Active Biotech: FDA Approves IND for Phase II Studies of TASQ
The review of Active Biotech's IND (Investigational New Drug) for the TASQ prostate cancer project has been completed by the US food and Drug Administration (FDA). A Phase II proof of concept trial in prostate cancer patients will now be initiated, and the first patients in this trial will start treatment before the end of 2007.
The approved trial is a randomized, placebo controlled, double-blind Phase II trial investigating 1 mg/day of TASQ (ABR-215050) versus placebo in 200 patients. The trial will be performed in asymptomatic patients with metastatic, castrate resistant, prostate cancer. This is a similar patient population as that previously treated in the TASQ Phase I program. As previously reported, TASQ therapy here showed encouraging anti-tumor effects.
The primary endpoint will be the reduction of the number of patients with disease progression after 6 months of TASQ therapy. Secondary clinical endpoints of importance for this group of patients include time to clinical progression and initiation of treatment with cytostatics. Exploration of such endpoints is of importance for future TASQ development and registration.
The trial will be carried out as a multi-centre trial in the US and Europe. Coordinating investigator will be Dr Roberto Pili at Johns Hopkins Medical Institution, Baltimore, US.
Other news from the department research and development
Get the life science industry in your inbox
From now on, don't miss a thing: Our newsletter for biotechnology, pharma and life sciences brings you up to date every Tuesday and Thursday. The latest industry news, product highlights and innovations - compact and easy to understand in your inbox. Researched by us so you don't have to.
