The Swedish Medical Products Agency has approved for Active Biotech to expand Phase I-trials and include patients with multiple sclerosis
During the autumn 1999, SAIK-MS, a substance intended for use in patients with multiple sclerosis, has been tested on healthy volunteers with very promising results. The Swedish medical products agency has now approved a more extensive study in more subjects with higher doses.
A later phase will also be included in this extended Phase I-trial, in which tolerance and dosing studies will be carried out in diseased patients.
It is therefore anticipated that SAIK-MS will enter Phase II trials to study its clinical effect in Q4 2000, this is earlier than originally expected.
The current market for existing pharmaceuticals used in the treatment of MS is 5 billion SEK per year which expected to grow by more than 50%. There are over 50,000 new patients every year, only a portion of which can be treated with existing therapies.
Lund 11 February 2000
Active Biotech AB (publ)
President & CEO