Infinity Pharmaceuticals, Inc. (INFI) Stops Cancer Trial - Saridegib

Infinity Pharmaceuticals, Inc. (INFI) stock is dropping 40% today after the company plans to stop their phase 2 cancer trial, Saridegib.

Infinity Reports Update from Phase 2 Study of Saridegib Plus Gemcitabine in Patients with Metastatic Pancreatic Cancer
 

Infinity Stops Phase 2 Study Following Preliminary Analysis Showing Trial Would Not Meet Primary Endpoint of Overall Survival –

– No Unexpected Adverse Events Observed in Study –
– Phase 2 Trials Exploring Distinct Biological Hypotheses in Myelofibrosis and Chondrosarcoma Continuing –
– Company to Host Conference Call Today at 8:30 a.m. ET –

 

Infinity Pharmaceuticals, Inc. (INFI) today announced interim data from its double-blind, randomized, placebo-controlled Phase 2 study comparing saridegib (also known as IPI-926) in combination with gemcitabine to placebo plus gemcitabine in 122 patients with previously untreated, metastatic pancreatic cancer. The primary endpoint of the Phase 2 study is overall survival.

While the final analysis is not complete, a preliminary analysis of data from the study that was completed yesterday showed a difference in survival favoring the placebo plus gemcitabine arm due to a higher rate of progressive disease in the saridegib plus gemcitabine arm. The median survival for patients receiving saridegib plus gemcitabine was less than the historical median survival for single-agent gemcitabine of approximately six months1,2, as compared to a median survival for the placebo plus gemcitabine arm of greater than six months. The adverse events observed in both arms were consistent with the known safety profile of each agent, with no unexpected toxicities. Based on this interim analysis, Infinity is voluntarily stopping the trial. The company expects to present the final data after the analyses are complete.

“While the outcome of this study is disappointing, we continue to believe in the therapeutic potential of Hedgehog pathway inhibition. As the Hedgehog pathway plays distinctly different biological roles in myelofibrosis and chondrosarcoma, our Phase 2 trials in these disease settings are ongoing,” stated Julian Adams, Ph.D., president of research and development at Infinity. “We would like to especially acknowledge the patients and caregivers who have participated in this trial and thank them for their support.”
Infinity is conducting Phase 2 trials of saridegib as a single agent in myelofibrosis, an incurable malignancy of the bone marrow, and in chondrosarcoma, a rare and life-threatening cancer of the cartilage. Infinity expects to report data from its single-arm, exploratory Phase 2 trial of saridegib in up to 45 patients with myelofibrosis in the second half of 2012. The company expects to complete enrollment in its double-blind, randomized, placebo-controlled trial of saridegib in approximately 140 patients with metastatic or locally advanced, unresectable chondrosarcoma in the second half of 2012 and to report data from this trial in the first half of 2013.

Infinity has underway six clinical trials across three development programs, including saridegib, retaspimycin HCl (also known as IPI-504), a novel heat shock protein 90 inhibitor, and IPI-145, a potent, oral inhibitor of phosphoinositide-3-kinase delta and gamma. Infinity expects to report data from each of its three development programs in the second half of 2012.

“Despite the disappointment that this news represents, our financial foundation combined with the strength of our pipeline and team enable us to continue to invest in our pipeline of innovative product candidates,” stated Adelene Q. Perkins, president and chief executive officer at Infinity. “We remain committed to our vision of building a sustainable company that discovers, develops and delivers important new therapies to patients.”
Infinity expects to provide updated financial guidance during its fourth quarter earnings call to be scheduled for later this quarter.

Saridegib Update on January 31, 2012, Cancelled

Infinity’s planned review of the saridegib program on January 31, 2012, at the Hotel Sofitel in New York City has been cancelled.