OSI will apply for orphan drug status in the adrenocortical carcinoma setting. Orphan drug designation, when granted by the FDA's Office of Orphan Products Development, allows for up to seven years of marketing exclusivity after gaining FDA approval, as well as clinical study incentives, study design assistance, waivers of certain FDA user fees, and potential tax credits.

About the Phase I/II OvarianTrial

The Phase I/II trial is a multi-center, randomized, open-label study evaluating intermittent and continuous OSI-906 and weekly paclitaxel in patients with recurrent epithelial ovarian cancer and other solid tumors. Approximately 169 patients will be treated in the study; up to 40 patients in the Phase I portion and up to 129 patients in the randomized Phase II portion.

The Phase I dose escalation of the study will establish the maximum tolerated dose (MTD) of intermittent and continuous OSI-906 in combination with weekly paclitaxel in patients with advanced solid tumors. The Phase II study will begin after the recommended dose has been established. The Phase II study will enroll patients with relapsed/recurrent epithelial ovarian cancer and will be randomized 1:1:1 to three treatment groups. Arm A will include intermittent OSI-906 QD (once a day) on days 1-3, 8-10, and 15-17 with paclitaxel on days 1, 8, and 15; Arm B will include continuous OSI-906 BID (2 times a day) from day 1 onwards with paclitaxel on days 1, 8, and 15; and Arm C will include paclitaxel on days 1, 8, and 15.

The primary objective of this study is to evaluate in parallel the anti-tumor efficacy as determined by CA125 response rate of two different schedules of OSI-906 in combination with weekly paclitaxel in recurrent/refractory ovarian cancer patients.

For more information about enrolling in either of these studies, please visit www.clinicaltrials.

osip