REDWOOD CITY, Calif., May 1 /PRNewswire-FirstCall/ --
Genelabs Technologies, Inc. (Nasdaq: GNLB) announced today that it has entered
into a collaboration with the University of Iowa Research Foundation (UIRF) to
study the impact of the hepatitis G virus (HGV, also known as GB virus C, or
GBV-C) on human immunodeficiency virus (HIV) infection.
On September 6, 2001, Jack T. Stapleton, M.D., Professor of Medicine at
the University of Iowa Roy J. and Lucille A. Carver College of Medicine and
Director of the Helen C. Levitt Center for Viral Pathogenesis and Disease, and
his colleagues published "Effect of Coinfection with GB Virus C on Survival
Among Patients with HIV Infection" in the "New England Journal of Medicine"
(Xiang, et. al., NEJM 2001; 345:707-714). Dr. Stapleton's research showed
that patients infected with both HIV and GBV-C had a significantly reduced
mortality rate compared to those infected only with HIV. Mortality of
HIV-infected patients over the 4.1-year mean duration of the study was
28.5% for those with an HGV infection compared to 56.4% for those without HGV
infection (p<0.001). This study confirmed previous reports suggesting delayed
progression of HIV in patients coinfected with HGV and, furthermore, found
that the infectious HGV clone developed by the University of Iowa research
group inhibited the growth of HIV in a cell culture model.
Dr. Stapleton stated, "Our findings may have implications for future
treatments for HIV. I am pleased to be working with Genelabs and look forward
to expanding upon our studies elucidating the role HGV may play in increasing
survival of HIV-infected patients."
Through the collaboration, Genelabs has granted UIRF a nonexclusive
research license to Genelabs' HGV patent portfolio and the parties have
exchanged research materials. Because of the potential importance of the
University of Iowa's observations showing improved survival for HIV patients
who also have an HGV co-infection, UIRF and Genelabs will make research
licenses and materials available at no cost to other academic institutions
interested in further scientific research in this area.
Genelabs scientists first discovered HGV, which is transmitted by blood
and other bodily fluids, while seeking to identify what was then an unknown
hepatitis virus. Patents covering the HGV genome, peptides and their uses
have issued to Genelabs. Since the discovery of HGV was announced by Genelabs
in 1995, HGV infection has not been associated with any significant disease.
The virus has been reported to be found in approximately 2 percent of all
blood donated in the United States, in 15 percent of people infected with
hepatitis C, and as high as 40 percent of people infected with HIV.
Genelabs has previously granted diagnostics licenses for HGV to Boehringer
Mannheim (now Roche Diagnostics), Chiron Corporation and Ortho Diagnostic
Systems. Genelabs retains all other commercial rights to its discovery of
HGV.
Genelabs Technologies, Inc. is a biopharmaceutical company pioneering the
discovery and development of novel pharmaceutical products to improve human
health. We have built drug discovery and clinical development capabilities
that can support various research and development projects, while
concentrating these capabilities on two core programs: developing a
late-stage product for lupus and discovering novel drug candidates targeting
DNA. Our research efforts are currently directed toward anti-microbial drug
discovery and we have synthesized many lead compounds targeting DNA in
bacteria, fungi and viruses. Our clinical development efforts are
concentrated on Aslera(TM), potentially the first new drug for systemic lupus
erythematosus in over 40 years, for which we have an exclusive license from
Stanford University.
NOTE: This press release contains forward-looking statements. These
forward-looking statements are based on Genelabs' current expectations and are
subject to uncertainties and risks that could cause actual results to differ
materially from the statements made. Uncertainties and risks include without
limitation the early stage of Genelabs' research programs and uncertainties
associated with the optimization of compounds, including whether a compound
will advance to preclinical testing, clinical trials, or ultimately become a
product, and the uncertainty of the timing of any of these; the validity,
scope and enforceability of patents related to the company's technologies;
whether the results of the company's clinical trials of Aslera(TM) and other
supporting information will be sufficient to support the approval of
Aslera(TM) by the U.S. Food and Drug Administration; delays regarding the
regulatory approval process including the timing and scope of approval
received, if any; uncertainties and risks regarding market acceptance of
Aslera(TM) as a treatment for systemic lupus erythematosus (SLE or lupus); the
company's capital requirements and history of operating losses; and
uncertainties and risks regarding the company's ability to consummate
strategic or corporate partner transactions on favorable terms or at all. The
active ingredient in Aslera(TM) is prasterone, the synthetic equivalent of the
androgenic hormone dehydroepiandrosterone (DHEA). Products containing DHEA are
currently being marketed by others as dietary supplements. The company has not
submitted applications for regulatory review of Aslera(TM) outside the U.S. In
addition, neither U.S. nor foreign regulatory authorities have made a
determination as to the safety or efficacy of Aslera(TM) for SLE. Please see
the information appearing in the company's filings with the Securities and
Exchange Commission for more discussion regarding these uncertainties and
risks and others associated with the company's research programs, early stage
of development and other risks which may affect the company. The company does
not undertake any obligation to update these forward-looking statements to
reflect events or circumstances after the date of this release.
This and past press releases are available at Genelabs' website at
http://www.genelabs.com and at PR Newswire's Company News on Call at
http://www.prnewswire.com.
CONTACT: Matthew M. Loar, Chief Financial Officer of Genelabs
Technologies, Inc., +1-650-562-1424
www.aegis.org