GOLDEN, CO / ACCESSWIRE / April 3, 2021 / Vitro Biopharma, Inc. (formerly Vitro Diagnostics, Inc.) announced the appointment of Dr. Caroline Mosessian, PhD, DRSc, FACMPE, ACHE as its acting Director of Regulatory Affairs. Dr. Mosessian has an extensive background in regulatory science including a PhD, MS and Masters in Healthcare Administration degrees from USC in LA. In 2016 she was honored with the prestigious Top Ranked US Executive Award awarded to the top 1% of the millions of active executives in the United States. She is a trusted advisor for strategic development and operations to a variety of technology firms promoting innovation excellence to enhance quality of life for patients, caregivers and providers while optimizing outcomes and overall corporate success. In addition to regulatory expertise, she has extensive experience in the development, management and licensing of intellectual property, government and private fund raising, strategic planning and clinical research operations. She is fluent in several languages that support her international business development skills. She is also actively involved in local, national and international charitable organizations that emphasize humanitarian aid.
She has led numerous clinical studies of medical devices and pharmaceuticals through regulatory agency approval including the FDA and EMA leading to successful development of multi-million dollar clinical programs. She presently assists Vitro Biopharma in the guidance, drafting and submission of its pending IND phase I application to the FDA (Randomized, Double-blinded, placebo-controlled study of the safety and efficacy of therapeutic treatment with AlloRx Stem Cells® in adults with COVID-19). As a result, the FDA has authorized several expanded access/compassionate use INDs that employ IV infusion of AlloRx Stem Cells in the treatment of COVID-19 patients.
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These results together with several additional clinical studies using MSCs are now providing substantial clinical evidence of safety and efficacy of stem cell therapy for COVID-19. Furthermore, since MSC therapy is independent of the genome of the virus, this MSC therapy is likely to be effective in treatment of COVID-19 patients infected with new variants resulting from viral mutation.
Dr. Jack Zamora, MD and CEO said, "We are elated to add Dr Mosessian to our regulatory team targeting FDA approval of AlloRx Stem Cells®. She has been instrumental in establishing a strong working relationship between Vitro Biopharma and the FDA. She will also be a key driver of the execution of our pending Phase I trial and future INDs targeting additional indications of AlloRx Stem Cells®."
Dr. Mosessian said, "I am inspired by Vitro Biopharma's mission to deliver innovative solutions and access to regenerative therapies to deliver unmet needs of the vulnerable patients. I feel fortunate to become part of the team thriving to achieve such an ambitious goal."
John Evans C.F.O. and Chairman of the Board said "We are pleased to have Caroline join the Board of Directors of the company, she adds such a wide breadth of experience in the regulatory, clinical and legal areas of board governance.
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.
Vitro Biopharma has a proprietary and scalable manufacturing platform to provide stem cell therapies to critically ill Coronavirus patients and other conditions including multiple sclerosis, OA, Crohn'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. Our stem cells have been shown to be safe and effective in Phase I clinical trials.
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. Jack Zamora, MD
Chief Executive Officer
Vitro Biopharma, Inc.
(303) 999-2130 x 1
www.vitrobiopharma.com
SOURCE: Vitro Diagnostics, Inc.