Phase II clinical trial for Active Biotech's multiple sclerosis drug SAIK-MS


The Principal Investigator of the SAIK-MS Phase II study will be Professor Chris Polman at VU Medical Centre in Amsterdam, the Netherlands. Chris Polman is Professor of Neurology at the Free University as well as Clinical and Scientific Director of the Multiple Sclerosis Centre at the VU Medical Centre. Professor Polman is one of Europe's leading MS specialists.

The Phase II study of Active Biotech's multiple sclerosis drug SAIK-MS will be performed as a multicenter study, with trial centers in the UK, the Netherlands and Sweden. The aim of the study is to demonstrate that SAIK-MS has a therapeutic effect on multiple sclerosis. The treatment of patients is expected to start during the first quarter 2002. The study is planned to run for 18 months.

Evaluation of the study will be done by frequent MRI (Magnetic Resonance Imaging) measurements of the brain lesions related to the disease. In addition, clinical score evaluation of the patients disability will be performed. The MRI evaluation will be centralised and done under the supervision of Frederik Barkhof, Professor of Neuroradiology and Senior Researcher at the MS-MRI Research Centre, and Director of the Image Analysis Centre (IAC) at the VU Medical Centre, Amsterdam.

Both Professor Polman and Professor Barkhof have an extensive experience of the clinical development of immunomodulatory compounds like the SAIK-MS drug.

"Through the collaboration with Professor Polman and Professor Barkof, we get access to leading clinical expertise for the treatment of multiple sclerosis. We are very pleased to be able to perform our Phase II study in cooperation with this reputable centre", says Sven Andréasson, President & CEO Active Biotech.

Before summer 2001, the successful results from Phase I trials of the drug were reported. The Maximal Tolerable Dose (MTD) in MS patients was defined. The therapeutic dose range calculated from pre-clinical data is estimated well below which gives a considerably large safety margin with respect to toxicity.

SAIK-MS has previously shown good efficacy in experimental models of MS. Also based on previous experience from a closely related product, the company has great confidence in the success of the Phase II study. The SAIK product is patented by Active Biotech in Europe, USA and Japan, with an expire year of 2019.

Multiple sclerosis (MS) is a chronic autoimmune disease. The body's own immune defence attacks the insulating myelin sheaths surrounding the nerve fibres in the central nervous system, thereby disrupting nerve impulses. The disease has a drawn-out cycle and often occurs in flares with interim periods of disease stability.

There is currently no treatment to halt MS, although beta interferon injections have been demonstrated to reduce the frequency and severity of relapses in some MS patients. Active Biotechs product SAIK-MS is assumed to target a new mode of action, which is expected to give an improved result. The product has also the significant competitive advantage of being available in tablet form.

The first oral MS drug that reaches the market will have a great potential to capture a large part of the MS market. There are today over 1 million MS sufferers all over the world, with an increase of around 30% estimated over the next four years. The value of the total market for MS drugs is currently 2.3 BUSD (UBS Warburg Pharmaceuticals & Biotechnology, April 2001).

Lund, Sweden 25 October 2001

Active Biotech AB (publ)

Sven Andréasson
President & CEO

After receiving his M.D. from Nijmegen University in 1982, Professor Polman trained in neurology at the Free University. He was awarded his Ph.D. in experimental allergic encephalomyelitis in 1988 and in 1994 received his Professorship. Professor Polman is a member of several medical societies and bodies, such as the Research and Programs Advisory Committee and the Advisory Committee on Clinical Trials of the National MS Society US. Furthermore, he is also vice-president of ECTRIMS (European Committee Treatment and Research in MS) and Chairman of the Scientific Advisory Board of the Dutch MS Society. He is the author of over 100 peer-reviewed scientific publications on MS.

Active Biotech 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. Main platforms include orally administered small molecules with unique immunomodulatory properties that can be used to treat autoimmune and inflammatory diseases, as well as a novel concept for use in cancer immunotherapy.

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