TELIK DRUG FAILS THREE PHASE III TESTS

Telik Dec. 26 announced preliminary results from three separate Phase 3 clinical trials of its investigational drug Telcyta.

The ASSIST-3 trial, a 244 patient randomized trial conducted in the U.S., was designed to demonstrate a statistically significant improvement in overall tumor response to the combination of Telcyta plus carboplatin compared to liposomal doxorubicin in the second-line treatment of platinum resistant ovarian cancer.

Under the trial protocol, patients were to have received treatment until tumor progression or unacceptable toxicity. However, a major discordance was observed between the clinical review of the tumor scans and the independent radiology review. Approximately 25 percent of the patients were discontinued prematurely from the assigned study treatment as judged by the independent review of the scans. Therefore, the company believes the trial was compromised and may not be suitable for a regulatory submission. The company plans to meet with advisors to review the results and also to determine if any changes should be made to the protocol and/or trial conduct procedures for the ongoing ASSIST-5 trial.

The ASSIST-1 and ASSIST-2 trials did not achieve a statistically significant improvement in overall survival, the primary endpoints.

"These results are extremely disappointing. We are conducting additional, detailed analyses of the data from these three trials and plan to discuss those results with our advisors to determine the next development steps," said Michael Wick, chairman and CEO.