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Cardium begins Phase 2b Excellarate clinical study for diabetic ulcers

Cardium Therapeutics : 14 November, 2007  (New Product)
Cardium Therapeutics and its subsidiary, Tissue Repair Company (TRC) announced the start of recruitment for its Phase 2b clinical trial (Matrix) to evaluate the safety and efficacy of Excellarate for the potential treatment of non-healing diabetic foot ulcers.
Excellarate is a DNA-based topical gel for administration once or twice to stimulate wound healing.

The Matrix study (GAM501 for the Treatment of Diabetic Ulcers in the Lower Extremities), a randomised, double-blind, placebo-controlled, comparator arm clinical trial 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 present 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 standardised 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.

'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,' stated Christopher J Reinhard, chairman and chief executive officer of Cardium.

The Excellarate topical gel employs TRC's Gene Activated Matrix technology and is designed to provide localised and sustained cellular release of platelet-derived growth factor-BB protein (PDGF-BB). Sustained delivery of PDGF-BB directly at the wound site is believed to stimulate angiogenesis and granulation tissue formation through the recruitment and proliferation of cells such as monocytes, fibroblasts and endothelial cells, which are necessary for the stimulation of a variety of wound healing processes. A previous Phase 1/2 clinical trial showed that Excellarate appeared to be safe and well-tolerated and resulted in a high rate of complete wound closure.
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