DNAPrint Announces Discovery of Genetic Marker for Statin-Induced Myalgia
Findings From Company's Statnome Project Successfully Validated; Article on Study to Be Published in Noted Academic Journal
SARASOTA, FL -- (MARKET WIRE) -- December 19, 2006 -- DNAPrint Genomics, Inc. (OTCBB: DNAG), today announced that the Company's research staff has discovered a genetic marker for statin-induced myalgia (chronic muscle pain), that a patent has been filed to protect the discovery and that the research on which the discovery is based will be published in an upcoming issue of The Journal of Pharmacogenetics and Genomics (JPG).
The marker was the primary discovery from the Company's Statnome project initiated in 2000 and the manuscript to be published in JPG describes the validation of this finding in different patient samples.
"Myalgia or chronic muscle pain is a common side effect reported by patients who take statins for cholesterol control, and it is likely to be part of a disease continuum that includes myositis and rhabdomyolysis, which is a breakdown of muscle fibers that frequently results in kidney damage and is a potentially fatal side-effect," according to DNAPrint Chief Science Officer Tony Frudakis, Ph.D. "Deaths associated with statin-induced rhabdoymyolysis lead Bayer to withdraw Cerivistatin in 2001. We are satisfied to have brought one of our first pharmacogenetics programs full circle from discovery through validation and we consider the R&D phase for this project complete. With the filing of a patent to protect this discovery, the Company will be able to develop a proprietary test for this gene variant and thereby reduce the likelihood of illness or death in those patients who are taking statins. This study also criticizes the original clinical trials for statins, which did not fully or adequately explore the relationship between statins and myalgia or even rhabdomyolysis."
"This is the culmination of a project that was begun when the company was founded," stated DNAPrint President and Chief Executive Officer Richard Gabriel. "It has taken until now to validate the original findings, but validated they are. The Company has filed a patent to protect this process. We plan to bring to market a definitive test product to identify this genetic variant and to potentially prevent painful -- and in some cases, fatal -- side effects in thousands of patients who are taking a very common prescription drug."
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DNAPrint's study of 750 patients who had taken either atorvastatin (Lipitor®) or simvastatin (Zocor®) showed that patients carrying one specific genetic marker were approximately 2.5 times more likely to experience mild to severe muscle pain (myalgia). The effect was most pronounced for atorvastatin and the study showed that approximately one half of the patients who were removed from atorvastatin therapy due to muscle symptoms possess this genetic marker, whereas in the general population (with and without cardiovascular disease) only approximately 15%-25% of people carry the marker. DNAPrint applied its technology for measuring population structure (e.g., ancestry) in order to prove that the finding in both the discovery and validation samples was genuine, and in so doing received praise from JPG reviewers. This observation indicates that the genetic marker may be related not only to response to statins but also to a possible relationship with higher cholesterol levels, according to the study.
"DNA Print Genomics was founded on the underlying genomic screening methods developed to more efficiently scan the genome for medically important genetic markers of drug responses," stated Dr. Frudakis. "The current findings are another example of the efficiency of the Company's methods."
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.
Company Contact:
Richard Gabriel
CEO and President
941 366-3400
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