Infinity Pharmaceuticals’ top execs sometimes get strange looks when they say they are developing a new drug for pancreatic cancer. This, after all, is a wicked malignancy that usually kills patients in just a few months, and has dashed the hopes of many cancer drug developers over the years.
Yet Cambridge, MA-based Infinity (NASDAQ: INFI) is moving full steam ahead with a new drug candidate for pancreatic cancer, IPI-926, in a mid-stage trial of 120 patients this year. Infinity will offer a clearer picture of why it has moved ahead with this program during a presentation this weekend at the American Society of Clinical Oncology in Chicago. That’s where researchers will present data on the first 16 patients with pancreatic cancer who got the Infinity drug in combination with a standard chemo drug.
An interim peek at the data from the first-phase trial showed that three of the first nine patients (33 percent) had their tumors shrink by half or more when they got IPI-926 in combination with standard gemcitabine (Gemzar) chemotherapy. The study was designed to look at safety of a variety of doses, and there was no control group, so it’s impossible to say for sure how good that really is compared to anything else. But it was an eye-opening result nonetheless, given that only about 5 percent of patients will typically see that kind of tumor shrinkage when getting the gemcitabine alone, says Julian Adams, president of R&D at Infinity. Common side effects were fatigue, nausea, and an elevation in liver enzymes which can be a sign of liver damage, but which weren’t considered serious in this trial, and which were reversible.
“We are circumspect. We don’t want to create unbridled enthusiasm. We are humbled by the challenge of this disease,” Adams says. That said, he notes that the ongoing mid-stage study of 120 patients is recruiting patients fast, and should be completely enrolled by the end of this year. “The investigator community is jazzed,” Adams says.
Pancreatic cancer, once it has spread through the body, usually gives people a life expectancy of just under six months, Adams says. About 36,800 people in the U.S. die each year from pancreatic cancer, according to the American Cancer Society. The really big test for Infinity will be to see if its drug can help those pancreatic cancer patients live longer, which is the main goal of the ongoing trial of 120 patients. Results from that study are expected by late in 2012, Adams says.
Part of what draws attention to the Infinity program is the science. The drug is designed to inhibit a biological pathway known as Hedgehog, which is thought to help tumors grow and thrive when flipped into a mutated form. Infinity scientists showed, in a paper published in Science in 2009, that the drug by itself had no effect on pancreatic cancer in mice, but that it disrupted the dense tissue matrix surrounding tumors, Adams says. By disrupting the tumor’s microenvironment, it is thought to help enable cell-killing chemotherapy like gemcitabine to do a better job of penetrating the tumor, Adams says.
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