Cardium Therapeutics has revealed that all patients enrolled in the MATRIX clinical study have completed their initial 12-week evaluation period. The company plans to provide detailed safety and efficacy data in late September 2009.
The phase 2b MATRIX clinical trial is a randomised, double-blind, placebo-controlled study of Excellarate, for the potential treatment of chronic diabetic foot ulcers.
The company said that the clinical study is designed to evaluate the safety and key efficacy measures, which will be used to develop a phase 3 clinical study.
In addition, following the initial 12-week efficacy evaluation period, patients whose wounds have closed are now being followed for three months to further evaluate wound healing durability.
The company said that based on a continuing review of safety information, the Excellarate product candidate appears to be both safe and well-tolerated, with no serious adverse events attributed to use of the study product.
Based on a comparative review of multiple, protein-based wound healing studies, three key efficacy measures: Wound Closure Incidence, Wound Closure Efficiency, and Wound Closure Rate, appear to be occurring at rates higher than would be expected for patients receiving only standardised therapy.
The company said that if substantial differences in these key efficacy measures are confirmed in the final unblinded data set, the data could form the basis for a phase 3 study designed to further demonstrate the safety and effectiveness of Excellarate (for the potential treatment of patients with non-healing diabetic ulcers).