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Positive Results Announced from Phase II Trial of Telcyta in Non-Small Cell Lung Cancer
Patients enrolled in this trial received TELCYTA™ as second- or third-line treatment for advanced non-small cell lung cancer. An 11% objective response rate was observed in the 19 patients evaluable for efficacy at the time of analysis. The overall disease stabilization rate was 69%. Median survival has not yet been reached. TELCYTA™ continues to be well tolerated, with the most common adverse events categorized as Grade 1 or 2 (mild to moderate).
“These maturing results further confirm the clinical activity of TELCYTA™ that has been reported in non-small cell lung cancer, including earlier data from this trial presented at the American Society of Clinical Oncology meeting in June, and data from a previous Phase 2 trial in non-small cell lung cancer,” said Gail L. Brown, M.D., senior vice president and chief medical officer. “We look forward to the initiation of the TELCYTA™ Phase 3 registration trial in non-small cell lung cancer later this year.”
In Phase 2 trials, TELCYTA™ has demonstrated clinical activity in ovarian, breast and colorectal cancer, in addition to non-small cell lung cancer. A high proportion of these tumors express GST P1-1, which activates TELCYTA™ within the tumor. A Phase 3 registration trial of TELCYTA™ in women with advanced ovarian cancer is in progress, in addition to ongoing trials evaluating TELCYTA™ in combination with standard chemotherapies.
About Non-Small Cell Lung Cancer and TELCYTA™
Lung cancer results in 28% of all cancer deaths in the U.S., and it is the leading cause of cancer deaths, according to the American Cancer Society (ACS). The ACS estimates that 171,900 new cases of lung cancer, most of the non-small cell type, will be diagnosed in 2003, and an estimated 157,200 deaths will result from the disease.
TELCYTA™ is a small molecule prodrug which is activated by GST P1-1, an enzyme present in higher levels in many human cancers than in normal tissues. Upon activation, an intracellular process known as apoptosis, or programmed cell death, is initiated. TELCYTA™, which has been evaluated in clinical trials in more than 400 patients, was discovered through the application of Telik’s proprietary drug discovery technology, TRAP. Telik has retained worldwide commercialization rights.
Source: Telik, Inc.