Ixion Awarded Grant For O. Formigenes Diagnostic Test Kit
ALACHUA, Fla., August 28, 2002 - Ixion Biotechnology announced today that it has received National Institutes of Health funding for its SBIR Phase II study, "Oxalobacter formigenes diagnostic kit development." The award will allow Ixion to scale up and evaluate clinically a diagnostic test that detects the presence of Oxalobacter formigenes (Oxf) in humans.
(PRWEB) September 4, 2002
The absence of Oxf from the GI-tract may be a risk factor for the development of hyperoxaluria and calcium oxalate kidney stones. Oxf is absent in about 30% of the normal adult population and in much higher percentages from persons at risk of stone disease and other oxalate-related conditions. Recent data indicate that patients with recurrent urolithiasis may have a lower prevalence rate of Oxf than non-stone forming individuals. In addition, urinary oxalate levels are higher in non-colonized individuals than they are in colonized individuals. The standard culture method of detecting Oxf is cumbersome, expensive, and nonspecific.
"There is a clinical need for a rapid accurate test that can identify patients who are not colonized with Oxf," says the study's principal investigator Harmeet Sidhu, PhD, Ixion's vice president and oxalate research director. "Together with Ixion's oral drug candidate, currently in clinical trials, we have a unified approach to management of excess oxalate conditions. Testing for Oxf can become part of the routine metabolic evaluation of patients with hyperoxaluria and kidney stone disease."
The 24-month, $774,544 Small Business Innovation Research award recognizes Ixion's prior success in this area. In the Phase I study, Ixion researchers developed a reliable and rapid kit to detect Oxf in human fecal samples. This Phase II project will allow the researchers to complete the development of a production prototype of the O. formigenes Monitor Kit, and to evaluate the clinical performance of the kit in a multi-center clinical trial. The study population will consist of 275 stone patients matched with 275 controls. The study design should obtain sufficient analytical and clinical data to seek FDA approval as well as to firmly establish the association of Oxf with urinary oxalate excretion and the risk of kidney stones..
Co-investigators on the project are Dean G. Assimos, MD, and Ross P. Holmes, PhD, both at Wake Forest Medical School, and Roger Low, MD, at the University of California Davis Medical School.
In less than three years, Ixion has received 11 SBIR/STTR awards, totaling nearly $3 million in research funds for its cell-based treatments of metabolic disease programs.
In addition to its work in the treatment of excess oxalate conditions, Ixion is engaged in developing an adult stem cell somatic cellular treatment for diabetes. Q-Med AB (QMED. ST), whose shares are listed on the Stockholm stock exchange, is a major investor in and collaborator with Ixion. For more information about Ixion's current activities, visit Ixion's web site at www. ixion-biotech. com or call 386-418-1428.
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:
Weaver H. Gaines
Chairman and CEO
Ixion Biotechnology, Inc.
13709 Progress Blvd., Box 13
Alachua, FL 32615
386-418-1428, Ext. 304 (voice)
386-418-1583 (fax)
Info@ixion-biotech. com
Lisette Hilton
561-392-5649 (voice)
561-392-7496 (fax)
Info@ixion-biotech. com