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ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it has initiated a Phase 2 clinical trial to examine the efficacy and safety of oral deforolimus, its investigational mTOR inhibitor, in patients with advanced breast cancer. In collaboration with Merck & Co. Inc., deforolimus is currently being evaluated in multiple clinical trials, both alone and in combination with other therapies, for the treatment of patients with several different cancer types. Under terms of the agreement, ARIAD will receive a $15 million milestone payment from Merck for treating the first patient in the breast cancer clinical trial.
The multi-center, single-arm, Phase 2 study will evaluate oral deforolimus in combination with intravenous trastuzumab (Herceptin(R)) in patients with metastatic, HER2-positive breast cancer who have developed resistance to trastuzumab therapy. The primary endpoint for the study is clinical response to the experimental combination therapy.
"There is a significant unmet medical need for the effective treatment of patients with metastatic breast cancer who are HER2 positive and refractory to trastuzumab," stated Pierre F. Dodion, M.D., senior vice president and chief medical officer of ARIAD. "Recent data suggest that activation of the mTOR pathway is implicated in resistance to trastuzumab. This study will evaluate the anti-tumor activity of oral deforolimus, combined with trastuzumab, in a clinical setting."
The clinical study will enroll approximately 33 patients at about 15 medical centers in the United States and Europe. The trial is expected to be completed by the second half of 2009.
"The start of this clinical study is another important step for deforolimus and for the continued execution of the global development program with Merck to assess our investigational mTOR inhibitor in a broad range of cancers," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "In keeping with a key corporate objective for 2008, we are exploring the deforolimus opportunity in multiple potential cancer indications, and we look forward to the start of two additional Phase 2 clinical trials in endometrial and prostate cancers this year."
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