Wound Repair and Regeneration publishes positive findings from CXM's Matrix Phase 2b clinical study

Mar 9 2011

Cardium Therapeutics (NYSE Amex: CXM) today announced the publication of positive findings from the Company's Matrix Phase 2b clinical study.  The clinical paper titled, "Formulated Collagen Gel Accelerates Healing Rate Immediately after Application in Patients with Diabetic Neuropathic Foot Ulcers," to be published in Wound Repair and Regeneration, an official journal of the Wound Healing Society, is now available online at http://dx.doi.org/10.1111/j.1524-475X.2011.00669.x.

Findings of the Excellagen Matrix 2b Clinical Study

Cardium's highly-refined collagen-based topical gel wound care dressing (Excellagen™ 2.6% collagen formulation) was evaluated in the controlled, double-blind randomized Matrix Phase 2b clinical study for the treatment of chronic non-healing diabetic lower extremity ulcers.  Analysis of the data found Excellagen to be safe and well tolerated, demonstrated improved wound area reductions and wound closure incidences at 12 weeks following only one or two treatments, and showed a statistically significant acceleration of wound healing during the first week following a one-time application compared to patients receiving standard of care therapy.  In the first week following treatment, the radius of Excellagen-treated wounds decreased on average by 0.20 cm compared to 0.08 cm for standard of care-treated wounds (p<0.05).  

From the perspective of planned commercialization, the data were especially encouraging in that the observed treatment effect was particularly evident in patients with larger-sized wounds (>3.0 cm(2)), which are often very difficult to treat and can ultimately lead to amputations. For example, at 12 weeks, 45% of all Excellagen-treated wounds achieved complete closure, compared to 31% in the standard of care group, representing a 45% overall improvement.  Based on safety data and the immediate acceleration of healing, the authors suggest that more frequent applications of Cardium's Excellagen product candidate hold promise to significantly improve overall incidence of complete wound closure.

"The publication of these positive clinical findings from the Excellagen Matrix 2b clinical study together with recently announced preclinical research demonstrating that Excellagen activates platelets and release of platelet-derived growth factor (PDGF), which plays a critical role in the wound healing process, provide us insight into the significant and rapid healing response to Excellagen.  The Company and the researchers believe that multiple treatments of Excellagen over a 12-week treatment period may provide an opportunity to sustain accelerated healing rates and enhance the wound management process for patients suffering with non-healing chronic diabetic foot ulcers.  We look forward to the commercial market launch of Excellagen, upon clearance by the FDA of our pending 510(k) application, and to the development of new product extensions based on our custom formulated collagen platform," stated Christopher J. Reinhard, Cardium's Chairman and Chief Executive Officer.

SOURCE Cardium Therapeutics