HUDDINGE, Sweden, March 29, 2004 (PRIMEZONE) -- Medivir and Peptimmune jointly announce today that an orally active, small molecule inhibitor of the protease enzyme Cathepsin S has been selected as a Candidate Drug (CD). The designation of a CD in the Cathepsin S discovery program is an important step for the project and paves the way towards clinical trials. Cathepsin S is a protease (protein processing enzyme) that plays a significant role in the activation of certain immune responses. Potential clinical applications of the inhibitors include controlling the initiation and/or progression of immune system disorders such as multiple sclerosis (MS), rheumatoid arthritis (RA), allergic asthma and pain among others.
The project now enters the authority-regulated phase of pre-clinical development with the aim to file an Investigational New Drug application (IND) and to enter clinical phase I trials. The IND stage includes many different tasks including safety studies and synthesis of larger amounts of drug compound, and takes approximately 12-18 months (according to the industry average).
The Cathepsin S program is a joint-venture between Medivir and Peptimmune Inc. The program has a strong research and intellectual property position in the autoimmune and inflammatory disease areas. The program includes a license to the intellectual property rights to Cathepsin S as a therapeutic target from the Massachusetts Institute of Technology and issued and pending patents in the United States, Europe and rest of world.
Representative compounds from the Cathepsin S program have been shown to have potent reversible inhibitory activity in in vitro enzymatic assays and in blocking an immune response to antigen in cellular assays. These compounds, after oral administration, also exhibit good activity in disease models of multiple sclerosis (MS), rheumatoid arthritis (RA) and allergic asthma.
There is a large unmet medical need for new treatments that can regulate or stop the progression of these common and chronic debilitating diseases. These findings raise hope of new treatment paradigms for these and several other immune diseases. About Medivir Medivir is an innovative, specialised research company that develops pharmaceuticals with the aim of becoming a sustainable and profitable pharmaceuticals company. The company is located in Huddinge, Sweden and Cambridge, UK.
Medivir's research focuses on developing new pharmaceutical compounds based on polymerases and proteases as target enzymes. The Group comprises Medivir AB, its subsidiary Medivir UK Ltd. and Medivir Personal AB. At the end of 2003, the Group had 109 employees. In 1996, Medivir was listed on Stockholmsborsen and since 1 July 2003, the company's shares are traded on the Attract40 segment of the O-list.
The research portfolio includes projects in the area of HIV infection, hepatitis, shingles, cold sores, osteoporosis, rheumatoid arthritis (RA), asthma and multiple sclerosis (MS). Medivir has five individual projects in the clinical development phase, all with a unique clinical profile. The company's broad pre-clinical research portfolio includes five defined projects and some ten activities in different pre-clinical phases.
About Peptimmune
Peptimmune, Inc. is a privately held biotechnology company developing specific immunotherapies for treating autoimmune and allergic diseases. These therapies are designed to be safer and more effective than currently marketed products. Peptimmune's therapies are focused on treating autoimmune and allergic disorders by intervening in the body's immune response processes. Current approaches to treating these diseases typically involve non-specific immunosuppression, an approach associated with severe side effects. Peptimmune's products are designed to arrest disease progression in a targeted way by neutralizing disease-causing immune cells only. For information, access our website at http://www.peptimmune.com.
This press release contains forward-looking statements, including statements concerning: a potential therapy for RA, MS, allergic asthma; and other potential indications for Cathepsin S inhibitors. Actual results may materially differ due to numerous factors, including without limitation: the results of development efforts; the safety and efficacy of products in humans; decisions made by regulatory authorities; and the risks and uncertainties described.
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