Cardium Reports Positive Data From Matrix Phase 2b Study of Excellarate(TM) Topical Gel for Non-Healing Diabetic Foot Ulcers and Plans for Phase...(unct to existing wound care therapies su...),Health

Date:10/14/2009

unct to existing wound care therapies, such as debridement. Since collagen has been approved by the FDA as a medical device, Cardium intends to a develop a registration pathway for its collagen to be used in conjunction with debridement, which is typically applied as standard of care for all diabetic foot ulcers and many other types of soft tissue wounds. As announced today, the Company plans to advance this collagen-based product termed Excellagen(TM) along an abbreviated 510(k) registration process in consultation with the FDA.

Following completion of safety and preliminary efficacy data, the Company also plans to schedule a meeting with the FDA to review the complete integrated data set and outline plans for a Phase 3 clinical study program designed to confirm the safety and effectiveness of Excellarate as compared to standard of care, since PDGF-B is known to contribute to the biologic process of wound healing and is itself an approved protein product for use in advanced wound care. The Company believes that the combination of collagen and PDGF-B as provided by the Excellarate product candidate holds the potential to further promote wound healing in non-healing diabetic foot ulcers and other difficult-to-treat wounds. Based on feedback from study investigators, and with the additional positive safety data from the Phase 2b study, the Phase 3 program is also expected to allow for one or two follow-up doses in patients that exhibit a slower healing rate or who have not yet achieved substantial closure following the initial administration of product.

Regranex® (becaplermin, 0.01%) is a PDGF-B protein therapy that is currently the only FDA-approved advanced care biologic for the treatment of patients with lower extremity neuropathic diabetic foot ulcers. PDGF-B protein-based therapy is a daily use prescription medication for treatment for up to 20 weeks, which would require up to 140 daily administrations of product and an additional
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SOURCE Cardium Therapeutics Copyright©2009 PR Newswire. All rights reserved

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