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Biotec Pharmacon enters clinical study for treatment of diabetic foot ulcers with UK hospital

Biotec Pharmacon enters into agreement with leading hospital in the UK to perform clinical trial (phase II) with SBG for treatment of chronic foot ulcers in diabetes patients.

Biotec Pharmacon enters into agreement with leading hospital in the UK to perform clinical trial (phase II) with SBG for treatment of chronic foot ulcers in diabetes patients.

The biopharmaceutical company Biotec Pharmacon has entered into an agreement with Nottingham City Hospital NHS Trust to perform a clinical phase II study entitled “A randomised, double-blind, placebo-controlled study to determine the efficacy of soluble beta-1,3/1,6-glucan in chronic foot ulcers in diabetes.” A total of 104 patients will be included in the study.
The protocol for the study and the application to UK health authorities have been completed. The trial is likely to commence during the first half of 2006, pending approval by the Nottingham Research Ethics Committee and the Medicines and Health Care Products Regulatory Agency (MHRA).

Nottingham City Hospital NHS Trust is engaged in the diagnosis, treatment and prevention of disease and clinical research for the improvement of healthcare, and has a particular interest and expertise in diabetes.

Biotec Pharmacon is very pleased to have initiated a collaboration with this hospital. The company currently performs a similar study in hospitals in Archangelsk and St. Petersburg in Russia. These trials were initiated based on very promising results from a pilot study with SBG on patients with diabetic ulcers. Additional clinical data from a leading hospital within the EU will be advantageous for Biotec Pharmacon in later discussions with regulatory authorities and commercial partners.

Biotec Pharmacon’s concept for treatment of ulcers is based on effect of the company’s pharmaceutical compound SBG which acts on immune cells in the skin to advance healing of wounds and ulcers. Diabetic patients often suffer from complicated ulcers due to dysfunctional immune cells in the skin. SBG binds to and activates immune cells in such a way that new tissue develops.

Chronic ulcers among diabetes patients represent a severe medical problem. Within OECD, an estimated 3 million diabetics are believed to be affected by ulcers, and there are few effective forms of treatments available today.

Treatment of chronic ulcers is one of the priority therapeutic areas of Biotec Pharmacon based on it’s pharmaceutical compound SBG. The other priority is immunotherapy of cancer where a clinical phase I/II study is ongoing at Memorial Sloan-Kettering Cancer Center in New York, and two studies are underway in Ullevaal University Hospital and Rikshospitalet-Radiumhospitalet in Oslo.

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