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First Triplet Combination Trial Initiated With Telcyta as Front-Line Treatment of Non-Small Cell Lung Cancer

PALO ALTO, Calif., June 30 /PRNewswire-FirstCall/ -- Telik, Inc. (NASDAQ:TELK) announced the initiation of a new Phase 2 clinical trial in which TELCYTA(TM) (TLK286) will be evaluated in combination with carboplatin and paclitaxel in the front-line treatment of Stage IIIb or IV non-small cell lung cancer (NSCLC). The trial is expected to enroll approximately 50 NSCLC patients who have not previously received chemotherapy. Platinum and taxane-based drug combinations are the current standard for the front-line chemotherapy of lung cancer.

The trial is being conducted at teaching affiliates of the Harvard Medical School including the Dana-Farber Cancer Institute, Massachusetts General Hospital and Beth Israel Deaconess Medical Center. Thomas Lynch, M.D., Medical Director, Center for Thoracic Cancers, Massachusetts General Hospital and Associate Professor of Medicine, Harvard Medical School, is Principal Investigator of the study.

"There is a great need for new and effective therapies applicable across the entire range of advanced non-small cell lung cancer types," said Dr. Lynch. "We look forward to conducting this study incorporating TELCYTA, which has shown promising results in non-small cell lung cancer, into our standard front-line chemotherapy regimen."

The initiation of this trial follows positive data reported from two Phase 2 trials of single agent TELCYTA in platinum-resistant NSCLC, and two recently reported Phase 2 trials using TELCYTA in combination with docetaxel and carboplatin. In the TELCYTA plus docetaxel trial in platinum-resistant NSCLC, a 27% objective response rate by RECIST was reported, including one complete response and 7 partial responses; the disease control rate was 67%. In the TELCYTA plus carboplatin trial in platinum refractory or resistant ovarian cancer, the objective response rate by RECIST was 56%, including three complete responses (19%) and six partial responses (38%); the disease control rate was 88%. The augmented response rates compared to expected with the standard drugs were not accompanied by increased toxicities in these trials. The combination data were reported at the recent annual meeting of the American Society of Clinical Oncology.

About Non-Small Cell Lung Cancer and TELCYTA(TM)
Lung cancer is the leading cause of cancer deaths, according to the American Cancer Society (ACS). The ACS estimates that 173,770 new cases of lung cancer will be diagnosed in 2004 and an estimated 160,440 deaths will result from the disease, representing approximately 28% of all cancer deaths in the U.S.

TELCYTA is currently in Phase 3 registration trials in NSCLC (www.assist-2trial.com) and ovarian cancer (www.assist-1trial.com), and it has been successfully tested in Phase 2 trials in NSCLC, ovarian, 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.

Source: Telik, Inc.

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