GAITHERSBURG, MD -- (Marketwire) -- 07/18/12 -- Cytomedix, Inc. (OTCBB: 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. Duke University Medical Center, through the Robertson Clinical & Translational Cell Therapy Program, will fund the trial and be responsible for all other aspects of the study.
"We are excited to initiate patient recruitment in this study and to explore the use of this cellular therapy to treat the neuro-cognitive side effects of treating these devastating cancers," said Dr. Desjardins.
Martin P. Rosendale, Chief Executive Officer of Cytomedix, stated, "We are delighted to be working on this important trial with leading clinicians at Duke University Medical Center, one of the world's leading brain cancer centers for both treatment and research. Malignant glioma patients who undergo surgery, radiation therapy and temozolomide treatment oftentimes experience deterioration of neuro-cognition and have poor patient-reported outcomes. Earlier studies suggest that ALDH bright cells may repair neural brain damage. We expect this study to corroborate those results and look forward to advancing the development of this very promising product candidate."
About Malignant Glioma
Primary central nervous system ("CNS") tumors represent about 1.35% of all cancers and 2.2% of all cancer-related deaths. Glial neoplasms represent about 40% of all primary CNS tumors and about 75% are malignant. Malignant gliomas include WHO grade III: anaplastic astrocytoma, anaplastic oligodendroglioma and anaplastic oligoastrocytoma, and WHO grade IV: glioblastoma and gliosarcoma. Because of their extensive infiltrative and invasive nature, malignant gliomas present unique challenges. This infiltrative nature, combined with their proximity to critical intracranial structures as well as operative difficulty distinguishing between normal and neoplastic cells, significantly reduces the efficacy of surgical resection. Radiation therapy and systemic chemotherapy are necessary adjuncts to treatment. Children and adults who receive radiation therapy involving the brain frequently experience a progressive cognitive decline, significantly affecting their quality of life.
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