Negative interim data for Progenics

An unplanned early analysis on a subset of the 880 patients in PGNX's open label Phase III trial of GMK, a GM2 ganglioside conjugate melanoma vaccine, showed that the Crelapse-free and overall survival rates for patients receiving the vaccine were lower than those for patients receiving high-dose alpha interferon, PGNX said. The Eastern Cooperative Oncology Group, which performed the analysis, will end its participation in the trial.

However, the company said it will continue the trial as an extension study in the belief that the follow-up period has been too brief for the full benefit of GMK therapy to be realized. PGNX said the analysis was conducted at a time when only half of the patients had received the planned two years of GMK therapy, while most of the interferon patients had completed their full course of therapy. GMK was better tolerated than alpha interferon with less frequent and less severe side effects, PGNX said. The subgroup upon which the analysis was performed consisted of less than 780 patients, the company said. ...