Cardium Reports Positive Data From Matrix Phase 2b Study of Excellarate(TM) Topical Gel for Non-Healing Diabetic Foot Ulcers and Plans for Phase...(which led to exclusions before study com...),Health

Date:10/14/2009

which led to exclusions before study completion and unblinding). The Matrix study evaluated safety as assessed by adverse events, clinical laboratory measurements, vital signs, concomitant medications, physical exam findings and serum antibody concentrations to collagen and adenovector. Preliminary measures of efficacy included the incidence of complete wound closure by 12 weeks and the effect of Excellarate on healing rates as measured by the change of the ulcer radius during the 4-week period following Excellarate treatment. In addition, patients whose wounds were successfully closed are being followed for up to three additional months to further evaluate wound healing durability. Durability results will be reported at a later date.

Excellarate appeared to be both safe and well tolerated in human patients with diabetic neuropathy. There were no substantial differences observed with respect to adverse events, clinical laboratory results, physical exam findings or immunological antibody responses to collagen or the adenovector in patients receiving either one or two doses of Excellarate or collagen matrix, as compared to each other or to standard of care.

Collagen, an FDA approved medical device, is an important and required element of the Company's Gene Activated Matrix technology and was also included as a key comparator group in the Phase 2b study, as an independent collagen-only treatment arm. Based on preclinical animal data suggesting that collagen would not contribute substantially to wound healing, the study was expected to demonstrate that collagen administration would be equivalent to standard of care, and that these groups would collectively form a control group. However, based on a preliminary review of the top line data, collagen appears to contribute to the healing response in human diabetic patients. While the standard of care (SOC) control group in the Phase 2b study was too small to support statistical differentiation o
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SOURCE Cardium Therapeutics Copyright©2009 PR Newswire. All rights reserved

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