GOLDEN, CO / ACCESSWIRE / August 19, 2021 / Vitro Biopharma, Inc. announced the signing of a contract with European Wellness Biomedical Group headquartered in Kuala Lumpur, Malaysia and it's start-up subsidiary BioPep being registered in Delaware, USA to develop FDA-approval of biological products derived from existing mitochondrial peptide extracts now used globally as treatment of various conditions including aesthetic dermatology and skin revitalization, autism spectrum disorders, cardiovascular, metabolic and degenerative disorders, CKD and fertility through its global network of 12 (twelve) biomedical regenerative centers located throughout Europe and Asia Pacific. The contract provides for direct payments to Vitro Biopharma, Inc. of $2 million over 2-years for its services to gain FDA approval. The contract specifies distinct stages to gain FDA-approval including the steps needed to produce a research product for extensive preclinical and clinical testing to support an FDA IND filing, biomanufacturing infrastructure to support BLA-compliant upstream and downstream operations, development of a certified Quality Management System to support FDA-approval of target products and technology transfer to BioPep.
Dr. Jack Zamora, MD, Vitro Biopharma's CEO said, "Vitro Biopharma continues on the path of commercializing various aspects of its intellectual property created by Dr. Jim Musick and held by Vitro Biopharma. The development of this relationship with European Wellness to assist in the creation of peptide products has potential for a longer term manufacturing relationship."
Desiree Cox, MD, PhD, the CEO of BioPep said: "BioPep is focused on conducting scientific laboratory and clinical trials on organopeptides manufactured at the US-based FDA registered cGMP facility in Golden, Colorado with the view to obtaining FDA authorized INDs for select peptides for various disease indications. We are very pleased about this collaboration, as it enhances BioPep, European Wellness Biomedical Group and Vitro BioPharma by developing new scientifically tested non-cellular biological therapies that improve the lives of patients."
ABOUT VITRO BIOPHARMA
Out of years of research, we developed our patent-pending and proprietary line of human 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, DVC Stem. We have an approved clinical trial using our AlloRx Stem Cells® to treat musculoskeletal conditions at The Medical Pavilion of the Bahamas in Nassau. Our nutraceutical stem cell activation product, STEMulize™, marketed as Stemulife™ by Fitore Nutraceuticals 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, osteoarthritis, Crohn's disease, and numerous medical conditions that are under-treated by the current standard of care. We have an FDA authorized IND to conduct clinical trials of the safety and efficacy of AlloRx Stem Cells® in the treatment of COVID-19 patients and have treated several COVID-19 patients through FDA-authorized compassionate use INDs producing evidence of safety and efficacy. Our cGMP manufacturing is CLIA, ISO9001, ISO13485 certified, and we are FDA registered.
The Company's cosmetic stem cell serum and its line extensions are private labelled as InfiniVive MD™ and are being applied as a topical cosmetic serum in medical spas and plastic surgery offices. InfiniVive MD™ Cosmetic Serum is revolutionizing the cosmetic industry. Patients are experiencing unparalleled improvements in the appearance of fine lines and wrinkles. 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.
The Company previously developed, operated, and sold an upstream biomanufacturing operation that generated purified human pituitary hormones and tumor markers for diagnostic and therapeutic applications. Similar biologics manufacturing technology will be employed in the contract with European Wellness Biomedical Group.
ABOUT EUROPEAN WELLNESS BIOMEDICAL GROUP
European Wellness Biomedical Group (EW Group) is an award-winning European group founded by Prof. Mike Chan and Prof. Michelle Wong in early ‘90's in Switzerland through the culmination of early cell therapy research efforts spanning across Switzerland, Germany, Russia and Austria since the mid ‘80s.
Today, EW Group is most renowned for its pioneering developments in precursor (progenitor) organ specific stem cell therapeutics, biological and synthetic peptides, biological regenerative medicine, immunotherapies, nutraceuticals, and cosmeceuticals.
EW Group's multinational business divisions include research and development, bio-manufacturing, biomedical academies with training and education, anti-aging centers and nutraceutical product distribution to trained physicians, and consumers across over 70 countries worldwide. EW Group also owns a growing network of internationally accredited Regenerative Biomedical Hospital and Wellness Centers globally. Currently, the Group is headquartered in Germany and Malaysia (Asia Pacific) with research facilities vested in Germany, Switzerland, Czech Republic, and United Kingdom.
Since January 2020, EW Group molded the idea of BioPep together with its current USA's CEO Dr. Desiree Cox, MD, PhD, and a group of American scientists to devotedly study, research and pursue regulatory development and plans for its European award-winning series of organ-specific biologics in the American markets.
Prof. Mike Chan, CEO of European Wellness Biomedical Group, views this collaboration opportunity as: 'Meeting of great scientific minds and vibes to achieve incredible discoveries in biotechnology on cell therapeutics and peptides. The dedicated teams in the USA, Europe and Asia Pacific who collectively bring over 60 years of experience in scientific discoveries are committed to the success of their mission to caring for patients and healthcare consumers.
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 marketplace, 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 x1
Source: Vitro Biopharma, Inc.
http://www.vitrobiopharma.com
SOURCE: Vitro Diagnostics/DBA Vitro Biopharma