PETACH TIKVA, Israel, Dec. 11, 2014 (GLOBE NEWSWIRE) -- Macrocure Ltd. (Nasdaq:MCUR), a clinical-stage biopharmaceutical company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, today announced that it has completed its mechanism of action ("MOA") study. The objective of the study was to define the molecular and cellular mechanisms of CureXcell, the Company's lead product candidate for the treatment of chronic and hard-to-heal wounds.
"Our comprehensive approach to this study included an assessment of cytokines, chemokines, and regenerative factors present in CureXcell, and the product's effect on angiogenesis and tissue regeneration. From a clinical perspective, these effects can influence the quality of repaired tissue and play a significant role in improving patient outcomes," stated Nissim Mashiach, President and Chief Executive Officer of Macrocure. "We believe that by evaluating the underlying science and MOA of CureXcell, we will gain a better understanding of the outcome of our two ongoing pivotal, Phase III clinical studies. In addition, we intend to utilize the results of the MOA study in several ways, including supporting the regulatory and reimbursement pathway for CureXcell and its market acceptance upon approval and commercialization and by broadening the application of our technology by building a platform of product candidates that extends beyond wound care," concluded Mr. Mashiach.
Macrocure will disclose the MOA study results at an upcoming Analyst and Investor Day in the first quarter of 2015.
Mechanism of Action Study Design
The MOA study was designed using splinted full-thickness dermal wound model in athymic rats. The study evaluated CureXcell's effect on wound closure, granulation tissue thickness, tissue maturation and angiogenesis throughout different phases of wound healing.
About Macrocure Ltd.
Founded in 2008, Macrocure Ltd. is a clinical-stage biotechnology company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, such as DFUs and VLUs. The Company's novel approach is to treat and close chronic and other hard-to-heal wounds by injecting the human body's own wound healing and regenerative components directly into the wound itself. For more information, please visit www.Macrocure.com.
About CureXcell
Macrocure's lead product candidate, CureXcell, is a unique combination of living human white blood cells that have been activated to facilitate the healing process and stimulate wound closure. CureXcell addresses each phase of healing in the impaired wound, including the production of growth factors and other biochemical factors involved in fibroblast activation, cell migration and extracellular matrix production, stimulating the body's natural healing process. CureXcell is currently in two pivotal, Phase III, double-blind clinical trials targeting a broad indication for the treatment of all types of wounds below the knee. For more information, please visit: www.macrocure.com.
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the US Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions and results related to financial results forecasts, commercial results, clinical trials and regulatory authorizations. Forward-looking statements are based on Macrocure's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, unexpected results of clinical trials, delays or denial in regulatory approval process or additional competition in the market. The forward-looking statements made herein speak only as of the date of this release and Macrocure undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.