Databases locked in both the phase III clinical studies with SBG for
diabetic foot ulcer
(Thomson Reuters ONE) - Biotec Pharmacon is pleased to inform that all data managementprocedures have been completed, and that the databases have beenlocked in both of the company's phase III studies with solublebeta-1,3/1,6 glucan (SBG) for treatment of diabetic foot ulcer. Nofurther data will be added. Two clinical research organizations willstart to analyse the data. The timing of the database lock isconsistent with previous communication, and Biotec Pharmacon expectsto 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 ofSBG. The studies included 122 and 133 patients, respectively, andwere initiated in June 2007 and October 2008. Patient treatment andfollow-up was completed during the third quarter 2009. Providedpositive and confirmatory results Biotec Pharmacon plans to submit anapplication for market authorisation in Europe next year, and hasbeen allocated a slot with the UK authorities (MHRA) in July 2010.The UK will act as reference member state in a decentralizedprocedure and coordinate the review of an application submittedsimultaneously in EU/EAA member states.SBG targets a potentially large patient group. On an annual basis, anestimated 3.5 million of a total 70 million diabetes patients in theOECD-area develop foot and leg ulcers. These ulcers frequentlydevelop into a chronic condition with high risk of infection and area frequent cause of amputation in patients with diabetes. BiotecPharmacon's SBG reactivates immune cells in the skin and therebyenhances the body's own wound healing capabilities. Today' there areno standard well established treatments available beyond generalwound care.For further information:CEO Lars Viksmoen, tel: +47 40620870CFO Jørn Lunde, tel: +47 90733486About Biotec Pharmacon:The biopharmaceutical company Biotec Pharmacon developspharmaceutical products for prevention and treatment of immunerelated diseases. The company has developed the bioactive substanceSBG (soluble beta glucan), which is in clinical phase III for twoindications; treatment of diabetic ulcers and prevention andtreatment of oral mucositis. The company's clinical developmentprogram also includes immune therapy of cancer, where combinationtreatments with SBG and monoclonal antibodies are being studied inclinical phase I/II. In addition, the company is involved in severalpreclinical studies with SBG. Biotec Pharmacon also produces andmarkets non-pharmaceutical health- and diagnostic products and owns100% of Immunocorp Consumer Health AS and the marine enzyme companyBiotec Marine Biochemicals AS.This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 03.11.2009 - 08:31 Uhr
Sprache: Deutsch
News-ID 7818
Anzahl Zeichen: 0
contact information:
Town:
London
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 240 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Databases locked in both the phase III clinical studies with SBG for
diabetic foot ulcer"
steht unter der journalistisch-redaktionellen Verantwortung von
Biotec Pharmacon ASA (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
