Bioenvision, Inc (NEW YORK, NY), a company focused on the development and marketing of compounds and technologies for the treatment of cancer, announced the filing of a clinical trial authorization (CTA) to begin two phase I studies in Germany of clofarabine gel for the treatment of psoriasis. Bioenvision filed the CTA (the German equivalent of filing an investigational new drug [IND] application with the US FDA) with the Federal Institute for Drugs and Medical Devices (BfARM) in Germany. Enrollment in the first trial is expected to begin in December 2006, upon receiving ethics board approval of the clinical trial protocol.

Study BIOV-141 will test the clofarabine gel in 20 healthy individuals. The second study, BIOV-142, is a controlled proof of concept study which will determine the gel's activity in 15 patients with psoriasis. The two trials will be conducted on the company's behalf by Bioskin Institute for Dermatological Research and Development GmbH in Hamburg, a German clinical research organization that specializes in testing dermatology products.

Bioenvision developed the gel formulation in the US and has worldwide rights to clofarabine in autoimmune disease. Testing in psoriasis marks the start of a new phase of product development for Bioenvision.

Clofarabine is a potent purine nucleoside analog. The rationale for using clofarabine as a topical application is that the drug is known to effectively kill lymphocytes, which are the causative agents in psoriasis. Bioenvision holds an exclusive worldwide license (excluding US and Canada) for cancer applications of clofarabine and an exclusive worldwide license for all noncancer indications. Bioenvision granted an exclusive sublicense to Genzyme Corporation to develop and commercialize clofarabine for certain cancer indications in the US and Canada, which Genzyme markets under the name of Clolar®. Bioenvision originally obtained clofarabine development and commercialization rights under patents held by Southern Research Institute.

—A. Techman

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