Alteon's Investigational Drug Alagebrium Demonstrates Ability to Improve Functional Membrane Transport in a Rat Model of Chronic Peritoneal Dialysis, Indicating a Potential Role in Kidney Disease
PARSIPPANY, N.J., February 20, 2007 /PRNewswire-FirstCall/ -- Alteon Inc. announced today that a preclinical study presented at the 27th Annual Dialysis Conference in Denver, February 18-20, 2007 (www.muhealth.org/~dialysis) demonstrates the beneficial effects of Alteon's drug alagebrium, an A.G.E. crosslink breaker, in a rat model of peritoneal dialysis. Conducted by Jeong-Ho Lee, M.D. of the Department of Nephrology, Dongguk University Medical Center, Kyongju, Korea, the study entitled, "The breakdown of preformed advanced glycation end products (AGEs) by intraperitoneal alagebrium" indicates a potential role for alagebrium in the treatment of kidney diseases and as an adjunct to dialysis. The investigational team was honored with the "Best Abstract" award at the conference.
AGEs are pathological carbohydrate-protein bonds that cause tissues, organs and vessels to stiffen and lose function over time, and have been associated with diabetic complications and other age-related diseases. The gradual failure of peritoneal dialysis (PD) may be related to the use of glucose-containing peritoneal dialysis solutions that lead to accumulation of AGEs on the peritoneal membrane, and consequent alteration of filtration and permeability.
The study combined both structural and functional analysis of the peritoneal membrane and looked at the effects of an AGE breaker, alagebrium, and an AGE formation inhibitor, pimagedine. In fact, the removal of pre- formed AGEs on the peritoneal membrane as assessed by microscopic visualization correlated well with the improvement of permeability characteristics in this rodent model of long-term PD and the effect of alagebrium was significantly superior to the effect of pimagedine. The study provided evidence for the ability of alagebrium, but not pimagedine, to reduce pre-formed tissue A.G.E.s and confirmed the biologic activity of alagebrium in cleaving tissue AGEs.
"The ability to remove preformed AGEs has far-reaching therapeutic implications in many complications of diabetes mellitus which generate an accelerated burden of vascular and tissue AGEs," said Noah Berkowitz, MD, PhD, President and CEO of Alteon. "Dr. Lee's discoveries complement previous work demonstrating the impact of AGE's on renal function, and a role for alagebrium in decreasing proteinuria, by protecting the glomerular basement membrane from thickening and inflammation. By demonstrating a means by which alagebrium can protect the peritoneum from damage normally caused by long term dialysis, this study could support the use of alagebrium as an adjunct to dialysis -- an orphan indication by market size, but one linked to considerable healthcare resource utilization."
About ESRD and Peritoneal Dialysis
End-stage Renal Disease (ESRD) is a condition in which the kidneys no longer function, resulting in an increase of waste products in the body. Latest statistics show that approximately 10-15% of the more than 200,000 Americans undergoing weekly dialysis for ESRD are undergoing peritoneal dialysis, a method of dialysis that works on the same principle as hemodialysis but uses the patient's peritoneum to filter out waste products rather than a machine. It is less expensive than hemodialysis, and by some measures more effective at the start. Yet, it is time consuming, often plagued by abdominal infections and characterized by a gradual deterioration in effectiveness, thought to be associated with the accumulation of AGEs.
Alteon is a product-based biopharmaceutical company engaged in the development of small molecule drugs to treat and prevent the inflammatory aspects of cardiovascular disease and diabetes. The Company has identified several promising product candidates that it believes represent novel approaches to some of the largest pharmaceutical markets.
Alagebrium, a product of Alteon's drug discovery and development program, is being developed for the treatment of diastolic heart failure. This disease represents a rapidly growing market of unmet medical need, particularly common among diabetic patients. Alagebrium has demonstrated relevant clinical activity in two Phase 2 clinical trials in heart failure, as well as in animal models of heart failure and nephropathy, among others. Alagebrium has been tested in approximately 1,000 patients in multiple Phase 1 and Phase 2 clinical trials, which represents a sizeable human safety database.
The Company's portfolio also includes orally bioavailable, organoselenium mimics of glutathione peroxidase that metabolize lipid peroxides and have the potential to limit myocardial damage subsequent to a myocardial infarction. Alteon's lead compound for that program, ALT-2074, is in Phase 2 clinical trials. The Company also has rights to a diagnostic assay that identifies a large subset of diabetic patients at highest risk for cardiovascular complications, because of a defect in oxidized lipid metabolism that results in increased cardiovascular inflammation. For more detailed information about Alteon's research and development, please visit Alteon's website at www.alteon.com.
Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties including, but not limited to, those relating to the impact of the preclinical results described in this press release on the future clinical development of Alteon's product candidates (including the possibility that early preclinical or clinical trial results may not be predictive of results that will be obtained in large-scale testing or that any clinical trials will not demonstrate sufficient safety and efficacy to obtain requisite approvals or will not result in marketable products), Alteon's ability to obtain sufficient funding to continue as a going concern and continue the development of alagebrium and ALT-2074, technology and product development regulatory approval processes, intellectual property rights and litigation, competitive products, and other risks identified in Alteon's filings with the Securities and Exchange Commission. Further information on risks faced by Alteon are detailed under the caption "Risk Factors" in Alteon's Annual Report on Form 10-K for the year ended December 31, 2005 and in its subsequent Quarterly Reports on Form 10-Q. These filings are available on a website maintained by the Securities and Exchange Commission at http://www.sec.gov. The information contained in this press release is accurate as of the date indicated. Actual results, events or performance may differ materially. Alteon undertakes no obligation to publicly release the result of any revision to these forward- looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
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Posted: February 2007