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. 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.
About ALD-451ALD-451 is the population of autologous pluri-potent ALDHbr stem cells isolated from the patients' bone marrow using Cytomedix' proprietary technology. These adult stem cells express high levels of the enzyme ALDH, an indicator of biological activity in heterogenous early stage stem cells. Preclinical research with ALD-451 bright cells suggests that they may promote the repair of tissue damage. Recently, preliminary data presented at the 2012 International Society of Cell Therapy showed that ALDHbr bright cells reduced severity of intracranial inflammation after brain irradiation in an animal model. Investigators have also completed preclinical research that showed improvements in motor function, improvements in the slowing of decrease in brain volume, the reversal of decline in stroke-induced cell viability and improved blood flow, or perfusion, in the brain.
About Cytomedix, Inc. Cytomedix, Inc. is an autologous regenerative therapies company commercializing innovative platelet technologies for orthopedics and wound care with a pipeline of adult stem cell therapies for tissue repair. The Company markets the AutoloGel System, a device for the production of autologous platelet rich plasma ("PRP") gel for use on a variety of exuding wounds and the Angel Whole Blood Separation System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma ("PPP") and PRP in surgical settings. On February 8, 2012 Cytomedix closed the acquisition of Aldagen, a biopharmaceutical company developing regenerative cell therapies based on its proprietary ALDH bright cell ("ALDHbr") technology, currently in a Phase 2 trial for the treatment of ischemic stroke. For additional information please visit http://www.cytomedix.com
Safe Harbor StatementStatements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including among many others, risks and uncertainties related to the Company's ability to successfully integrate the Aldagen acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes," "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2011 and other subsequent filings. These filings are available at http://www.sec.gov.
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Cytomedix Announces Collaboration With Duke University on Phase I Clinical Study of ALD-451 in Malignant Glioma