SpectraDigital Corporation to Begin Phase 1 Pilot of HIV Diagnostic Tool: Initiation of First US Clinical Trial for “HIV SpectraPoint”(tm) Assay.
SpectraDigital Corporation, has begun a Phase I clinical pilot of its HIV SpectraPoint™ diagnostic system with AIDS ReSearch Alliance of America (ARA). Up to 40 patients will receive a standard phenotype test as well as the antiviral efficacy test generated by the new HIV SpectraPoint assay. The system could allow physicians to receive results within 24 hours, allowing essential treatment decisions to be made before the virus can develop new, unseen resistance patterns.
GUELPH, ONTARIO (PRWEB) November 9, 2004 -- SpectraDigital Corporation, a
privately held diagnostic company, announced today that it has begun a Phase I
clinical pilot of its HIV SpectraPoint™ diagnostic system.
The study
will take place at AIDS ReSearch Alliance of America (ARA) in West Hollywood,
California. The Principal Investigators of the trial will be ARA’s Medical
Director, Stephen J. Brown, M.D., and ARA's Director of Scientific
Communications Marjan Hezareh, Ph.D. This is SpectraDigital’s first U.S.-based
clinical study of the HIV SpectraPoint system.
The double blind,
controlled trial, which is currently enrolling patients, is expected to be
completed by the end of the year. In total, an analysis involving up to 40 HIV
positive patients will be performed. Each patient will receive a standard
phenotype test, an increasingly common tool in the treatment of HIV that can
help physicians determine which drugs may no longer be effective against the
predominant strain in an HIV-infected person. The same forty subjects will also
receive another antiviral efficacy test generated by the new HIV SpectraPoint
assay. If the new system works as planned, physicians could have the results of
this rapid diagnostic test within 24 hours. This, in turn, allows essential
treatment decisions to be made before the virus can develop new, unseen
resistance patterns.
The hope is that in many cases patients will
receive real clinical benefit from rapidly available data supplanting the
traditional time window of weeks, and that HIV clinicians will have at the same
time a more accurate “snapshot” of their patient’s HIV
disease.
“This pilot study represents an important
step in the development of our HIV diagnostics solutions,” said SpectraDigital
President Satish Deshpande. “In addition to our primary objective of comparing
HIV SpectraPoint to a standard phenotypic resistance assay, we also will
determine the ability of our system to detect resistance among individuals with
viral loads well below the limit of detection of traditional assays.”
Irl
Barefield, Executive Director of ARA added, "HIV SpectraPoint represents the
possibility of advancing HIV diagnostics by providing useful data for
interpreting antiviral efficacy more rapidly than ever thought possible. The
relative ease and lower cost of the test also make it likely that patients would
be monitored more frequently, enhancing their clinical options.”
About
SpectraDigital Corporation:
SpectraDigital Corporation (SDC) is a privately
owned diagnostics company based in Guelph, Ontario. SDC’s core competency is the
development and application of cell-based technologies to resolve various
problems in drug development, environmental monitoring, and medical
diagnostics.
For further information about
SpectraDigital Corporation:
- In Canada, contact Satish Deshpande at (519)
829-6012
- In the United States, contact Judy Carrick at (847) 736-8057
-
Or visit our website at www.spectradigital.net.
About AIDS ReSearch Alliance
of America:
AIDS ReSearch Alliance of America is a nonprofit medical research
organization fighting HIV/AIDS on multiple fronts around the world. Founded in
1989 by a group of Los Angeles-area physicians, ARA has grown into the nation’s
leader in fast-track research targeting HIV, through collaborations with
scientists, universities and researchers worldwide. ARA's work is driven by its
continued commitment to the idea that a cure for HIV must be found.
For
further information contact Irl Barefield, Executive Director, at (310)
360-3860. Extensive information is also available at www.AIDSRESEARCH.org.
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Source : http://www.prweb.com/releases/2004/11/prweb176707.htm