Infinity Pharmaceuticals, Inc. updated its development program for IPI-926, including completing enrollment of its Phase 2 trial in patients with previously untreated pancreatic cancer.
IPI-926 is a novel, oral, small molecule that inhibits Smoothened, a key component of the Hedgehog pathway. In preclinical models of pancreatic cancer, the Hedgehog pathway signals from the tumor to the surrounding environment to create a thick, fibrous tissue that provides support for tumor growth and prevents chemotherapy from reaching the tumor effectively. Inhibiting Smoothened with IPI-926 may represent a new approach to treating pancreatic cancer by depleting the fibrous tissue and facilitating the delivery of chemotherapy to the tumor.
The double-blind, placebo-controlled trial of 122 randomized patients is designed to compare IPI-926 in combination with gemcitabine (also known as Gemzar) to treatment with placebo and gemcitabine. Infinity initiated this Phase 2 trial in February 2011, with the primary endpoint being overall survival.
“IPI-926 as part of combination therapy may represent a new approach to treating pancreatic cancer by inhibiting the Hedgehog pathway and potentially improving delivery of chemotherapy to the tumor,” says Charles Fuchs, MD, MPH, director, Gastrointestinal Cancer Center at Dana-Farber Cancer Institute and professor of medicine at Harvard Medical School. “Clinical trials evaluating possible new treatments for pancreatic cancer, like this study with IPI-926, will hopefully lead to advances with the potential to improve survival for patients.”
In June 2011, researchers presented data from a Phase 1b trial evaluating once daily, oral administration of IPI-926 at escalating doses in combination with the standard dose of gemcitabine administered intravenously once weekly for three weeks with one week of rest in previously untreated patients with metastatic pancreatic cancer. A partial response was observed in five of the 16 patients, for a 31% response rate. The historic overall response rate to gemcitabine is less than 10%. Infinity continues to follow patients still enrolled in the trial and intends to report additional data from the Phase 1b trial at a future medical meeting.
“We look forward to obtaining the results from the ongoing trial in pancreatic cancer, which will inform our Phase 3 development plans,” states Pedro Santabárbara, MD, PhD, chief medical officer at Infinity. “Beyond pancreatic cancer, we are focused on advancing IPI-926 in Phase 2 trials in myelofibrosis and chondrosarcoma, as well as exploring a range of indications through investigator sponsored trials.”
Release Date: Oct. 17, 2011
Source: Infinity Pharmaceuticals, Inc.
http://www.dddmag.com/Pancreatic-Cancer-Drug-Completes-Trial-101911.aspx
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