snake bit company gets a break.......
Tuesday July 30, 6:27 pm Eastern Time
Press Release
SOURCE: Triangle Pharmaceuticals, Inc.
Triangle Pharmaceuticals, Inc. Announces Data Safety Monitoring Board's Recommendation to Unblind Coviracil Pivotal Trial Early
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 - News) 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® (efavirenz) and Videx® 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 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. |
