Dr. Robert Synder, professor and director of Clinical Research for the Paul & Margaret Brand Research Center in Barry’s School of Podiatric Medicine, has co-authored an article detailing the results of a [mid-stage] phase 2b trial for a unique cell-based therapy in venous leg ulcers.
The article and findings were recently published in the prestigious medical journal, The Lancet.
The study evaluated HP802-247, an investigational allogeneic living cell bioformulation containing keratinocytes and fibroblasts currently being developed by Healthpoint Biotherapeutics for the treatment of venous leg ulcers.
Venous leg ulcers affect approximately 2.5 million Americans and are caused by high blood pressure in the veins. These wounds, which typically occur on the lower legs, are increasingly common and costly, and a cause of prolonged pain and suffering for patients. Because many venous ulcers fail to heal with standard treatment, the availability of innovative and more effective treatment strategies for such high-risk wounds could provide tremendous benefits to both patients and society.
The trial results showed that approximately 70 percent of subjects in the active treatment group receiving the optimal observed dose of HP802-247 achieved complete wound closure at 12 weeks compared with 46 percent in the vehicle control group.
“These significant findings are a hopeful sign for the millions of patients and their families who are currently suffering from these often debilitating wounds,” noted Dr. Snyder, who also serves as president of the Association for the Advancement of Wound Care.
Following the favorable results achieved in this trial, a multicenter Phase 3 study for HP802-247 is scheduled to begin later this year. Snyder and the Paul & Margaret Brand Research Center will again be a participating study center.
For more information on the Phase III trial, contact: Robert Snyder, DPM, 777 East 25th Street, Suite 316, Hialeah, FL 33013 Telephone: 305-836-7550 Ask for Maria Swartz, Clinical Research Coordinator.