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Astion Pharma presents first promising human experience with ASF-1096 in cutaneous lupus erythematosus


The first promising human experience with ASF-1096 in cutaneous lupus erythematosus is published
as part of the scientific section of European Academy of Dermatology and Venerology (EADV) congress in Rhodes, Greece, October 4-8.

Nine refractory patients with various forms of CLE were treated with ASF-1096.

Four patients suffering from sub-acute cutaneous lupus erythematosus (SCLE), a subtype of cutaneous lupus, were treated for 2-4 weeks. Patients were aged 11 to 82 years and had suffered from SCLE for 1-20 years. The treatment was highly effective in all of these four patients.
Five patients aged 35 to 66 years were diagnosed with discoid lupus erythematosus(DLE). These patients had suffered from the disease for 10 to 34 years. Four out of five patients had a clear positive effect of the treatment. A particularly convincing effect was seen with freshly developed discoid lesions, but a positive effect was also observed in older discoid lesions, which are notoriously difficult to treat.

The product was generally well tolerated with few adverse effects. Two patients suffered
from local irritation following a particular cream formulation of the product. The skin irritation
faded quickly on cessation of treatment, and has not been observed with later versions of the cream.

The scientific poster is available on the Astion website:

Astion makes its first public appearance towards the community of European dermatologists simultaneously with the scientific presentation. We are present at the conference and look forward to meeting dermatologists with an interest in getting involved in our European clinical trials programs and gaining experience with ASF-1096 in cutaneous lupus, says Lars Smedegaard Andersen, EVP Commercial Affairs. To develop a product relevant for a rare disease such as discoid lupus we need to establish a far reaching network of physicians with an interest in building experience with new therapeutic options.

ASF-1096 is formulated as a cream for topical treatment of cutaneous lupus. ASF-1096
holds a promising therapeutic potential due to a unique pharmacodynamic profile characterised by inhibition of inflammatory processes relevant for cutaneous lupus.

Astion Pharma has an ongoing phase 2 clinical development program with ASF-1096 in
DLE and other cutaneous lupus sub-types.
There is presently no effective and safe long-term treatment available today. Patients suffering from DLE are typically treated with strong topical steroids, such at Betamethasone. Systemic 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. An application for orphan drug designation for ASF-1096 is being compiled and will be submitted to the EMEA in 2007.

Cutaneous lupus appears in several sub-types, of which discoid lupus erythematosus(DLE) is the most common. DLE is a chronic skin disorder characterised by red, raised plaques with sharply defined margins. The lesions usually occur on sun-exposed areas,
especially the face, scalp, neck and hands. If untreated, the lesions eventually resolve
with scarring, dyspigmentation and, for occurrences in the scalp, also alopecia. The subacute
sub type (SCLE) of cutaneous lupus is very similar to DLE. The lesions are usually less sharply defined, and when the inflammation resolves it does not leave scarring. In Europe, DLE affects two to three people out of 10,000. SCLE is even less common. More women than men are affected, and onset of the disease is typically in the 30ies and 40ies.
The cause of the disease is unknown, the disease is chronic and normally persists for decades.


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