharma-signs-mou-with-GIOSTAR-for-covid-19-ind-using-allorx-stem-cells/. The data obtained from these studies corroborates our studies of safety and efficacy. Mesenchymal Stem Cells ("MSCs") block the cytokine storm that occurs in COVID-19 patients in acute respiratory distress through their powerful anti-inflammatory effects. The cytokine storm leads to the need for assisted breathing by ventilators, transfer to ICU and tremendous burdens on the US health care system. It is important to note that AlloRx Stem Cells® are therapy for other viral attacks including influenza since stem cells block acute respiratory distress and damage to other major organs including cardiovascular, pulmonary and renal systems. AlloRx Stem Cells® are very likely to assist in recovery from failure of various organ systems in COVID-19 survivors, as our case study is demonstrating.

We entered into an exclusive Memorandum of Understanding (MOU) with Global Institute of Stem Cell Therapy and Research, Inc. ("GIOSTAR") a leading stem cell research institute based in San Diego, California to jointly partner together for a separate COVID-19 Investigational New Drug ("IND") application to the FDA using Vitro Biopharma's umbilical cord MSC product AlloRx Stem Cells in a clinical trial to treat Covid-19 patients https://vitrobiopharma.com/vitro-biopharma-signs-mou-with-GIOSTAR-for-covid-19-ind-using-allorx-stem-cells/ GIOSTAR is a worldwide leader in the in the field of stem cell research and has stem cell research and treatment facilities around the world. GIOSTAR is leading the way for filling the joint IND application for a Covid-19 trial with the FDA while Vitro will provide its AlloRx Stem Cells® for use in the study and post-approval stages through a supply agreement with GIOSTAR. GIOSTAR has already obtained EUAs from the FDA for using stem cell treatment for severe Covid-19 hospitalized patients using AlloRx Stem Cells®. https://www.GIOSTAR.com/2020/05/01/GIOSTAR-announces-fda-approval-compassionate-use-treat-covid-19-stem-cells-2/

Vitro will continue to seek FDA authorization of its pending IND. As the approval process proceeds, Vitro will seek AlloRx Stem Cells® FDA approval through Phase 2/3 IND filings for indications other than COVID-19 such as osteoarthritis while at the same time continuing to supply GIOSTAR AlloRx Stem Cells® for treatment of COVID-19 patients in global markets.

GIOSTAR in collaboration with government of Gujarat, India is building one of the world's largest stem cell hospitals. This is a dream project of India's Prime Minister Narendra Modi. The MOU stated the intended discussions regarding the use of AlloRx Stem Cells® at GIOSTAR's various international stem cell facilities that would provide quality and economic advantages.

The company is doubling its laboratory and manufacturing facilities and expanding its clean room by 100% in size and capacity. This new facility is expected to be online during the 1st quarter of next year. This represents approximately $6M of AlloRx Stem Cell Vitro Biopharma revenue capacity per year. Furthermore, the completion of the 2nd clean room processing facility at the beginning of the 2021 year will expand our capacity to approximately 100 Billion AlloRx Stem Cell s a month or approximately $1.7 Million of AlloRx Stem Cell Vitro Biopharma revenue capacity per month. This would give Vitro Biopharma a revenue run rate capacity of $20M a year.

Our increased capacity is rigorously controlled by our Quality Management System, now certified to the ISO9001 Quality and the ISO13485 Medical Device Standards as well. This provides GMP-compliant manufacturing of the highest quality stem cells/medical devices for clinical trial testing to provide further evidence of safety and efficacy for treatment of a wide variety of indications. Highly regulated GMP biologics manufacturing within an FDA-compliant facility provides numerous opportunities to the Company to drive strong revenue growth. We are presently focused on our partnerships in the Caribbean with DVC Stem in Grand Cayman Island, Infinivive MD in the US and emerging opportunities in the Commonwealth of the Bahamas. We are actively pursuing other partnership opportunities as well.

We have reformulated with our Contract Manufacture to produce STEMulize in large quantity manufacturing runs. STEMulize contains natural substances that activate the body's own stem cells to enhance recovery from injury such as TBI, stroke, MS, PD and other autoimmune, inflammatory and neurological diseases. The STEMulize product will be offered as a private label product to Infinivive MD clinics and is being implemented as supplemental support to clinical treatments now ongoing in the Cayman Islands. Patients report positive benefits from STEMulize therapy following stem cell transplants including increased overall energy and enhancement of improved motor function in MS patients. We are currently pursing licensing arrangements with nutraceutical companies that can scale our formulation under their own private label.

The Company's cosmetic stem cell serum private labelled as Infinivive MD Serum is being applied as a topical cosmetic serum in medical spas and plastic surgery offices. Infinivive MD revenue was reduced by the Coronavirus pandemic and as a result, revenues declined by 50% in the quarter to approximately $50,000 vs $100,000 in the prior quarter. This also compares to $50,000 in the current quarter of 2020 vs $130,000 in the prior comparative quarter of 2019.

The Joint Development and Supply Agreement dated May 15th 2018 between Vitro Biopharma and Jack Zamora is being renegotiated due to the Coronavirus pandemic and as such the minimum exclusivity requirements have been delayed by approximately a year.

Infinivive MD Cosmetic Serum is revolutionizing the cosmetic industry. Patients are experiencing unparalleled improvements in the appearance of fine lines and wrinkles. This is one of the fastest growing revenue streams for Vitro Biopharma. We work with a variety of regulatory experts to assist us in the appropriate regulatory pathway. At this point it is regulated as a cosmetic topical product but may be reclassified based on regulatory input.

http://www.jackzamoramd.comwww.infinivivemd.com

Infinivive MD also has an exclusive agreement to distribute AlloRx Stem Cells into the countries of Saudi Arabia, U.A.E., and Colombia. A trial was conducted in Kuwait prior to the pandemic and upon reopening of the country the first commercial orders will be shipped. The agreement calls for minimum commitments to maintain exclusivity and provides for minimum revenue of $250,000 annually in 2020. However due to the worldwide Corona Virus lockdown of business and customers the agreement for performance requirements have been delayed by approximately a year.

Vitro Biopharma's OEM cosmetic topical serum is being distributed exclusively by Infinivive MD into cosmetic clinics that are providing the topical treatment as a beautification product. To date the company's product is being offered in a number of clinics throughout the United States and soon internationally; but with the clinics just opening again for business and with limited occupancy rules we do not expect this revenue to recover back to peak levels with growth until the first half of 2021.

Update on the Clinical Trial of Musculoskeletal Conditions in the Bahamas

This initiative broadens Vitro Biopharma's expansion into highly regulated stem cell trials in collaboration with the Nassau-based Medical Pavilion of the Bahamas (TMPB).

Home

We will now be able to extend stem cell therapy based on our novel, patent-pending AlloRx Stem Cell product to a variety of musculoskeletal conditions. These include OA of any joint, ACL/MCL tear, Achilles tendon rupture, rotator cuff injury, tennis elbow and herniated disc that are highly prevalent and have few disease-modifying options. It is important to note that many stem cell treatments now performed are problematic due to limited potency and failure to meet basic qualification criteria of MSC stem cells.. Also, contamination due to poor production methods that are not in compliance with FDA regulations has caused serious complications, resulting in FDA warning letters due to manufacturing infractions. Vitro Biopharma operates a highly regulated, FDA-compliant commercial biologics manufacturing operation for several years and is cGMP compliant, ISO 9001 Certified, ISO 13485 Certified, CLIA Certified and FDA registered. All manufacturing occurs in a certified sterile clean room with extensive and advanced testing to assure the absence of contamination. Furthermore, in numerous patients treated to date by IV infusion of AlloRx Stem Cells there have been no significant adverse events.''

The company is partnered with Dr. Conville Brown, MD, MBBS, FACC, FESC, PhD, the founder and CEO of the Medical Pavilion of the Bahamas who is the Principal Investigator of this trial and director of its clinical administration. Dr Brown was instrumental in the establishment of the National Stem Cell Ethics Committee in the Bahamas.

About the Medical Pavilion of the Bahamas: TMPB operates within a 40,000 square foot building as a partnered care specialty medical facility with 10 different centers in various areas including cardiology, cancer, clinical research and kidney disease. One of the centers is the Partners Stem Cell Centre, where the present trial will be conducted. The Partners Stem Cell Centre provides an environment to conduct stem cell research and clinical trials under the model of ''FDA rigor in a Non-FDA Jurisdiction'' TMPB employs 20 medical specialists in various fields. See http://www.tmp-bahamas.com for additional information.

The company expects to begin patient enrollment for the clinical trial in late QIV but does not expect to realize revenue until QI/QII of 2021.

Due to the Corona virus pandemic the Cayman Islands closed itself and its businesses down for the majority of the quarter and next quarter, the current status is listed as locked down until Sept. 1st 2020. However, our partner reports that customers are staying on the waiting list and will return for their treatments as soon as the island opens back up. There currently is a backlog of patients of over 40 treatments pending which exceeds all of the treatments performed in 2019. We expect to see a surge in revenues from this backlog to bring back our revenue stream in the fourth quarter of 2020 and into the first half of 2021.

The Company has several patent applications (11) pending in the US and foreign jurisdictions. These patents cover our AlloRx Stem Cell line and various aspects of our STEMulize stem cell activation products & processes as well as specific diagnostic tests of stem cell activity and therapeutic effectiveness. During the quarter, the Company has responded to office actions and continues to vigorously prosecute & expand its patent filings.

Dr. Jim Musick, CEO of Vitro Biopharma, said, "We are pleased to report our activities in fighting the Covid-19 with filings of our eIND and INDs and partnership with GIOSTAR. While we are disappointed in the extraordinary impact of the Corona Virus pandemic and its results on our operations, we have taken the time to advance our clinical applications and partnerships in further preparation for realized growth in 2021 as a result of these activities.

Our stem cell products are distinctly superior to stem cell transplants in the USA. The latter usually involve use of impure products lacking validation as stem cells and containing insufficient numbers of stem cells to achieve therapeutic benefits. These are produced without regulatory oversight and have been known to cause serious adverse effects. Hence the use of highly purified and well characterized stem cells (AlloRx Stem Cells) is needed to provide safety and efficacy in regenerative medicine therapies.

In summary, Vitro Biopharma is advancing as a key player in regenerative medicine with 10+ years' experience in the development and commercialization of stem cell products for research, recognized by a Best in Practice Technology Innovation Leadership award for Stem Cell Tools and Technology and a growing track record of successful translation to therapy. We plan to leverage our proprietary technology platform to the establishment of international Stem Cell Centers of Excellence and regulatory approvals in the US and worldwide.

Vitro Biopharma has supplied major biopharmaceutical firms, elite university laboratories and clinical trials worldwide with its Umbilical Cord Mesenchymal Stem Cells (AlloRx Stem Cells), and it's MSC-Grow Brand of cell culture media along with advanced stem cell diagnostic services. http://www.vitrobiopharma.com

Sincerely yours,

James R. Musick, PhD. President, CEO & Chairman of the Board http://www.vitrobiopharma.com

Forward-Looking Statements

Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company's 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 Company's 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 Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's 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. James Musick Chief Executive Officer Vitro BioPharma (303) 999-2130 Ext. 3 E-mail: jim@vitrobiopharma.com http://www.vitrobiopharma.com

Vitro Diagnostics, Inc.

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Vitro Diagnostics, Inc.

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Equipment,Patent and other capital Expenditures

Net cash used in operations during the Quarter

Cashflows from Financing Activities during the Quarter

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Vitro Bio-Pharma 2nd Quarter Ended April 30th 2020 Financial Results of Operations and Shareholder Letter - Stockhouse

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Stem Cell Assay Market To Witness Growth Acceleration During 2020 to 2026 – News by aeresearch

Posted: June 30, 2020 at 10:53 am

Growing at a steady pace, this Stem Cell Assay market research values the industry size in USD million terms for 2020 and expected USD million value by the end of 2026 is provided for decision makers and stakeholders interested in Stem Cell Assay market. The report on Stem Cell Assay market provides qualitative as well as quantitative analysis in terms of market dynamics, competition scenarios, opportunity analysis, market growth, industrial chain, etc.

The Stem Cell Assay market research report provides a thorough analysis regarding the production and the consumption patterns of this industry vertical. Based on production aspect, the study offers crucial insights pertaining to the manufacturing patterns of the items, revenue share, and its respective impact on the overall gross margins of the producers.

As per consumption patterns, the document assesses the consumption value and volume regarding each of the product offerings, their sale prices and import & export conditions across various regions listed. Additionally, the report also delivers production and consumption expectations, during the ongoing COVID-19 pandemic.

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Categorize data at the regional level as well as revenue and growth of in these regions

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Upstream raw materials and manufacturing equipment are investigated.

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Stem Cell Assay Market To Witness Growth Acceleration During 2020 to 2026 - News by aeresearch

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Global Cell Isolation/Cell Separation Market Industry Analysis and Forecast (2019-2026) – Morning Tick

Posted: June 30, 2020 at 10:53 am

Global Cell Isolation/Cell Separation Market was valued US$ XX Bn in 2018 and is expected to reach US$ 17.92 Bn by 2026, at a CAGR of around XX % during a forecast period.

The report covers all the trends and technologies playing a major role in the growth of the Cell Isolation/Cell Separation market during the forecast period. It highlights the drivers, restraints, and opportunities expected to influence the market growth during 2019-2026.

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Some of the market drivers for the cell isolation/cell separation market are increasing incidences & prevalence of chronic diseases with the aging population, technological advancement in cell isolation, growing demand for bio-pharmaceuticals, personalized medicine, and increasing stem cell research. Cell isolation or separation is a tool used to sort cells into a specific population from a heterogeneous group of cells without contamination. The use of cell isolation techniques helps to open the door of cell-based therapies and thereby improve the quality of treatment and clinical outcome.

However, the ethical issues regarding the isolation of embryonic stem cells and the high cost of cell separation instruments are expected to restrict the growth of this market during the forecast period.

Based on cell type, the human cell segment is expected to register a major revenue share in the cell isolation/cell separation market globally. Owing to increasing investments by public and private organizations for research on human cells, growing application areas of human stem cells, and the high frequency and growing incidence of diseases such as cancer.

Based on the product, the consumables segment is expected to witness the fastest growth during the forecast period. Because of the increasing investments by companies to develop advanced products and the rising government initiatives for improving cell-based research are driving the growth of this segment.

North America region is expected to grow at a XX % rate of CAGR during the forecast period owing to increasing government support for cancer and stem cell research, the expanding biotechnology and biopharmaceutical industries and the increasing prevalence of chronic and infectious diseases in which cell isolation is required for diagnosis and treatment. Which results in, increase in demand for cell isolation products.

The objective of the report is to present a comprehensive assessment of the market and contains thoughtful insights, facts, historical data, industry-validated market data and projections with a suitable set of assumptions and methodology. The report also helps in understanding Global Cell Isolation/Cell Separation Market dynamics, structure by identifying and analyzing the market segments and project the global market size. Further, the report also focuses on the competitive analysis of key players by product, price, financial position, product portfolio, growth strategies, and regional presence. The report also provides PEST analysis, PORTERs analysis, and SWOT analysis to address the question of shareholders to prioritizing the efforts and investment in the near future to the emerging segment in Global Cell Isolation/Cell Separation Market.

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Scope of the Global Cell Isolation/Cell Separation Market

Global Cell Isolation/Cell Separation Market, By Product

Consumableso Reagents, Kits, Media, and Serao Beadso Disposables Instrumentso Centrifugeso Flow Cytometerso Magnetic-activated Cell Separator Systemso Filtration SystemsGlobal Cell Isolation/Cell Separation Market, By Cell Type

Human Cellso Differentiated Cellso Stem Cells Animal CellsGlobal Cell Isolation/Cell Separation Market, By Cell Source

Adipose Tissue Bone Marrow Cord Blood/Embryonic Stem CellsGlobal Cell Isolation/Cell Separation Market, By Technique

Centrifugation-based Cell Isolation Surface Marker-based Cell Isolation Filtration-based Cell IsolationGlobal Cell Isolation/Cell Separation Market, By Application

Biomolecule Isolation Cancer Research Stem Cell Research Tissue Regeneration & Regenerative Medicine In Vitro DiagnosticsGlobal Cell Isolation/Cell Separation Market, By End user

Research Laboratories and Institutes Hospitals and Diagnostic Laboratories Biotechnology and Biopharmaceutical Companies Other End UsersGlobal Cell Isolation/Cell Separation Market, By Region

North America Europe Asia Pacific Middle East & Africa South AmericaKey players operating in the Global Cell Isolation/Cell Separation Market

Thermo Fisher Scientific Beckman Coulter Becton, Dickinson and Company GE Healthcare Merck KgaA Miltenyi Biotech pluriSelect STEMCELL Technologies Inc. Terumo BCT Bio-Rad Laboratories Inc.

MAJOR TOC OF THE REPORT

Chapter One: Cell Isolation/Cell Separation Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Cell Isolation/Cell Separation Market Competition, by Players

Chapter Four: Global Cell Isolation/Cell Separation Market Size by Regions

Chapter Five: North America Cell Isolation/Cell Separation Revenue by Countries

Chapter Six: Europe Cell Isolation/Cell Separation Revenue by Countries

Chapter Seven: Asia-Pacific Cell Isolation/Cell Separation Revenue by Countries

Chapter Eight: South America Cell Isolation/Cell Separation Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Cell Isolation/Cell Separation by Countries

Chapter Ten: Global Cell Isolation/Cell Separation Market Segment by Type

Chapter Eleven: Global Cell Isolation/Cell Separation Market Segment by Application

Chapter Twelve: Global Cell Isolation/Cell Separation Market Size Forecast (2019-2026)

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Global Cell Isolation/Cell Separation Market Industry Analysis and Forecast (2019-2026) - Morning Tick

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Human Genetics Market 2020: Challenges, Growth, Types, Applications, Revenue, Insights, Growth Analysis, Competitive Landscape, Forecast- 2025 – Cole…

Posted: June 30, 2020 at 10:51 am

Genetics is that the study of genes, their functions and their effects. Among the varied sorts of biology like genetic science, developmental genetic science, population genetics and quantitative genetic science, human genetics is that the study that deals with the inheritance happens in folks. It encompasses a range of overlapping fields like classical biology, genetics, genetic science, genetics and plenty of additional.

The Human Genetics Market is expected to exceed at a CAGR of 9.5% in the given forecast period.

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The Human Genetics Market is segmented on the lines of its methods, product, applications, end-users and regional. Based on methods segmentation it covers cytogenetic, molecular, presymptomatic and prenatal. Based on product it covers Consumables, devices and accessories. Based on end-user analysis it covers hospitals, clinics, research centers and forensic departments. Based on application it covers research, diagnostic and forensic science and others. Based on Others it covers Hysteroscopy Instruments Market on geographic segmentation covers various regions such as North America, Europe, Asia Pacific, Latin America, Middle East and Africa. Each geographic market is further segmented to provide market revenue for select countries such as the U.S., Canada, U.K. Germany, China, Japan, India, Brazil, and GCC countries.

This report provides:

1) An overview of the global market for Human Genetics Market and related technologies.2) Analyses of global market trends, with data from 2015, estimates for 2016 and 2017, and projections of compound annual growth rates (CAGRs) through 2024.3) Identifications of new market opportunities and targeted promotional plans for Human Genetics Market.4) Discussion of research and development, and the demand for new products and new applications.5) Comprehensive company profiles of major players in the industry.

Report Scope:

The scope of the report includes a detailed study of Human Genetics Market with the reasons given for variations in the growth of the industry in certain regions.

The report covers detailed competitive outlook including the market share and company profiles of the key participants operating in the global market. Key players profiled in the report include Agilent Technologies, Bode Technology, GE Healthcare, Illumina, LGC Forensics, Orchid Cell mark, Inc., Promega Corporation, QIAGEN N.V., Thermo Fisher Scientific, Inc. Company profile includes assign such as company summary, financial summary, business strategy and planning, SWOT analysis and current developments.

The Human Genetics Market has been segmented as below:

The Human Genetics Market is Segmented on the lines of Application Type, Methods, Product Type, End-user and Regional Analysis. By Application Type this market is segmented on the basis of Research, Diagnostic, Forensic science and Others. By Methods this market is segmented on the basis of Cytogenetic, Molecular, Presymptomatic and Prenatal.

By Product Type this market is segmented on the basis of Consumables, Devices and Accessories. By End-user this market is segmented on the basis of Hospitals sector, Clinics sector, Research centers sector and Forensic departments sector. By Regional Analysis this market is segmented on the basis of North America, Europe, Asia-Pacific and Rest of the World.

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Human Genetics Market 2020: Challenges, Growth, Types, Applications, Revenue, Insights, Growth Analysis, Competitive Landscape, Forecast- 2025 - Cole...

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Race Is Real, But It’s Not Genetic – Discover Magazine

Posted: June 30, 2020 at 10:51 am

A friend of mine with Central American, Southern European and West African ancestry islactose intolerant. Drinking milk products upsets her stomach, and so she avoids them. About a decade ago, because of her low dairy intake, she feared that she might not be getting enough calcium, so she asked her doctor for abone density test. He responded that she didnt need one because blacks do not get osteoporosis.

My friend is not alone. The view that black people dont need a bone density test is a longstanding and common myth. A2006 studyin North Carolina found that out of 531 African American and Euro-American women screened for bone mineral density, only 15 percent were African American women despite the fact that African American women made up almost half of that clinical population. A health fair in Albany, New York, in 2000,turned into a ruckuswhen black women were refused free osteoporosis screening. The situationhasnt changed muchin more recent years.

Meanwhile,FRAX, a widely used calculatorthat estimates ones risk of osteoporotic fractures, is based on bone density combined with age, sex and, yes, race. Race, even though it is never defined or demarcated, is baked into the fracture risk algorithms.

Lets break down the problem.

First, presumably based on appearances, doctors placed my friend and others into a socially defined race box called black, which is a tenuous way to classify anyone.

Race is a highly flexible way in which societies lump people into groups based on appearance that is assumed to be indicative of deeper biological or cultural connections. As a cultural category, the definitions and descriptions of races vary. Color lines based on skin tone can shift, which makes sense, but the categories are problematic for making any sort of scientific pronouncements.

Second, these medical professionals assumed that there was a firm genetic basis behind this racial classification, which there isnt.

Third, they assumed that this purported racially defined genetic difference would protect these women from osteoporosis and fractures.

Some studies suggestthat African American women meaning women whose ancestry ties back to Africa may indeed reach greater bone density than other women, which could be protective against osteoporosis. But that does not mean being black that is, possessing an outward appearance that is socially defined as black prevents someone from getting osteoporosis or bone fractures. Indeed, this same research also reports that African American women are more likely to die after a hip fracture. The link between osteoporosis risk and certain racial populations may be due to lived differencessuch as nutritionandactivity levels, both of which affect bone density.

But more important:Geographicancestry is not the same thing as race. African ancestry, for instance, does not tidily map onto being black (or vice versa). In fact, a2016 studyfound wide variation in osteoporosis risk among women living in different regions within Africa. Their genetic risks have nothing to do with their socially defined race.

When medical professionals or researchers look for ageneticcorrelateto race, they are falling into a trap: They assume thatgeographic ancestry, which does indeed matter to genetics, can be conflated with race, which does not. Sure, different human populations living in distinct places may statistically have different genetic traits such as sickle cell trait (discussed below) but such variation is aboutlocal populations(people in a specific region), not race.

Like a fish in water, weve all been engulfed by the smog of thinking that race is biologically real. Thus, it is easy to incorrectly conclude that racial differences in health, wealth and all manner of other outcomes are the inescapable result of genetic differences.

The reality is that socially defined racial groups in the U.S. and most everywhere else do differ in outcomes. But thats not due to genes. Rather, it is due to systemic differences in lived experience and institutional racism.

Communities of color in the United States, for example, often have reduced access to medical care, well-balanced diets andhealthy environments. They are often treated more harshly in their interactions withlaw enforcement and the legal system. Studies show that they experience greater social stress, includingendemic racism, that adversely affects all aspects of health. For example, babies born to African American women are more thantwice as likely to diein their first year than babies born to non-Hispanic Euro-American women.

Systemic racism leads to different health outcomes for various populations. The infant mortality rate, for example, for African American infants is double that for European Americans. (Credit: Kelly Lacy/Pexels)

As a professor of biological anthropology, I teach and advise college undergraduates. While my students are aware of inequalities in the life experiences of different socially delineated racial groups, most of them also think that biological races are real things. Indeed, more than half of Americans still believe that their racial identity is determined byinformation contained in their DNA.

For the longest time, Europeans thought that the sun revolved around the Earth. Their culturally attuned eyes saw this as obvious and unquestionably true. Just as astronomers now know thats not true,nearly all population geneticistsknow that dividing people into races neither explains nor describes human genetic variation.

Yet this idea of race-as-genetics will not die. For decades, it has been exposed to the sunlight of facts, but, like a vampire, it continues to suck blood not only surviving but causing harm in how it can twist science to support racist ideologies. With apologies for the grisly metaphor, it is time to put a wooden stake through the heart of race-as-genetics. Doing so will make for better science and a fairer society.

In 1619, the first people from Africa arrived in Virginia and became integrated into society. Only after African and European bond laborers unified in various rebellions did colony leaders recognize the need to separate laborers.Race dividedindentured Irish and other Europeans from enslaved Africans, and reduced opposition by those of European descent to the intolerable conditions of enslavement. What made race different from other prejudices, including ethnocentrism (the idea that a given culture is superior), is that it claimed that differences were natural, unchanging and God-given. Eventually, race also received the stamp of science.

Over the next decades, Euro-American natural scientists debated the details of race, asking questions such as how often the races were created (once, as stated in the Bible, or many separate times), the number of races and their defining, essential characteristics. But they did not question whether races were natural things. They reified race, making the idea of race real by unquestioning, constant use.

In the 1700s, Carl Linnaeus, the father of modern taxonomy and someone not without ego, liked to imagine himself asorganizing what God created. Linnaeus famously classified ourown species into racesbased on reports from explorers and conquerors.

The race categories he created includedAmericanus,Africanus, and evenMonstrosus(for wild and feral individuals and those with birth defects), and their essential defining traits included a biocultural mlange of color, personality and modes of governance. Linnaeus describedEuropeausas white, sanguine and governed by law, andAsiaticusas yellow, melancholic and ruled by opinion. These descriptions highlight just how much ideas of race are formulated by social ideas of the time.

Swedish taxonomist Carl Linnaeus divided humanity up into racial categories according to his notion of shared essences among populations, a concept researchers now recognize has no scientific basis. (Credit: Wikimedia Commons/Public Domain)

In line with early Christian notions, these racial types were arranged in a hierarchy:a great chain of being, from lower forms to higher forms that are closer to God. Europeans occupied the highest rungs, and other races were below, just above apes and monkeys.

So, the first big problems with the idea of race are that members of a racial group do not share essences, Linnaeus idea of some underlying spirit that unified groups, nor are races hierarchically arranged. A related fundamental flaw is that races were seen to be static and unchanging. There is no allowance for a process of change or what we now call evolution.

There have been lots of efforts since Charles Darwins time to fashion the typological and static concept of race into an evolutionary concept. For example, Carleton Coon, a former president of the American Association of Physical Anthropologists, argued inThe Origin of Races(1962) that five racesevolved separatelyand became modern humans at different times.

One nontrivial problem with Coons theory, and all attempts to make race into an evolutionary unit, is that there is no evidence. Rather, all the archaeological and genetic data point to abundant flows of individuals, ideas and genes across continents, withmodern humansevolving at the same time, together.

Afew pundits such asCharles Murrayof the American Enterprise Institute and science writers such asNicholas Wade, formerly ofThe New York Times, still argue that even though humans dont come in fixed, color-coded races, dividing us into races still does a decent job ofdescribinghuman genetic variation. Their position is shockingly wrong. Weve known for almost 50 years that race does not describe human genetic variation.

In 1972, Harvard evolutionary biologist Richard Lewontinhad the idea to testhow much human genetic variation could be attributed to racial groupings. He famously assembled genetic data from around the globe and calculated how much variation was statistically apportioned within versus among races. Lewontin found that only about 6 percent of genetic variation in humans could be statistically attributed to race categorizations. Lewontin showed that the social category of race explains very little of the genetic diversity among us.

Furthermore, recent studies reveal that the variation between any two individuals isverysmall, on the order of onesingle nucleotide polymorphism(SNP), or single letter change in our DNA, per 1,000. That means that racial categorization could, at most, relate to 6 percent of the variation found in 1 in 1,000 SNPs. Put simply, race fails to explain much.

In addition, genetic variation can be greaterwithingroups that societies lump together as one race than it is between races. To understand how that can be true, first imagine six individuals: two each from the continents of Africa, Asia and Europe. Again, all of these individuals will be remarkably the same: On average, only about 1 out of 1,000 of their DNA letters will be different. A study by Ning Yu and colleaguesplaces the overall difference more precisely at 0.88 per 1,000.

The researchers further found that people in Africa had less in common with one another than they did with people in Asia or Europe. Lets repeat that: On average, two individuals in Africa aremoregenetically dissimilar from each other than either one of them is from an individual in Europe or Asia.

Homo sapiensevolved in Africa; the groups that migrated out likely did not include all of the genetic variation that built up in Africa. Thats an example of what evolutionary biologists call thefounder effect, where migrant populations who settle in a new region have less variation than the population where they came from.

Genetic variation across Europe and Asia, and the Americas and Australia, is essentially a subset of the genetic variation in Africa. If genetic variation were a set of Russian nesting dolls, all of the other continental dolls pretty much fit into the African doll.

What all these data show is that the variation that scientists from Linnaeus to Coon to the contemporary osteoporosis researcher think is race is actually much better explained by a populationslocation. Genetic variation is highly correlated togeographic distance. Ultimately, the farther apart groups of people are from one another geographically, and, secondly, the longer they have been apart, can together explain groups genetic distinctions from one another. Compared to race, those factors not only better describe human variation, they invoke evolutionary processes to explain variation.

Those osteoporosis doctors might argue that even though socially defined race poorly describes human variation, it still could be a useful classification tool in medicine and other endeavors. When the rubber of actual practice hits the road, is race a useful way to make approximations about human variation?

When Ive lectured at medical schools, my most commonly asked question concerns sickle cell trait. Writer Sherman Alexie, a member of the Spokane-Coeur dAlene tribes, put the question this wayin a 1998 interview: If race is not real, explain sickle cell anemia to me.

OK! Sickle cell is a genetic trait: It is the result of an SNP that changes the amino acid sequence of hemoglobin, the protein that carries oxygen in red blood cells. When someone carries two copies of the sickle cell variant, they will have the disease. In the U.S., sickle cell disease is most prevalent in people who identify as African American, creating the impression that it is a black disease.

(Credit: SciePro/Shutterstock)

Yet scientists have known about the much more complexgeographic distributionof sickle cell mutation since the 1950s. It is almost nonexistent in the Americas, most parts of Europe and Asia and also in large swaths of Northern and Southern Africa. On the other hand, it is common in West-Central Africa and also parts of the Mediterranean, Arabian Peninsula, and India. Globally, it does not correlate with continents or socially defined races.

Inone of the most widely citedpapers in anthropology, American biological anthropologist Frank Livingstone helped to explain the evolution of sickle cell. He showed that places with a long history of agriculture and endemic malaria have a high prevalence of sickle cell trait (a single copy of the allele). He put this information together with experimental and clinical studies that showed how sickle cell trait helped people resist malaria, and made a compelling case for sickle cell trait being selected for in those areas.Evolution and geography, not race, explain sickle cell anemia.

What about forensic scientists: Are they good at identifying race? In the U.S., forensic anthropologists are typically employed by law enforcement agencies to help identify skeletons, including inferences about sex, age, height and race. The methodological gold standards for estimating race are algorithms based on a series of skull measurements, such as widest breadth and facial height. Forensic anthropologists assume these algorithms work.

The origin of the claim that forensic scientists are good at ascertaining race comes from a 1962 study of black, white and Native American skulls, which claimed an 8090 percent success rate. That forensic scientists are good at telling race from a skull is a standard trope of both thescientific literatureandpopular portrayals.But my analysisof four later tests showed that the correct classification of Native American skulls from other contexts and locations averaged about two incorrect for every correct identification. The results are no better than a random assignment of race.

Thats because humans are not divisible into biological races. On top of that, human variation does not stand still. Race groups are impossible to define in any stable or universal way. It cannot be done based on biology not by skin color, bone measurements or genetics. It cannot be done culturally: Race groupings have changed over time and place throughout history.

Science 101: If you cannot define groups consistently, then you cannot make scientific generalizations about them.

Skull measurements are a longstanding tool in forensic anthropology. (Credit: Internet Archive Book Images/Flickr/Public Domain)

Wherever one looks, race-as-genetics is bad science. Moreover, when society continues to chase genetic explanations, it misses the larger societal causes underlying racial inequalities in health, wealth and opportunity.

To be clear, what I am saying is that human biogenetic variation is real. Lets just continue to study human genetic variation free of the utterly constraining idea of race. When researchers want to discuss genetic ancestry or biological risks experienced by people in certain locations, they can do so without conflating these human groupings withracial categories. Lets be clear that genetic variation is an amazingly complex result of evolution and mustnt ever be reduced to race.

Similarly, race is real, it just isnt genetic. Its a culturally created phenomenon. We ought to know much more about the process of assigning individuals to a race group, including the category white. And we especially need to know more about the effects of living in a racialized world: for example, how a societys categoriesand prejudiceslead to health inequalities. Lets be clear that race is a purely sociopolitical construction with powerful consequences.

It is hard to convince people of the dangers of thinking race is based on genetic differences. Like climate change, the structure of human genetic variation isnt something we can see and touch, so it is hard to comprehend. And our culturally trained eyes play a trick on us by seeming to see race as obviously real. Race-as-genetics is even more deeply ideologically embedded than humanitys reliance on fossil fuels and consumerism. For these reasons, racial ideas will prove hard to shift, but it is possible.

Over 13,000 scientistshave come together to form and publicize a consensus statement about the climate crisis, and that has surely moved public opinion to align with science. Geneticists and anthropologists need to do the same for race-as-genetics. The recent American Association of Physical AnthropologistsStatement on Race & Racismis a fantastic start.

In the U.S., slavery ended over 150 years ago and the Civil Rights Law of 1964 passed half a century ago, but the ideology of race-as-genetics remains. It is time to throw race-as-genetics on the scrapheap of ideas that are no longer useful.

We can start by getting my friend and anyone else who has been denied that long-overdue bone density test.

Alan Goodmanis a professor of biological anthropology at Hampshire College in Massachusetts. This story was originally posted onSAPIENS. Read the original articlehere.

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Race Is Real, But It's Not Genetic - Discover Magazine

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Seattle Genetics Announces Positive Topline Results from Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer -…

Posted: June 30, 2020 at 10:51 am

- Full Data to be Presented at an Upcoming Medical Meeting -

Seattle Genetics, Inc. (Nasdaq:SGEN) today announced positive topline results from the phase 2 single-arm clinical trial known as innovaTV 204 evaluating tisotumab vedotin administered every three weeks for the treatment of patients who have relapsed or progressed on or after prior treatment for recurrent or metastatic cervical cancer. Results from the trial showed a 24 percent confirmed objective response rate (ORR) by independent central review [95% Confidence Interval: 15.9%-33.3%] with a median duration of response (DOR) of 8.3 months. The most common treatment-related adverse events (greater than or equal to 20 percent) included alopecia, epistaxis (nose bleeds), nausea, conjunctivitis, fatigue and dry eye. The data will be submitted for presentation at an upcoming medical meeting.

Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) directed to tissue factor, which is expressed on cervical cancer and can promote tumor growth, angiogenesis and metastases.1 Standard therapies for previously treated recurrent and/or metastatic cervical cancer generally result in limited objective response rates of typically less than 15 percent with median overall survival ranging from 6.0 to 9.4 months, in an all-comers population.1-8 Tisotumab vedotin is being developed by Seattle Genetics in collaboration with Genmab.

"Available therapies upon progression after first line chemotherapy in recurrent or metastatic cervical cancer are limited, and there is a significant unmet need for new treatment options," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "Tisotumab vedotin has demonstrated clinically meaningful and durable objective responses with a manageable safety profile, and we look forward to discussing with the FDA the potential submission of a Biologics License Application to support an accelerated approval."

Cervical cancer originates in the cells lining the cervix. Over 13,500 women are expected to be diagnosed with cervical cancer in the U.S. in 2020, with approximately 4,200 deaths.9 Cervical cancer remains one of the leading causes of cancer death in women globally, with over 311,000 women dying annually; the vast majority of these women being in the developing world.10 Routine medical examinations and the human papillomavirus (HPV) vaccine have lowered the incidence of cervical cancer in the developed world. Despite these advances, women are still diagnosed with cervical cancer, which often recurs or becomes metastatic.

Additional clinical trials of tisotumab vedotin are currently enrolling patients, including in combination with pembrolizumab, carboplatin or bevacizumab, and with a weekly dosing schedule in patients with locally advanced or metastatic cervical cancer. Tisotumab vedotin is also being evaluated in other tissue factor expressing tumor types, including ovarian and other solid tumors.

About innovaTV 204 Trial

The innovaTV 204 trial (also known as GCT1015-04 or innovaTV 204/GOG-3023/ENGOT-cx6) is an ongoing single-arm, global, multicenter study of tisotumab vedotin for patients with recurrent or metastatic cervical cancer who were previously treated with doublet chemotherapy with or without bevacizumab. Additionally, patients were eligible if they had received up to two prior lines of therapy in the metastatic setting. In the study, 101 patients were treated with tisotumab vedotin at multiple centers in the U.S. and Europe. The primary endpoint of the trial was confirmed objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by independent central review. Key secondary endpoints included duration of response, progression-free survival, overall survival, safety and tolerability.

The study was conducted in collaboration with European Network of Gynaecological Oncological Trial Groups (ENGOT) and Gynecologic Oncology Group (GOG). For more information about the phase 2 innovaTV 204 clinical trial and other clinical trials with tisotumab vedotin, please visit http://www.clinicaltrials.gov.

About Tisotumab Vedotin

Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) composed of Genmabs fully human monoclonal antibody specific for tissue factor and Seattle Genetics ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody and releases it upon internalization, inducing target cell death. In cancer biology, tissue factor is a protein that can promote tumor growth, angiogenesis and metastases.1 Based on its high expression on many solid tumors and its rapid internalization, tissue factor was selected as a target for an ADC approach. Tisotumab vedotin is being co-developed by Genmab and Seattle Genetics, under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.

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Tisotumab vedotin is being evaluated in ongoing clinical trials as monotherapy in a range of solid tumors, including recurrent and/or metastatic cervical cancer, ovarian cancer and in combination with other commonly used therapies in recurrent or metastatic cervical cancer. These trials are evaluating tisotumab vedotin on a weekly or every three weeks dosing schedule.

About Seattle Genetics

Seattle Genetics, Inc. is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in peoples lives. ADCETRIS (brentuximab vedotin) and PADCEVTM (enfortumab vedotin-ejfv) use the companys industry-leading antibody-drug conjugate (ADC) technology. ADCETRIS is approved in certain CD30-expressing lymphomas, and PADCEV is approved in certain metastatic urothelial cancers. TUKYSATM (tucatinib), a small molecule tyrosine kinase inhibitor, is approved in certain HER2-positive metastatic breast cancers. The company is headquartered in the Seattle, Washington area, with locations in California, Switzerland and the European Union. For more information on our robust pipeline, visit http://www.seattlegenetics.com and follow @SeattleGenetics on Twitter.

Forward Looking Statements

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the potential submission of a BLA to the FDA under the FDAs accelerated approval program and the potential for regulatory approval of tisotumab vedotin based on the innovaTV 204 trial; the therapeutic potential of tisotumab vedotin, its possible benefits and uses, including as monotherapy or in combination with other agents, and in other tumor types or with a weekly dosing regimen, and the tisotumab vedotin future development program. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the possibility that the data from innovaTV 204 may not be sufficient to support accelerated approval; the possibility of impediments or delays in the submission of a potential BLA to the FDA; the risk of adverse events, including the potential for newly-emerging safety signals; delays, setbacks or failures in clinical development activities for a variety of reasons, including the difficulty and uncertainty of pharmaceutical product development, adverse regulatory action, possible required modifications to clinical trials, failure to properly conduct or manage clinical trials and failure of clinical results to support continued development or regulatory approvals. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption "Risk Factors" included in the companys Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

References:

1 Van de Berg YW et al. Blood 2012;119:924.2 Miller et al., Gynecol Oncol 2008; 110:65.3 Bookman et al., Gynecol Oncol 2000; 77:446.4 Garcia et al., Am J Clin Oncol 2007; 30:428.5 Monk et al., J Clin Oncol 2009; 27:1069.6 Santin et al., Gynecol Oncol 2011; 122:495.7 Schilder et al., Gynecol Oncol 2005; 96:1038 Chung HC et al. J Clin Oncol 2019; 37:1470.9 National Cancer Institute SEER. "Cancer Stat Facts: Cervix Uteri Cancer." Available at https://seer.cancer.gov/statfacts/html/cervix.html. Last accessed April 2020.10 Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 countries https://www.iarc.fr/news-events/global-cancer-statistics-2018-globocan-estimates-of-incidence-and-mortality-worldwide-for-36-cancers-in-185-countries/.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200629005802/en/

Contacts

Seattle Genetics Media:Monique Greer, 425-527-4641mgreer@seagen.com

Investors:Peggy Pinkston, 425-527-4160ppinkston@seagen.com

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Seattle Genetics Announces Positive Topline Results from Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer -...

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