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Positive Results Announced From Phase 2 Trial of Telcyta in Combination With Doxil

PALO ALTO, Calif., Oct. 4 /PRNewswire-FirstCall/ -- Telik, Inc. reported additional positive data from a Phase 2 study of TELCYTA™ (TLK286) administered in combination with Doxil® in platinum refractory or resistant ovarian cancer. The data were reported at the Tenth Biennial International Gynecologic Cancer Society (IGCS) meeting in Edinburgh, Scotland.

A total of 51 patients with documented platinum refractory or resistant ovarian cancer have been enrolled in the trial, including 12 in a separate dose-escalation phase. Thirty-nine patients were enrolled in Phase 2, in which patients receive standard doses of TELCYTA plus Doxil. At the time of analysis, 19 patients in Phase 2 are evaluable for efficacy; 20 patients are too early to evaluate.

The objective response rate by RECIST is 42%, with eight partial responses that have been independently reviewed. The overall disease control rate is 74%. The Kaplan-Meier estimate of median progression-free survival is 34.1 weeks. The TELCYTA/Doxil combination is well-tolerated and no new or unanticipated toxicities have been observed.

"The results from this trial demonstrate that the TELCYTA/Doxil combination is an active regimen in women with platinum refractory or resistant ovarian cancer, and support further studies of the TELCYTA/Doxil combination regimen," said John J. Kavanagh, M.D., Chair Ad Interim, Gynecologic Medical Oncology at the University of Texas M.D. Anderson Cancer Center, the principal investigator for the trial. "There is urgent unmet need for new alternatives that provide activity without additive toxicity when ovarian cancer has progressed following front-line treatment. The TELCYTA/Doxil combination regimen may ultimately help meet that need."

"The 42% objective response rate and 34.1 week estimated progression-free survival seen in this trial are encouraging since the objective response rate with single agent Doxil in platinum refractory or resistant ovarian cancer is 12.3%, and the estimated progression-free survival for Doxil is 9.1 weeks in this patient population(1)," said Telik Senior Vice President and Chief Medical Officer Gail L. Brown, M.D.

(1) Gordon et al., Journal of Clinical Oncology, Vol. 19, No. 14, July 2001 About Ovarian Cancer and TELCYTA™

Approximately 25,580 new cases of ovarian cancer will be diagnosed in 2004, according to the American Cancer Society. Ovarian cancer causes more deaths than any other cancer of the female reproductive system.

TELCYTA is currently in Phase 3 registration trials in advanced ovarian and non-small cell lung cancer (NSCLC), and it has been successfully tested in Phase 2 trials in ovarian, NSCLC, breast and colorectal cancer. This small molecule drug is activated by GST P1-1, an enzyme present in cancer cells. Upon activation, an intracellular process known as apoptosis, or programmed cell death, occurs. TELCYTA was discovered through the application of Telik's proprietary drug discovery technology, TRAP.

For information on the TELCYTA Phase 3 ovarian cancer trial, visit http://www.assist-1trial.com/. For information on the TELCYTA Phase 3 non-small cell lung cancer trial, visit http://www.assist-2trial.com/ .

Source: Telik

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