PR with the results -
...The Company also updated investors on the progress of its OSI-774 development program. Together with its partners, Genentech Inc. (NYSE: DNA - news) and Roche, OSI has been formulating a global development plan for OSI-774. The alliance partners intend to initially pursue the development of the product in all of the major tumor markets, including non-small cell lung cancer (NSCLC), in which the alliance will focus on front-line combination approaches. Additional programs directed toward unmet clinical needs in refractory solid tumor indications will also be conducted. Moving forward, the Company intends to update investors on this program as studies are initiated and data reported.
``Our co-development alliance with Genentech and Roche is off to a great start,'' commented Dr. Goddard. ``We are delighted with the quality and commitment of the development teams on the OSI-774 program and the speed and focus with which a comprehensive development program is coming together.''
The Company also announced that OSI-774 has been accepted by the National Cancer Institute (NCI) for development through their Cancer Therapy Evaluation Program (CTEP). Recommendations for proposals for NCI sponsored studies in glioma, head and neck, hepatobiliary, gastro-esophageal junction, endometrial, cervical, ovarian, and renal carcinomas have been issued.
The Company informed investors that it anticipates presenting data on its current Phase II program at this year's American Society of Clinical Oncologists (ASCO) meeting in San Francisco from May 12-15, 2001. Studies were conducted in NSCLC, head and neck and ovarian cancers, that examined the use of OSI-774 as a single agent in advanced, refractory patients. Intermediate data on the two main studies, a 56 patient study in NSCLC and a 113 patient study in head and neck cancer was presented at the European Organization for the Research and Treatment of Cancer (EORTC) meeting in November 2000. The drug has been generally well tolerated in all indications with an acneiform rash being the most prevalent of reported side effects. Forty-eight percent of the lung cancer patients had either stabilization of their disease or a partial response (6 with partial responses) and 42% of the 78 evaluable patients in the head and neck cancer study had either disease stabilization or partial response (10 with partial responses). The Company also stated that initial summary data of the smaller 34 patient ovarian study showed encouraging indications of activity. Scans taken at eight weeks indicated 3 of 30 evaluable patients with partial responses and 15 of 30 patients with stable disease. Data documenting the duration of responses was only available for 2 of the patients with partial responses and 3 with stable disease. Detailed updates on all three trials will be presented at the ASCO session. |
