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news.Biotechnology firm OxThera has announced that all 42 patients have been enrolled in their pivotal Phase II/III study using Oxabact for the treatment of primary hyperoxaluria.
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Results from this 28 week randomized, double-blind, placebo-controlled, multi-center pivotal study will be presented during the fourth quarter of 2008 and be used to file for licensure in EU, US and the rest of the world.
Jon Heimer, CEO and president of OxThera, said: “After several years of intensive research on Oxalobacter formigenes and Oxabact, a significant milestone is met with the inclusion of all patients in this pivotal study. A successful outcome will put us in a position to file for licensure and making the product available to treating physicians and patients during 2009 which is very exciting.”