Infinity announces enrollment in IPI-926 Phase 1b/2 clinical trial for pancreatic cancer

Infinity Pharmaceuticals, Inc. today announced that enrollment is ongoing locally for a Phase 1b/2 clinical trial of IPI-926, Infinity's oral molecule that inhibits Smoothened, a key component of the Hedgehog pathway, in combination with Gemzar^® (gemcitabine) in patients with previously untreated, metastatic pancreatic cancer. Inhibition of the Hedgehog pathway represents a fundamentally new approach for addressing a broad range of cancers, including pancreatic cancer, which is especially difficult to treat. As part of its ongoing efforts to discover, develop and deliver new therapies that can meaningfully improve patients' lives, Infinity is using November's Pancreatic Cancer Awareness month to highlight the unmet need in this disease and to continue local enrollment in this study.

"Despite recent advances in treating a wide range of cancers, pancreatic cancer remains one of the most difficult to treat. In fact, it has the highest mortality rate of all major cancers, with only six percent of patients surviving more than five years from their diagnosis," said Charles Fuchs, M.D., MPH, Director, Gastrointestinal Cancer Center at Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. "Clinical trials that evaluate potential new treatments for pancreatic cancer, like this study with IPI-926, represent important efforts and potentially promising clinical advances to find more effective ways to better treat patients and make a meaningful difference in their lives."

Pancreatic cancer is the fourth leading cause of cancer death in the U.S. and it is estimated that this year in the U.S., 43,140 people will be diagnosed with pancreatic cancer and 36,800 will die from the disease. In Massachusetts, there were an estimated 880 deaths due to pancreatic cancer in 2009, according to the American Cancer Society. Notoriously difficult to treat, pancreatic cancer has the highest mortality rate of all major cancers -- 94 percent of all patients will die within five years of a pancreatic cancer diagnosis and 75 percent of patients die within the first year. The average life expectancy for patients with metastatic disease is just three to six months. Unfortunately, pancreatic cancer is one of the few cancers for which the survival rate has not improved substantially over nearly 40 years. (Source: American Cancer Society, PanCan.org).

IPI-926 has shown promising clinical results with data from a Phase 1 study just presented at the European Society for Medical Oncology Congress in October. These data showed that treatment with IPI-926 was well tolerated and resulted in clinical activity in patients with basal cell carcinoma (BCC). The study also showed that IPI-926's pharmacokinetic profile supports once daily oral dosing. Further, in a previously conducted preclinical study that has been published in the journal Science, IPI-926 in combination with Gemzar^® (gemcitabine) demonstrated improved drug delivery, caused tumor death, decreased metastases and doubled median survival compared to control.

Following on these data, Infinity launched the Phase 1b portion of its pancreatic cancer clinical trial earlier this year. The trial is evaluating IPI-926 in combination with gemcitabine, a chemotherapy, in patients with previously untreated, metastatic pancreatic cancer. The Phase 1b portion of the study is a dose escalation, and once the recommended Phase 2 doses for IPI-926 and gemcitabine have been established, the Phase 2 portion will commence. The Phase 2 trial is a multi-center, randomized, double-blind study with a primary endpoint of overall survival. Secondary endpoints are progression free survival, time to progression, and overall response. To learn more about the trial, please visit www.infi.com or www.clinicaltrials.gov.