DGAP-News

Biotest AG: Monoclonal antibody BT-061 shows potential in the indication multiple sclerosis

Biotest AG  / Key word(s): Miscellaneous

21.10.2010 10:25

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Monoclonal antibody BT-061 shows potential in the indication multiple
sclerosis

- Biotest generates positive pre-clinical data in the indication multiple
  sclerosis        
- Further development in this indication supported by the German Federal
  Ministry of Education and Research in the framework of the ´Neu²
  Konsortium´

Dreieich, 21. October 2010. Biotest has obtained positive pre-clinical data
indicating the potential of BT-061 for the treatment of multiple sclerosis
(MS).
Current scientific publications by respected academic research groups show
that the regulatory T-cells in particular play a central part in the
development and progression of MS; impairment of their function in the
patient appears to be causally linked with the disease. The monoclonal
antibody BT-061 specifically activates regulatory T-cells. The pre-clinical
data that have now been obtained show that BT-061 reinforces the function
of regulatory T-cells derived from MS patients.

´We are very pleased that the data now available confirm our expectations
that the immunomodulatory mechanism of action of BT-061 has considerable
potential in the indication MS, ´ comments Dr. Frank Osterroth, director of
the Biotherapeutics Division at Biotest, on the data. ´Particularly in MS,
there is still a significant medical need for effective and better
tolerated and safe active agents despite modern approved products´.

Further pre-clinical analyses are now aimed at preparing for the clinical
trial of BT-061 in the indication MS. Evidence is to be sought on which
patient populations might respond particularly well to therapy with BT-061.
The analyses will be conducted in collaboration with leading academic study
groups working in this area.

To deal with this and other questions, Biotest has joined the ´New active
agents for neurological diseases´ consortium (Neu² Konsortium). This is a
consortium of institutes and pharmaceutical companies that work on the
development of new active agents to treat neurological diseases, supported
by the German Federal Ministry of Education and Research (BMBF). The
consortium represents an optimal platform for further studies focused on
clinical development.

The decision-making body of the Neu² Konsortium voted unanimously to
support the development programme of BT-061 in MS and this decision has now
been confirmed by the BMBF.

The approved support programme extends over a three-year period and may
also include a phase IIa clinical trial, which will investigate the
potential of BT-061 in patients with MS (proof-of-concept trial).