Represents First Allowed IP Claims in Stroke Indication
GAITHERSBURG, Md., April 3, 2014 (GLOBE NEWSWIRE) — Cytomedix, Inc. (CMXI), a leading developer of biologically active regenerative therapies, and its wholly owned subsidiary, Aldagen, Inc., announced today the receipt of a notice of allowance for U.S. divisional patent application 12/966,401 with claims covering methods of use of ALDH bright cells in the treatment of neurological damage arising from an ischemic stroke.
The divisional application under the title Stem Cell Populations and Methods of Use was filed in December 2010. When issued upon the payment of applicable fees, the patent covering such methods will be an Aldagen and bright cell related patent that specifically covers an ischemic stroke indication. More specifically, the claims set covers methods of using a cell population of ALDH bright cells to ameliorate neural damage or degeneration while promoting neural cell regrowth. In addition to this allowed patent, Cytomedix’s wholly owned subsidiary, Aldagen, presently owns or has licenses to six issued U.S. patents and six issued and one allowed patent in international jurisdictions covering methods of isolating bright cells, chemical composition of the reagent used in isolating bright cells and the composition of the bright cell population.
Martin Rosendale, Chief Executive Officer of Cytomedix, commented, “The USPTO allowance for this patent in a stroke indication is a positive development as we await top line data from the RECOVER Stroke study expected next month. We anticipate initial safety and efficacy data will be available in May and the monitoring and final data collection activities are proceeding as expected. Strong intellectual property protection is a critical component in all clinical development efforts and we believe the Aldagen IP estate is a valuable asset that can be exploited if the biological and therapeutic potential of the bright cell technology demonstrates clinically meaningful benefits.”
About ALDH Bright Cells
ALDH Bright Cells are a population of autologous stem cells isolated from the patient’s bone marrow using Cytomedix’ proprietary Bright Cell technology. These adult stem cells express high levels of the intracellular enzyme aldehyde dehydrogenase (ALDH), an indicator of biological activity in heterogeneous early stage stem cells. Preclinical research suggests that ALDH Bright Cells may promote the repair of ischemic tissue damage by producing signaling molecules that are involved in cell homing, angiogenesis and neurogenesis. ALD-401 has shown improvements in motor function, in mitigation of the decrease in brain volume, the reversal of decline in stroke-induced cell viability, and improved blood flow in the brain in ischemic stroke animal models.
The RECOVER Stroke Trial is a double-blind, multi-center, placebo-controlled trial designed to assess the safety and efficacy of ALD-401 to improve clinical outcomes in patients with unilateral, cerebral ischemic stroke with an NIH (National Institute of Health) stroke scale score of less than 22 when administered between 13 and 19 days post the ischemic event. The primary endpoint of the study is safety and the primary efficacy endpoint is neural function based on the modified Rankin Scale assessed at three months following treatment. Strokes remain one of the leading causes of long-term disability. With the majority of strokes occurring in patients 65 years and older, it is also a major financial burden for our healthcare system.
About Cytomedix
Cytomedix, Inc. is an autologous regenerative therapies company commercializing innovative platelet technologies for wound care. The Company markets the AutoloGel(TM) System, a device for the production of autologous platelet rich plasma (“PRP”) gel for use on a variety of exuding wounds. For additional information please visit cytomedix.com.