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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

140 daily wound cleansings by patients. Based on published studies reflected in the prescribing information sheet for becaplermin, daily application of product combined with daily wound cleansings resulted in a 35% relative improvement in wound closures at 20 weeks (i.e. a 50% wound closure rate for becaplermin-treated patients compared to a 37% wound closure rate for control patients). Based on additional published data from these studies, by 12 weeks (as in the shorter Excellarate study period), the wound closure rate was about 34% for becaplermin-treated patients as compared to a 25% complete closure rate for control patients, representing a 36% relative improvement in wound closure.

In contrast to becaplermin, the Excellarate product candidate is designed to stimulate a physiologic level of sustained and locally-confined PDGF-B protein by cells at the wound site. It is estimated from preclinical analyses that following a single Excellarate administration the localized cellular expression of PDGF-B would be about 55 nanograms, which is on the order of 60,000-fold lower than the approximately 3.0 million nanograms of PDGF-B protein that would be topically applied by patients over a 20-week treatment course with becaplermin. Also, unlike becaplermin, the PDGF-B protein encoded by Excellarate is a naturally-occurring version of the protein that retains its native extracellular matrix-binding domain, which further promotes retention of the growth factor within the wound site.

"The completion of the Matrix Phase 2b clinical study represents a major advance in our plans to establish an important new therapeutic class of biologics for the potential treatment of diabetic foot ulcers and other wounds. Despite years of research and effort, diabetic wounds remain a serious unmet clinical need. Lower limb amputations occur up to 30 times more often in diabetic patients, and the resulting mortality rates for these patients can be similar to or wor
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SOURCE Cardium Therapeutics
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