The study established the safety of HDL therapy as a potential treatment for atherosclerosis, a disease of blood vessels caused by the build-up of cholesterol-filled plaques in the coronary arteries. Data also showed the treatment could cause plaque formation to regress, although the trial population was too low to be fully conclusive.
The study animals were monitored before, during, and after each of 12 weekly infusions of plasma that was delipidated. The data included over 3,000 assays of blood chemistry and physiological variables, such as blood pressure, heart rate, temperature, and respiration rate, collected throughout the study.
No significant changes in any of the monitored variables were noted during the course of the study.
The study involved 12 African green monkeys, a widely accepted primate model for human atherosclerosis. These animals had been on a high fat diet for seven years. Each primate was evaluated with intravascular ultrasound (IVUS) to establish a baseline of atheroma volume (plaque buildup) at the beginning of this study. A second IVUS was conducted at the conclusion of the sequence of 12 weekly infusions of delipidated plasma.
Dr Steve Nissen, director of the Cleveland Clinic Cardiovascular Coordinating Center, said: “This was the first attempt to use IVUS to study an anti-atherosclerotic therapy in an animal population. There were only 12 animals in the study, too few to reach any conclusions about the efficacy of the therapy, but the effort will help develop the methodology necessary for future trials.”
The company said the safety data was a critical step towards submitting an application to the FDA to seek consent to test the therapy in human trials. Lipid Sciences expects to do this in time to start clinical trials by the beginning of 2006.