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Palo Alto, CA, - October 4, 2004 – Telik, Inc. (Nasdaq: TELK) 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 www.assist-1trial.com. For information on the TELCYTA Phase 3 non-small cell lung cancer trial, visit www.assist-2trial.com.
About Telik, Inc.
Telik, Inc. of Palo Alto , CA is a biopharmaceutical company dedicated to discovering, developing and commercializing small molecule drugs to treat cancer and other serious diseases. The company’s most advanced drug development candidate is TELCYTA™ (TLK286), a cancer cell-activated small molecule product candidate that is in Phase 3 registration trials in advanced ovarian and non-small cell lung cancer. Telik’s product candidates were discovered using its proprietary drug discovery technology, TRAP, which enables the rapid and efficient discovery of small molecule drug candidates. Additional information is available at www.telik.com.
This press release contains “forward-looking” statements. For this purpose, any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including any statements regarding the potential for TELCYTA (TLK286) to treat one or more types of cancer. There are a number of important factors that could cause Telik's results to differ materially from those indicated by these forward-looking statements, including, among others, the following: none of Telik’s product candidates, including TELCYTA, has been determined to be safe or effective in humans or received regulatory approval for marketing; it may take us several years to complete clinical trials of our product candidates, including TELCYTA, prior to seeking regulatory approval for any indication; success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful, and interim results of clinical trials do not necessarily predict final results; if our competitors develop and market products that are more effective than our product candidates, or obtain regulatory approval before we do, our commercial opportunity will be reduced or eliminated; if we do not obtain regulatory approval to market products in the United States and foreign countries, we will not be permitted to commercialize our product candidates; if we are unable to contract with third parties to manufacture our product candidates in sufficient quantities and at an acceptable cost, clinical development of product candidates could be delayed;and if we are unable to raise adequate funds in the future, we will not be able to continue to fund our operations and clinical trials to develop our product candidates. These and other risks are detailed from time to time in our SEC filings, including under the heading “Additional Factors that May Effect Future Results” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2004 . Telik does not undertake any obligation to update forward-looking statements.
### Contact:
Carol DeGuzman
Senior Director, Corporate Communications
Telik, Inc.
Tel 650-845-7728
Email cdeguzman@telik.com
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