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Press Release Source: Telik, Inc.


Telik Reports Positive Interim Results of TELCYTA in Combination With Carboplatin and Paclitaxel in First-Line Non-Small Cell Lung Cancer
Friday May 13, 1:00 pm ET


PALO ALTO, Calif., May 13 /PRNewswire-FirstCall/ -- Telik, Inc. (Nasdaq: TELK - News) reported positive interim data from a multicenter Phase 1-2a clinical study evaluating TELCYTA(TM) (TLK286) in combination with carboplatin and paclitaxel in the first-line treatment of advanced non-small cell lung cancer (NSCLC) at the annual meeting of the American Society of Clinical Oncology. In the trial, a 62% objective response rate (by RECIST), including one complete response and seven partial responses and a disease stabilization rate of 92% were observed in the evaluable patients at the time of the interim analysis.

At the time of analysis, all 13 patients in the Phase 1 stage of the trial were evaluable for safety and efficacy. Four dose levels of TELCYTA were evaluated (400, 500, 750 and 1,000 mg/m2) along with standard doses of carboplatin (AUC 6) and paclitaxel (200 mg/ m2), administered every three weeks.

Responses were accompanied by improvement in clinical symptoms as well as performance status. Objective responses were observed in both squamous cell and adenocarcinoma subtypes, in males and females, and in current, former and never smokers. Overall the TELCYTA combination was generally well tolerated, without unanticipated toxicities. Median survival has not yet been reached

"While it is early, I am very encouraged by the responses seen with the combination of TELCYTA, carboplatin and paclitaxel," said Thomas J. Lynch, M.D., Medical Director, Center for Thoracic Cancers, Massachusetts General Hospital, Associate Professor of Medicine, Harvard Medical School and Principal Investigator of the study. "TELCYTA is a new type of tumor-activated chemotherapeutic that may add activity to the widely used carboplatin/paclitaxel regimen. Non-small cell lung cancer is the leading cause of cancer death in America, and it is essential that we confirm these exciting preliminary data."

About TELCYTA

TELCYTA is a novel, small molecule tumor-activated drug candidate. It 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 has been evaluated in multiple Phase 1 and 2 clinical trials as a single agent and in combination regimens in advanced ovarian, non-small cell lung, breast and colorectal cancer.

Three Phase 3 registration trials of TELCYTA are underway: ASSIST-1, a single agent trial in platinum refractory or resistant ovarian cancer; ASSIST- 2, a single agent trial in platinum resistant non-small cell lung cancer; and ASSIST-3, a trial to evaluate TELCYTA in combination with carboplatin in second line platinum refractory or resistant ovarian cancer. TELCYTA was discovered through the application of Telik's proprietary drug discovery technology, TRAP. For additional information on the ASSIST trials in ovarian cancer, visit www.ASSIST-ovarian.com; additional information on the ASSIST trial in non-small cell lung cancer may be found at www.ASSIST-2trial.com

Conference Call and Webcast

Telik will host a conference call today at 4:30 p.m. Eastern time (1:30 pm. Pacific time). The conference call will be accessible via Telik's website at www.telik.com or by telephone at 877-209-0397 or 612-332-1025. An archive of the conference call will be available on the Telik website or by telephone at 800-475-6701 or 320-365-3844, access code 780992, from approximately 8:00 p.m. Eastern time on May 13 through May 20, 2005.

About Telik

Telik, Inc. of Palo Alto, CA is a biopharmaceutical company working to discover, develop and commercialize small molecule drugs to treat serious diseases. The company's most advanced drug development candidate is TELCYTA (TLK286), a tumor-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 adversely and 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 Telik several years to complete clinical trials of its 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 Telik's competitors develop and market products that are more effective than Telik's product candidates, or obtain regulatory approval before Telik does, Telik's commercial opportunity will be reduced or eliminated; if Telik does not obtain regulatory approval to market its products in the United States and foreign countries, it will not be permitted to commercialize its product candidates; if Telik is unable to contract with third parties to manufacture its product candidates in sufficient quantities and at an acceptable cost, clinical development of product candidates could be delayed; and if Telik is unable to raise adequate funds in the future, it will not be able to continue to fund its operations and clinical trials to develop its product candidates. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Telik's periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled "Risk Factors" in its quarterly report on Form 10-Q for the quarter ended March 31, 2005. TELIK, TRAP, TELCYTA and TELINTRA are trademarks of Telik, Inc. All other brand names or trademarks appearing in this press release are the property of their respective owners. Telik does not undertake any obligation to update forward-looking statements contained in this press release.




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Source: Telik, Inc.