Vitro Biopharma Announces Advancement of its Traumatic Brain Injury Clinical Trial and a Favorable Ruling from the FDA
GOLDEN, CO / CRWEPRESSRELEASE / September 2, 2015 /Vitro Diagnostics, Inc. (OTCMKTS: VODG), dba Vitro Biopharma, announced advances in clinical applications of its products and a favorable ruling by the FDA regarding this trial. The Company’s phase I clinical trial consists of combining two previously FDA-approved drugs in a novel manner to treat TBI, including concussion, by regeneration of damaged cells through the activation of resident stem cells within the brain. TBI is a high incidence condition with few therapeutic options besides reduction of secondary injury and rehabilitation or physical therapy. Brain stem cells exist in only restricted parts of the brain but appear to be capable of regenerating cells of the brain when activated by the appropriate biological signal, in this case, a unique combination of drugs previously approved for other indications. While stem cell therapy is often achieved by stem cell transplants, it is also possible to activate stem cells by biological signaling agents that activate specific pathways resulting in stem cell proliferation, differentiation and migration. There are FDA-approved drugs used to stimulate red and white blood cell formation that have been used for decades now to treat patients undergoing chemotherapy and the resulting blood cell deficiencies. Other stem cell activating compounds are known and being developed.
The trial is mainly a test of safety of a specific drug combination in TBI patients. There is evidence from other clinical studies that this combination is safe. We requested an exemption from investigational new drug (IND) requirements from the FDA since this trial relies on previously marketed products. The FDA has reviewed our request and sent the Company notice of Acknowledgement of IND exemption for the drug combination that we will be testing. The Company plans future development of improved formulations, delivery routes and other technical attributes to assure optimal activation of stem cells within the brain. Also, this trial requires advanced measurement of brain functional status including brain imagining and use of biomarker chemistry profiling in order to insure adequate activation of stem cell function.
Dr. Jim Musick, Vitro Biopharma’s President & CEO, said, “We are pleased to announce advances in our TBI clinical trial and notification from the FDA that our trial meets all requirements for exemption from IND regulations. This is a tribute to our regulatory team and should enable further trials targeting the treatment of other neurological conditions such as autism, stroke, Alzheimer’s disease, etc. Our trial of TBI will also require approval by an institutional review board (IRB) prior to enrollment. However, this review process is relatively rapid and we anticipate completion of all regulatory approvals for this trial within the near future. We have advanced analytical capabilities to provide support of this trial through diagnostic assessment of stem cell activation within the brain. This work is predominantly focused on biomarker profiling of biological processes of stem cell activation that may result in restoration of neurological functioning. Imaging of brain stem cells together with advanced cognitive functional assessment and the quantitative determination of the effect of stem cell activation is an overall objective. The Company is developing a new medical device to quantify extent of injury, neurogenesis, neuroprotection, angiogenesis and anti-inflammatory/anti-apoptotic status in TBI.”
About Vitro Biopharma
Vitro Biopharma’s mission is “Harnessing the Power of Cells(TM)” for the advancement of regenerative medicine to its full potential. Vitro Biopharma operates within a modern, GMP-compliant biotechnology manufacturing and R&D facility in Golden, Colorado. Vitro Biopharma manufactures and sells “Tools for Stem Cell and Drug Development(TM),” including human mesenchymal stem cells and derivatives, the MSC-Gro(TM) Brand of optimized media for MSC self-renewal and lineage-specific differentiation. Our cell lines also include cancer-associated fibroblasts (CAFs) and MSC-derived progenitor cells, including neural stem cells as well as a growing line of terminally differentiated cells: alpha-motor neurons, osteoblasts, chondrocytes, cardiomyocytes, proximal tubular epithelial cells, etc. A key target of these terminally differentiated cells is their use in cell-based assays of pre-clinical toxicology of drugs, drug candidates and drug combinations that may produce toxic effects on cardiac, neural or renal cells either as drugs or drug metabolites derived from interaction with specific cells such as liver cells. Vitro Biopharma is developing clinical products through various partnerships that include providing its clinical grade media for expansion of stem cells prior to transplantation and preliminary studies of stem cell activation in ASD & autoimmunity in central Europe.
Vitro Biopharma received the Frost and Sullivan Technology Innovation Leadership Award for the industry sector: Stem Cell Tools and Technology in North America, 2014.
Safe Harbor Statement
Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. 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. James Musick
Chief Executive Officer
(303) 999-2130 Ext. 3
SOURCE:Vitro Diagnostics, Inc.