Thursday, February 24, 2011

Infinity Pharmaceuticals begins enrolling for pancreatic cancer drug trial

By Lori Valigra, Mass High Tech correspondent

Infinity Pharmaceuticals Inc. (Nasdaq: INFI) of Cambridge  is moving forward with the first drug candidate stemming from its $75 million alliance with Purdue Pharmaceutical Products LP of Stamford, Conn., and Mundipharma International Corporation Ltd. of the UK.

The Phase 2 trial for the company’s IPI-926 drug combined with gemcitabine (also known as Gemzar) aims to recruit 120 patients with previously untreated, metastatic pancreatic cancer. Julian Adams, Infinity’s R&D president, would not comment about when he expected enrollment to be completed.

“We’re now seeing the fruits of our labor start to transfer into meaningful clinical trials with the endpoint of survival,” Adams said.

IPI-929 is a small molecule taken orally that inhibits Smoothened, a key component of the Hedgehog pathway, which operates only when cancer is present and that signals tumor cells, spreading the cancer. The IPI-926 is believed to block and deplete the dense, fibrous growth that encases pancreatic tumors and prevents chemotherapy from entering them.

Adams added that other preclinical data suggest that Hedgehog pathway inhibition could be applied to a broad range of difficult-to-treat cancers. He said Infinity plans to begin additional studies with IPI-926 this year.

Pancreatic cancer is the fourth leading cause of cancer death in the United States, with some 43,000 people diagnosed with the disease annually. The cancer is difficult to treat and has the lowest survival of all major cancers, with a five-year survival rate of only about 5 percent, according to the National Cancer Institute. Survival has not improved substantially in more than 40 years due in large part to the lack of effective treatment options for patients, said Julie Fleshman, CEO of the Pancreatic Cancer Action Network.

“IPI-926 may represent a novel method for treating pancreatic cancer by altering the tumor microenvironment and improving the delivery of chemotherapy to the tumor,” Charles Fuchs, MD, director of the Gastrointestinal Cancer Center at Dana-Farber Cancer Institute in Boston, said in a press release when Infinity announced the trial enrollment. Fuchs is using the drug in his patients. “The start of this Phase 2 trial marks an important step in exploring the potential of IPI-926 in this area of cancer research,” he added.

The deal with Purdue includes an equity investment and access to a $50 million line of credit. Adams said the backing from Purdue funds ongoing research, including clinical trials, and is part of the company’s cash flow plan into 2014.

In January, Infinity released guidance for 2011, including that it entered the year with $345 million in committed capital. The amount includes about $100 million in cash and investments (unaudited), $195 million in committed research and development funding from Mundipharma, and access to the $50 million line of credit from Purdue.

Exclusive of business development activities, Infinity expects a cash burn of $30 million to $40 million and estimates a year-end cash and investments balance of $60 million to $70 million.

The company has four drug candidates in clinical development and a fifth is expected to enter the clinic this year. In addition to starting the Phase 2 trial with IPI-926 and Gemzar, the company plans to present data from the Phase 1b portion of its pancreatic cancer study. It also plans to present Phase 1 data from its IPI-504 intravenous drug in combination with Taxotere.