By Lisa Seachrist

Washington Editor

In light of positive data from an interim analysis, Alteon Inc. has decided to expand a Phase II clinical trial of Pimagedine in diabetic patients suffering end-stage renal disease (ESRD) into a pivotal Phase III study.

The data from the Phase II trial remains blinded to the company. However, Alteon was advised by its data safety monitoring board that results indicate a positive trend in mortality comparing treated patients to the placebo arm.

"This is certainly exciting," said Susan Pietropaolo, manager of corporate communications for the Ramsey, N.J., company. "This is still just an early result and it has yet to reach statistical significance, but it is an important result."

The data safety monitoring board also noted the Phase II trial of Pimagedine in ESRD paralleled other clinical studies of the drug, lowering lipid levels in treated patients. (See BioWorld Today, April 18, 1997, p. 1.)

Pimagedine is designed to inhibit the formation of advanced glycosylation end-products (AGE) by preventing glucose from binding to proteins in the blood. Everyone develops AGE, but diabetic patients are prone to high levels as a result of excess glucose in their bloodstreams. Accumulation of AGE can damage kidneys, blood vessels and nerves.

Progressive damage to the kidneys can lead to end-stage renal disease, in which the kidneys fail to filter and remove wastes from the bloodstream. Patients with ESRD need dialysis; but even with dialysis, 40 percent of patients with ESRD will die in two years. Diabetic patients represent one-third of the 50,000 new cases of ESRD each year.

"There really isn't any option for patients suffering ESRD," Pietropaolo said. "We are thrilled that our clinical trial data is corresponding to what we found in our preclinical studies."

The ESRD Phase II trial originally was designed to test a low and high dose of Pimagedine in 120 patients. The trial, however, was designed to be converted into a Phase III trial should the data warrant. After discussions with the FDA, Alteon decided to increase enrollment to 225 patients.

Ken Cartwright, Alteon's vice president of development and regulatory affairs, said the company intends to complete enrollment within the next nine to 12 months and follow patients for two years. Mortality will be the final endpoint for the trial.

With the expansion of this trial, Alteon's lead product is now in three pivotal trials: two testing the drug in diabetic kidney disease and one in ESRD.

Alteon's stock (NASDAQ:ALTN) was up $0.125 on the news to close at $3.75. *