SOURCE: DNAPrint Genomics, Inc.

August 04, 2006 07:00 ET

DNAPrint Pharmaceuticals Completes the Development of a Second Assay for Its Anemia Drug

SARASOTA, FL -- (MARKET WIRE) -- August 4, 2006 -- DNAPrint Genomics, Inc. (OTCBB: DNAG) today announced that KBI BioPharma, Inc., has completed and validated a second analytical method for PT-401, based on SDS-PAGE, a well established separation technique that will be used for in-process analysis, release and stability testing for its PT-401 anemia drug, which is being developed by its subsidiary, DNAPrint Pharmaceuticals, Inc.

The SDS-PAGE process enhances the ability to identify and to determine the purity of the active ingredient produced by the CHO cell line that forms the basis for PT-401, and which will be used to create the "frozen bank," or future source, of PT-401 and for Good Manufacturing Practices (GMP) material for clinical trials.

"Separation of proteins plays a major role in characterizing GMP material, which in turn is necessary to advance pre-clinical testing of PT-401 and to prepare a successful Investigational New Drug (IND) filing with the U.S. Food and Drug Administration," stated Hector J. Gomez, M.D., Ph.D., Chairman and Chief Medical Officer of DNAPrint Genomics and the Company's DNAPrint Pharmaceuticals subsidiary. "We are very pleased with the progress of the research to date and we are especially pleased with KBI BioPharma's development of this crucial step."

"The development of the SDS-PAGE protein separation process is essential to the on-schedule, on-budget development of PT-401," stated DNAPrint President and Chief Executive Officer Richard Gabriel. "This selection contributes to the Company's consistent and orderly development of PT-401, which we expect will result in a successful treatment for anemia and the first of many theranostic drugs to treat any number of human afflictions."

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, which currently exceeds $10 billion and is rapidly growing.

Previously, DNAPrint Pharmaceuticals had announced the successful testing of CHO cell lines, the first in a series of steps that will be conducted in conjunction with Dr. Arthur Sytkowski of Harvard Medical School's Beth Israel Deaconess Medical Center (BIDMC) with regards to the development of "theranostic" genetic test/drug combinations, designed to improve a drug's efficacy and reduce potential side effects.

DNAPrint Genomics utilizes its EPOFusion™ model to simulate the cellular and molecular dynamics influenced by the administration of the Erythropoietin class of protein drugs in anemia treatments. EPOFusion™ 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™ can be manipulated to test hundreds of conditions and variables by simulating what occurs in the whole blood cell production process. The EPOFusion™ 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 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™, RETINOME™, ANCESTRYbyDNA™ and EURO-DNA™. 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.

Contact Information

  • Company Contact:
    Richard Gabriel
    CEO and President
    941-366-3400

    -or-

    Ron Stabiner
    The Wall Street Group, Inc.
    212-888-4848