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Jan 24, 2011
 |  BioCentury  |  Product Development

Details matter to ridaforolimus story

Docs want to see the full Phase III data for Ariad's ridaforolimus in sarcoma

While ridaforolimus has produced statistically significant top line Phase III data in metastatic sarcoma, partners Ariad Pharmaceuticals Inc. and Merck & Co. Inc. still may have to convince regulators, prescribers and payers that a 3.1-week increase in median progression-free survival vs. placebo is also clinically significant. The companies hope to receive additional ammunition this year, when detailed results from the trial emerge.

Sarcoma is a heterogeneous group of cancers originating in the soft tissue or bone. Patients with metastatic sarcoma face a poor prognosis, as the only approved treatments are chemotherapeutics that tend to produce a clinical response rate of about 20%.

Ariad's ridaforolimus (formerly desforolimus) is an oral small molecule inhibitor of mammalian target of rapamycin (mTOR; FRAP; RAFT1), a protein kinase that regulates cell growth and proliferation via the phosphoinositide 3-kinase (PI3K) and protein kinase B (PKB; Akt) pathway. Abnormal mTOR activation occurs in a range of solid tumors, including sarcoma.

According to Chairman and CEO Harvey Berger, patients with metastatic sarcoma typically receive multiple lines of chemotherapy. Once they achieve disease stabilization or shrinkage, they do not receive additional treatment until...

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