DNAPrint Selects Proteos to Manufacture PT-401 for Pre-Clinical Evaluation
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14 June 2005, 09:44am ET
SARASOTA, Fla., June 14 /PRNewswire-FirstCall/ -- DNAPrint genomics, Inc. (BB
NAP) (the "Company") today announced that it has selected Proteos, Inc. to manufacture the first batch of its new therapeutic candidate PT-401 (Super EPO dimer) for pre-clinical testing. "Proteos has 20 years of experience in protein and peptide chemistry and has proven its ability as a Contract Research Organization (CRO) dealing with biologically complex therapeutics," stated DNAPrint Chairman and Chief Medical Officer Hector Gomez, M.D., Ph.D. "The selection of Proteos is the culmination of a competitive bidding process solicited by DNAPrint management. In addition, Proteos` staff has previously worked with erythropoietin (EPO), the simpler, monomer form of the drug that major pharmaceutical companies currently have on the market."
DNAPrint announced in April that it has acquired an exclusive worldwide license from Harvard Medical School`s Beth Israel Deaconess Medical Center (BIDMC) to develop a new, more potent and longer acting form of the anemia drug erythropoietin. DNAPrint is working on the project with Dr. Arthur J. Sytkowski, Director for the Laboratory for Cell and Molecular Biology, Division of Hematology and Oncology at Beth Israel Deaconess. The PT-401 to be manufactured by Proteos will be used to generate pre-clinical data required for an Investigational New Drug (IND) application as required by the U.S. Food and Drug Administration.
"We are now beginning the clinical development process and today`s announcement is a major step for DNAPrint toward compiling the data for its first IND application," stated President and Chief Executive Officer Richard Gabriel. "Dr. Sytkowski, who has worked his entire career on Erythropoietin and similar molecules, and Dr. Gomez selected Proteos for its technical skills and background and will monitor the data collection very closely."
DNAPrint also announced that it has agreed to a six-month contract with Dr. Sytkowski to provide continued support for the completion of the PT-401 clinical research program. "Dr. Sytkowski holds eight patents covering this technology and is the author of a book on the subject, `Erythropoietin, Blood, Brain and Beyond.` He brings a knowledge base to the development of our licensed product, and his agreement is structured to give him appropriate incentives to help move the product through clinical development," Dr. Gomez stated.
About Proteos
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Proteos, Inc. ( http://www.proteos.net ) is a provider of high quality proteins and peptides for enabling and facilitating drug discovery. The Proteos Process includes target identification, expression using various cell lines, purification and production of proteins. Unique protein services include Expression in baculovirus, mammalian cells, and E coli, Refolding of proteins from inclusion bodies, Purification, and Assay Development. Peptide services include Design and Modification, and Antigen Design, Production and Purification. Proteos, based in Kalamazoo, Mich., was founded by eight scientists following the August 2002 acquisition of Pharmacia by Pfizer, Inc.
About DNAPrint genomics, Inc.
DNAPrint genomics, Inc. ( http://www.dnaprint.com ) is a developer of genomics-based products and services focused on drug development, pharmacogenomic diagnostic tests, forensics technology and consumer genetic tests. The Company`s first theranostic product (drug/test combination) is PT-401, a "Super EPO" (erythropoietin) dimer protein drug for treatment of anemia in renal dialysis patients (end stage renal disease). Currently in pre-clinical development, PT-401 will be targeted to patients with a genetic profile indicating their propensity to have the best clinical response.
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 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
President and CEO
941-366-3400