October 15, 2009
Phase 1/2 study of Excellarate for the treatment of non-healing diabetic foot ulcersCardium 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.
For more information call (858) 436-1000 or visit www.cardiumthx.com.