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DNAPRINT GENOMICS NEW (U-DNAG) - News Release DNAPrint Pharmaceutical Completes Sterility Testing on Anemia Drug Cell Lines for Clinical Development
2006-07-20 07:00 ET - News Release
SARASOTA, FL -- (MARKET WIRE) -- 07/20/06
DNAPrint Genomics, Inc. (OTCBB: DNAG) today announced that sterility tests of specific cell lines for producing PT-401, the lead drug in the Company's product pipeline, have been completed satisfactorily, a significant step in developing material for preclinical and clinical trials.
Studies performed by BioReliance®-Invitrogen Bioservices consisted of tests for the presence of bacterial and fungal contaminants, tests for bacteriostatic and fungistatic activity, tests for the presence of Mycoplasma and tests for the detection of MMV (murine minute virus). All of the tests were successful and no contamination was reported.
As a result of the tests, preclinical development of PT-401, a more powerful form of the anemia drug erythropoietin (EPO), is continuing as planned. The sterile cell lines, called CHOs, will be used to create the frozen bank, or future source of PT-401, and for producing Good Manufacturing Practices (GMP) material for clinical trials.
"The sterility testing is a major key in order for us to make GMP material, advance the pre-clinical testing and prepare a successful Investigational New Drug (IND) filing with the U.S. Food and Drug Administration (FDA)," stated Hector J. Gomez, M.D., Ph.D., Chairman and Chief Medical Officer of DNAPrint Genomics and the Company's DNAPrint Pharmaceuticals subsidiary. "KBI Pharma has accepted the sterile cell lines and is now proceeding with the GMP manufacturing of PT-401. We are very pleased with the progress of this project."
"Establishing our bank of sterile CHO cells is a crucial step in the development of PT-401," stated DNAPrint President and Chief Executive Officer Richard Gabriel. "This cell line will become the 'factory' work-horse for producing PT-401 in commercial quantities not just for the pre-clinical and clinical testing but for production of the final drug."
DNAPrint Pharmaceuticals is working with Dr. Arthur Sytkowski of Harvard Medical School's Beth Israel Deaconess Medical Center (BIDMC) on the development of "theranostic" genetic test/drug combinations designed to improve a drug's efficacy and reduce potential side effects. Dr. Gomez noted that Dr. Sytkowski's laboratory was crucial in achieving the successful test results for the cell lines. PT-401 is a "Super EPO," a more powerful form of Erythropoietin, a well-known drug used for the treatment of anemia. PT-401 is a potential competitor in the EPO market that currently exceeds $10 billion and is rapidly growing.
DNAPrint Genomics is utilizing its EPOFusion(TM) model to simulate the cellular and molecular dynamics influenced by the administration of the Erythropoietin class of protein drugs in anemia treatments. EPOFusion(TM) models the interaction of PT-401 -- a novel 2-copy (dimer) form of Erythropoietin -- with the cells that trigger the production of new red blood cells. EPOFusion(TM) can be manipulated to test hundreds of conditions and variables by simulating what occurs in the whole blood cell production process. The EPOFusion(TM) model has already identified important differences between PT-401 and currently marketed drugs or drugs in development by other companies. This type of information may provide a competitive advantage and is critical for transparent regulatory filings and effective physician education upon FDA approval of a drug for clinical testing.
About Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center is a patient care, research and teaching affiliate of Harvard Medical School and ranks fourth in National Institutes of Health funding among independent hospitals nationwide. BIDMC is clinically affiliated with the Joslin Diabetes Center and is a research partner of the Dana-Farber/Harvard Cancer Center. BIDMC is the official hospital of the Boston Red Sox. For more information, visit www.bidmc.harvard.edu.
About DNAPrint Genomics, Inc.
DNAPrint Genomics, Inc. (www.dnaprint.com) is a developer of genomics-based products and services in two primary markets: biomedical and forensics. DNAPrint Pharmaceuticals, Inc., a wholly owned subsidiary, develops diagnostic tests and theranostic products (drug/test combinations) using the Company's proprietary ancestry-informed genetic marker studies combined with proprietary computational modeling technology. Computational Biology and Pharmacogenomics services are also offered externally to biopharmaceutical companies. The Company's first theranostic product is PT-401, a "Super EPO" (erythropoietin) dimer protein drug for treatment of anemia in renal dialysis patients (with end stage renal disease). Preclinical and clinical development of all the Company's drug candidates will benefit from simulated pre-trials to design actual trials better and are targeted to patients with genetic profiles indicating their propensity to have the best clinical responses. DNAPrint is proud of its continued dedication to developing and supplying new technological advances in law enforcement and consumer ancestry heritage interests. Please refer to www.dnaprint.com for information on law enforcement and consumer applications which include DNAWITNESS(TM), RETINOME(TM), ANCESTRYbyDNA(TM) and EURO-DNA(TM). DNAWitness-Y and DNAWitness-Mito are two tests offered by the Company. The results from these tests may be used as identification tools when a DNA sample is deteriorated or compromised or other DNA testing fails to yield acceptable results.
Forward-Looking Statements
All statements in this press release that are not historical are forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including, but not limited to, uncertainties relating to technologies, product development, manufacturing, market acceptance, cost and pricing of DNAPrint's products, dependence on collaborations and partners, regulatory approvals, competition, intellectual property of others, and patent protection and litigation. DNAPrint Genomics, Inc. expressly disclaims any obligation or undertaking, except as may be required by applicable law or regulation to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in DNAPrint's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based.
Company Contact: Richard Gabriel CEO and President 941-366-3400 -or- Ron Stabiner The Wall Street Group, Inc. 212-888-4848
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