Biotec Pharmacon is pleased to inform that all data management
procedures have been completed, and that the databases have been
locked in both of the company's phase III studies with soluble
beta-1,3/1,6 glucan (SBG) for treatment of diabetic foot ulcer. No
further data will be added. Two clinical research organizations will
start to analyse the data. The timing of the database lock is
consistent with previous communication, and Biotec Pharmacon expects
to provide final study results during the fourth quarter 2009.
Both of the two phase III studies are randomized, double-blind,
"placebo" controlled studies to assess the efficacy and safety of
SBG. The studies included 122 and 133 patients, respectively, and
were initiated in June 2007 and October 2008. Patient treatment and
follow-up was completed during the third quarter 2009. Provided
positive and confirmatory results Biotec Pharmacon plans to submit an
application for market authorisation in Europe next year, and has
been allocated a slot with the UK authorities (MHRA) in July 2010.
The UK will act as reference member state in a decentralized
procedure and coordinate the review of an application submitted
simultaneously in EU/EAA member states.
SBG targets a potentially large patient group. On an annual basis, an
estimated 3.5 million of a total 70 million diabetes patients in the
OECD-area develop foot and leg ulcers. These ulcers frequently
develop into a chronic condition with high risk of infection and are
a frequent cause of amputation in patients with diabetes. Biotec
Pharmacon's SBG reactivates immune cells in the skin and thereby
enhances the body's own wound healing capabilities. Today' there are
no standard well established treatments available beyond general
wound care.
For further information:
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. In addition, the company is involved in several
preclinical studies with SBG. Biotec Pharmacon also produces and
markets non-pharmaceutical health- and diagnostic products and owns
100% of Immunocorp Consumer Health AS and the marine enzyme company
Biotec Marine Biochemicals AS.
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