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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

ost=http%3A%2F%2Fpowerlink%2Epowerstream%2Enet&w=349&h=400&clip=1&contID=MatrixTrial&bypass=">click here to view a television segment featuring an investigator in the study, Dr. Peter A. Blume of the Yale University School of Medicine, and click here to view a segment featuring Dr. Barbara Aung of the Aung Foothealth Clinics, and their patients enrolled in the Matrix clinical study. The Matrix study media segments can also be accessed at www.cardiumthx.com.

Matrix Phase 2b Clinical Study

The Matrix Phase 2b clinical study was a multi-center U.S.-based study designed to evaluate Excellarate for the potential treatment of non-healing diabetic foot ulcers. Enrollment in the study was 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. The study, which was conducted at 20 medical centers, evaluated patients that were treated with the gene-activated Excellarate product candidate (Ad5PDGF-B / 2.6% collagen) or the collagen matrix component of Excellarate, compared to patients who received only standard of care treatment without any applied Ad5PDGF-B or collagen. A per protocol data analysis included 113 patients with lower extremity neuropathic ulcers that were chronically non-healing despite receiving standard of care. Eleven additional patients who were initially recruited into the trial were excluded (7 patients were lost to evaluation or had a disqualifying surgical procedure and 4 were determined to have been mis-enrolled based on prespecified enrollment criteria,
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