Phase III results with SBG for diabetic foot ulcer not positive
(Thomson Reuters ONE) - (Oslo/Tromsø, 23 November 2009) Biotec Pharmacon has received theresults from both its phase III studies with SBG for diabetic footulcer and regrets to inform that the results are not positive. Thestudies failed to show superiority of SBG vs. placebo in terms ofulcer healing, and the company will thus not proceed with the furtheractivities planned for this indication."The completion of these phase III studies was a major milestone forBiotec Pharmacon, and the results are a disappointing setback foreverybody involved, internally as well as externally," says CEO LarsViksmoen in Biotec Pharmacon.Overall, the results from both studies are very consistent. Bothgroups received the best available general wound care, and on top ofthat either SBG or placebo. The primary endpoint of the phase IIIdiabetic ulcer program was the percentage of target ulcers healedafter eight weeks, which was at a 30 percent level in both treatmentgroups. No harmful effects to patients were reported.From a study design point of view, selecting another primary endpointwould not have resulted in a different outcome. Furthermore, responserates were similar between different clinical centres and countries.Samples are being collected for analysis of biological activity toexclude that SBG was exposed to any unexpected harm.Blinded interim analyses for both studies had already provided advicenot to increase the size of the patient populations. The company hasstressed that this merely outlined the following possible studyoutcomes; (i) that the treatment response from the two patient groupswere trending towards demonstrating a significant difference betweenthe two treatment groups, in either direction, or, (ii) that thedifference was so small that not even a large increase in the size ofthe patient population would be expected to yield a statisticallysignificant difference. As described above, the latter turned out tobe the case."We have been very careful not to take a positive outcome for grantedbut are obviously very disappointed to see that results received inearlier clinical stages were not confirmed in phase III. This isunfortunate, although not unique in the pharmaceutical industry,"says Viksmoen."We proceed with our ongoing phase III study with SBG for oralmucositis, where the results are expected in the first quarter nextyear. The Board and management will carefully consider the optionsfor the further development of the SBG portfolio", says Viksmoen.Although the oral mucositis study is a completely different study, itis still part of the company's ulcers and wound franchise, and BiotecPharmacon's expectations for these results have been lowered due tothe outcome of the diabetic foot ulcer studies.Biotec Pharmacon also has a clinical program with SBG inimmunotherapy of cancer, where pre-clinical and early stage clinicaldata indicate a synergistic effect between SBG and monoclonalantibodies. The company has also done pre-clinical research withinteresting results looking into other indications for SBG.Furthermore, Biotec Marine Biochemicals, a fully owned subsidiary ofBiotec Pharmacon, has a profitable and fast growing business withcold adapted enzymes targeting the molecular biology market.For further information, please contact:CEO Lars Viksmoen, tel: +47 40620870This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 23.11.2009 - 07:30 Uhr
Sprache: Deutsch
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