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Astion Pharma initiates Phase 2 trial with ASF-1096 in Discoid Lupus Erythematosus


Astion Pharma A/S has initiated its first clinical study with ASF-1096 in patients suffering from Discoid Lupus Erythematosus. Discoid Lupus Erythematosus is a serious, scarring skin disease affecting two to three in every 10,000 people in Europe.

This trial is the first of two identical proof of concept studies to be carried out with ASF-1096 in Discoid Lupus Erythematosus (DLE), a diagnostic sub-type of Cutaneous Lupus Erythematosus.

The study is a double blind, placebo controlled trial, being conducted at six clinical centres in Denmark. 32 patients suffering from DLE will be treated twice a day for eight weeks with ASF-1096 or placebo. To participate, the patient must present with at least one newly developed and active lesion, the target lesion, which will be the primary treatment objective in the study. Patients are seen every two weeks, where the development of the inflammation of the target lesion is evaluated for clinical efficacy using a localised CLASI score system. The CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) is a validated measurement instrument for DLE capturing both the activity and damage from the disease.

An identical study will be initiated at four clinical sites in Germany and the UK later this year, pending ethics committee and regulatory approval in these countries. This study also includes 32 patients.

Results of both studies are expected in 2007.

ASF-1096 has a unique pharmacodynamic profile which makes it highly relevant for the treatment of DLE. ASF-1096 is formulated as a moisturising cream for application to the affected area.

Cutaneous lupus appears in several sub-types, of which Discoid Lupus Erythematosus (DLE) is the most common. DLE is a chronic skin disorder characterized by red, raised plaques with sharply defined margins. The lesions usually occur on sun-exposed areas, especially the face, scalp, neck and hands. Untreated the lesions eventually resolve with scaring, dyspigmentation and, for occurrences in the scalp, also alopecia. In Europe, DLE affects two to three in every 10,000 people. More women than men are affected and on-set of disease is typically in the 30ies and 40ies. The cause of the disease is unknown; the disease is chronic and normally persists for decades.

There is no effective and safe long-term treatment available today. Patients suffering from DLE are typically treated with strong topical steroids, such as betamethasone. Sys-temic treatment, such as steroids, anti-malarials or even thalidomide is being used for patients when topical treatment is insufficient to control symptoms.

Astion intends to pursue the further development under the orphan drug legislation, if the clinical trials successfully document the efficacy and safety of ASF-1096 in DLE. An appli-cation for orphan drug designation for ASF-1096 is being compiled and will be submitted to the EMEA in 2007.

The first clinical experience with ASF-1096 will be presented under the scientific section at the 2006 European Academy of Dermatology and Venerology (EADV) congress in Rhodes, Greece, October 4-8.

Contact: Lars Smedegaard Andersen, EVP Commercial Affairs
Telefon: +45 4112 8551

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Astion Pharma A/S develops pharmaceutical products for the treatment of skin diseases. It is estimated that one person in four worldwide will suffer from a skin disease sometime in life, causing a deterioration of their quality of life. It is the Company’s goal to become a leading player in the treatment of skin diseases for which there is cur-rently a major need for new and better therapies. Astion Pharma has a strong platform of proprietary technologies for the development of new and innovative products. The Company pursues development activities through a strong international network of scientific partners and leading contract research organisations. The Company cur-rently has three development projects in Phase 2 clinical studies in Hand Dermatitis, Seborrheic Dermatitis and Cutaneous Lupus in addition to a large portfolio of product candidates and research programmes in earlier phases. For additional information please visit our web site:


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