Thursday, May 19, 2011

Infinity Pharma: One cancer drug advances, one ends development

By Julie M. Donnelly, Boston Business Journal

Infinity Pharmaceuticals Inc. (Nasdaq:INFI) is launching a Phase 2 trial of its potential treatment for non-small cell lung cancer, retaspimycin HCl in combination with the approved chemotherapy drug, Taxotere, marketed by French drug maker Sanofi (NYSE: SNY). The Cambridge-based biotechnology company also said it would halt development on a second potential cancer treatment, known at IPI-493, because it did not perform as well in trials as retaspimycin HCl.

The new trial follows positive results from a Phase 1-b trial for retaspimycin HCl and Taxotere, which showed the two drugs were well-tolerated when taken together and that it showed clinical activity in some of the sickest patients.

The Phase 2 trial will evaluate the anti-tumor activity, tolerability and safety of Infinity’s drug candidate in combination with Taxotere, compared to Taxotere alone, in approximately 100 patients who have previously taken other drugs unsuccessfully. Infinity said that following an interim analysis, the company may add more patients in certain groups that respond best to the drug combination.

“We are encouraged by the results seen in our Phase 1b trial, where response rates in NSCLC patients with a poor prognosis and limited treatment options were among the highest seen to date,” Infinity Chief Medical Officer Dr. Pedro Santabarbara said in a statement. “These clinical results suggest that retaspimycin HCl may provide an important therapeutic benefit in specific forms of NSCLC when used as part of combination therapy. We look forward to validating our early findings in a rigorous, adaptive Phase 2 clinical trial designed to quickly and efficiently identify the patients most likely to benefit from this combination.”

Infinity said it completed a preliminary review of data from two Phase 1 trials for IPI-493, in patients with solid tumors and hematological cancers, and decided to “focus its efforts exclusively on retaspimycin HCl,” which has peformed better.

Lung cancer is the second most common form of cancer and the most common cause of cancer-related death in the United States, with over 220,000 new cases and 157,000 deaths estimated in 2010, according to the American Cancer Society.