Alteon suspends cardio trial enrollment

The company is currently testing alagebrium in patients with systolic hypertension, heart failure and erectile dysfunction. Patients already enrolled in the clinical trials are continuing treatment.

In December 2004, the company announced that findings of a two-year toxicity study indicated that male Sprague Dawley rats exposed to high doses of alagebrium over their natural lifetime developed dose-related increases in liver cell alterations and tumors, and that the liver tumor rate was slightly over the expected background rate in this gender and species of rat.

The company also announced its intent to conduct a series of preclinical experiments to explore the mechanism by which the liver tumors developed and the relevance of such tumors to human exposure. These preclinical experiments are still ongoing, with results expected by mid-year.

“This decision was made after we received initial data from one of our ongoing studies in rats, which provided insights and direction for further analysis,” said Judith Hedstrom, COO of Alteon.

“The relevance of these rat findings to humans has not been established, and we do not believe that the recent data change the information previously provided to patients who are already in the alagebrium studies. Nevertheless, in the current environment, we have decided it is prudent to temporarily suspend enrolling new patients.”

The decision to suspend enrollment was made voluntarily and does not appear to have adversely affected confidence in the company as its share price has risen by 8% following the announcement.