Infinity Pharma Lead Cancer Drug Trial Halted, Ends in Failure

4/15/09

Infinity Pharmaceuticals’ (NASDAQ:INFI) lead cancer drug has crashed and burned in a late-stage clinical trial for treating relapsed forms of malignant stomach tumors, after interim results showed that more patients were dying when taking the drug than those who weren’t on the drug, the company reports.

The decision to halt the Phase III “RING” trial came last night after preliminary safety data showed that there was a higher mortality rate among the first 46 patients in the study who were treated with Cambridge, MA-based Infinity’s drug, dubbed IPI-504 (retaspimycin hydrochloride for injection). The drug is intended to knock out a tumor growth protein known as Hsp90. The company is telling clinical trial centers involved in the study to stop giving the drug to patients. The firm is continuing separate trials using the drug to treat non-small cell lung cancer, metastatic breast cancer, and advanced solid tumors, but it plans to consult with other parties to decide if any changes are needed in those studies.

“We continue to believe in the therapeutic potential of Hsp90 inhibition, and are committed to the development of both IPI-504 and our oral Hsp90 inhibitor, IPI-493,” said Julian Adams, chief scientific officer of Infinity, in a statement. “We have now fully enrolled and look forward to sharing at ASCO data from our ongoing trial of IPI-504 in non-small cell lung cancer.”

The end of the RING trial follows London-based drug giant AstraZeneca’s decision, revealed in December, to hand back to Infinity its 50-percent ownership stake in IPI-504, giving little reason for the decision and leaving Wall Street guessing. In May, Infinity reported that the drug could stabilize tumors for two-thirds of patients in a study of 36 patients, and keep tumors from spreading for about three months in patients who failed on all other treatments. The RING trial is said to have included a higher proportion of patients with more advanced tumors than the earlier study.

Infinity says that it still has enough cash in the bank to operate through 2012. The firm plans to disclose that it ended March with $153 million in cash, cash equivalents, and available-for-sale securities. There is also a $50 million line of credit available to the company from Stamford, CT-based drugmaker Purdue Pharma, with which Infinity struck partnership deal initially worth up to $75 million late last year.

Infinity’s stock has taken a licking in morning trading, down 30.8 percent to $5.97 cents per share as of 10:45 am.

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