Coviracil(R) Demonstrates Superiority to Zerit(R) in FTC-301; All Patients
Offered Rollover to Coviracil Regimen
DURHAM, N.C., July 30, 2002 /PRNewswire-FirstCall/ --
Triangle Pharmaceuticals, Inc. (Nasdaq: VIRS) today announced positive
findings from FTC-301, an ongoing pivotal Phase III trial of Coviracil
(emtricitabine), its nucleoside reverse transcriptase inhibitor for the
treatment of HIV disease. With these results, the Company confirmed plans to
submit an NDA in the third quarter of this year.
FTC-301 is an ongoing 48-week, double-blind, placebo-controlled Phase III
trial comparing once-a-day Coviracil to Zerit (stavudine) given twice daily,
each combined within a background regimen of Sustiva(R) (efavirenz) and
Videx(R) EC (didanosine). A total of 571 patients were enrolled in the United
States, Europe, Mexico and South America. An independent Data Safety
Monitoring Board (DSMB), established to provide oversight of the study,
reviewed a planned interim analysis. In view of a compelling difference in
favor of the Coviracil arm, the DSMB recommended that the study be unblinded
and all patients be offered the regimen containing Coviracil. The interim
results evaluated by the study's DSMB showed that the Coviracil arm was
statistically superior to the stavudine arm for primary and secondary
endpoints for safety and efficacy. Eighty-seven percent of the patients in
the once-a-day Coviracil arm had persistent virologic response through six
months compared to 80% for the twice daily Zerit arm. Patients in the
Coviracil arm also had significant improvements in immunologic function.
The full results of the trial will be presented at upcoming scientific
meetings.
Commenting on the results, Chris Rallis, Triangle's President and Chief
Operating Officer, said, "We are very pleased with the results of this trial,
which exceeded our expectations. We believe that Coviracil will become another
option for clinicians designing once daily regimens for patients with HIV
disease."
Given these favorable interim results, Triangle confirmed its plans to
submit an NDA for Coviracil with the FDA in the third quarter of this year.
Regulatory submission packages for Europe and other countries are also
scheduled to be completed this year.
A conference call to discuss the information contained in both press
announcements released today will be held on Wednesday, July 31, 2002 at 11:00
a.m. EDT. Interested parties in the U.S. may join the call toll free by
dialing 1-877-679-9049. International callers may join the call by dialing 1-
952-556-2803. The call will be Webcast on the Triangle Pharmaceuticals
website at http://www.tripharm.com and archived for replay on our site for one week
after the call. Slides to supplement the presentation may also be accessed on
our website.
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 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 the Company will not file the NDA and
other submission packages as planned, and that final clinical trial results
may differ from those announced today. Moreover, future events or changes in
our drug development strategies may impact the timing and degree of actual
spending. Additionally, other risks include the fact that clinical trials for
our drug candidates may not proceed as planned and regulatory submissions for
those drug candidates may be delayed, the Company may be unable to
successfully complete pivotal clinical trials or its trials could be halted or
terminated by regulatory authorities, its regulatory submissions may be
delayed, its inability to commercialize amdoxovir and ISS-based therapies due
to patent rights held by third parties, its ability to obtain additional
capital, its ability to obtain patent protection and required regulatory
approvals for its drug candidates, the development of competitive products by
others, the cost of coactive therapy and the extent to which coactive therapy
achieves market acceptance, the Company's success in identifying new drug
candidates, acquiring rights to the candidates on favorable terms and
developing any candidates to which the Company acquires any rights, and that
the Company's collaborations with third parties may not prove successful.
These and other risks are discussed in detail from time to time in the
Company's 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. The Company 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:
Chris A. Rallis, President and Chief
Operating Officer, or Robert F. Amundsen, Jr., Chief Financial
Officer, of Triangle Pharmaceuticals, Inc., +1-919-493-5980, or
http://www.tripharm.com
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