Active Biotech fulfills important milestone for the SAIK-MS project

4/24/2001 4:22 AM EST

The clinical Phase 1 study on Active Biotech's SAIK-MS compound, ABR-
215062 in healthy volunteers and MS patients is concluded.

The study has successfully reached its clinical endpoint, and has
provided the future clinical development programme with valuable
information.

A million people worldwide are affected by multiple sclerosis (MS), 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 or discontinuing the nerve impulses.
The disease has a slow, drawn-out cycle and often occurs in spells with
alternating periods of improvement and deterioration.

There is currently no treatment to halt MS, although beta interferon
injections has been demonstrated to slow the disease in some patients.
Active Biotech has selected a new treatment strategy with its SAIK
immunomodulators, which also have the advantage of being available in
tablet form.

The study now concluded was designed as a dose escalation study with the
objective to document safety of the compound in humans. In the first
part of the study, healthy volunteers in groups of 5 (of which 1
received placebo), were treated for five consecutive days with
escalating doses from 0.05 mg up to 2.4 mg/day. All treatments were well
tolerated and there were no treatment related clinically important
changes in laboratory safety parameters.

Subsequently, MS patients (6 patients/group, 1 placebo) were included
and treated for four weeks. At the starting dose, 1.2 mg/day, treatment
was, also in this part of the study, well tolerated and no treatment
related clinically important changes in laboratory safety parameters
could be registered.

Among the group of MS-patients that received the highest dose (2.4
mg/day), all treated patients showed increases in laboratory parameters
indicating inflammatory activity. The reactions observed were remarkably
uniform with respect to degree and time spent after the first dose. We
regard this uniform result as very positive. According to the clinical
protocol, such increases in 2 or more patients is defined as dose
limiting toxicity. Thus, the study has met its endpoint and the Maximal
Tolerable Dose (MTD) in MS patients is defined as 1.2 mg/day, i.e. the
highest dose at which there are no measurable negative changes in safety
parameters.

The defined MTD is in good agreement with the predictions calculated
from pre-clinical safety data. According to these calculations, the
therapeutic dose-response range of the SAIK-MS substance in MS patients
can be expected to be 0.03 - 0.3 mg/day, i.e. well below the MTD, which
means a considerably large safety margin with respect to toxicity.

Totally the study comprised of 35 healthy volunteers and 11 MS patients.

The next step in the development of the SAIK-MS product is now to
prepare for and perform a clinical Phase 2 study designed to show
"clinical proof of concept" in a larger group of MS patients, i.e. to
demonstrate that SAIK-MS has therapeutic activity on the disease
multiple sclerosis.

Active Biotech has previously communicated the ongoing discussions with
potential business partners regarding clinical development and future
marketing of SAIK-MS. Active Biotech will proceed with these
discussions, with no delay in the preparations and work with the Phase
II study. A collaboration with a partner will only be initiated if and
when Active Biotech finds that the agreement terms corresponds to the
company's estimated value of the project.

The results from the concluded Phase I study are very promising and
valuable. However, extensive development work and trials need yet to be
performed before an approval of a product for the treatment of MS can be
achieved from the authorities, and for the medicine to reach patients.

Lund 24 April

Active Biotech AB (Publ)

Sven Andréasson
President & CEO

Active Biotech AB is a biotechnology company focusing on research and
development of medicines and vaccines. Our expertise lies in the
knowledge of the human immune defence system. We have a high-quality
project portfolio and financial strength. The most important products
and projects are medicines for multiple sclerosis (SAIK) and cancer
(TTS), the SBL Cholera Vaccine, and Dukoral and ETEC vaccines against
tourist diarrhoea. Active Biotech's turnover was MSEK 280 in 2000.

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