SOUTH SAN FRANCISCO, Calif. and SECAUCUS, N.J., Oct. 27 /PRNewswire-FirstCall/ -- Corgentech Inc. and AlgoRx Pharmaceuticals, Inc. today announced that enrollment has been completed for a multi-center Phase 1/2 clinical trial of Avrina(TM), Corgentech's NF-kappaB Decoy drug candidate for the treatment of atopic dermatitis, a chronic skin disease also known as eczema that affects about 15 million adults in the United States. This is the first of two Phase 1/2 trials that are currently underway. Enrollment is ongoing in a second trial in Australia and Switzerland to randomize approximately 120 patients.
The multi-center, randomized, double-blind, placebo-controlled, dose-ranging trial is evaluating the safety and feasibility of repeated application of three concentrations of Avrina to the skin of adult patients with mild-to-moderate eczema.
Avrina is a highly selective and potent inhibitor of the transcription factor, NF-kappaB, which is implicated in inflammatory diseases such as eczema, asthma and inflammatory bowel disease (IBD).
"We need to continue to evaluate potential alternative therapies for the treatment of eczema, as there remains an unmet medical need for these patients," stated Jon Hanifin, M.D., professor, department of dermatology, Oregon Health & Science University. "We are pleased that this study has completed enrollment as we will soon be able to better evaluate the therapeutic potential of this new drug in the clinic."
"We are pleased indeed to have completed enrollment for this multi-center trial of Avrina for eczema. While we have a pending proposed merger agreement with AlgoRx Pharmaceuticals that will significantly enhance our product portfolio with three pain management products, we remain committed to and excited about the future potential of Avrina for the treatment of eczema," said Daniel J. Gennevois, M.D., vice president, medical affairs at Corgentech. "Avrina may have the potential to provide durable, long-lasting inflammation reduction while providing patients with more convenient dosing regimens and fewer side effects. We will collect the results from this trial and look forward to reporting data during the first quarter of 2006."
The study includes approximately 75 evaluable patients randomized in parallel to one of three active treatment dose groups or a control group. Patients are applying the study drug twice daily for 21 days to targeted areas of the skin and are being followed for 28 days after the final treatment. The study will assess the safety, tolerability and systemic pharmacokinetic profile of Avrina. Periodic physician assessments of the targeted area will be made to measure the degree of symptom severity as well as patient evaluations of itchiness.
The second study being conducted in Australia and Switzerland is enrolling approximately 120 individuals randomized in parallel to one of three groups divided between patients receiving Avrina once a day, patients receiving Avrina twice a day and patients receiving placebo. Study participants are applying the study drug for 28 days to targeted areas of the skin and are then being followed for 14 days after the final treatment.
Characterized by itchiness, redness and thickening of the skin, eczema is often associated with elevated levels of immunoglobulin E (IgE) and a personal or family history of allergies, allergic rhinitis and asthma. While topical corticosteroids are currently used to treat eczema, their chronic use is limited due to the potential for significant side effects. Topical calcineurin inhibitors have also shown potential in the treatment of this disease; however these potent immunosuppressive agents have yet to produce long-term safety data. In preclinical studies, Avrina was efficiently delivered to intact skin using several easy-to-manufacture, inexpensive formulations and was effective in reducing the swelling and inflammation associated with eczema with minimal side effects. Clinical trials will demonstrate whether results obtained in preclinical studies will be indicative of future results.
Corgentech is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for significant unmet medical needs. Corgentech and private company, AlgoRx Pharmaceuticals, Inc., recently announced that they have signed a definitive agreement to merge and create a late-stage company that will be focused on developing and commercializing products for pain management and inflammation. For more information on the company and its technologies, please visit www.corgentech.com.
Forward Looking Statements
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Corgentech and AlgoRx undertake no obligation and do not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.
Additional Information and Where to Find It
Corgentech Inc. has filed a registration statement on Form S-4, and Corgentech and AlgoRx Pharmaceuticals, Inc. have filed a related joint proxy statement/prospectus, in connection with the merger transaction involving Corgentech and AlgoRx. Investors and security holders are urged to read the registration statement on Form S-4 and the related joint proxy statement/prospectus because they contain important information about the merger transaction. Investors and security holders may obtain free copies of these documents and other documents filed with the SEC at the SEC's web site at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC by contacting Corgentech Investor Relations at the email address: firstname.lastname@example.org.
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