GAITHERSBURG, MD--(Marketwire -07/18/12)- Cytomedix, Inc. (CMXI) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announces the initiation of a Phase I clinical study with ALD-451 in brain cancer patients in collaboration with Duke University Medical Center. The open-label study will enroll up to 12 patients and is intended to demonstrate the feasibility and safety of ALD-451 when administered intravenously in World Health Organization ("WHO") grade IV malignant glioma patients following surgery, radiation therapy and treatment with temozolomide. The trial also will obtain an initial description of the effects of ALD-451 on neuro-cognition. The clinical study is open for enrollment having received Investigational New Drug clearance from the U.S. Food and Drug Administration and Investigational Review Board clearance from Duke University Medical Center(ClinicalTrials.gov Identifier: NCT01639612). The study's principal investigator is Dr. Annick Desjardins, Assistant Professor of Medicine at The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center. Co-investigators are Dr. Henry S. Friedman, Deputy Director, The Preston Robert Tisch Brain Tumor Center and Dr. Joanne Kurtzberg, Chief Scientific Officer and Medical Director, Robertson Clinical & Translational Cell Therapy Program. Cytomedix will be responsible for manufacturing ALD-451 for the clinical trial. … Continue reading
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