SOURCE: DNAPrint Genomics, Inc.

October 16, 2006 07:00 ET

DNAPrint Pharmaceuticals Completes the Development of a Third Assay for PT-401

Next-to-Last Step for Testing Company's Anemia Drug Prior to Pre-IND Meeting With FDA

SARASOTA, FL -- (MARKET WIRE) -- October 16, 2006 -- DNAPrint Genomics, Inc. (OTCBB: DNAG) today announced that KBI BioPharma, Inc., Good Manufacturing Practices manufacturer of PT-401 for the Company's DNAPrint Pharmaceuticals division, has completed and validated a third analytical method using a specially developed isoelectric focusing (IEF) method to be used on PT-401, the dimeric Erythropoietin fusion protein for treating anemia that is currently in preclinical stage.

"IEF is an analytical method for separating molecules which differ in their charge characteristics and will be used to support process development, in-process analysis, release and stability testing for PT-401," stated Hector J. Gomez, M.D., Ph. D., Chairman and Chief Medical Officer of DNAPrint Genomics and the Company's DNAPrint Pharmaceuticals subsidiary. "The IEF method is used to assess the isoelectric point of PT-401 and its isoforms, which are critical in their formation because they directly impact product potency. This stage is necessary in order to prepare a successful Pre-Investigational New Drug (IND) filing with the U.S. Food and Drug Administration (FDA), and we are pleased with KBI BioPharma's development of this third and next-to-final step."

"The IEF assay's development will contribute to the on-schedule, on-budget delivery of PT-401 as a treatment for anemia," stated DNAPrint President and Chief Executive Officer Richard Gabriel. "We believe we are just one step removed from submitting a Pre-IND package in preparation for our first meeting with the FDA."

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 and the use of SDS-PAGE, a well-established separation technique for the testing of cell lines, a vital part of the DNA mapping process. These were the first two steps in developing an application for PT-401. The initial research has been conducted in conjunction with Dr. Arthur Sytkowski of Harvard Medical School's Beth Israel Deaconess Medical Center (BIDMC).

DNAPrint utilizes its proprietary 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