Second Interim Results from Phase 3 trial expected by March 31 (NASDAQ:ARIA)
Oral ridaforolimus is a drug that has been developed and manufactured by ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA). This drug can be used to treat patients who are suffering from “metastatic soft-tissue and bone sarcomasâ€. The company now wants to bring the drug into the market of the United States of America. However, in order to do so, it must gain the approval from the country’s toughest regulator – the Food and Drug Administration (FDA). The company has been conducting a series of clinical trials on vilazodone over the last few years so that the results from the trials could be used to persuade the FDA. The company started conducting the Phase 3 trial on the drug in September 2007. After that, a lot of time was spent enrolling the study participants. It was only last December when the company announced that it had completed enrolling all the participants for the Phase 3 trial. The first interim results from the trial have already been achieved. Now, with the complete enrollment of participants, the company expects to obtain the second interim results by March 31, 2010.
The Phase 3 trial was named as SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Ridaforolimus). About 650 patients – who are suffering from metastatic sarcoma but who have previously resorted to chemotherapy for treatment – participated in the trial. The large number of study participants and also the long duration makes the Phase 3 trial the “largest†trial on any drug treating sarcomas.
Right after the news of the completion of participant enrollment was released, Harvey J. Berger, M.D, who is the Chief Executive Officer as well as the Chairman of Ariad, said:
“We are extremely proud of this accomplishment. Achieving full patient enrollment in the SUCCEED clinical trial was a major global undertaking, and our many R&D groups deserve tremendous recognition for their work. We are very pleased to have achieved this milestone in the timeframe that we established at the outset and now look forward to completing the trial and reporting data from the study next year.â€

By John McCalister on 03/23/2010 10:26 am PST -- Biotech