Hedgehog news -
my comment: how freaking long is it goin to take Roche to give some results from the NCI collaboration in GDC449 in indications other than BCC?
AMBRIDGE, Mass., June 22, 2011 (GLOBE NEWSWIRE) -- Infinity Pharmaceuticals, Inc. (Nasdaq:INFI - News) today announced that it is expanding its clinical development program for IPI-926, a novel, oral small molecule that inhibits Smoothened, a key component of the Hedgehog pathway. As part of this expansion, Infinity plans to initiate an exploratory Phase 2 clinical trial in patients with myelofibrosis, an incurable malignancy of the bone marrow which is characterized by the replacement of normal bone marrow by fibrotic tissue and the production of blood cells in other organs, such as the spleen and liver.
The single-arm, Phase 2 trial is designed to evaluate the safety and efficacy of IPI-926 administered orally once daily in up to 45 patients with myelofibrosis. The primary endpoint of the trial is hematologic response rate. The trial is expected to begin in the third quarter of 2011.
"The important role of the Hedgehog pathway in pathogenic fibrosis leads us to believe that IPI-926 may have application across a range of malignancies, including pancreatic cancer and myelofibrosis, in which malignant cells create a dense, fibrotic, protective microenvironment via the Hedgehog pathway signaling to the stroma," stated Pedro Santabarbara, M.D., Ph.D., chief medical officer at Infinity. "While other agents in development for the treatment of myelofibrosis reduce spleen size, there is still a significant need for novel treatment options that can directly target the malignant fibrosis underlying this disease."
Infinity scientists and their academic collaborators have led the way in validating the role of Hedgehog pathway signaling in the tumor-stroma interaction in pancreatic cancer. Earlier this month, Infinity presented encouraging Phase 1b results for IPI-926 in combination with gemcitabine in patients with metastatic pancreatic cancer. Data from the study showed that IPI-926 was well tolerated and clinically active. Partial responses were observed in five out of 16 patients, for a 31 percent response rate.
Infinity continues to explore other potential indications for IPI-926 and plans to initiate multiple investigator-sponsored trials this year.
