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news.Cardium Therapeutics, a medical technology company, and its subsidiary Tissue Repair Company, or TRC, have completed patient recruitment for the Phase IIb Matrix clinical trial to evaluate the safety and efficacy of the Excellarate product candidate for the potential treatment of non-healing foot ulcers in patients with type 1 or type 2 diabetes.
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The Matrix IIb clinical trial which has now completed recruitment is a prospective, randomized, double-blind, placebo-controlled study that screened approximately 285 patients at 30 US medical centers and recruited more than 120 patients with lower extremity neuropathic ulcers that were chronically non-healing despite receiving standard of care.
The study is designed to evaluate safety and efficacy in patients receiving one or two doses of Excellarate compared to placebo controls. A standard of care reference arm is also included in the study.
The primary endpoint of the study is complete wound closure at or before the initial 12-week study period. Other key efficacy endpoints include time to complete wound closure, absolute and percent change in ulcer area, and wound healing trajectories at various time points.
Excellarate is designed to require only one or two physician-administered treatments, in contrast to most diabetic wound healing agents or devices in use that require repeated administrations over a long term (weeks to months), the company said.
Christopher Reinhard, chairman and CEO of Cardium, said: “Our Excellarate product candidate, which is driven by TRC’s Gene-Activated Matrix technology platform, is being developed to address a number of therapeutic and administration limitations of existing drugs and other currently available therapies for diabetic patients suffering with chronic foot ulcers.
“Our Matrix clinical study, which included extensive photographic documentation, as well as computerized ulcer planimetry measurements on a weekly basis, represents one of the most extensively evaluated DNA-based wound healing therapeutics ever developed. The valuable information from this study is also expected to support Cardium and TRC advancing into other important product opportunities including pressure ulcers, venous stasis ulcers, bone injury repair and potentially other advanced therapeutic applications.”