Summary: Solbec’s psoriasis treatment, SBP002 cream, achieves its first milestone in testing on healthy volunteers. Stage 1 was fully enrolled and the stage has now finished with no unwanted effects or reactions noted. Stage 2 of the Phase I clinical trials can now begin.
Perth, Australia. 30th September 2004. Solbec Pharmaceuticals Ltd (ASX:SBP) announced that it has successfully completed the first stage of its Phase I clinical trial of its lead compound SBP002 in the treatment of psoriasis.
The trial is the first formal human testing of an SBP002 based cream targeted at the treatment of psoriasis, a common non-infectious chronic skin disease for which there is no cure. The trial is being conducted for Solbec by CMAX, a division of IDT Australia Ltd.
CMAX is located in the Royal Adelaide Hospital and was chosen by Solbec to conduct this important trial because of its track record in managing clinical trials and specific experience in psoriasis.
In the first stage of the trial, SBP002 cream was applied to area of skin of healthy individuals who were monitored for unwanted-effects and reactions. Reaching this milestone opens the way for the trial to move to the next stage of testing in which the dosage regime will be similar to the proposed therapeutic administration.
The trial’s overall objective is to show that SBP002 can be used by psoriasis patients safely, without significant side-effects, and warrants larger Phase II studies. The Company expects final completion of the trial during the first quarter of 2005.
Psoriasis affects 3 to 5% of the population. It is uncomfortable at best, may have major impact on quality of life, and occasionally can result in death. While its exact cause is unknown, the prominent red scaly patches are thought to be triggered by an immune system defect that leads to excessive skin cell division. The patches are often itchy and constantly shed skin cells.
SBP002 contains two compounds extracted from a plant known as the Devil’s Apple and is undergoing parallel development for the treatment of cancers, such as mesothelioma and melanoma, and psoriasis. It is presumed to act on psoriasis skin lesions by inhibition of the pro-inflammatory cytokine, interleukin-6. It is one of several compounds now in development around the world thought to work in this way.
Solbec has identified the need for a product to treat psoriasis successfully that is more active than other creams in use today and is not given by injection or linked to potentially serious side-effects.
For further information, please contact
Business Development Manager
Solbec Pharmaceuticals Ltd
Phone +61 (08) 944 67555
Rebecca Christie or Amy Winter
Phone: +61 (02) 9293 2836 / 0417 382 391
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