Vasogen ends Phase III arterial disease drug trial early on recommendation

TORONTO (CP) - Vasogen Inc. said Tuesday it has brought an early close to a Phase III trial of its Celacade drug for the treatment of chronic inflammation associated with cardiovascular disease.

The Toronto-based drug developer said it ended the study of the trial designed to assess Celacade's effectiveness in treating intermittent claudication, or pain in the legs from narrowed arteries, on the recommendation of the project's steering committee.

The company said a safety and efficacy monitoring panel recommended the close "based on the absence of a sufficiently strong efficacy signal and their observation of a modest

imbalance in the distribution of a small number of malignancy cases."

"While the steering committee does not agree that a safety concern existed, our knowledge that the . . .analysis also considered efficacy led to our decision to recommend stopping the study at this time," Dr. Jeffrey Olin, chairman of the steering committee, said in a release.

"We are now proceeding to lock the data base, fully analyze the data, and report the final results of the trial."

The company (TSX:VAS) said clinical assessments of the trial's six-month primary endpoint were completed in July and the majority of patients in the study have completed an additional six months of therapy as outlined in the study protocol.