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Cardium Reports Positive Data From Matrix Phase 2b Study of Excellarate(TM) Topical Gel for Non-Healing Diabetic Foot Ulcers and Plans for Phase 3 Program
Date:10/14/2009

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.

The collagen matrix, which forms an integral component of Excellarate (by promoting Ad5PDGF-B binding and PDGF-B protein retention within the wound site), had not been associated with substantial wound healing responses in preclinical animal models used for design of the clinical studies. In human diabetic patients, however, the collagen matrix appeared to contribute substantially to wound healing responses. As a result, the collagen arm was not a negative control as expected based on preclinical studies. While the clinical study was not powered
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SOURCE Cardium Therapeutics
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