SAN DIEGO, Aug. 25 /PRNewswire-FirstCall/ -- Cardium Therapeutics 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.
Observational Safety and Efficacy Insights
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.
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.
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: (1) improve patient compliance, based on a one- or two-treatment regimen, and (2) 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.
Excellarate is a collagen-based topical gel employing TRC’s Gene Activated Matrix(TM) that is designed to locally stimulate the release of platelet-derived growth factor-B protein (PDGF-B), an important key in the human body’s wound healing process. Sustained, localized micro-release of PDGF-B by a patient’s own cells directly at the wound site is believed to stimulate angiogenesis and granulation tissue formation through the recruitment and proliferation of cells such as monocytes, fibroblasts and endothelial cells. These cell types are critical for the effective stimulation of a variety of wound healing processes.
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Forward-Looking Statements
Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development of complex biologics and in the conduct of human clinical trials, including the timing, costs and outcomes of such trials, our ability to obtain necessary funding, regulatory approvals and expected qualifications, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
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