Cardium Completes Initial Patient Evaluation Period for MATRIX Phase 2b Excellarate Clinical Study
Monday, 24 August 2009 18:32
SAN DIEGO--Cardium Therapeutics (NYSE Amex:CXM) today announced that all patients enrolled in the Company's MATRIX clinical study have now completed their initial 12-week evaluation period and that it plans to provide detailed safety and efficacy data in late September 2009.
The Phase 2b MATRIX clinical trial is a prospective, randomized, double-blind, placebo-controlled study of Excellarate(TM) for the potential treatment of chronic diabetic foot ulcers.The clinical study is designed to evaluate safety and key efficacy measures including complete wound closure, time to complete wound closure, absolute and percent change in ulcer area, and wound healing trajectories at various time points, as well as a wide range of other safety and comparative healing metrics 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 successfully closed are now being followed for three months to further evaluate wound healing durability.
"With the data set now complete for the initial 12-week evaluation period, we look forward to completion of the formal statistical review and analysis and, as previously reported, we expect to announce safety and efficacy data around the end of September," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium Therapeutics."During the course of this landmark gene therapy trial, we have observed some remarkable healing responses, based on a one or two physician-administered treatment protocol, instead of current therapies which require multiple treatments by physicians or patients either on a daily or weekly basis for up to 20 weeks.We look forward to reviewing the MATRIX study's complete data set."(Click here to see selected information from Cardium's May 14, 2009 webcast or visit the Investor section at Cardium's website at www.cardiumthx.com
Observational Safety and Efficacy Insights
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.
With respect to efficacy, while the study remains blinded until all key data are collected and fully analyzed, the Company and investigators are encouraged by several observations related to wound healing in the enrolled patient population.First, a number of study investigators have observed very rapid reductions in ulcer area after initial treatment (whereas the ulcers had not substantially reduced in size during a prior 2-week run-in period that was used to screen all patients entering the study).These findings are similar to what had been observed in the Phase 1/2 study.
In addition, the current blinded pooled data set, which includes patients that received the Excellarate product candidate or standardized therapy (placebo or standard of care) is also encouraging.In particular, based on a comparative review of multiple, well documented protein-based wound healing studies, three key efficacy measures: Wound Closure Incidence (percent of patients achieving complete closure over time), Wound Closure Efficiency (percent reduction in wound size), and Wound Closure Rate (wound closure trajectories over time), all appear to be occurring at rates higher than would be expected for patients receiving only standardized therapy.
If substantial differences in these key efficacy measures are confirmed in the final unblinded data set, we would expect the data to 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.In addition, as discussed recently, we believe that the Gene Activated Matrix (GAM) technology used for Excellarate has the potential to be applied to other types of wound and tissue repair settings, including not only the potential treatment of other soft tissue injuries such as pressure ulcers, but also hard tissue injuries such as those associated with bone fractures and other orthopedic applications.
To learn more about the Excellarate product candidate and the MATRIX clinical study, click here to view a television segment featuring an investigator of the study, Dr. Vickie Driver, D.P.M., Director of Research, Foot Care, Department of Surgery at Boston Medical University and Medical Center, and click here to view a segment featuring Dr. Peter A. Blume, DPM, FACFAS, of the Yale University School of Medicine, and their patients enrolled in the MATRIX study.The MATRIX study media segments can also be accessed at www.cardiumthx.com