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Infinity Drug Fails in Pancreatic Cancer Trial, Shares Fall

Bad news out today from Infinity Pharmaceuticals. The Cambridge, MA-based biotech company said it is halting a mid-stage clinical trial of its drug for pancreatic cancer early after learning that patients were living longer in the placebo comparison group. Infinity (NASDAQ: INFI) shares fell more than 30 percent after the news.

The trial of 122 patients showed that when patients got Infinity’s saridegib (IPI-926) in addition to gemcitabine chemotherapy, they were living less than the six months they were expected to based on historical studies with the chemo drug alone. No unexpected side effects were seen among patients on the Infinity drug or in the control group, the company said.

This is a painful setback for Infinity. The company just last week released some more encouraging data from an early-phase study of the drug in 16 patients, which suggested it offered a benefit by shrinking tumors and helping them live a median time of about 10 months. The plan for this year was to wait for the results from the more rigorous study of 122 patients, to get a firm answer on whether it could help pancreatic cancer patients live more than the expected six months. Even though the drug failed in that study, Infinity said it still believes in the drug’s potential because it inhibits a pathway known as hedgehog that plays a role in multiple cancers. Infinity currently is testing the new compound in mid-stage trials against myelofibrosis and chondrosarcoma. Those studies are continuing, the company said.

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  • Pharmaguy

    This is not, IMHO, a major setback. They stopped the trial due to the fact that there was a major difference in patient types in the saridegib arm, which had nothing to do with the drug’s ability to double median survival currently seen with Gemzar. Decision to stop the trial was purely a good/strategic business move as they are very costly to run, as you know, plus they would have needed a second phase-3 trial to run for years after positive results in the now cancelled phase-2. If they had any doubts about the drugs ability to extend life in or “cure” other cancers they would have pulled the plug on their Chondro and MF trials. The Hedgehog inhibitors in development by the major players are all pretty much the same, if anything this news should affect Genentech/Curis stock more than Infinity’s, as they are currently under FDA review with vismodegib for BCC and have 5 trials in pancreatic cancer recruiting!

    I, for one, will buy a ton of stock if/when it goes south by another $1…

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