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Updated:2006-05-16 07:36:55 DNAPrint Pharmaceutical Completes Computational Model to Guide Preclinical Development on Anemia Drug
SARASOTA, FL -- (MARKET WIRE) -- 05/16/06 -- DNAPrint Genomics, Inc. (OTC BB: DNAG) today announced that DNAPrint Pharmaceuticals, Inc.'s Computational Biology Division completed a pre-clinical, first generation computational model of the characteristics and mechanisms of its PT-401 drug under development for the treatment of anemia.
"The model, called EPOFusion(TM), is already being used as a guide for preclinical studies of PT-401 to reduce risk of clinical failures and to reduce the cost and time to 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 head of the Company's pharmaceuticals operations.
"One of the most difficult steps in any drug development program is the leap from animal test data to initiating human studies," Dr. Gomez said. "We are experiencing how rigorous computational models can help us to bridge the gap with much more confidence as we determine how data generated from testing on laboratory mice can be applied to human biology."
DNAPrint Pharmaceuticals is working on the development of "theranostic" genetic test/drug combinations designed to improve a drug's efficacy and reduce potential side effects. PT-401 is the lead drug in DNAPrint's product pipeline. 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 exceeds $11 billion and is rapidly growing.
The EPOFusion(TM) model simulates 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.
"We are beginning to reap the benefits of computational biology technology acquired by the Company in November 2005," stated DNAPrint President and Chief Executive Officer Richard Gabriel. "This first generation of EPOFusion(TM) is designed to support the basic science studies required for drugs before human testing. Our Computational Biology Division will be advancing EPOFusion(TM) to a second generation model, using knowledge gained in the preclinical phase, for an expanded version (EPOFusion(TM) II) used to simulate clinical (human) studies."
Mr. Gabriel said that EPOFusion(TM) II will model the molecular and cellular effects of PT-401 so that researchers can ask more "what if" questions about dosage levels and scheduling, as well as the drug's influence on varying patient factors. "The data gathered from these simulations help guide the design of actual clinical trials," he said. "We believe that application of EPOFusion(TM) enhances the potential for successful trials targeted to the right patients with an effective dosing regimen and we anticipate that this will result in reduced time and costs of clinical studies."
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Updated:2006-05-16 09:49:43 Market-Pulse.com Announces Trade Alert for DNAPrint Genomics, Inc. PrimeZone ATLANTA, May 16, 2006 (PRIMEZONE) -- Market-Pulse.com announces its trade alert for DNAPrint Genomics, Inc. (OTCBB:DNAG). According to Bernard R. Schmitt of Market Pulse, "The company just had excellent news out today regarding its Computational Biology Division completed a pre-clinical, first generation computational model of the characteristics and mechanisms of its PT-401 drug under development for the treatment of anemia." PT-401 is a potential competitor in the EPO market that exceeds $11 billion and is rapidly growing.
DNAPrint Pharmaceuticals is working on the development of "theranostic" genetic test/drug combinations designed to improve a drug's efficacy and reduce potential side effects. PT-401 is the lead drug in DNAPrint's product pipeline. PT-401 is a "Super EPO," a more powerful form of erythropoietin, a well-known drug used for the treatment of anemia.
In a press release issued earlier today by DNAPrint, "We are beginning to reap the benefits of computational biology technology acquired by the Company in November 2005," stated DNAPrint President and Chief Executive Officer Richard Gabriel. "This first generation of EPOFusion(tm) is designed to support the basic science studies required for drugs before human testing. Our Computational Biology Division will be advancing EPOFusion(tm) to a second generation model, using knowledge gained in the preclinical phase, for an expanded version (EPOFusion(tm) II) used to simulate clinical (human) studies."
The EPOFusion(tm) model simulates 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 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.
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