Speaking of approvals (or lack thereof), ALTN just lost more than half of its value today as their TZD, Pimagedine (like Rezulin), did not fair well at the FDA: Alteon tumbles on endangered Type 2 diabetes trial
NEW YORK, March 19 (Reuters) - Shares of Alteon Inc. ALTN.O tumbled Thursday after a company advisory panel recommended ending a late-stage trial of Alteon's candidate drug pimagedine for Type II diabetic patients with overt nephropathy, or kidney disease. Shares were off 4-9/16 to 5-5/16, or 46 percent, in morning trade. The Ramsey, N.J., company said Wednesday its External Safety Monitoring Committee advised ending the phase III trial based on "observation of an increased incidence of side effects in the Type II population" tested with the drug. Alteon said the independent committee, comprised of physicians and medical specialists, made its recommendation after seeing data from a trial that began in July 1995 of 599 patients with adult-onset Type II diabetes. Alteon said the committee, however, recommended continuation of a Phase III trial of the drug among 690 patients with the typically more severe Type I early-onset form of diabetes. That trial, also of patients with nephropathy, began in January 1994 and is expected to be completed late this year. |