DNAPrint Presents Statin Classifier At Chicago DMC Meeting.
Business Editors/Health & Medical Writers
SARASOTA, Fla.--(BUSINESS WIRE)--Sept. 23, 2002
DNAPrint genomics, Inc. (OTCBB OTCBB
See OTC Bulletin Board (OTCBB). :DNAP DNAP Division of Natural Areas and Preserves
DNAP Diplôme National d'Arts Plastiques (French: Visual Arts National Diploma)
DNAP DNAPrint Genomics, Inc. ) announced on Friday successful results from its ongoing research into the genetic basis for variable Statin stat·in
Any of a class of drugs that inhibit a key enzyme involved in the synthesis of cholesterol and promote receptor binding of LDL cholesterol, resulting in decreased levels of serum cholesterol. response. The results were presented to an audience of health care professionals at the 7th Annual Disease Management Congress in Chicago, IL.
CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. Dr. Tony Frudakis described Company research that has resulted in the identification of certain gene variants associated with and predictive for Statin response. Statins Statins
A class of drugs commonly used to lower LDL cholesterol levels.
Mentioned in: C-Reactive Protein are a class of drugs used to treat lipid disorders and reduce the risk of cardiovascular disease Cardiovascular disease
Disease that affects the heart and blood vessels.
Mentioned in: Lipoproteins Test
cardiovascular disease . Largely due to patient genetics, about 25% of patients fail to respond positively to any given Statin, but those that fail to respond to one often respond to another. The findings are the result of a two-year study that focused on 575 patients and seven different clinical measures of response. Using proprietary screening methods, Company scientists were able to identify an unexpectedly large number of variants linked to response. Those associated with response to standard doses of Artorvastatin (sold under the trade name Lipitor by Pfizer, NYSE NYSE
See: New York Stock Exchange :PFE 1. (text, editor) PFE - Programmer's File Editor.
2. (language) PFE - Portable Forth Environment. ) were generally different from those associated with response to standard doses of Simvistatin (sold under the trade name Zocor by Merck, NYSE:MRK MRK Merck & Company (stock symbol)
MRK Mayer-Rokitansky-Kuster (anomaly)
MRK Manual Remote Keying ), and those predictive for efficacy (how well the drug does its job) were different from those predictive of adverse events such as early stage hepatocellular toxicity (liver stress) or myalgia myalgia /my·al·gia/ (mi-al´jah) muscular pain.myal´gic
epidemic myalgia see under pleurodynia.
n. (muscle pain). The research condensed mathematical encodings for these variants, which the Company calls "eigengenotypes", into a complex genetics classifier capable of explaining almost all of the observed variability in response. Details on how the "eigengenotypes" were measured and computed, or from what genes they are derived were not presented.
The results were described as the fabric for a new genomics test, called STATNOME(TM), which the Company intends to market to the managed health care industry. By allowing physicians to match patients with the Statin most appropriate for their genetic constitution, STATNOME(TM) could enable a dramatic enhancement the therapeutic benefit of this class of drugs. The Company hopes that STATNOME(TM) will reduce the need for frequent follow up visits to the doctors office, obviate an entire menu of clinical tests for monitoring Statin response and reduce the waste that comes from giving medicines to people who are genetically incapable of responding to them. In so doing, the new test could help managed care providers save thousands of dollars per patient, while at the same time, treat their patients more effectively.
Until the tests are manufactured and distributed, Dr. Frudakis explained that the Company plans to exclusively provide STATNOME(TM) classification services for early clinical adopters and progressive patients. The commencement of this service would be announced at a later date. He also outlined Company plans to begin offering services based on the OVANOME(TM) test, which was introduced by the Company last year as the world's first genomics-based test for flagging patients who are incompatible with paclataxel and carboplatin combination chemotherapy (which is the current FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. approved first-line therapy for ovarian cancer; paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia); is sold under the trade name Taxol and carboplatin is sold under the trade name Paraplatin, both are manufactured by Bristol-Myers Squibb, NYSE:BMY BMY Bristol Myers Squibb ). The commencement of STATNOME(TM) and OVANOME(TM) services would make DNAPrint the only laboratory in the world using internally-developed, wholly owned and drug-specific classifiers for the individualization individualization,
n the process of tailoring remedies or treatments to cure a set of symptoms in an indiv-idual instead of basing treatment on the common features of the disease. of drug treatment. The tests would be among the very first genomics-based tests ever applied before routine drug use, or for any other clinical practice.
The STATNOME(TM) test could have significant implications for the safety and effectiveness of Artorvastatin and Simvistatin, which combine to serve a $12 billion annual market projected to grow to $20 billion by 2003. Though generally well tolerated, adverse events associated with the use of Statins have recently begun to receive widespread attention. Recently Bayer (NYSE:BAY) was forced to pull their Statin "Baycol" from the market due to a fatal response linked to muscle damage and myalgia. Though myalgia is reversible, like hepatocellular toxicity, it is part of a continuum of pathology that leads physicians to switch treatments. By flagging the genetically incompatible before treatment, the Company hopes that STATNOME(TM) will help minimize the negative impact of this widely used class of drugs and change the "trial and error" mentality of today's drug prescription process. In addition, STATNOME(TM) could help expand the market for Statins, many of which are already considered "blockbuster" drugs. For example, Statins are usually given to patients that have a lipid condition that can lead to cardiovascular disease, but there are an estimated 30 million healthy people in the US who are at risk of developing this condition for whom Statins would serve as an effective prophylactic. Mainly due to side effects, and the cost of monitoring these side effects, the cost/impact and risk/reward values for a healthy person at risk of developing a lipid disorder is less desirable than that for the already afflicted. As a result, Statins are still not used in the healthy population. By accurately flagging those who would develop an adverse reaction to them before the drug is given, STATNOME(TM) could someday help Statins overcome this barrier for more widespread use.
About DNAPrint genomics, Inc.:
DNAPrint genomics Inc. was founded by a team of scientists with research and commercial experience in high-level mathematical and statistical modeling, programming and molecular genetics. Our quest is to become the leader in the development of complex pharmacogenomics and forensics classifiers for a personalization of drug prescription and enhancement of our criminal justice system. DNAPrint is the only company in the world building an eigengenotype database for routine complex/quantitative genetics analysis from population level genomics data. The Company is traded on the NASDAQ NASDAQ
in full National Association of Securities Dealers Automated Quotations
U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on OTC Bulletin Board OTC Bulletin Board
An electronic quotation listing of the bid and asked prices of OTC stocks that do not meet the requirements to be listed on the NASDAQ stock-listing system. under the ticker symbol: DNAP. For more information about the company, please visit http://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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.
When a person begins a civil lawsuit, the person enters into a process called 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.