- Ixion Initiates Treatment in German Pilot Clinical Trial
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 Alachua, FL-September 6, 2002- Ixion Biotechnology, Inc., the world leader in oxalate-related disease technology, announced the initiation of treatment in a pilot study of its oral oxalate therapy, IxOC-2. The study is being conducted by Bernd Hoppe, MD, of the Division of Pediatric Nephrology, University Children's Hospital, Cologne, Germany. The first study arm is being conducted on five children with confirmed diagnosis of Primary Hyperoxaluria Type I (PH1). Study arms two and three will be conducted on 10 subjects from the Cystic Fibrosis population and subjects with secondary, absorptive hyperoxaluria due to other reasons. All three arms are open label, involving four weeks of active treatment and two weeks of follow up. Results will be made available only after completion of all arms of the study and analysis of the data.
- Primary Hyperoxaluria is a rare, autosomal recessive disease, caused by deficiency of an enzyme in the liver, affecting approximately 3,000 to 4,000 children and adolescents. Because the kidneys are the main pathway for reducing oxalate, hyperoxaluria leads to calcium oxalate kidney stones and nephrocalcinosis, mostly resulting in renal failure in PH1 patients. Up to 50% of patients suffering from Primary Hyperoxaluria reach end-stage renal failure by 15 years of age. The decline in renal function results in an accumulation of oxalate within various organs and tissues, such as bones, hearts, arteries, retina, and nerves, leading to severe and even lethal consequences. The only current treatment is vitamin B6, but only a few subjects respond to this treatment. In addition the subjects often undergo a combined liver/kidney transplant.
- IxOC-2, in its current formulation, is a frozen cell paste of live Oxalobacter formigenes, a naturally-occurring beneficial gut-dwelling bacteria. Oxalobacter formigenes's only function is to break down oxalate and prevent it from being absorbed from the diet. Robust colonization with O. formigenes might also enhance elimination of endogenous oxalate via enteric elimination.
- "The pilot study is based on the hypothesis that O. formigenes, if taken orally with meals, will degrade oxalate throughout the GI-tract and reduce absorptive hyperoxaluria. The therapy should also provide robust colonization with O. formigenes. Degradation of oxalate may also allow for elimination from the blood, thereby further lowering the urinary oxalate levels," said Dr. Hoppe, study director.
- "Results from an earlier safety study demonstrated good safety and tolerability for IxOC-2. The main outcome of the German pilot study will be further assessment of safety and an indication of efficacy in terms of colonization of the GI-tract with O. formigenes and its effect on 24-hour urinary oxalate levels in patients with various forms of hyperoxaluria," said Harmeet Sidhu, VP and Director of Research, Oxalate Division of Ixion.
- Ixion's other business unit is developing an adult stem cell-based cellular treatment for insulin-dependent diabetes. Ixion has demonstrated the feasibility of using adult stem cells to produce new transplantable islets for the treatment of diabetes. For more information about Ixion's current activities and recent news releases, visit Ixion's Web site at www.ixion-biotech.com or call 386-418-1428, Ext. 301.
- This news release discusses historical information and includes forward-looking statements that involve a number of risks and uncertainties, such as risks associated with pre-clinical and clinical development in the biotechnology industry, determinations by regulatory and administrative governmental authorities, competitive factors, technological developments and costs of developing, producing and selling products.
- Contact:
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- Louis G. Kessler, Ph.D.
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Ixion Biotechnology, Inc.
386-418-1428, Ext. 304 (voice)
386-418-1583 (fax)
Info@ixion-biotech.com
- Lisette Hilton
- 561-392-5649 (voice)
- 561-392-7496 (fax)
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