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news.Infinity Pharmaceuticals has initiated a Phase II clinical trial evaluating IPI-926 as a treatment for patients with metastatic or locally advanced, inoperable chondrosarcoma.
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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.
Infinity has received orphan drug designation from the US Food and Drug Administration for IPI-926.
The randomised, double-blind trial is designed to evaluate the safety and efficacy of IPI-926 compared to placebo and will enroll over 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.