Anticipated Release of Oxabact in 2009

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Listmates,

This announcement by Oxthera of the release of the by-prescription-only

probiotic of oxalobacter formigenes undoubtedly is the " early release " sort

of advertising that pharmaceutical companies do to build up

anticipation. Nevertheless, it gives us a feel for the timing of the

availability of their product which I hope will deal effectively with the

relationship between the leaky gut and oxalate that may occur with

bariatric surgery. Of course, if you look at the numbers, many conditions

with enteric hyperoxaluria comprise a much larger market than those with

primary hyperoxaluria. (By the way, I have no association with these

people except that I've met them and shared with them about the Autism

Oxalate Project and its urgent need for their product to make lowering

oxalates easier.)

Also, today, there was some buzz about a different but related study:

Bacteria for the prevention of kidney stones

Posted by Jim Marino on April 7, 2008

According to a new study published in the Journal of the American Society

of Nephrology, Oxalobacter formigenes, a naturally occurring bacteria,

reduces recurring kidney stones in the body by about 70%. The research

studied 247 patients with recurrent calcium oxalate stones in the kidney

and compared these to a control group of 259 adults. The researchers

collected data and observed a strong inverse association between presence

of O. formigenes and kidney stones.

Please note that the association to bariatric surgery is mentioned

below. Some of you might like to forward this announcement to some of the

surgeons who may not have been following this association with oxalate.

Announcement:

OxThera 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 " .

Short facts about OxThera

OxThera is a biotechnology company active in the development of products

for the treatment of metabolic disorders resulting from excess levels of

oxalate from endogenous and exogenous sources. Currently, OxThera has two

products in its pipeline, Oxabact™ for the treatment of primary

hyperoxaluria, and Oxazyme™, for the prevention of recurring

calcium-oxalate kidney stones due to secondary hyperoxaluria.

Oxalate is a metabolic end product in humans. It is endogenously produced

by the liver and also derived by absorption from the diet. The majority of

oxalate is eliminated from the body through the kidneys and a small

percentage is eliminated through the GI-tract. Oxalate forms a

calcium-oxalate salt which is insoluble at physiological pH and its

accumulation can result in serious renal conditions. Consistent high levels

of urinary oxalate are known as " hyperoxaluria " , which can result in

recurrent kidney stones and renal complications. Hyperoxaluria is currently

classified as:

- Primary hyperoxaluria types I and II are rare genetic diseases resulting

from overproduction of oxalate in the liver (PH I) or in all body cells (PH

II); urinary oxalate excretion is usually greater than 100 mg/day (normal

level

- Secondary hyperoxaluria due to excessive absorption of dietary oxalate.

This is common in patients with excessive absorption of dietary oxalate and

in patients with fat malabsorption due to underlying enteric diseases such

as IBD, or cystic fibrosis. Further, it is often seen in patients following

jejunoileal bypass surgery or bariatric surgery, and in patients with

absorptive hyperoxaluria.

Primary hyperoxaluria is a rare, serious disease with very limited

treatment options available. The urinary oxalate excretion rate in affected

patients is typically three to six times normal with severe clinical

consequences. Kidney stones and/or calcification of the kidney occur in

childhood or adolescence. Renal injury due to oxalate and consequences of

the stones often leads to renal failure. Loss of renal function, if not

addressed promptly by transplantation, leads to markedly increased plasma

concentrations of oxalate with deposition of calcium-oxalate in body

tissues. Renal failure occurs in 50% of the patients by the age of 15 years

and has reached 80% by the age of 30 years. Renal replacement therapy is

not able to eliminate sufficient amounts of oxalate, hence systemic oxalate

deposition occurs.

OxThera

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