OxThera today announced that all 42 patients have been enrolled in their pivotal phase II/III study using Oxabact™ for the treatment of Primary Hyperoxaluria. Results from this multicenter study will be presented during Q4 of 2008 and be used to file for licensure in EU, US and the rest of the world.

Primary Hyperoxaluria is a rare genetic disease in which excessive oxalate is produced by the liver and excreted in the urine by the kidneys. High levels of urinary oxalate cause kidney stones and/or calcification of the kidney which could lead to kidney failure and in many cases premature death. OxThera estimates that there are about 2000 patients with Primary Hyperoxaluria in EU and US combined.

Oxabact™ consists of a unique intestinal bacterium, Oxalobacter formigenes, naturally colonizing the intestinal tract of most humans with the purpose to degrade oxalate. Previous studies with Oxabact™ have already shown a significant effect in lowering urinary oxalate which in turn leads to a decreased risk of kidney damage. Oxabact™ has been designated orphan drug status in both EU and the US.

The 28 week pivotal study is a randomized, double-blind, placebo-controlled, multi-center study being conducted at eight Primary Hyperoxaluria referral sites in the Netherlands, France, UK, Germany and US.

“Primary Hyperoxaluria is a very serious disease often leading to early kidney failure and in particular systemic oxalate deposition with all its complications including death with no effective medical therapy currently available. For majority of patients the only real option today is a combined liver-kidney transplantation which is available to a very limited number of patients worldwide. Therefore, the Primary Hyperoxaluria community has great hopes that Oxabact™ will offer a new treatment opportunity. A confirmation of earlier study results with Oxabact™ will reflect scientific breakthrough and a new chapter in the treatment of this rare and severe disease”, says Prof. Bernd Hoppe, University Hospital in Cologne, Germany.

Jon Heimer, CEO and President of OxThera comments: ”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”.



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For further information, contact:

Jon Heimer, CEO, OxThera – Phone no.: +46 761 171 820



Short facts about OxThera

OxThera is a biotechnology company active in the development of products for the...