Phase 3 trial in metastatic non-small cell lung cancer

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http://www.nexcura.com/Newsletter/eNews ... C0FF744F17

Source: (Business Wire)

Friday, October 14, 2005

BOSTON – Oct 14, 2005 (Business Wire) – Point Therapeutics, Inc. (NASDAQ: POTP) announced that it initiated its Phase 3 program in metastatic non-small cell lung cancer (NSCLC). This news follows a successful End-of-Phase 2 meeting with the Food and Drug Administration.

"We are pleased with our End-of-Phase 2 meeting discussions with the FDA and the fact that there were no major changes to the Phase 3 study protocols. We look forward to continuing to clinically develop talabostat in this advanced lung cancer population," said Dr. Margaret Uprichard, chief development officer and senior vice president of Point Therapeutics.

Point's Phase 3 program will further evaluate the company's lead compound, talabostat, in patients with Stage IIIB/IV NSCLC after failure of a platinum-based chemotherapy. The program will consist of two randomized, double-blind, placebo-controlled trials in up to 800 patients at approximately 100 sites in North America. The first 400-patient trial has opened to enrollment. This trial will evaluate talabostat in combination with docetaxel versus docetaxel with placebo.

The second 400-patient trial will evaluate talabostat in combination with pemetrexed versus pemetrexed with placebo. Docetaxel and pemetrexed are the current standard of care in this advanced patient population. The primary study endpoint is progression-free survival. Secondary endpoints include overall survival, objective response rate, complete response, duration of response and quality of life.

"I am encouraged by the positive results in Point's Phase 2 trial of talabostat and docetaxel. As reported at this year's ASCO meeting" said Dr. Casey Cunningham, an oncologist at Mary Crowley Medical Research Center in Dallas. "Five patients demonstrated at least a 50 percent reduction in tumor size, of which two had a complete response, defined as a complete disappearance of their tumor. To see complete responders in a second or third line setting in advanced non-small cell lung cancer is rare and merits further study.

"Talabostat has the potential to become an important treatment for non-small cell lung cancer and the initiation of Point's Phase 3 program is a significant step towards achieving this goal," said Cunningham, who is also a member of Point's Clinical Advisory Board.

Talabostat is taken orally and has the potential to be used in both solid and hematologic malignancies and in combination with a range of chemotherapies, monoclonal antibodies and other forms of cancer treatment, according to the company.