Oslo, NORWAY - March 16, 2009: Biotec Pharmacon has reached a significant milestone with completion of patient inclusion in the first of two phase III studies with SBG for treatment of diabetic foot ulcer. A total 121 patients has been included in the study. Treatment and follow-up of the last patients included will be finalized in the third quarter, with a subsequent period of data collection and analysis. Biotec Pharmacon should be ready to announce results from the study in the fourth quarter 2009, and remains on track to file for marketing authorization with SBG for treatment of diabetic foot ulcer in Europe in mid-2010.
“Patient inclusion rates have been strong in both diabetic ulcer studies over the winter, and we look forward to presenting the results in the November - December time frame. We believe SBG will offer an effective therapy in a large number of patients, currently having few good and well established treatment alternatives,” says CEO Lars Viksmoen in Biotec Pharmacon.
“Reaching target inclusion is a major effort and an important milestone for all investigators”, says Professor William Jeffcoate at the Nottingham University Hospital. “We should be on track to complete patient follow-up and deliver high quality clean data by October this year” continues Jeffcoate. “We are very excited about this product and are anxiously waiting for the final results.” There are more than 250 million adults with diabetes in the world, and one in six of these will at some stage develop a foot ulcer. Untreated foot ulcers may develop into a chronic condition with high risk of infections, and some 15-25 percent of diabetic foot ulcer patients will eventually require amputation. No standard drug treatments are available, other than general wound care. Biotec Pharmacon’s immune stimulating drug SBG (soluble beta-glucan) reactivates immune cells in the patients’ skin and thus enhances the body’s own wound healing capabilities.
Biotec Pharmacon initiated a second phase III study in diabetic foot ulcer in November 2008. By the end of February more than three quarters of the planned patients were included, and the company commissioned an independent interim analyses to re-assess the sample size. Results from the analysis will be available before summer 2009.
Having received positive phase II data in 2006, Biotec Pharmacon raised funds to take SBG for diabetic ulcer through phase III on its own. The company has over the past six months stepped up its work to secure either global or regional partners for the commercialization phase, and in October last year recruited Dr. Sven Rohmann as VP Business Development.
“We are meeting with a number of potential partners, and also get to present our SBG product portfolio at key partnering events. This week we are presenting at the BIO-Europe Spring 2009 meeting in Milan, and being able to tick off completion of patient inclusion in our first phase III study should be well received by the audience,” says Dr. Sven Rohmann.
After a somewhat slow start in the fourth quarter last year, Biotec Pharmacon also has accelerated the patient inclusion rate in the first phase III study with SBG for prevention and treatment of oral mucositis in patients with head and neck cancer. The company is also nearing completion of a phase I/II program with SBG for use in combination with monoclonal antibodies in immunotherapies of cancers, and expects to decide on the future developmental roadmap in the first half of 2009.
For further information, please contact: CEO Lars Viksmoen, tel: +47 40620870 CFO Jørn Lunde, tel: +47 90733486
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 56 employees, and offices in Tromsø, Oslo, and in Long Beach, California.
