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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
Date:10/14/2009

studies for wound repair (as the collagen matrix component of Excellarate). Excellagen is believed to provide a physical and biological substrate conducive to cell migration and proliferation at the wound site, which are believed to be important for promoting robust wound repair responses. In the context of wound healing, the Company believes that its Excellagen formulation has certain advantages over other forms of collagen and may provide an important adjunct to surgical debridement, which is an essential component of standard care for all diabetic foot ulcers. Debridement removes dead or damaged tissue in and around the wound site and is known to promote wound healing. Cardium believes that Excellagen applied to a debrided wound provides a scaffold that can then promote and support the influx of repair cells in the wound bed.

Cardium's Excellarate product candidate comprises not only the collagen matrix but an adenovector encoding PDGF-B protein. PDGF-B is believed to promote wound healing by directly stimulating cells involved in wound repair and also by eliciting the production of other growth factors. Excellarate is being developed to provide advanced wound care for chronic non-healing diabetic foot ulcers, which are difficult to heal with standard of care and are associated with substantial risks of infection or amputation.

The Phase 2b Matrix clinical study was not powered to nor did it differentiate between the relative contributions of the individual Ad5PDGF-B and collagen components that make up Excellarate - but both the Excellarate and the collagen matrix study arms showed substantial improvements in achieving wound closure as compared to standard of care, which is the FDA-accepted control considered appropriate for product registration studies. Approximately 45% of patients receiving the collagen matrix in the Phase 2b study had complete wound closure by 12 weeks, compared to a 31% wound closure rate for the standard of c
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SOURCE Cardium Therapeutics
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