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DNAPRINT ANNOUNCES PHARMACOGENOMICS COLLABORATION
SARASOTA, FL. and Jacksonville, FL, Nov. 08, 2000 –DNAPrint genomics, Inc. (OTCBB: “DNAP”) announced today that the
company has partnered with a group of independent physicians of internal family medicine in the Jacksonville, Florida area to conduct
original research in order to discover and develop new personalized medical products. The products produced through the
collaboration could be used in the near future to genetically match hypercholesterolemic and dyslipidemic patients with optimal
chemotherapy regimens. Specific terms of the agreement were not disclosed.
Hypercholesterolemic and dyslipidemic patients are at increased risk for atherosclerotic vascular (heart) disease. Currently, these
patients are prescribed medications, nicknamed “statins”, to ameliorate this risk. Statins function to decrease cholesterol levels by
inhibiting a key enzyme (HMG-Co enzyme A reductase) in the cholesterol pathway. According to the National Heart, Lung, and Blood
Institute’s National Cholesterol Education Program, high cholesterol is one of the key risk factors for heart disease. Heart disease is
the number one cause of death for both men and women in the United States, and more than 90 million American adults, or about 50
percent of the population, have elevated blood cholesterol levels. A study published in the New England Journal of Medicine in
September 1998 says heart disease deaths have declined steadily over the last 30 years, decreasing by 10.3 percent between 1990 and
1994 alone. This improvement is largely attributable to better prevention of heart disease through the wide-spread use of statins.
Notwithstanding the efficacy of this class of drugs, individual patients respond differently to statins based on a variety of
inter-individual genetic and environmental differences. About 2%-5% of patients are discontinued from statin treatment due to adverse
experiences including hepatocellular toxicity (indicated by elevated serum levels of certain liver enzymes), and more rarely,
Rhabdomyolysis with acute renal failure. In fact, it is recommended that physicians monitor this toxicity by performing liver function
tests prior to, and at 12 weeks following, both the initiation of therapy and any elevation of dose, and periodically thereafter.
As a recent Time magazine article points out, statins may potentially serve as a useful preventative tool to reduce the risk of heart
disease in the general, healthy population. A key impediment for the expansion of the statin market in this way is the danger posed by
adverse events associated with use of these drugs. For example, the long term affects of hepatocellular injury is not clearly
understood.
Diagnomics products could potentially help reduce the risk associated with the use of statins in the general population. The project
announced today is expected to result in a “diagnomics” test solution for routine patient pre-screening prior to statin prescription.
Based on the prevalence of dyslipidemia and hypercholesteremia in the population, such a product could enjoy a market in excess of
several billion dollars in the near future.
The specific aims of the collaboration are to qualify and quantify the genetic and environmental determinants underlying variation of
hypercholesterolemic and dyslipidemic patient response to statin chemotherapy. The collaboration will provide DNAPrint the unique
opportunity to explore the connection between human genetic variation (polymorphism), environment, and treatment response using a
rare combination of resources, including a heavily annotated and consent-qualified specimen databank, prospective and retrospective
patient tracking, state-of-the-art automated genomics equipment and proprietary analytics for complex genetics. Under the terms of
the agreement a group of Jacksonville physicians will supply consent qualified, biographed and annotated patient specimens as well as
prospective and retrospective patient disease and treatment data. DNAprint genomics will perform the background variability
discovery, high-throughput genotyping and complex genetic analysis.
Dr. Elyssa A. Bissenbach, M.D., P.A. will serve as the chief physician for the project. Dr. Bissenbach has prior research experience
at SUNY and is board certified in Internal Medicine. Also joining the project are Dr. Reuben Louis Smith and Dr. Richard Flynn, who
together have a combined patient census of 20,000 individuals, 35% of whom are dyslipidemic and/or hypercholesterolemic.
Robert Preston White, PA-C, will serve as primary coordinator and principal investigator for the study. Mr White has previous
experience managing complex specimen collections, having performed similar work with N.I.H. funded collections at the University of
Miami School of Medicine and Mt. Sinai Medical Center in Miami Beach, FL.
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“Critics of preventative coronary medicine for the general healthy population often, and rightly, invoke unacceptable risk vs. reward
levels associated with the use of drugs such as Statins.”, said Tony Frudakis, Ph.D., CEO/CSO of DNAprint genomics, Inc. “Only
through progress in the area of complex pharmacogenomics is it logical to contemplate an era of rational and safe preventative
medicine involving this class of drugs.”
DNAPrint genomics, Inc. is developing complex genetic analytics and information resources for next generations personalized
medicine. The companies products will provide practitioners of genomic research and personalized medicine with a
comprehensive system for complex trait dissection and patient classification. DNAPrint genomics Inc. was founded by a group
of scientists with research and commercial experience in high-level mathematical modeling, programming and molecular
genetics. For more information about the company, please visit www.dnaprint.com
All statements in this press release that are not historical are forward-looking statements within the meaning of Section 21E of
the Securities Exchange Act as amended. 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. |
