Cardium Therapeutics (Cardium), a bio-medical product developer, has completed initial 12-week evaluation period for MATRIX clinical study of Excellarate. The company is anticipating 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 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 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.
Excellarate is an advanced care DNA-based biologic product candidate that is being developed to provide physicians and patients with a potentially simpler and easy to use treatment as compared to current therapies. Based on the positive data from the Phase 1/2 study, the company believes that the Excellarate topical gel provides a unique opportunity to, improve patient compliance, based on a one or two treatment regimen, and enhance acceptance by the medical community due to improved ease of use (as a pre-filled syringe, requiring only standard refrigeration and a 15-18 month shelf life), when compared to other treatment options. With this targeted registration profile, Cardium believes that Excellarate offers the unique potential to become an important new therapeutic class that, in certain cases, may supplant the use of current healing agents and medical devices, and, in other cases, may be used in concert with other agents and current therapies in certain wounds and under various medical conditions within an expanding spectrum of advanced wound care solutions.