OSI Pharmaceuticals (OSIP) Initiates Phase I Trial for OSI-027 in Patients with Lymphoma
OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) has initiated a Phase I clinical trial of OSI-027, an oral, potent and selective inhibitor of both the TORC1 and TORC2 complexes that inhibits the kinase activity associated with mTOR (mammalian target of rapamycin). The study is designed to determine the maximum tolerated dose (MTD) and to establish the recommended dose and dosing schedule for Phase II trials, and will evaluate the safety and pharmacokinetic profiles of OSI-027.
Preclinical studies demonstrated that orally administered OSI-027 has the potential for anti-tumor efficacy in a broad range of human cancers that depend on the mTOR pathway for tumor growth and survival, such as ovarian, colorectal, breast, lung, prostate and brain cancers, in addition to lymphoma.
“OSI-027 has the potential to be the next generation modulator of mTOR signaling by providing both TORC1 and TORC 2 inhibition, versus rapalogs that inhibit only TORC1 activity,” said Karsten Witt, M.D., Vice President, Clinical Development Oncology and Drug Safety, OSI Pharmaceuticals. “OSI-027 was fully discovered at OSI and we are encouraged by the pre-clinical data that also suggest that OSI-027 may show enhanced activity in combination with other molecular therapies, including Tarceva® (erlotinib).”[SM]
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