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VGI Launches Vigilance II - A 30,000 Patient, Cost Recovery, Open Label, HIV Genotyping Study
PR Newswire - May 19, 1999 09:03
TORONTO, May 19 /PRNewswire/ -- Visible Genetics Inc. (VGI) (Nasdaq: VGIN) announced today, following FDA protocol review, that it will proceed under its December 1998 Investigational Device Exemption (IDE) with Vigilance II, a US based open label, cost recovery HIV Genotyping study.
Vigilance II will use VGI's TruGene(TM) HIV-1 Assay kit, OpenGene(TM) DNA sequencing system, and GeneObjects(TM) software. VGI tests and kits will be reimbursable through third party, private and public payors on a cost recovery basis. The study has an enrollment target of 30,000 patients and will create the first large-scale research database of HIV resistance profiles with clinical outcomes. The database will consist of resistance profiles for up to 30,000 enrolled patients under strict patient confidentiality, including drug history, drugs selected as a result of genotyping, and viral loads at eight weeks and sixteen weeks after genotype directed drug selection. The database will be updated on a regular basis and will be made available to scientists, physicians and patients via the Internet.
"The infrastructure is being put in place for the Vigilance II study, and scheduled to be fully operational in the next three to four months, at which time we can begin active patient enrollment," said Dr. Gill Morgan, Director of Regulatory Affairs for VGI. "We have seen unexpectedly strong support for this large-scale open label project from providers, payors, as well as patients, and we are excited about the potential for the resistance database," she added.
Dr. Thomas C. Merigan, Becker Professor of Medicine and Director Center for AIDS Research, Stanford University, will serve as the principal investigator, and a panel of nine prominent HIV investigators have agreed to be on the advisory panel. The study will be open to an unlimited number of clinical sites and will have approximately 25 testing sites throughout the U.S.
"The existing prospective data (Viradapt and GART studies), as well as the scientific literature, lead us to believe that currently 70% or more of the HIV drug resistance in the US will be based on simple sets of mutations," said Dr. Merigan. "However, new drugs and wide-spread use of protease inhibitors have already produced complex interactions between groups of mutations and drugs that we have little or no hope of understanding without strong clinical data. This high quality, real-time clinical database with 30,000 or more data entries is our best hope of keeping up with the virus. The prevalence and distribution of resistance patterns and the relationship between these patterns and success or failure of the drugs all in one place may be of enormous scientific and clinical value."
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