IPI-926 is a novel, potent, orally-available small molecule inhibitor of the Hedgehog pathway. Malignant activation of the Hedgehog pathway is implicated in multiple cancer settings and Infinity's development strategy is designed to enable IPI-926 to target a broad range of critical oncology targets - from the tumor cell to the cancer microenvironment. This broadly applicable, targeted approach represents an innovative method for fighting cancer and has potential in treating a range of cancers, including pancreatic cancer, small cell lung cancer, ovarian cancer, bladder cancer, medulloblastoma, basal cell carcinoma, and certain hematological malignancies.

Infinity is actively enrolling patients in a Phase 1b/2 clinical trial evaluating IPI-926 in combination with gemcitabine, a chemotherapy, in patients with previously untreated, metastatic pancreatic cancer. The Phase 1b portion of the study is a dose escalation, and once the recommended Phase 2 doses for IPI-926 and gemcitabine have been established, the Phase 2 portion will commence. The Phase 2 is an international, multi-center, randomized, double-blind study with a primary endpoint of overall survival. Secondary endpoints are progression free survival, time to progression, and overall response.

Infinity is also evaluating IPI-926 in a Phase 1 trial in patients with advanced solid tumors. Data from this trial are expected to be presented in 2010.

Infinity has reported preclinical data on IPI-926 demonstrating significant anti-tumor activity and excellent pharmaceutical properties, including oral bioavailability, long plasma and tumor half-life, and dose-dependent inhibition of tumor growth. For all scientific publications relating to IPI-926 and the Hedgehog signaling pathway, click here.

Infinity has an issued U.S. patent broadly covering the composition of matter of a genus of compounds, including IPI-926, useful for modulating the Hedgehog signaling pathway.

The Hedgehog program is part of Infinity's global strategic alliance with Purdue Pharmaceutical Products L.P. and Mundipharma International Corporation Limited.