Active Biotech's Phase II Study Of SAIK-MS Has Started.

Business Editors

LUND, Sweden--(BUSINESS WIRE)--Apr. 11, 2002

Active Biotech is developing a new drug in tablet form, SAIK-MS, for the treatment of Multiple Sclerosis (MS).

The Phase II clinical study has now been initiated according to plan, and the first patients in Sweden are enrolled in the study.

The objective is to demonstrate that SAIK-MS reduces the progression of MS related brain lesions in patients suffering from relapsing MS (the form of the disease that progresses in flares), and to show that the progression of the disease is slowed down.

The Phase II study of SAIK-MS is a multicentre study and is planned to include several leading MS specialists (neurologists) and other staff at a total of 20 hospitals in the UK, the Netherlands, Russia and Sweden. It is a randomised, double blind, 3-arm, placebo-controlled study. The study duration will be approx. 18 months.

For more details, see the full release on our homepage www.activebiotech.com

The study will be evaluated with the help of frequent MRI exams (Magnetic Resonance Imaging) to study disease-related changes in patient brain tissue. In addition, a clinical evaluation will be performed based on the degree of handicap as defined by specific protocols (so-called EDSS/MSFC scores).

Professor Chris Polman from the VU Medical Centre in Amsterdam in the Netherlands, whose extensive merits include a large number of different research projects within the field of MS, is the Principal Investigator of the study. The MRI evaluation will be led by Frederik Barkhof, Professor of Neuroradiology and Senior Researcher at the MS-MRI Research Centre. He is also Director of the Image Analysis Centre (IAC) and like Professor Polman, he works at the VU Medical Centre in Amsterdam. Both Professor Polman and Professor Barkhof will have a significant contribution to the performance and upcoming scientific evaluation of the study.

Background

Multiple Sclerosis (MS) is currently an incurable disease, in the course of which the body's immune system attacks the myelin sheaths surrounding the nerves, including those in the brain. This disrupts nerve impulses or interrupts them completely so that sensory input fails to reach the brain for processing. This means that the brain can no longer communicate with the muscles in the body. Active Biotech's unique MS drug, SAIK-MS, is assumed to have a new active mechanism. The product is therefore expected to lead to better treatment results compared with currently available drugs. The product also has the major advantage of being administered in tablet form, as opposed to treatments that take the form of injections.

Active Biotech, listed on the Stockholm Stock Exchange, is a biotechnology company focusing on research in and development of pharmaceuticals. Active Biotech has a strong R&D portfolio and pipeline products with focus primarily on autoimmune/inflammatory diseases and cancer. Most advanced projects (clinical trials phase II) include orally administered small molecules with unique immunomodulatory properties that can be used to treat autoimmune and inflammatory diseases (SAIK), as well as a novel concept for use in cancer immunotherapy (TTS).