SOURCE: Active Biotech

August 10, 2007 02:30 ET

FDA Approves IND for Phase II Studies of TASQ

LUND, SWEDEN--(Marketwire - August 10, 2007) - 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.

"We are extremely pleased with the progress in the TASQ project and that we are now able to move into a controlled Phase II trial" says Sven Andréasson, CEO at Active Biotech. "With this study design we expect to deliver robust efficacy data on the anti-tumor effect of TASQ during 2009".

Lund, 10 August, 2007

Active Biotech AB (publ)

Sven Andréasson
President and CEO

About IND

An Investigational New Drug Application (IND) is a request for authorization from the US Food and Drug Administration (FDA) to administer an investigational drug to humans. Such authorization must be secured prior to the initiation of a clinical trial with any new drug that is not approved for marketing.

About TASQ

The objective for the company's TASQ project is to develop a pharmaceutical product that can be administered orally for chronic treatment of prostate cancer. Active Biotech is collaborating on this project with Professor John T. Isaacs of Johns Hopkins University in Baltimore, in the US.

About Prostate cancer

Prostate cancer has varying degrees of severity. Despite a relatively good prognosis, prostate cancer is the second most common cause of death among men. In 2006, it is estimated that slightly more than 2.2 million cases were diagnosed in the US alone. The pharmaceutical market for prostate cancer is estimated at slightly more than USD 3 billion a year.

About Active Biotech

Active Biotech AB is a biotechnology company focusing on research and development of pharmaceuticals. Active Biotech has a strong R&D portfolio with pipeline products focused on autoimmune/inflammatory diseases and cancer. Most advanced projects are laquinimod, an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis, as well as ANYARA for use in cancer targeted therapy, primarily renal cancer. Further key projects in clinical development comprise the three orally administered compounds TASQ for prostate cancer, 57-57 for SLE and RhuDex® for RA. In addition, the preclinical development of the I-3D project is conducted in cooperation with Chelsea Therapeutics.

Active Biotech AB
P.O. Box 724, SE-220 07 Lund, Sweden
Tel: +46 (0)46-19 20 00
Fax: +46 (0)46-19 20 50

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