FDA Approves Active Biotech’s Phase II Studies of TASQ

Following the FDA approval of its TASQ prostate cancer project investigational new drug application, Active Biotech said it will start a Phase II proof-of-concept trial in prostate cancer patients before the end of the year.

The trial is a randomized, placebo-controlled, double-blind Phase II trial investigating 1 mg/day of TASQ (ABR-215050) versus placebo in 200 patients in the U.S. and Europe, Active Biotech said.

The trial will be performed in asymptomatic patients with metastatic, castrate-resistant prostate cancer, the company added.

According to the company, the primary endpoint will be the reduction of the number of patients with disease progression after six months of TASQ therapy. Secondary clinical endpoints include time to clinical progression and initiation of treatment with cytostatics, the company said.