Golden, Colorado—February 11, 2013—Vitro Diagnostics, Inc. (OTCQB: VODG), dba Vitro Biopharma, announced that its revenues increased substantially (78%, unaudited) in its first 2014 fiscal quarter due to its growing and expanding business relationship with Neuromics, Inc. Vitro has now commercialized bio-analytical services as the initial stage in its expansion as a Contract Research Organization (CRO). The services now available include select and customized biomarker panel analysis providing customers quantitative levels of multiple biological molecules within various biological samples. The new business involves analysis of human serum samples collected from patients within a network of clinical treatment centers throughout central Europe. Our partner for these services is Joseph Smarta, Ph.D., a renowned immunologist who has orchestrated treatment of many patients suffering from a variety of diseases. While the analyses are for research purposes only, serial analysis of patients are provided to monitor status and indicate therapeutic effectiveness.
Vitro Biopharma continues development its stem cell-based products and services for drug discovery. We anticipate commercialization of an initial series of assays during the first half of 2014. These assays will include cell-based toxicology assays and drug discovery assays for new osteoporosis and osteoarthritis drugs. We plan additional expansion of this platform going forward. Together with expanding revenues from biomarker analytic services we anticipate further revenue increases during 2014. Because of these immediate business opportunities, we have decided to delay our merger with Neuromics until our operating losses are narrowed and the combination yields stronger profitability, reduced debt and generally improved financial conditions.
There remain significant regulatory obstacles to adult stem cell transplantation in the United States, e.g., a recent court ruling upheld prior decisions that stem cell transplants will be treated as drugs by the US FDA. However, another approach to utilization of the healing & regenerative effects of stem cells involves activation of endogenous stem cells to differentiate into specific cell types. For example, recombinant human erythropoietin, that stimulates regeneration of red blood cells from hematopoietic stem cells, has been used clinically for 25 years to treat anemia associated with chemotherapy to treat cancer. We are in the planning stages of clinical trials to test mobilization of endogenous stem cells in the treatment of traumatic brain injury and Autism Spectrum Disorders. This is based on substantial pre-clinical research suggesting that activation of certain cellular pathways in combination with epigenetic modulation of select gene expression yields increased proliferation, migration and differentiation of adult stem cells including neural stem cells and MSCs.
Dr. Jim Musick, Vitro Biopharma’s President said, “Adult stem cells continue to gain validation and support for use in various regenerative medicine applications. New research reports add to the growing body of evidence that adult stem cells possess pluripotency, the ability to differentiate into any cell type. This property was once thought to be exclusive to embryonic stem cells. Two current research reports in the journal, Nature show that stress factors induce or select pluripotent differentiation capacity as had been previously demonstrated (http://vitrobiopharma.com/2013/06/28/new-method-to-isolate-pluripotent-stem-cells-from-adult-tissues-implications-for-the-clinical-value-of-adult-stem-cells/). Also, significant prior research during the past 10 years shows that adult stem cells may be induced to pluripotency with properties comparable to iPSCs and embryonic stem cells by expression of a single gene (Oct 3/4) as opposed to the required 4 genes needed to reprogram somatic cells. Vitro Biopharma also conducted research supporting pluripotency induction by Oct 3/4/ expression in MSCs and also has reproduced earlier results showing that cellular stress of human MSCs induced or selected apparent pluripotent cells. We plan to offer these cells for research use in the near future.
While research shows the advanced regenerative properties of adult stem cells, there remain significant obstacles to regulatory approval of adult stem cell transplantation. We are pleased to be involved with an alternative approach that does not require stem cell transplantation. While there are numerous research reports supporting the induction of stem cell differentiation by activation of specific cell signaling pathways, there have been only limited clinical trials of this approach. We are planning Phase II trials to demonstrate pharmacodynamic metrics critical to further studies of this approach. This will involve quantitative measurement of multiple biomarkers selective to cell pathway activation and stem cell activation by developing additional custom panels similar to those being used in our expanding bio-analytical services described above.”
Pete Shuster, Neuromics, Inc, CEO, said, “I am excited about the opportunities we have identified for profitably growing revenue. These opportunities include strategically selling our solutions to Biopharmaceutical firms and Regenerative Medicine Clinics. Our plans call for a minimum of 30% in collective revenue growth over the next 3 years. We are in the process of finalizing a detailed 3 year business plan that will be the blueprint for achieving this aggressive growth goal.”
About Vitro Biopharma
Vitro Diagnostics, Inc. dba Vitro Biopharma (OTCQB: VODG; http://www.vitrobiopharma.com), owns US patents for production of FSH, immortalization of pituitary cells, and a cell line that produces beta islets for use in treatment of diabetes. In 2011, Vitro Biopharma out-licensed its intellectual property related to treatment of infertility to Dr. James Posillico, a renowned expert in Assisted Reproductive Technologies. Vitro Biopharma also owns a pending US patent for generation of pluripotent stem cells and an additional pending patent for methods of mesenchymal stem cell (MSC) generation and related materials. Vitro Biopharma’s mission is “Harnessing the Power of Cells™” for the advancement of regenerative medicine to its full potential. Vitro Biopharma operates within a modern biotechnology manufacturing, R&D and corporate facility in Golden, Colorado. Vitro Biopharma manufactures and sells “Tools for Stem Cell and Drug Development™”, including human mesenchymal stem cells and derivatives, the MSC-Gro™ Brand of optimized media for MSC self-renewal and lineage-specific differentiation. In addition to our FSH patent licensee, Vitro Biopharma maintains several strategic partnerships including an alliance with Neuromics, Inc. (www.neuromics.com). Neuromics, Inc. is a primary distributor of Vitro Biopharma products and a well established manufacturer and distributor of a large variety of life science research products especially focused on cell-based assay systems We jointly manufacture stem cell assay systems with HemoGenix®, Inc. (http://www.hemogenix.com/), known as the MSCglo quantitative assay for determination of MSC quality, potency and response to toxic agents. Also, Vitro Biopharma’s CEO is a consultant on an NSF grant at the City College of New York to advise Dr. Lane Gilcrest, Professor of Materials Science and Engineering, and his colleagues regarding the development of novel extracellular materials for use in self-renewal and differentiation of mesenchymal stem cells.
About Neuromics, Inc.
Neuromics (http://www.neuromics.com), located in Minneapolis, MN, is a privately-held, profitable and growing bio-reagents company. The company was initially built by supplying bio-markers to Neuroscience Researchers. Today, Neuromics provides a range of solutions that include markers, growth factors, gene expression analysis tools, apoptosis detection kits, primary cells, stem cells and related media. These solutions are increasingly being used in combinations by customers to help accelerate or improve the process of drug discovery.
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CONTACT:
Dr. James Musick
Chief Executive Officer
Vitro Biopharma
(303) 999-2130 Ext. 3
E-mail: jim@vitrobiopharma.com
Source: Vitro Diagnostics, Inc.
