Completed patient inclusion in phase III study for oral mucositis
(Thomson Reuters ONE) - Oslo September 7, 2009: Biotec Pharmacon has included 130 patientsand reached the planned number of patients in its phase III studywith SBG for prevention and treatment of oral mucositis. The studyresults are expected to be ready in the first quarter 2010, afterwhich Biotec Pharmacon will decide on the final plan to file formarket authorization for SBG for this indication.Depending on the results, Biotec Pharmacon will consider carrying outa second phase III study. The company has earlier received signalsthat one study may be enough to apply for market authorization,contingent compelling results.Oral mucositis is a common, very painful and potentially seriousside-effect of radiotherapy (with or without chemotherapy), inparticular with head and neck cancers. It develops as a result ofdamage to mucosal epithelial and immune cells inflicted by the cancertherapies. Approximately 400,000-600,000 incidents of oral mucositisare annually reported in the OECD area, and no standard treatment hasbeen established. Biotec Pharmacon's value proposition is that SBGboth can stimulate the immune system to prevent development of severeoral mucositis and support healing of the condition by enhancing thebody's own wound healing capabilities. The company has alreadyobtained an "orphan drug designation" in Europe for oral mucositis inpatients receiving radiotherapy for cancers in the head- and neckregion. This may offer improved protection from competitors if andwhen the company obtains market authorization.A decision was made earlier in August to stop patient inclusion asplanned after 130 patients. This was based on an interim analysiscarried out by an independent statistician, who in a "blinded"fashion measured the difference between two patients groups; onetreated with SBG and one given a non-active substance.Biotec Pharmacon also completed patient inclusion in two phase IIIstudies with SBG for treatment of diabetic foot ulcer. Results fromthese studies are expected by the end of the year and the company ispreparing to file a market authorization application for thisindication in Europe in July 2010.For further information, please contact: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: 07.09.2009 - 08:30 Uhr
Sprache: Deutsch
News-ID 5531
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