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Arriva-ProMetic Begins Phase II Clinical
Study to Evaluate Recombinant Alpha 1-Antitrypsin (rAAT) Gel
PRNewswire- FirstCall MONTREAL, Canada & ALAMEDA, California, USA Oct. 9, 2003 MONTREAL, Canada & ALAMEDA, California, USA, Oct. 9 /PRNewswire- FirstCall/ ProMetic Life Sciences (TSX: PLI) and Arriva Pharmaceuticals, Inc. announced today that their joint venture company, Arriva-ProMetic Inc. ("JV"), has opened a Phase II clinical study to evaluate its lead candidate rAAT topical gel in individuals with atopic dermatitis. The enrolment follows Therapeutic Products Directorate (TPD) approval received last week. "We are delighted that development of the rAAT gel is progressing at such a rapid pace. The pre- clinical and clinical results to date have been excellent. The promise of an efficient and non-immunosuppressive atopic dermatitis treatment is now a promising reality" commented Pierre Laurin, President and CEO of ProMetic Life Sciences Inc. "This study is perfectly in line with our strategy to develop safe, effective products that target unmet medical needs, while reducing the time to market," added Pierre Laurin. The phase II clinical study is a proof of concept study, mainly design to demonstrate the efficacy of the recombinant version compared to the positive clinical effect several years ago with plasma- derived AAT. In 1990 plasma- derived AAT was tested for its efficacy for the treatment of recalcitrant atopic dermatitis. All patients showed significant clinical improvement within 6 to 21 days of initiation of treatment. AAT stopped pain, pruritus, and promoted tissue healing without scarring. The current supply of natural plasma derived AAT, however, is only available in limited quantities leaving, untreated, a very large number of patients who could benefit from such therapy. The medical community is interested in new cost-effective alternatives to steroid therapy and it is believed that the recombinant Alpha 1-antitrypsin being developed by Arriva-ProMetic meets that requirement. Dr. Martin Preuveneers, CEO of Arriva Pharmaceuticals commented, "Following the positive results of the successful Phase I trial, Arriva-ProMetic is pleased to initiate this second phase of clinical development for patients affected with this condition. Therapies that are currently available to atopic dermatitis sufferers can cause side effects, which can severely outweigh the therapeutic benefits. About the Study The Phase II trial is a randomized, double blind, vehicle controlled, comparison study to evaluate the safety and efficacy of AP-102 gel containing rAAT, in subjects afflicted with atopic dermatitis. The study will be conducted in 4 centres in Canada with the objective to characterize the effect of AP-102 gel on the resolution of atopic dermatitis lesions. The trial, which has been through the regulatory submission and clearance process, will include up to 40 patients randomized to receive either placebo or AP-102 gel containing rAAT. About Alpha 1-Antitrypsin Alpha 1-antitrypsin is a glycoprotein primarily produced by hepatocytes, and to a lesser extent, immune system cells. AAT belongs to a family of structurally-related proteins classified as serine protease inhibitors or SERPINS, which are known to inhibit several proteases including trypsin, cathepsin G, thrombin, tissue kallikrein, as well as neutrophil elastase. The proteinase/antiproteinase balance is believed to be important for maintaining healthy skin. Alterations in local tissue proteinase/antiproteinase balance, resulting from genetic or environmental factors, may lead to an increased susceptibility to inflammatory diseases of the skin such as atopic dermatitis and psoriasis. The recombinant Alpha 1-antitrypsin (rAAT) produced by Arriva-ProMetic Inc. is a yeast-derived product, which has been developed to provide an abundant source of rAAT. The finished product is free from potential contamination of infectious pathogens (e.g. viruses and prions). About Atopic Dermatitis Atopic dermatitis is a common form of inflammation of the skin. Atopic dermatitis is a chronic skin disorder characterized by pruritus, dry skin, and excoriation, which may be localized to a few patches or involve large portions of the body. It is a common disease affecting approximately 6% of the general population and in the United States alone, it is estimated that more than 15 million individuals are afflicted with this disorder. Since 1970, the incidence of atopic dermatitis has increased by 30%. It is estimated that sales of therapies currently available to treat atopic dermatitis exceed $2 billion annually in the United States alone. About Arriva Pharmaceuticals, Inc. Arriva Pharmaceuticals, Inc., is a privately held biopharmaceutical company. The company's goals are to develop, manufacture and market clinical grade recombinant protease inhibitors. Arriva has developed technology for large-scale production of stable non-animal sources of recombinant proteins in Saccharomyces cerevisiae (baker's yeast). The areas of therapeutic focus are: - Respiratory diseases: hereditary emphysema, COPD, asthma, and other respiratory indications. - Dermatological diseases: atopic dermatitis, psoriasis, and wound healing. For more information, visit http://www.arrivapharm.com/ . About ProMetic Life Sciences (TSX: PLI) ProMetic Life Sciences Inc., is an international biopharmaceutical company with headquarters in Montreal, Quebec with additional facilities in the UK and the USA. ProMetic is engaged in research, development, manufacture and marketing of a variety of commercial applications from its proprietary platform technologies, which are used in therapeutics, large-scale drug purification, chemical genomics and proteomics, drug delivery and drug development. ProMetic has also developed a portfolio of products, which are at different stages of development, focusing on cancer and inflammation diseases. Additional information is available on the company's website: http://www.prometic.com/ . This press release contains forward-looking statements that involve risks and uncertainties, including, but not limited to the Company's ability to develop, manufacture, and successfully commercialize value-added pharmaceutical products and to obtain contracts for its products and services and commercial acceptance of advanced affinity separation technology. Shareholders are cautioned that these statements are predictions and these actual events or results may differ materially from those anticipated in these forward-looking statements. PROMETIC LIFE SCIENCES INC.CONTACT: ProMetic Life Sciences Inc., Pierre Laurin,President & CEO, (514) 341-2115; Sofie St. Laurent, Coordinator,Communications, (514) 673-1116, http://www.prometic.com/; Arriva Pharmaceuticals Inc., Martin Preuveneers, Chairman & CEO, (510) 337-2846; Hofman Communications, Patrick C. Hofman, (514) 673-1116; Renmark Financial Communications, InvestorRelations: John Boidman, Sylvain Laberge; Media Relations: Dominic Sicotte,(514) 939-3989
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