Infinity Pharmaceuticals has initiated a Phase II clinical trial to evaluate IPI-926 as a treatment for patients with metastatic or locally advanced inoperable chondrosarcoma, a rare bone cancer.
The randomised, double-blind trial is designed to evaluate the safety and efficacy of IPI-926 compared to placebo, and will enrol more than 100 patients worldwide.
The primary endpoint of the trial is progression-free survival, while secondary endpoints include time-to-progression, overall survival, overall response rate and response duration.
Infinity has also announced that it has received orphan drug designation from the US Food and Drug Administration (FDA) for IPI-926.
IPI-926 is a novel, oral molecule that inhibits Smoothened, a key component of the Hedgehog pathway.
The activation of the Hedgehog pathway is believed to be involved in tumour initiation, growth, survival and metastases in chondrosarcoma.
Chondrosarcoma has no approved systemic treatments. In the US, it accounts for approximately one-third of the 2,000 cases of primary bone cancer diagnosed each year.