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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

SAN DIEGO, Oct. 14 /PRNewswire-FirstCall/ -- 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).

(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO)

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
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SOURCE Cardium Therapeutics
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1. Cardium Announces Commercial Development of Excellagen(TM) a Customized Collagen-Based Topical Gel for Initial Use as an Adjunct to Surgical Debridement in Patients With Diabetic Foot Ulcers
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