Point Therapeutics Inc has initiated its Phase 3 programme in metastatic non-small cell lung cancer (NSCLC). This news follows a successful End-of-Phase 2 meeting with the Food and Drug Administration.
Point's Phase 3 programme will further evaluate the company's lead compound, talabostat, in patients with Stage IIIB/IV NSCLC after failure of a platinum-based chemotherapy. The programme will consist of two randomised, 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 enrolment. 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, claims a company release.
Dr. Casey Cunningham, an oncologist at Mary Crowley Medical Research Center in Dallas, TX and a member of Point's clinical advisory board stated that talabostat had the potential to become an important treatment for non-small cell lung cancer and the initiation of Point's Phase 3 programme was a significant step towards achieving this goal.
"Talabostat has several characteristics that make it an attractive drug candidate-it is orally available and has the potential to be used in both solid and haematological malignancies and in combination with a range of chemotherapies, monoclonal antibodies and other forms of cancer treatment. We are very excited to begin our Phase 3 programme in a serious disease where a need for more treatment options exists," said Don Kiepert, president and CEO of Point Therapeutics Inc.
According to the American Cancer Society, lung cancer is the leading cause of cancer death among men and women in the United States, with nearly 60% of people diagnosed dying within one year and nearly 75% dying within two years. 87% of all lung cancers are non-small cell. While treatment options for NSCLC continue to emerge, mortality rates have not improved in the last 10 years, leaving a significant need for advancement in current therapies.