RhuDex(R) Achieves Positive Results In Clinical Phase IIa Trial

Main Category: Arthritis
Also Included In: Clinical Trials / Drug Trials
Article Date: 24 Jun 2008 - 5:00 PDT

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Active Biotech AB's (OMX Nordic:ACTI) collaboration partner MediGene AG (Frankfurt, Prime Standard: MDG) has achieved its objectives in a clinical phase IIa trial of the candidate drug RhuDex® for the treatment of rheumatoid arthritis.

In addition to positive safety data and the good adsorption after oral administration, a first indication of biological activity of RhuDex® was observed. The data obtained in the trial regarding pharmacokinetics (behavior and distribution of the drug in the body) and bioavailability (concentration of the active ingredient in the blood after drug administration) will, among other aspects, form the basis of the design of a comprehensive phase II trial of RhuDex® which is scheduled for 2009. In parallel, a new pharmaceutical form of RhuDex® has been developed and this new tablet form will provide additional treatment facilitation for the patients.

In the planned phase II trial with the new formulation of RhuDex® as a tablet, the patients will be treated during three months, and efficacy data for RhuDex® are to be collected.

For further detailed information, please see http://www.medigene.com.

About RhuDex®

RhuDex® is a novel, orally available compound for the treatment of rheumatoid arthritis, originating from Active Biotech's patented CD80 antagonists, out-licensed to MediGene AG. RhuDex® is being developed as a disease-modifying drug for the treatment of rheumatic diseases and has a distinct competitive advantage in being the first orally available disease-modifying drug that blocks T-cell stimulation. RhuDex® inhibits the underlying disease process and blocks specific CD80 activation of inflammatory T cells, and inhibits the release of cytokines such as TNF.

About RA

RA - Rheumatoid Arthritis - is a chronic inflammatory disease that affects the body's joints and causes inflammations in synovial membranes and tendon sheaths. The inflammation can damage articular cartilage and surrounding skeletal areas, which means that the patient can eventually be affected by a physically debilitating handicap. Of those affected, approximately two of three are women. The disease affects more than 1% of the global population, can be found throughout the world and is equally as common on all continents. Medical treatment consists primarily of pain-alleviating and anti-inflammatory treatment. In 2007, the market for drugs against RA was estimated at close to USD 5.7 billion, distributed among Remicade, Enbrel, Humira, Orencia and Rituxan (Cowen & Co, Therapeutic Categories Outlook, March 2008).

About Active Biotech

Active Biotech AB (OMX Nordic: ACTI) is a biotechnology company focusing on research and development of pharmaceuticals. Active Biotech has a strong R&D portfolio with pipeline products focused on autoimmune/inflammatory diseases and cancer. Most advanced projects are laquinimod, an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis, as well as ANYARA for use in cancer targeted therapy, primarily renal cancer. Further key projects in clinical development comprise the three orally administered compounds TASQ for prostate cancer, 57-57 for SLE and RhuDex® for RA.

Active Biotech is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 11:45 a.m. CET on June 24, 2008.

MediGene AG