Good news today. Stock up sharply pre-open.
Headline: Visible Genetics on Track For FDA Submission in 2000
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- Enrollment in SEARCH Trial Closed -
TORONTO, Dec. 3 /PRNewswire/ -- Visible Genetics Inc. (VGI) (NASDAQ:VGIN)
reported that the US Food and Drug Administration (FDA) advised VGI that it is
not required to complete its clinical trial, SEARCH, for the TRUGENE(TM) HIV-1
Genotyping Assay. The FDA does not require further demonstration of the
clinical utility of HIV genotyping in the treatment of HIV infected
individuals. VGI will be required to complete its Proficiency Trial, which is
already underway. The results of the trial will be part of the Company's
market approval application to the FDA.
Based on the FDA's position, VGI will continue to provide genotyping to
all patients currently enrolled in the SEARCH study. However, enrollment of
new patients into SEARCH has been closed.
"I am very pleased at this news," stated Richard Daly, CEO of Visible
Genetics. "This confirms our belief that HIV resistance testing is a valuable
tool in the treatment of HIV infected patients. Given the current data
regarding HIV genotyping, it would be unethical to continue to randomize
patients into a non-genotyping arm. Not only will this event simplify and
reduce the cost of our trials, but it will also allow us to focus on our
Proficiency Trial."
VGI's multi-center Proficiency Trial, which should be completed by the end
of 1999, is designed to demonstrate the quality, reliability, accuracy, and
reproducibility of the TRUGENE(TM) HIV-1 Genotyping Assay and OpenGene(TM) DNA
Sequencing System. Analysis of the data from the trial, along with supporting
documentation regarding the manufacturing of the products, will be submitted
to the FDA in the first half of 2000, as part of VGI's market approval
application.
Two prospective studies, reported earlier this year, showed a
statistically significant decrease in HIV viral load by using HIV genotyping
to assist in HIV drug selection. The VIRADAPT study, sponsored in Europe by
VGI, and the GART study, an independent study conducted in the US by the
Community Program for Clinical Research on AIDS (CPCRA), both showed a 0.5 log
greater decrease in viral load for patients in the genotyping arm of the
study, versus those in the control arm. The VIRADAPT study was published in
the June 26, 1999 issue of The Lancet, a peer-reviewed medical journal.
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