Cardium Reports Positive Data From Matrix Phase 2b Study of Excellarate(TM) Topical Gel for Non-Healing Diabetic Foot Ulcers and Plans for Phase...(to nor did it differentiate between the ...),Health

Date:10/14/2009

to nor did it differentiate between the relative contributions of the individual Ad5PDGF-B and collagen components that make up Excellarate -- both the Excellarate and the collagen matrix study arms showed substantial improvements in achieving wound closure as compared to standard of care. The standard of care (SOC) arm is the accepted control based on FDA guidance for wound healing products, and is expected to be used as the control arm in a planned Phase 3 program for product registration.

The Company's customized collagen matrix is a modified form of collagen that includes certain structural stabilizers and hydrolytic enzyme inhibitors. Based on observations from the Phase 2b clinical study, it appears that this collagen formulation which is referred to as Excellagen(TM), may play an active role in promoting wound healing, particularly when used in combination with standard of care (including surgical debridement).

It is believed that the collagen matrix supports the body's inherent processes of wound repair by providing a molecular scaffolding within the wound bed to promote the infiltration and proliferation of cells associated with tissue repair such as monocytes, fibroblasts and endothelial cells. Surgical debridement, a process of removing dead or damaged tissue in and around the wound site, forms a key part of standard of care and is known to promote wound healing. Regular debridement was practiced in all patients in the Phase 2b clinical study and is believed to account for a substantial portion of the wound healing response observed in the SOC group. The data from this Phase 2b and prior studies suggest that collagen may further support the wound healing process in humans and that PDGF-B, which is a growth factor known to stimulate a variety of wound repair cells, may provide an additional biologic stimulus.

Based on these data, the Company believes that its collagen matrix may prove to be very beneficial as an adj
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SOURCE Cardium Therapeutics Copyright©2009 PR Newswire. All rights reserved

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