>>SOUTH SAN FRANCISCO, Calif., May 24 /PRNewswire-FirstCall/ -- Corgentech Inc. (Nasdaq: CGTK - News) today announced that the company has begun treating patients in a multi-center Phase 1/2 clinical trial of its NF-kappaB Decoy (NF-kB 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 to be initiated. The second trial will be conducted in Australia and Switzerland in approximately 120 patients and is expected to initiate enrollment by mid-2005.
The multi-center, randomized, double-blind, dose-ranging trial will evaluate the safety and feasibility of repeated application of three concentrations of NF-kB Decoy to the skin of adult patients with mild-to- moderate eczema.
NF-kB Decoy is a highly selective and potent inhibitor of the transcription factor, NF-kB, which is implicated in inflammatory diseases such as eczema, asthma and inflammatory bowel disease (IBD).
"We are enthusiastic about the prospects for our NF-kB Decoy based on the pre-clinical data in eczema models that we have observed to date and believe that the drug could someday provide patients with a more convenient dosing regimen and fewer side effects when compared with treatments that are currently on the market," said John P. McLaughlin, president and chief executive officer of Corgentech. "Given the nature of the disease and treatment, eczema studies can be fast clinical trials, so we expect to be able to announce data from these trials and move toward the next step in this program in early 2006."
"There is a medical need for additional treatment alternatives for atopic eczema," stated Jon Hanifin, M.D., professor, department of dermatology, Oregon Health & Science University. "NF-kB Decoy may reduce the inflammation that is part of atopic eczema. We are pleased to participate in the evaluation of this exciting new compound for the treatment of atopic eczema."
Study Details
The study will involve approximately 75 individuals randomized in parallel to one of three active treatment dose groups or a control group. Patients will apply the study drug twice daily for 21 days to targeted areas of the skin. Patients will be followed for 28 days after the final treatment. The study will assess the safety, tolerability and systemic pharmacokinetic profile of NF-kB Decoy. Periodic physician assessments of the targeted area will be made to measure the degree of symptom severity as well as patient evaluations of itchiness.
About Eczema
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, NF-kB Decoy 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.<<
snip
Cheers, Tuck |
