Cardium Therapeutics (NYSE Amex: CXM) today reported positive data from its Matrix Phase 2b clinical trial of Excellarate(TM) for the potential treatment of patients with chronic non-healing diabetic foot ulcers based on the Company's Gene Activated Matrix (GAM) technology platform. The study evaluated patients treated with the Excellarate product candidate (GAM501, which is a combination of Ad5PDGF-B and 2.6% collagen) or 2.6% collagen alone (matrix), compared to patients who received only the protocol-specified standard of care without any applied Ad5PDGF-B or collagen matrix. The Company will hold a webcast and conference call to discuss the clinical results of the Excellarate Matrix Phase 2b clinical study today, October 14, 2009, at 5:00 p.m. ET (access information is provided below).
The Excellarate product candidate and its components Ad5PDGF-B and collagen matrix appear to be both safe and well tolerated by patients. The Phase 2b study was abbreviated and enrollment ended early after key efficacy measures among blinded groups were observed at rates substantially higher than those expected for patients receiving only standard of care. Consistent with those observations, the unblinded data set showed a substantial (55%) relative improvement in achieving complete wound closure by 12 weeks (the key efficacy measure for a Phase 3 product registration program) among patients treated with a single dose of Excellarate as compared to patients receiving standard of care. Nearly half of patients (48%) receiving a one-time Excellarate treatment had complete wound closure by 12 weeks, compared to a 31% wound closure rate for standard of care. Among combined one and two dose groups of Excellarate approximately 41% of patients achieved complete closure by 12 weeks. However, since re-dosing was based on group randomization rather than apparent need, a majority of patients randomized to receive a second dose of Excellarate at 4 weeks following initial product administration either did not receive one because their wounds were closed by that point, or they received only a very small second dose (less than 100 microliters) because their wounds were extremely small.
In addition to overall wound closures by 12 weeks, the Phase 2b study also evaluated wound closure rates and trajectories following product administration in order to assess the timing and extent of bioactivity. The unblinded data revealed that patients receiving Excellarate exhibited early and rapid wound healing responses as evidenced by very substantial reductions in wound radius over the first several weeks following product administration, which responses were both greater and faster than those observed among patients that had received standard of care. For example, a 108% relative improvement (decrease in ulcer radius) compared to standard of care was observed over the first week following administration of Excellarate, and a 50% relative improvement was observed as an average over the first four weeks.