Phase III oral mucositis study proceeds as planned after interim
analysis
(Thomson Reuters ONE) - Oslo 10 August, 2009: Biotec Pharmacon will proceed as planned withits first phase III study with SBG for oral mucosits, following therecommendation from an independent statistician who has performed aninterim analysis based on the first 92 randomized patients in thestudy. Biotec Pharmacon has already included 123 of a total 130patients in the study, and expects to have results ready in the firstquarter 2010 as planned.Biotec Pharmacon commissioned the interim analysis in April, with anobjective to reassess the size of the patient population. Theindependent statistician has in a blinded fashion assessed thedifference in response between two patient groups, one which has beentreated with SBG and one which has been given a non-active compoundas comparator ("placebo"). The recommendation to proceed as plannedmeans that the study should be able to demonstrate a significantdifference between the two groups, in either direction, or that thedifference is so small that it would not become significant even witha substantial increase in the patient population."We are very close to reaching the target inclusion, and should be ontrack to complete patient follow-up and deliver data early next year.SBG has the potential to add significant value for the many patientswith head and neck cancers who suffer from oral mucositis, and mayalso play an important role in preventing the damage to the mucosa.We are all looking forward to seeing the final results from thestudy," says Professor Jean Bourhis, MD, PhD, coordinatinginvestigator at the Gustave Roussy Cancer Centre outside Paris,France.Oral mucositis is a common, very painful and potentially seriousside-effect of radiotherapy (with or without chemotherapy), inparticular for head and neck cancers. It develops as a result ofdamage to 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 already has"orphan drug designation" in Europe for oral mucositis in patientswith head and neck cancer treated with radiotherapy. This may open upfor improved protection from competitors, assuming the companyobtains market authorization."The results from this study will be decisive for the way forwardwith SBG for this condition. We will consider continuing with asecond phase III study but have earlier received signals that onestudy might be enough to apply for market authorization if theresults are compelling," says CEO Lars Viksmoen in Biotec PharmaconASA.Biotec Pharmacon also has two phase III studies ongoing with SBG fortreatment of diabetic foot ulcer. Results from these studies areexpected by the end of the year and the company is preparing to filea market authorization application for this indication mid-2010. Thismay open an even larger market opportunity, as one in six of the morethan 250 million adult patients with diabetes at some stage willdevelop a foot ulcer. As for oral mucositis, no standard drugtreatments are established other than general wound care.Biotec Pharmacon will present results for the second quarter 2009 onTuesday 11 August at 09:00 in the Vika Atrium Conference Center. Foradditional information related to this stock exchange release, pleasecontact: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: 10.08.2009 - 10:01 Uhr
Sprache: Deutsch
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