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TopoTarget A/S (CSE: TOPO), Copenhagen, Denmark, has announced that a Phase II clinical trial has been initiated, testing Avugane, a topical valproic acid - an HDAC inhibitor drug - in the treatment of acne vulgaris. This double-blind, randomised Phase II study comprises four trial arms, testing three different dose strengths of Avugane compared to a placebo control group. The trial follows the positive results with Avugane as previously announced.

This new Phase II study will investigate the efficacy and safety in a four-armed trial with three different dose strengths of topically applied Avugane in the treatment of mild to moderate acne vulgaris in comparison with a placebo controlled study arm. Patients in this study will be treated over 12 weeks, and the clinical end points include the evaluation of therapeutic efficacy based on counts of facial acne lesions as well as safety and tolerability measurements.

Prof. Dr. Hans Christian Wulf, the coordinating investigator of this new Phase II trial at Bispebjerg Hospital, Copenhagen, commented:

"Avugane comprises a novel mechanism-of-action in the treatment of acne vulgaris. The results obtained in the completed Phase II study show that Avugane may represent a new and interesting therapeutic option for patients who do not respond effectively to current standard medications. It will be very interesting to define the optimal dose strengths which may subsequently be used in advanced clinical development."

In a previous Phase II clinical trial, topical monotherapy with Avugane and treatment with the marketed standard product, isotretinoin, a vitamin A analogue, resulted in a comparable reduction in total counts of facial acne lesions. However, Avugane showed indications of an accelerated clinical response, and induced a reduction of inflammatory as well as non-inflammatory types of acne lesions. Furthermore, Avugane was predominantly assessed by the patients to be "well" tolerated, indicating a better local tolerability of Avugane compared with isotretinoin.

"We will continue the promising development of Avugane to further validate its therapeutic efficacy, while in parallel seeking an out-licencing partner with expertise in the field of dermatology. Avugane targets acne vulgaris which represents a significant unmet medical need and we are very encouraged by the therapeutic results obtained in our previous trial. Accordingly, we look forward to investigating the further potential of the drug", said Peter Buhl Jensen, CEO of TopoTarget.

About Acne Vulgaris

Acne vulgaris is the most common inflammatory skin disorder among adolescents. Approximately 80% of all adolescents show signs of acne in various degrees and 15% of adolescents suffer from acne so severely that they need clinical treatment. The more severe forms of acne typically have a significant effect on patients' physical and psychological well-being. Furthermore, many patients fail to respond adequately to available treatments or suffer from adverse effects associated with such treatments. The global sales of topical therapies for acne are estimated at USD 1.65 billion in 2005 and are expected to grow to annual sales of USD 1.83 billion in 2008 (Source: Fox Analytics; Business Insight, The Dermatology Market Outlook to 2011). Traditional treatments for mild to moderate facial inflammatory acne include over-the-counter topical medications for mild cases, and prescription topical medications or oral antibiotics for mild to moderate cases. For more severe forms of acne, oral treatment with the retinoid product isotretinoin is used.

About Avugane

Avugane comprises a novel and proprietary gel-based formulation of the moderate strength HDAC inhibitor, valproic acid, for topical therapy of inflammatory skin diseases including indications such as acne vulgaris, psoriasis and atopic dermatitis. The pathogenesis of acne vulgaris is multifactorial, being influenced by hormonal, microbiological, and immunological factors as well as proliferative cellular mechanisms which are targeted specifically by the HDAC inhibitory activity of Avugane. Avugane is a repurpose of the marketed drug, valproic acid, used in the treatment of epilepsy. This means that a large part of the work involved in demonstrating the safety of the drug has already been performed.

About TopoTarget

TopoTarget (OMX - The Nordic Exchange: TOPO) is a biopharmaceutical company, headquartered in Denmark and with subsidiaries in the UK, Germany and the USA, dedicated to finding ''Answers for Cancer'' and developing improved cancer therapies. TopoTarget is founded and run by clinical cancer specialists and combines years of hands-on clinical experience with in-depth understanding of the molecular mechanisms of cancer. Focus lies on highly predictive cancer models and key cancer enzyme regula-tors (mainly HDAC, mTOR, and topoisomerase II inhibitors) and a strong development foundation has been built. TopoTarget has a broad portfolio of small molecule preclini-cal drug candidates and seven drugs are in clinical development, including both novel anti-cancer therapeutics and new cancer indications for existing drugs. Savene is TopoTarget's first product on the market. In addition to organic growth, TopoTarget consistently looks for opportunities to strengthen and expand its activities through acquisitions and in-licensing.

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Publication:Worldwide Biotech
Article Type:Clinical report
Date:Jun 1, 2007

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