Ariad’s Partner Merck Initiates Phase II Prostate Cancer Trial
Ariad Pharmaceuticals, a developer of medicines to treat cancer, has announced the initiation of a Phase II clinical trial by Merck & Co to evaluate the safety and efficacy of oral deforolimus, Ariad’s investigational mTOR inhibitor, in patients with advanced prostate cancer.
In collaboration with Merck, deforolimus is currently being studied in multiple clinical trials, both alone and in combination with other therapies, in patients with several different types of cancer. Under the terms of the agreement, Ariad will receive a $12.5 million milestone payment from Merck upon treatment of the first patient in this clinical study.
The multi-center, randomized, double-blind clinical trial will compare oral deforolimus in combination with the anti-androgen drug bicalutamide against placebo and bicalutamide in men with asymptomatic, metastatic, androgen-independent prostate cancer. The primary endpoint of the study is based on the proportion of patients achieving a 30% decrease in prostate specific antigen compared to base line within 12 weeks of treatment.
The clinical trial will enroll approximately 150 patients at some 50 sites including medical centers in the US and abroad. Patients will be randomized (1:1) to oral deforolimus and bicalutamide versus placebo and bicalutamide.
This is the third Phase II clinical trial examining the safety and efficacy of oral deforolimus in patients with different solid tumors that the Ariad-Merck partnership has begun in the past three months.
Harvey Berger, chairman and CEO of Ariad, said: “The start of this clinical trial illustrates the ongoing progress being made in the clinical development of deforolimus in multiple indications. We are executing on the global development plan for deforolimus and achieving the milestones that have been set by the collaboration.”