BASEL, Switzerland, Oct. 28, 2004 (PRIMEZONE) -- Basilea announced today the enrolment of the first patients into its phase III program investigating the efficacy and safety of BAL4079 (alitretinoin) in severe chronic hand dermatitis refractory to topical treatment.
"Patients suffering from chronic hand dermatitis unresponsive to topical treatment are in urgent need of new effective treatments and the BAL4079 phase III studies are an important step forward", commented Professor Pieter-Jan Coenraads of the Occupational and Environmental Dermatology Unit of the University of Groningen, The Netherlands.
Basilea's BACH program (Basilea Alitretinoin in Chronic Hand Dermatitis) comprises two double blind, randomized studies that investigate the efficacy and safety of 10 mg and 30 mg BAL4079 capsules versus placebo following 12 to a maximum of 24 weeks of once-daily treatment. The primary efficacy endpoint for both studies is response rate as measured by the number of patients having clear or almost clear hands according to a physicians' global assessment. Safety assessments include regular monitoring of clinical and laboratory parameters. The international phase III program, starting in Europe is designed to enrol over 2,000 patients from about 200 centres.
"We are aware of the major impact that severe chronic hand dermatitis can have on patients' lives and are committed to develop novel effective treatments to help these patients", commented Anthony Man MD, Basilea CEO.
About BAL4079
BAL4079 is a naturally occurring vitamin A derivative with a chemical structure that resembles both natural and synthetic retinoids. BAL4079 is an investigational drug that has shown activity during phase II studies involving over 200 patients with refractory chronic hand dermatitis. Similar to all known synthetic vitamin A related drugs, BAL4079 is teratogenic and should not be administered to women who are, or may become pregnant. Basilea's phase III studies incorporate a pregnancy risk management program.
About Refractory Chronic Hand Dermatitis
Severe chronic hand dermatitis is a common inflammatory skin disease which is often refractory to topical therapy and has a major impact, limiting the professional and social life of patients. Basilea estimates that refractory chronic hand dermatitis affects approximately one million patients in leading markets. Few treatment options are currently available for patients who suffer from this disease and who do not benefit from topical therapies.
About Basilea
Basilea Pharmaceutica AG (BSLN) is an independent biopharmaceutical company headquartered in Basel, Switzerland that is actively engaged in the discovery and development of innovative medicines for the treatment of unmet medical needs.
The company's fully integrated research and development operations are currently focused on new anti-bacterials and anti-fungals to fight drug resistance, and dermatology drugs. Basilea was founded in October 2000 with significant resources to discover, develop and bring innovative medicines to market. Basilea is listed on the SWX Swiss Exchange.
Disclaimer
This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact the following:
Basilea Pharmaceutica AG Corporate Information P.O. Pox CH-4005 Basel Switzerland
The press release can be downloaded from the following link: http://hugin.info/134390/R/966058/140363.pdf