GOLDEN, CO / ACCESSWIRE / April 6, 2021 / Vitro Biopharma, Inc. announced receipt of FDA authorization and clearance to enroll patients in its phase I-2a, randomized, double-blinded, placebo-controlled study of the safety and efficacy of therapeutic treatment with AlloRx Stem Cells® in adults with COVID-19. Our Investigational New Drug (IND) application will investigate the clinical effects of AlloRx Stem Cells® by studying safety and efficacy in patients with moderate to severe COVID-19.
The FDA clearance of our IND opens the pathway to gain FDA approval of AlloRx Stem Cells® through completion of Phase I, II & III studies, thus expanding our business model to include domestic as well as international stem cell therapy markets. We expect this clearance to enhance our off-shore business by providing a product authorized for clinical studies by the US FDA, a globally recognized leader in new drug/biologics regulatory oversight.
Mesenchymal stem cells hold great promise to treat COVID-19 patients due to their potential in inhibiting the overactivated immune system and promoting the recovery of pulmonary and other organ failure in severe COVID-19 cases. "We are excited to have received clearance for this IND, which will enable us to evaluate the safety and efficacy of AlloRx Stem Cells® in COVID-19 patients in the United States," said Dr. Jack Zamora, M.D., Chief Executive Officer of Vitro Biopharma, Inc. "We look forward to working with investigators to initiate the trial in the United States and meet the needs of patients with COVID-19."
This Phase I-2a clinical trial of Vitro BioPharma will recruit approximately 20 COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS), an acute hypoxemic respiratory failure with high mortality rate.
Cytokine storm, as defined by increased levels of a set of proinflammatory cytokines, plays an important role in the pathogenesis of ARDS and the clinical progress of COVID-19 patients. Previous data from many groups, including Vitro Biopharma (through several Emergency Use Authorizations), have demonstrated that UC-MSC can decrease the level of multiple proinflammatory cytokines by modulating the immune cells or secreting anti-inflammatory factors in both preclinical and clinical studies of inflammatory diseases. The immunomodulatory activities of UC-MSC support their potential clinical use to combat the hyperinflammation status and improve the prognosis in ARDS of COVID-19 patients.
Dr. Jim Musick, Vitro Biopharma's founder, and CSO said, " We are pleased to have accomplished this key milestone in our development and its validation of our manufacturing and quality systems. We are able to provide a superior MSC product through our years of experience and development of a highly regulated biomanufacturing infrastructure. AlloRx Stem Cells® have application to various medical conditions that dominant healthcare global needs and expenses. We are pleased to participate in the advancement of stem cell-based regenerative medicine by providing AlloRx Stem Cells® and related products to the global healthcare community. The Vitro Biopharma team of professionals was essential to obtaining the FDA authorization of our trial, and we look forward to expeditious advancement to FDA approval of AlloRx Stem Cells®"
ABOUT VITRO BIOPHARMA
Out of years of research, we developed our patent-pending and proprietary line of umbilical cord-derived stem cells, AlloRx Stem Cells®, now being used in offshore regenerative medicine clinical trials. Our stem cells are used in regenerative medicine clinical trials with our partner in the Cayman Islands www.DVCStem.com. We have a recently approved clinical trial using our AlloRx Stem Cells® to treat musculoskeletal conditions at The Medical Pavilion of the Bahamas www.tmp-bahamas.com in Nassau. Our nutraceutical stem cell activation product, STEMulize™, complements AlloRx Stem Cells® as an adjuvant therapy to optimize therapeutic outcomes.
AlloRx Stem Cells® have been previously used in various clinical studies that showed no adverse events and evidence of efficacy. Vitro Biopharma has a proprietary and scalable manufacturing platform to provide stem cell therapies to treat critically ill Coronavirus patients and other conditions, including multiple sclerosis, OA, Chrohn's disease, and numerous medical conditions that are under-treated by the current standard of care. Our cGMP manufacturing is CLIA, ISO9001, ISO13485 certified, and we are FDA registered.
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.
Dr. Jack Zamora, MD
Chief Executive Officer
Vitro Biopharma, Inc.
(303) 999-2130 x 1
SOURCE: Vitro Biopharma, Inc.
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