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Biotest AG: Biotest Presents New Preclinical Data on Tregalizumab (BT-061) at the Annual


Biotest AG / Key word(s): Research Update

18.11.2014 / 11:30


/

PRESS RELEASE

Biotest Presents New Preclinical Data on Tregalizumab (BT-061) at the Annual
Meeting of the American College of Rheumatology in Boston

- New preclinical results confirm treatment rationale in mono- and combination
  therapy settings

- Pro-inflammatory cytokines or methotrexate have no negative impact on in vitro
  activation of regulatory T-cells by Tregalizumab


Dreieich/ Germany, November 18, 2014. Biotest AG announced that data from in vitro studies on tregalizumab have been presented yesterday at the American College of Rheumatology (ACR) Annual Meeting in Boston, entitled "The Effect of a Pro-Inflammatory Milieu on Tregalizumab (BT-061)-Induced Regulatory T Cell Activity" (Abstract # 1725).

Tregalizumab is an antibody that selectively activates naturally occurring regulatory T cells (Tregs), and is currently in Phase 2b clinical development for the treatment of rheumatoid arthritis (RA). This mode of action is unique and totally different from other treatment modalities currently used in RA. Activating regulatory cells may yield high treatment efficacy with less side effects due to lower over all suppression of the immune system.
The presented in vitro studies examined the potential of tregalizumab to activate regulatory T-cells in the presence of high levels of pro-inflammatory cytokines as observed in patients with autoimmune diseases such as RA. Further investigations focused on the influence of methotrexate which is widely used as co-medication in RA in combination with tregalizumab.
The experiments show that the in vitro activation of regulatory T-cells by tregalizumab is not inhibited either by MTX or by pro-inflammatory cytokines (IL-1ß, IL-6 and TNF-). The scientific evaluation was done in collaboration with the research group of Dr. Helmut Jonuleit, University of Mainz.

"These findings further increase our understanding on the mode of action of tregalizumab. The data support the therapeutic potential of tregalizumab's novel mechanism for the treatment of rheumatoid arthritis and other autoimmune diseases, both, in combination with methotrexate or as stand-alone therapeutic" said Dr. Jörg Schüttrumpf, Head of Research at Biotest AG. "We look forward to reporting the first clinical data from our phase 2b trial in RA (TREAT 2b) in the 2nd quarter of 2015." TREAT 2b is currently underway in 14 countries, with more than 80 study centers. Patient recruitment was completed in September 2014.

The poster is available online at www.biotest.de.

About Tregalizumab (BT-061)
Tregalizumab is a humanized monoclonal anti-CD4 antibody, which selectively activates regulatory T cells (Tregs). Tregalizumab thereby strengthens a natural function of the body that prevents excessive immune reactions. The antibody is being developed in collaboration with AbbVie to treat diseases due to an overreaction of the immune system, as in autoimmune diseases. Tregalizumab is currently in Phase 2b clinical development for the treatment of rheumatoid arthritis.

About TREAT 2b
TREAT 2b (T-cell REgulating Arthritis Trial 2b) study is assessing the efficacy and safety of tregalizumab in patients with moderate to severe rheumatoid arthritis. This double blind, randomised and placebo-controlled trial has four treatment groups. In the active treatment groups, the main part of the study, tregalizumab is administered at doses of 25mg, 100mg or 200mg subcutaneously once-weekly for a treatment duration of 24 weeks given in combination with methotrexate. Patients in the control arm receive methotrexate only. In patients who respond to treatment, the therapy can be extended for a further six months in an 'extension phase' of the trial. More information can be found on clinicaltrials.gov (identifier NCT 01999192).

About rheumatoid arthritis
Rheumatoid arthritis (RA) is a progressive inflammatory autoimmune disease that affects joints and organs. It is estimated that about 5 million people worldwide suffer from RA, with between 0.3% and 1% of the population of industrialized countries affected. The disease occurs three times more often in women than in men. Although RA can affect people of all age groups, the disease in most cases occurs between the ages of 40 and 60. Traditional treatment methods against RA include non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids and disease-modifying anti-rheumatic drugs (DMARDs). Treatments based on biotechnology preparations have been added recently.

Disclaimer

This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

About Biotest

Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In addition Biotest develops monoclonal antibodies in the indications of rheumatoid arthritis and cancer of plasma cells, which are produced by recombinant technologies. Biotest has more than 2.000 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, www.biotest.de
Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406,
e-mail: investor_relations@biotest.de
fax: +49 (0) 6103 801-347

Securities' ID No., ISIN ordinary shares: 522720, DE0005227201
Securities' ID No., ISIN preference shares: 522723, DE0005227235
Listing: Prime Standard
Open Market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hanover, Munich, Stuttgart





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