Excellarate is a DNA-based topical gel that is being developed to be administered once or twice to stimulate wound healing.
The trial, known as MATRIX (GAM501 for the treatment of diabetic ulcers in the lower extremities), is expected to enroll approximately 210 patients at about 25 US sites. The study will enroll patients diagnosed with type I or II diabetes with a non-healing foot ulcer that have been present for at least six weeks and who have failed standard of care therapy.
The five arms of the study will include standardized care, consisting of surgical debridement, dressing changes, and weight off-loading devices, one or two applications of placebo, and one or two applications of Excellarate. The study’s primary endpoint is complete ulcer closure at 12 weeks or earlier. Secondary endpoints will be time to complete ulcer closure, change in ulcer area, durability of wound closure, and safety and tolerance.
Christopher Reinhard, chairman and CEO of Cardium, said: “We believe that Cardium’s Excellarate topical gel product candidate, which is being developed as a physician-administered one or two-time treatment for diabetic patients with chronic, non-healing lower extremity ulcers, has the potential to be a best-of-class product compared to currently marketed products, products under development and other adjunctive therapies, including relatively expensive negative pressure pump systems and hyperbaric chamber therapies, which generally require daily treatments over extended periods of time. With our MATRIX clinical trial now underway, we expect to complete the study within approximately 12 months.”