DNAprint Genomics (DNAG)

[SlopsterSlasher]

Dnap's Statnome info. -
From 10Ksb 4-15-2003

Statnome. Statnome is the product we are developing in conjunction with a group of Jacksonville physicians to classify patients as adverse responders or good responders to a class of drugs called statins. Hypercholesterolemic and dyslipidemic patients are at increased risk for heart disease. Currently, these patients are prescribed medications, nicknamed "statins," to reduce this risk.Statins function to decrease cholesterol levels by inhibiting a key enzyme 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 leading 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 widespread use of statins.

Notwithstanding the efficacy of this class of drugs, individual patients respond differently to statins. 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, 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 effects of hepatocellular injury are not
clearly understood.

The Statnome product(s) could help reduce the risk associated with the use of statins in the general population. The Company expects its Statin project to result in several "diagnomics" test solutions 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 entry into a market in excess of several billion dollars (drug sales). At present our scientists have completed the screen of the xenobiotic genome for the Statnome project and are validating the performance of the resulting classifier.

***************************************************************************************

10k;
At present our scientists have completed the screen of the xenobiotic genome for the Statnome project and are validating the performance of the resulting classifier.

...and this:

Thus, the Company has scaled back its sample collection efforts and is focusing on validating its Statin prediction product (STATNOME) and building a market for and completing its DNA Witness 2.0 line of forensic products. Pending the acquisition of investment funding or the realization of profits from product sales, DNAPrint intends to resume previous rates of collection for its various developmental stage pharmacogenomics projects.
*************************************************************************************************
From the first Newsletter:

OTHER TESTS - We have finished both the genotyping and the computational screening for Lipitor and Zocor, and we have finished the genotyping but not the computational screening for about 15 other drugs we have good sample sizes for. As we complete these projects, we will disclose the results within a formal, peer-reviewed setting such as a professional meeting or in the scientific literature.

*************************************************************************************************

Sept. 23, 2002--DNAPrint genomics, Inc. (OTCBB:DNAP - News) announced on Friday successful results from its ongoing research into the genetic basis for variable Statin response. The results were presented to an audience of health care professionals at the 7th Annual Disease Management Congress in Chicago, IL.

CEO Dr. Tony Frudakis described Company research that has resulted in the identification of certain gene variants associated with and predictive for Statin response. Statins are a class of drugs used to treat lipid disorders and reduce the risk of 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:PFE) were generally different from those associated with response to standard doses of Simvistatin (sold under the trade name Zocor by Merck, NYSE:MRK), 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 (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 approved first-line therapy for ovarian cancer; paclitaxel 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). 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 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 - News) 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.

*************************************************************************************************Some of the Statinome drugs DNAP is reviewing...01-01-02
Baycol........>now banned by the FDA for high risks involved.
Lescol
Lipitor
Lopid
Mevacor
Niacin
Niaspan
Pravachol
Zocor
http://www.dnaprint.com/bioform.pdf

*************************************************************************************************

From the shareholders meeting March, 2003 -Reported by worktoplay - post# 232636
Ovanome is about a year from market, and DNAP anticipates marketing through a partner. I asked if Statnome was similarly a year out, and the response surprised me. Tony indicated that Statnome would be marketed sooner and the marketing would be handled by DNAP. Obviously, the company is anticipating a much larger market for the Statin classifers which would make it cost effective to run the samples on the UHT.

*************************************************************************************************