Macrocure Nominates Dr. Vickie Driver, President-Elect of the American Association of Advanced Wound Care, as Lead Principal Investigator in Phase III Clinical Trial
4/22/2013 10:49:02 AM
PETACH TIKVA, Israel – April 22, 2013 – Macrocure (www.macrocure.com), a biotechnology company developing advanced cell therapy products, announced today the nomination of podiatric surgeon, Dr. Vickie R. Driver, as the Lead Principal Investigator of the company's Phase III clinical study currently being conducted in the U.S., Canada and Israel.
Dr. Driver currently serves as the Podiatric Surgery Division Chief and Research Program Director- Limb Preservation and Wound Healing, Department of Surgery, VA New England Health Care Division, and is the President-elect for the American Association of Advanced Wound Care, the preeminent multidisciplinary organization dedicated to the research and clinical application of evidence-based wound care. Additionally, she is active in the Wound Healing Center of Rhode Island Hospital, a Brown University teaching hospital. Dr. Driver has been Director of Clinical Research, Limb Preservation and Wound Care and International Research Fellowship Programs at Boston Medical Center. She was also an associate professor of surgery at Boston University School of Medicine.
"I am pleased to have been appointed as Principal Investigator for Macrocure's Phase III clinical study," said Dr. Driver. "Previous studies of Macrocure's innovative CurXcell® cell therapy treatment have demonstrated positive results, indicating the tremendous potential it holds for the treatment of hard-to-heal wounds, currently effecting millions of people suffering from diabetes mellitus, hypertension, coronary artery disease and other chronic conditions."
Macrocure's phase III trial includes 400 adult patients suffering from chronic ulcers of the lower extremities that are being treated with CureXcell®. The objective of the study is to evaluate the safety and efficacy of CureXcell® as an adjunct to good wound care. The trial is being conducted as a randomized, double-blind, parallel group, sham-controlled study.
"We are excited to have someone with Dr. Driver's credentials and experience in wound healing leading this next phase of trials exploring CureXcell®'s potential for treating patients with hard-to-heal wounds," said Nissim Mashiach, President and CEO of Macrocure. "The multi-national trial currently underway follows our successful treatment of ulcer patients in Israel and will allow us to advance our solution in the global market."
Macrocure is a biotechnology company which focuses on the development and commercialization of advanced wound care therapies. Macrocure is pursuing regulatory market approval for CureXcell® in North America and Europe. CureXcell is also currently undergoing investigation in a Phase III randomized, double-blind trial for lower extremity chronic ulcers in adults with diabetes in the United States, Canada and Israel. The company has received marketing authorization of CureXcell® in Israel for the treatment of chronic ulcers, but is not yet licensed for sale in other countries.
CureXcell ® is an innovative, advanced wound care product comprised of activated allogeneic immune cells that are superficially injected into the wound bed, once a month. CureXcell® provides the solution for impaired wound healing by introducing the right combination of activated cells required to restore normal wound healing processes and achieve full wound closure.