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Biotech / Medical : Indications -- Psoriasis/Chronic Inflammation

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From: nigel bates5/9/2005 6:28:09 AM
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Avidex / CD80 antagonist PI

Oxford(UK), Avidex today announced that its first product candidate has entered Phase I clinical trials. RhuDex® is a small molecule, orally active, anti-inflammatory agent. It is principally indicated for rheumatoid arthritis (RA) and is also expected to find applications in a broad range of autoimmune diseases.

RA is a chronic, inflammatory disease affecting over 1% of the world’s population and more than two million people in the US alone. RA is caused by aberrant T cell activation, which leads to an immune response that eventually affects the synovial membranes of joints and joint destruction. RhuDex® offers a novel approach in the treatment of RA by blocking the inappropriate T cell response and blocking the release of inflammatory cytokines such as TNF, IL-1, IL-2 and IFN.

Mr James Noble, Chief Executive Officer at Avidex said, “We are delighted to announce what is a hugely significant step for Avidex. RhuDex® is unique with great commercial potential; we know of no other orally delivered small molecule in development that directly blocks T cell activation. Avidex plans to begin Phase II trials in 2006 and we are actively looking for a pharmaceutical partner to take the product through late stage clinical development and on to the market.”

RhuDex ® is the first drug from Avidex to enter trials in humans and represents a significant commercial opportunity for the Company. The annual market for rheumatoid arthritis drugs exceeds $14bn and RhuDex ®, as an oral drug, should be well placed to take a significant share of this when approved.

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Notes to Editors  

About Avidex

Avidex is a biotechnology company focused on the development of small molecule modulators of T cell function and protein therapeutics based on T cell receptors. Avidex has two key programmes leading to novel treatments in cancer, inflammation and autoimmune diseases. Its breakthrough monoclonal T cell receptor (mTCR) technology enables the production of fully human, soluble T cell receptors. These mTCRs can deliver immunological effector molecules to cancer cells, and can block activation of T cells in autoimmune disease.

In April 2002, Avidex entered into an exclusive licence agreement with Active Biotech AB , covering Active Biotech’s patented small molecule CD80 antagonists. The Agreement gave Avidex the exclusive right to evaluate these small molecules, and to develop and market products incorporating them or their derivatives. Since the signing of the Agreement, Avidex has made significant progress. Highly potent orally available lead compounds with activity in biochemical and cellular assays have been identified for further optimisation and are the basis for the publication today. From this work Avidex selected its lead compound, RhuDex®.

Avidex is developing these programmes and its strategy is to take products through final development phases and to the market through corporate alliances. Avidex also commercialises its proprietary mTCR platform through partnerships.

Avidex was formed in 1999 as a spin out from Oxford University . The Company employs 50 staff and is based in Milton Park, near Oxford , UK . The Company has raised over £30 million to date, and investors include Advent Venture Partners, Oxford Technology Venture Capital Trust plc and Quester.

About rheumatoid arthritis (RA)

Rheumatoid arthritis is an autoimmune disease that causes chronic inflammation of the joints. Rheumatoid arthritis can also cause inflammation of the tissue around the joints, as well as other organs in the body. Autoimmune diseases are illnesses which occur when the body tissues are mistakenly attacked by its own immune system, caused by T cell aberrant activation. There is no known cure for rheumatoid arthritis; current treatments focus on reducing joint inflammation and pain.

T cell activation is dependent on two key binding steps – firstly between the T cell receptor and HLA interface, and a ‘second signal’ co-receptor binding event involving CD80, which is at high levels in chronically diseased tissues, and CD28 on the T cell. RhuDex® therefore offers a novel approach in the treatment of RA by blocking the CD80-dependent co-stimulatory signal to down-regulate early stages of the inappropriate T cell response in autoimmunity.

Traditional treatments for RA consist of fast acting, oral, first-line drugs, which include non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids, and slow acting ‘second line’ drugs known as disease modifying antirheumatic drugs (DMARDs). However, over time irreversible joint destruction and disease progression still take place. Long term treatment can also cause unwanted side effects and toxicity. More recently, antibody based products to block inflammatory cytokines such as tumour necrosis factor (TNF), have come onto the market, but these have to be given parenterally...
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