July 16, 2008

OSI Initiates Phase I Study of Lymphoma Drug

OSI Pharmaceuticals 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.

The study is designed to determine the maximum tolerated dose and to establish the recommended dose and dosing schedule for Phase II trials, and will evaluate the safety and pharmacokinetic profiles of OSI-027.

The Phase I trial is a multi-center, open-label, dose escalation study to evaluate the safety, tolerability and pharmacokinetics of single-agent OSI-027 in patients with advanced solid tumors or lymphoma.

The study will also evaluate pharmacodynamic correlation between OSI-027 exposure and upstream or downstream circulating markers of the mammalian target of rapamycin (mTOR) pathway as well as preliminary antitumor activity assessed by positron emission tomography imaging and paired tumor biopsies. The study will enroll a maximum of 75 patients.

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.

KarstenWitt, vice president of clinical development oncology and drug safety at Osi, said: "OSI-027 was fully discovered at OSI and we are encouraged by the preclinical data that also suggest that OSI-027 may show enhanced activity in combination with other molecular therapies, including Tarceva (erlotinib)."