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Biotec Pharmacon ASA (OSL:BIOTEC) The first 3 patients have been enrolled in the second of Biotec Pharmacon's two phase III-studies with SBG for treatment of diabetic ulcers. An estimated 3.5 million diabetes patients in the OECD-area annually develop foot and leg ulcers, for which there are no well-established treatments available. These ulcers often develop into a chronic condition with high risk of infections, which in many cases may end with amputation. Results from Biotec Pharmacon's first phase III-study is expected during 2009, and the company targets filing for marketing authorisations for SBG for this indication mid-2010.
-The progress in the diabetic ulcer program is on track. We have included close to 80 percent of the patients in the first phase III-study and have now got underway with the second study. This is a very important program both for us for the many diabetes patients who are unable to find good treatment options for their bothersome and potentially dangerous foot and leg ulcers, says CEO Lars Viksmoen in Biotec Pharmacon.
There is currently no well-established standard treatment of diabetic ulcers beyond general wound care. Biotec Pharmacon's program studies the effect of the immune stimulating drug SBG (soluble beta-glucan), which reactivates immune cells in the skin and enhances the body's own wound healing capabilities.
The first 3 patients were included at a hospital in Spain. This centre is one of 17 study centres in three different countries in Europe and Eastern Europe. The company has obtained all necessary study approvals in two countries and ethical review committee approval in the third.
Both the studies for diabetic ulcers are designed for populations of 120 patients. Later in November, the company expects results from an interim analysis based on the first two-thirds of the patients in the first phase III-study.
-This blinded interim analysis is carried out to asses whether the planned patient population is sufficient to generate statistically significant differences between the two treatment groups that are being studied. Provided that we can carry on as planned, and stop the patient inclusion at 120 patients, we expect to receive efficiency data from this diabetic ulcer study in 2009. These data will be an important part of the fundament for a filing for a marketing authorisation mid-2010. By then we also expect to have entered into one or several agreements with international partners to develop the commercial potential of SBG, says Viksmoen.
Biotec Pharmacon is also in phase III with SBG for another indication, namely prevention and treatment of patients with oral mucositis. This is a painful and potentially serious side effect of radiotherapy for cancer patients, in particular head and neck cancers. The first patient was enrolled in the first of two oral mucositis studies in October, whereas patient enrolment in the second study is expected to commence late this year. As for diabetic ulcers, the company's objective is to file for a marketing authorisation for SBG in patients with oral mucositis in mid-2010.
For further information, please contact: CEO Lars Viksmoen, tel: +47 40620870
About Biotec Pharmacon: The biopharmaceutical company Biotec Pharmacon develops pharmaceutical products for prevention and treatment of immune related diseases. The company has developed the bioactive substance SBG (soluble beta glucan), which is in clinical phase III for two indications; treatment of diabetic ulcers and prevention and treatment of oral mucositis. The company's clinical development program also includes immune therapy of cancer, where combination treatments with SBG and monoclonal antibodies are being studied in clinical phase I/II. Biotec Pharmacon also produces and markets non-pharmaceutical health- and diagnostic products. Biotec Pharmacon has 53 employees, and offices in Oslo, Tromsø and in Long Beach, California.
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