OHS performs clinical drug trial to reduce cholesterol levels with just one injection

Duke UniversityJun 17 2014

Research One, Inc., an affiliate of Orlando Heart Specialists (OHS), is seeking candidates for a clinical drug trial that could reduce cholesterol levels with just one injection, twice a month. Led by principal investigator Dr. B. Alex Vakili, respected interventional cardiologist and chief operating officer of OHS, the FDA-sponsored trial is being conducted in partnership with Duke University and Sanofi pharmaceuticals.

"It's exciting to bring a national clinical trial of this stature to our patients and community," said Dr. Vakili. "We are testing a drug that has shown the capability to dramatically reduce cholesterol levels during Phase 2 studies. The future implications for patient treatment are incredible." Called the Odyssey Trial, this monoclonal antibody accelerates the removal of bad LDL cholesterol by the liver through blocking the PCKS9 receptors.

If approved for the marketplace, the new drug would be a potential replacement for statins, currently among the few options for lowering cholesterol levels. Drugs such as Lipitor and Crestor stimulate the breakdown of the artery clogging substance, but come with side effects that not all patients can tolerate.

Dr. Vakili, 44, who also serves as chief of cardiology for South Seminole Hospital, a division of Orlando Regional Healthcare, has worked years to bring this trial to Central Florida, conducting vital research and ensuring that the trial meets stringent federal guidelines. He is also clinical director of Research One, Inc., overseeing other significant trials that help bring new, potentially life-saving drugs to the market. Dr. Vakili has also been published extensively, having authored articles for nearly sixty scientific and medical research publications.

To be considered as a candidate for this trial, patients need to have an LDL above the goal of 70 while currently taking statin drugs. The Odyssey Trial is being performed across the country as part of a five-year process, with potential FDA approval still years away. To qualify, the patient must have experienced a heart attack or heart disease. Patients interested in being part of the Odyssey Trial should contact Research One, Inc., Clinical Research Coordinator Shadeen Wright at [email protected].