Alteon issued a press release today highlighting the further development of Alagebrium chrloride(formerly ALT 711). I haven't gotten a chance to review the paper, but the results reported in this press-release look promising. Alteon also issued 9 million more shares of stock and warrants for an additional 9 million shares yesterday through a private-placement. This raised a few million more bucks to help fund development. I'm not sure if Alteon will have enough money to make it all the way to market with Algaebrium, but it's good to see more money and research dollars spent on a type of therapy that has implications for SENS.
Alteon's alagebrium Indicates Protective Effect in Preclinical Diabetic Nephropathy Model
Wednesday September 20, 3:03 pm ET
-- Alagebrium appears to prevent, delay, and reverse kidney damage --
-- Study highlights biological marker associated with drug response --
PARSIPPANY, N.J., Sept. 20, 2006 (PRIMEZONE) -- Alteon Inc. (AMEX:ALT - News) announced today that the results of a preclinical study of alagebrium, a novel Advanced Glycosylation End-product (A.G.E.) breaker and Alteon's lead compound, expands existing evidence of the potential ability of alagebrium to reverse diabetic kidney disease. It also identifies a role for biomarkers that can be used to track drug effectiveness in anticipated clinical trials of alagebrium for diabetic nephropathy and diastolic heart failure. These results are published in the current issue of the American Journal of Nephrology (Am J Nephrol 2006;26:430-436).
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``This body of experiments performed by Peppa et al., attests to the potential of alagebrium to prevent, delay and reverse diabetic kidney disease, even when therapy is initiated late in the natural disease process,'' said Howard B. Haimes, Ph.D., Executive Director, Preclinical Sciences of Alteon. ``One of the major obstacles impeding the development of drugs in heart failure and diabetic nephropathy,'' continued Noah Berkowitz, M.D, Ph.D., Alteon President and CEO, ``is the lack of surrogate markers that can provide companies with early indications of their drug's efficacy. This study indicates that alagebrium can decrease the leakage of protein in the urine and markers of A.G.E.s in the blood. These markers may help us gain early recognition of the clinical effect of alagebrium in diabetic nephropathy and diastolic heart failure.''
Diabetic nephropathy, if unchecked, typically leads to organ failure, dialysis or organ transplantation. The study by Peppa et al., evaluated the effects of alagebrium on 3, 7 and 12 month old db/db mice. This strain of mice represents a model of human diabetes and is commonly used for drug evaluation. The authors made the following observations:
-- A.G.E.s can be important pathologic agents responsible for the
morphologic and functional deficits of diabetic nephropathy.
-- Alagebrium appears to protect kidney structure and function and
reverses A.G.E - mediated effects on the kidney.
-- As early as the 3rd week of treatment, alagebrium decreases the
serum concentration of eN-carboxymethyllysine (CML), a marker of
Advanced Glycation End-products (A.G.E.s), by 41%, concomitant
with increasing urinary excretion of CML by 138%.
-- By 3 months of treatment, alagebrium reduces serum, skin and
kidney levels of CML, while increasing their output in the urine.
-- A rise in the albumin/creatinine ratio and morphological and
structural changes associated with diabetic nephropathy can be
slowed or reversed by alagebrium.
Diabetic nephropathy is a major contributor to the overall morbidity of diabetes. The American Diabetes Association estimates that 20-30% of people with type 1 and type 2 diabetes will develop evidence of overt nephropathy, an advanced stage of the disease marked by proteinuria (the presence of proteins in the urine). After the onset of proteinuria, over 75% of type 1 diabetics and 20% of type 2 diabetics progress to ESRD (End-Stage Renal Disease) within 20 years. The discrepancy may be explained by the fact that patients with type 2 diabetes have a greater risk of dying from coronary artery disease than from kidney failure and therefore do not progress to ESRD. Nonetheless, because type 2 diabetes accounts for up to 95% of all diabetes cases, over half of the diabetic patients starting dialysis are type 2. After the start of dialysis, the mortality rate for people with diabetic nephropathy is approximately 38% within two years, and nearly 73% die within 5 years.