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Biotech / Medical : Visible Genetics Inc.(VGIN) -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (296)	6/25/1999 8:50:00 AM
From: Robert G. Hanah	Respond to of 337

Lancet Report Shows Drug Resistance Testing Effective in Improving Therapeutic Outcomes in HIV Patients Study is the First of its Kind to Demonstrate the Potential Clinical Utility of Genotyping TORONTO, June 25 /PRNewswire/ -- Visible Genetics Inc. (VGI) (Nasdaq: VGIN - news), announced today that the June 26th issue of The Lancet (Vol. 352, No. 9171) reports that drug selection based on genotyping is effective in producing a statistically significant benefit in lowering the viral loads of HIV patients who were failing triple drug combination therapy. The six-month results of the VIRADAPT study, which was sponsored by Visible Genetics Inc. suggest that genotypic resistance testing shows promising results for treating and managing persons infected with HIV. ''Visible Genetics is excited that these six month results first reported last year as an abstract in Glasgow are now published in such a well known, peer-reviewed journal as The Lancet,'' said John Stevens, Chairman and CEO of Visible Genetics Inc. ''These prospective clinical results taken with the positive twelve month VIRADAPT results reported yesterday at the 3rd International Workshop on Drug Resistance and Treatment Outcomes, and the positive prospective GART results reported at the 6th Annual Conference on Retroviruses and Opportunistic Infections in Chicago, give us a strong reason for optimism that genotyping may play a major role in the treatment of HIV/AIDS. We are committed to further demonstrating the importance of genotyping in the treatment of this devastating disease. We have started several important prospective clinical trials in the United States and Europe, which we hope will confirm and amplify what we have learned from this important paper.'' Genotyping is a genetic test that identifies the drug resistance characteristics of a patient's HIV strain and provides doctors with information that tells them which drugs probably won't work against the virus. This data may help them select the drugs that may be more effective in reducing the levels of HIV circulating in a patient's bloodstream. ''VIRADAPT is the first prospective study to confirm that genotyping may play a crucial role in the selection of drugs that will help physicians improve their HIV patients' lives,'' stated Pierre Dellamonica, MD, lead trial investigator and Professor of Medicine, Centre Hospitalier, Universitaire de Nice, Nice, France. ''Our data not only provide clear evidence that genotyping is a significant improvement in the rational treatment of HIV; but also the findings show that this form of genetic testing has the potential to revolutionize the way doctors treat HIV in the same way that viral load testing changed HIV treatment in recent years.'' In this study, 32.3 percent of the patients who were tracked with genotyping technology including VGI's TruGene HIV(TM) test, had undetectable levels of HIV (i.e., less than 200 copies/ml), compared with only 13.9 percent of patients whose treatment was based on the current standard of care (SOC) (i.e., triple drug selection practices (p=0.067)). The data also show that drug selection based on genotyping was twice as effective in reducing viral loads for patients in the trial. Originally designed to be a year-long study, the VIRADAPT trial was switched to an open label trial (the SOC group received genotyping) in January 1999 because of a six-month interim analysis that showed patients in the genotyping arm derived statistically significant benefit (as determined by an average reduction in viral load) compared to the patients in the standard of care arm. These 12-month results were reported yesterday at the 3rd International Workshop on Drug Resistance and Treatment Outcomes meeting in San Diego. VIRADAPT was a prospective, randomized, controlled, open, pilot study conducted at the Centre Hospitalier Universitaire de Nice. Led by Professor Pierre Dellamonica, the study evaluated 108 patients at three sites. Patients enrolled in the study had high HIV viral loads (average 4.7 logs or more than 10,000 copies/ml) and had failed triple drug therapy at least once and were taking at least one protease inhibitor. Research has shown that HIV is a genetically variable or polymorphic virus that constantly mutates in infected patients. The virus is so variable that it is unlikely that the HIV virus isolated from any two patients will share the same genetic characteristics. As a result of this rapid mutation rate, drugs used to treat HIV, while often effective for a period of time, eventually lose efficacy to newly mutated drug-resistant HIV. This results in an increase in a patient's viral load. Experts have demonstrated that by genotyping HIV on a regular basis, it may be possible to treat individual patients by selecting drugs to which the virus has not yet developed resistance, and thus keep the virus at low levels.