Ariad Initiates Phase II Breast Cancer Trial
Ariad Pharmaceuticals has initiated a Phase II 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, 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 II study will evaluate oral deforolimus in combination with intravenous trastuzumab (Herceptin) 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.
The clinical study will enroll approximately 33 patients at about 15 medical centers in the US and Europe. The trial is expected to be completed by the second half of 2009.
Harvey Berger, chairman and CEO of Ariad, said: “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.”