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.
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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.
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By GlobalDataChondrosarcoma 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.
