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Biotech / Medical : Alteon (ALT) -- Ignore unavailable to you. Want to Upgrade?

To: tnsaf who wrote (304)	11/21/2001 4:06:51 PM
From: tnsaf	Read Replies (1) \| Respond to of 318

Alteon Announces Initiation of Phase I Human Testing of ALT-711 In ESRD Patients Undergoing Peritoneal Dialysis RAMSEY, N.J., Nov. 7 /PRNewswire/ -- Alteon Inc. (Amex: ALT - news) announced today that it has expanded the clinical testing of ALT-711, its lead A.G.E. Crosslink Breaker, into patients with end-stage renal disease (ESRD) who are undergoing peritoneal dialysis (PD). ESRD is a condition in which the kidneys no longer function, resulting in an increase of waste products in the body that cause a number of cardiovascular complications, including left ventricular hypertrophy (enlarged heart). PD is a method of dialysis that uses the patient's peritoneum (a membrane in the abdomen) to filter out waste products. The new Phase I study is an important component of Alteon's clinical strategy in developing ALT-711 for cardiovascular disease, and will provide data necessary for Alteon to evaluate further development of ALT-711 in the critically ill peritoneal dialysis population. ALT-711 is concurrently in two Phase IIb trials, the SAPPHIRE (Systolic And Pulse Pressure Hemodynamic Improvement by Restoring Elasticity) and SILVER (Systolic Hypertension Interaction with Left VEntricular Remodeling) trials, evaluating its effectiveness on systolic hypertension in individuals with or without left ventricular hypertrophy. The Phase I safety and pharmacokinetic study, which has been initiated at Wake Forest University Medical Center in Winston-Salem, NC, will evaluate the way ALT-711 is metabolized in PD patients with ESRD. Recruited patients will receive drug or placebo in tablet form once a day. The dosage amount will be increased over a 4-week treatment period. Peritoneal dialysis works on the same principle as hemodialysis, but the blood is cleaned while inside the body rather than through a machine. In most cases, this treatment can be performed without assistance, at home or at work. The peritoneal cavity is filled with dialysis fluid through a permanently implanted catheter. Excess water and waste pass through the peritoneum into the dialysis fluid. The fluid is then drained from the body and discarded. Latest statistics show that almost 25,000 of the 400,000 Americans living with ESRD are undergoing peritoneal dialysis. This patient population has a limited 5-year survival (less than 30%) and significant cardiovascular complications, which are the primary cause of death. ALT-711 is the most clinically advanced drug in a new class of compounds, known as Advanced Glycosylation End-product (A.G.E.) Crosslink Breakers, which were discovered by Alteon. By ``breaking'' the pathological bonds that cause tissues, organs and vessels to stiffen and lose function over time, ALT-711 has demonstrated the ability to reverse certain age-related and diabetes-related conditions. In a 93-patient Phase IIa clinical trial, treatment with ALT-711 resulted in statistically significant and clinically meaningful effects of increasing vascular wall elasticity and lowering pulse pressure, each major contributing factors in cardiovascular disease.