Shows what I know. And that's not much. PR from today below.
Tularik Moving Forward with T67 Pivotal Trial Program in Patients with Hepatocellular Carcinoma
Monday August 26, 4:59 pm ET
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Aug. 26, 2002-- Tularik Inc. (Nasdaq:TLRK - News) today announced that it has a received written response from the FDA that the study design for its pivotal trial program for T67, Tularik's lead anti-cancer drug for patients suffering from Hepatocellular Carcinoma (HCC), is satisfactory. As a result of the FDA's feedback, the End-of-Phase 2 meeting scheduled for today to discuss T67 was not necessary.
This pivotal Phase 2/3 study is expected to include approximately 750 1st line HCC patients and will be performed at numerous centers across the U.S., Europe and Asia. The planned study design will compare survival in patients who receive T67 at a dose of 250mg/m(2) given by intravenous infusion every week to doxorubicin at a dose of 60mg/m(2) given by intravenous infusion every three weeks. The purpose of this study is to evaluate the safety and efficacy of T67 in patients with HCC. Tularik expects to open this trial early next year.
David V. Goeddel, Ph.D., CEO of Tularik said, "We are very excited to be moving T67 forward and are optimistic that T67 will ultimately benefit patients suffering from HCC. T67 was discovered by Tularik scientists, so it is especially gratifying to see it move forward. We believe today's news brings us closer to achieving our vision of becoming a premier biopharmaceutical company."
"This announcement marks a significant milestone in our development program for T67," added Dr. Michael D. Levy, VP of Development and Chief Medical Officer at Tularik. "With an average survival rate of 6 months from time of diagnosis and no approved systemic chemotherapy available, HCC patients are in real need of a drug that can potentially prolong their lives. We are eager to get our pivotal trial program underway and move one step closer to getting T67 approved for these severely ill patients."
In May, Tularik disclosed data from Phase 2 human clinical trials using T67 at a dose of 165mg/m(2) administered intravenously every week to patients with HCC. The low incidence of adverse events and hematologic toxicity in that Phase 2 study, together with a related pharmacokinetic analysis, supports conducting the planned pivotal trial using a dose of 250mg/m(2) given by intravenous infusion every week.
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