Cardium Therapeutics announced positive findings from a Phase 1/2 clinical study of Excellarate (GAM501, Ad5PDGF-B / 2.6% collagen) for the treatment of non-healing diabetic foot ulcers. This multicenter, open-label, dose-escalation study was conducted in 15 patients with chronic non-healing foot ulcers who received either a single dose of Excellarate or up to four administrations of Excellarate at one-week intervals and were then evaluated for up to seven months.
Ten of the 15 patients (67%) achieved ulcer closure, with two additional patients achieving at least a 50–99% decrease in ulcer area. Onset of response was rapid with 7 of 15 (47%) patients achieving a 50–99% decrease in ulcer area by week 2, and 9 of 15 (60%) patients achieving a 50–99% decrease in ulcer area by week 6. Overall, most of the patients (93%) had a positive response, as assessed by decreases in ulcer size.
Excellarate is a collagen-based topical gel that utilizes Cardium’s Gene Activated Matrix technology to locally stimulate the release of platelet-derived growth factor-B protein (PDGF-B) and provide a matrix for cell migration. Sustained localized production of PDGF-B by a patient’s own cells directly in 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.
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