Triangle Pharmaceuticals, Inc. Presents Coviracil Data at 42nd Interscience
Conference on Antimicrobial Agents and Chemotherapy (ICAAC)
SAN DIEGO, C.A., Sept. 27, 2002 /PRNewswire-FirstCall/ --
Triangle Pharmaceuticals, Inc. (Nasdaq: VIRS) presented data at the Late
Breaker Session at the 42nd Interscience Conference on Antimicrobial Agents
and Chemotherapy (ICAAC) which showed that Coviracil (emtricitabine) was
statistically superior to Zerit (stavudine) in all primary and secondary
endpoints for safety and efficacy in a Phase III trial comparing the two
products. Triangle submitted a New Drug Application (NDA) for Coviracil for
the treatment of HIV disease to the Food and Drug Administration on
September 3, 2002.
Results from the interim analysis of FTC-301, a Phase III trial for
Coviracil, Triangle's potent once-a-day nucleoside reverse transcriptase
inhibitor (NRTI), demonstrated that Coviracil, as part of a fully once-daily
regimen, provided improved antiviral activity and enhanced tolerability when
compared to Zerit in a standard of care, highly active antiretroviral
treatment (HAART) regimen. Michael Saag, MD, Professor of Medicine and
Director of the AIDS Clinic at the University of Alabama at Birmingham and
Principal Investigator for FTC-301 in the United States, presented the results
of the trial.
Dr. Saag commented, "It is quite impressive that the fully once-a-day
regimen of Coviracil, Videx(R)EC, and Sustiva(R) showed clear superiority to a
widely-used regimen. The efficacy, tolerability and convenience of the
Coviracil regimen should make it an attractive treatment option for physicians
and their patients."
"The Coviracil regimen outperformed a highly effective standard of care,"
commented Franck Rousseau, MD, Executive Vice President of Research,
Development and Medical at Triangle. "Coviracil demonstrated significant
improvement compared to one of the most commonly prescribed products for HIV
disease. This trial also illustrated the potential of successfully treating
patients with fully once-a-day regimens. Upon approval, the potency and
robust pharmacokinetics of Coviracil should provide physicians with the option
to simplify HAART regimens for their patients."
FTC-301 Design and Results
FTC-301 is a 48-week, double-blind Phase III trial comparing once-a-day
Coviracil to Zerit given twice-daily, each combined within a background
regimen of once-daily Sustiva (efavirenz) and Videx EC (didanosine). As
announced on July 30, 2002, an independent Data Safety Monitoring Board
(DSMB), established to provide oversight of the trial, reviewed a planned
interim analysis of the trial. In view of a compelling difference in favor of
the Coviracil arm, the DSMB recommended that the trial be unblinded and all
patients be offered the regimen containing Coviracil.
A total of 571 patients (85% male) were enrolled in the United States,
Europe, Mexico and South America. At entry into the trial, the median HIV RNA
was 4.9 log10 copies/mL and the median CD4+ cell count was 288 cells/mm3.
The primary endpoint of the trial was the proportion of patients with HIV
RNA less than 50 copies/mL. Secondary endpoints included measures of
Virologic Failure (viral load > 400 copies/mL at week 12 or after), Efficacy
Failure (defined as Viral Failure, death, progression of disease or loss to
follow-up) and Tolerability Failure (defined as permanent discontinuation of
the blinded medication due to an adverse event.)
The Coviracil arm was statistically superior to the stavudine arm for all
primary and secondary endpoints for safety and efficacy. For measures of
efficacy at week 24, 81% of the patients in the Coviracil arm had undetectable
viral loads (< 50 copies/mL) compared to 70% in the stavudine arm (p=0.002).
At 52 weeks, Coviracil produced superior antiviral activity when compared
to Zerit as the probability of Virologic Failure was 14.1% for Zerit and 4.7%
for Coviracil (p<0.001). Coviracil also produced a superior immunologic
response with a mean CD4+ increase of 152 cells/mm3 in the Coviracil arm as
compared to an increase of 117 cells/mm3 in the Zerit arm (p=0.004). Lastly,
Coviracil was also better tolerated than Zerit with 6.7% of Coviracil patients
and 13.9% of Zerit patients experiencing treatment limiting toxicities
(p=0.03).
"We are pleased with the results of this important trial," said Daniel
Welch, Chairman and Chief Executive Officer of Triangle. "As a potent once-
daily agent, we believe that, upon approval, Coviracil should provide
physicians and patients broader opportunities for effective and convenient
regimens. To our knowledge, this is the first well-controlled trial where one
NRTI has been shown to be superior to another NRTI as part of a triple-drug
regimen."
Triangle Pharmaceuticals, Inc. is a specialty pharmaceutical company
engaged in the development of new antiviral drug candidates, with a particular
focus on therapies for the human immunodeficiency virus (HIV) and the
hepatitis B virus. Triangle's proprietary drug candidates under development
for HIV and/or hepatitis B include Coviracil(R) (emtricitabine), amdoxovir
(formerly DAPD), and clevudine (formerly L-FMAU). Triangle is also developing
immunotherapies for hepatitis B in collaboration with Dynavax Technologies
Corporation (Dynavax) utilizing Dynavax' immunostimulatory sequence (ISS)
technology. More information about Triangle's portfolio, management and
product development strategy is available on Triangle's website.
Statements in this press release that are not historical facts are
forward-looking statements and are subject to numerous risks and
uncertainties, including the risk that our Coviracil NDA may not receive
regulatory approval, or if approved, Coviracil may not achieve market
acceptance or the medical results we expect, others may develop competitive
products and we may be unable to commercialize our drug candidates
successfully. These and other risks are discussed in detail from time to time
in our filings with the Securities and Exchange Commission. As a result of
these and other risks and uncertainties, actual results may differ materially
from those predicted in this press release. Triangle disclaims any
obligations to update any forward-looking statements in this press release.
SOURCE Triangle Pharmaceuticals, Inc.
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Related links:
http://www.tripharm.com
CONTACT:
Daniel G. Welch, Chairman and Chief Executive
Officer or Robert F. Amundsen, Jr., Executive Vice President and
Chief Financial Officer, all of Triangle Pharmaceuticals, Inc.,
+1-919-493-5980
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