June 21, 2012
Macrocure’s CureXcell Targets Hard-To-Heal Wounds
Connie K. Ho for redOrbit.com
Chronic wounds are a growing issue. Luckily, Macrocure´s CureXcell addresses that issue. Macrocure, a biotechnology company that specializes in cell therapy for hard-to-heal wounds, is currently conducting a multi center Phase III study in North America and Israel under a Special Protocol Assessment for lower extremity chronic ulcers for adults with diabetes.
Macrocure´s lead product is CureXCell, an approach to treating hard-to-heal wounds by replenishing imbalanced inflammatory environment in non-healing wounds with a variety of functionally-active allogenic immune cells that give off needed growth factors for healing. This provides an environment that allows for natural wound healing and debridement. These cells give off the needed cytokines and growth factors to help the wound heal. Around 5,000 patients with different types and severities of hard-to-heal wounds have been treated in Israel with CureXcell, which was approved for reimbursement by the Israeli Ministry of Health.
"Macrocure is a true pioneer in wound healing, providing a systematic approach in treating hard to heal wounds in diabetic patients, a multi-billion dollar annual market," commented Mashiach, the company´s new President and Chief Executive Officer. "If our clinical studies are successful, we will be well-positioned as the only company capable of successfully treating all hard-to-heal wounds."
Wound healing requires interaction of various cell types, the extracellular matrix and chemical mediators. The elements mostly involved in the process include lymphocytes, monocytes/macrophages, and neutrophils. Different immune cells produce different sets of cytokines and growth factors in temporal arrangements and at controlled levels. Chronic non-healing wounds are related to impaired function of immune cells and causes disruption of the process that wounds undergo when healing.
CureXcell is a combination of white blood cells, including monocytes/macrophages, neutrophils, and lymphocytes, taken from the blood of a young, healthy donor. The cells are then put in a more active state. During treatment, the suspension is generally injected superficially throughout the wound with a 25-gauge needle.
“The cells know how to activate from inside—it´s an interactive and active process, it´s a live solution, not mechanical, not something coming from a different organization,” explained Masiach. “That´s the value and beauty of it.”
The treatment was developed in Israel and has been approved in the country for chronic wounds. CureXcell has been used to treat a number of wound types like diabetic foot ulcers; post-operative wounds such as deep wound infections, post abdominal surgeries, post cesarean operation, and post orthopedic surgery; as well as pressure ulcers. In Israel, the clinical trials have demonstrated a 90 percent reduction of mortality in patients who undergo deep sterna; wound infections after open-heart surgery as well as showed improved healing rate for those who have pressure ulcers.
Macrocure is working on regulatory market approval in North America, Europe, and Israel.
“We´re very excited about the opportunity,” said Mashiach.
Mashiach, who recently joined Macrocure in June, hopes to move forward with the operation.
"Nissim joins Macrocure at a time when the company is focused on our goal of achieving clinical approval for CureXcell(R), which will clear the path to commercial development in numerous markets around the world," commented David Ben-Ami, Chairman of the Board for Macrocure, in a prepared statement.
General effects of chronic wounds include morbidity and mortality, longer hospital stays, and a rise in healthcare costs. As well, patients and caregivers suffer negative impacts in the quality of life. Other wound care products currently on the market include antiseptic agents, device dressings, gels, and ointments. These products can provide an environment for wound healing, but sometimes show limited effectiveness in terms of chronic, infected, or severe wounds.