Telik, Inc. Reports Positive Interim Data from Telcyta Clinical Studies

Telik, Inc. announced positive interim data from two ongoing phase 2 clinical studies evaluating Telcyta in combination with standard chemotherapy for the treatment of advanced non-small cell lung cancer. The data were presented at the Eleventh World Conference on Lung Cancer in Barcelona, Spain. One trial evaluated the combination of Telcyta with carboplatin and paclitaxel, resulting in an objective tumor response rate of 58% with 15 patients responding, including one complete response and 14 partial responses. The disease stabilization rate was 92%. The regimen was generally well tolerated. A second trial evaluated Telcyta in combination with cisplatin, resulting in an objective partial response rate of 32% and a disease stabilization rate of 88%. Both regimens were well tolerated and objective responses were confirmed by independent radiologic review.

Key Takeaways:

• The combination of Telcyta with standard chemotherapy resulted in objective tumor responses in 58% and 32% of patients in two separate phase 2 clinical trials.
• The disease stabilization rate was 92% and 88% in the two trials, indicating a potential benefit for patients with advanced non-small cell lung cancer.
• The regimen was generally well tolerated in both trials, with no major safety concerns reported.
• The Telcyta regimen was evaluated by RECIST (Response Evaluation Criteria In Solid Tumors) and confirmed by independent radiologic review.
• The trials demonstrated the efficacy and safety of Telcyta in combination with standard chemotherapy for the treatment of advanced non-small cell lung cancer.
• Telcyta is a novel, small molecule tumor-activated drug candidate that is activated by GST P1-1, an enzyme present in cancer cells.
• The drug is being evaluated in multiple phase 1 and 2 clinical trials for various types of cancer, including ovarian, colorectal, and breast cancer.

Statistics:

• 35 patients were enrolled and evaluable for safety in the first trial, with 26 patients also evaluable for efficacy.
• 49 patients were enrolled and evaluable for safety in the second trial, with 25 patients also evaluable for efficacy.
• Objective tumor responses were observed in 15 patients (58%) and 8 patients (32%) in the two trials, respectively.
• The disease stabilization rate was 92% and 88% in the two trials, respectively.
• 96% of patients in the first trial were evaluable for safety, and 96% of patients in the second trial were evaluable for safety.

Sources:

• Eleventh World Conference on Lung Cancer
• American Society of Clinical Oncology annual meeting (May 2005)
• Health & Medicine Week editors
• NewsRx.com
• Telik, Inc.