Lausanne, Switzerland; February 24, 2016 — Stemedica International, SA, a Stemedica Cell Technologies, Inc., a subsidiary and leader in the development of innovative stem cell-based treatments for Alzheimer’s Disease announced today that it has received IRB approval from Emory University in Atlanta, Georgia to initiate a clinical study entitled, “A Phase IIa Multicenter, Randomized, Single-Blind, Placebo-Controlled, Crossover Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Human Mesenchymal Stem Cells in Subjects with Mild to Moderate Dementia Due to Alzheimer’s Disease.”
This study will enroll approximately 40 subjects diagnosed with mild to moderate dementia at least three months prior to enrollment, based on the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer’s criteria.
“We are very excited to take this next step in our clinical plan to develop a treatment for this devastating disease,” says Nikolai Tankovich, M.D., Ph.D., President and Chief Medical Officer of Stemedica Cell Technologies and Executive Chairman for Stemedica International “Patients will be treated at Emory and additional trial sites to be announced.”
About Stemedica International S.A.
Stemedica International S.A. is a biotechnology company that develops therapeutic applications for the treatment and prevention of Alzheimer’s disease and vascular dementia. The company is a subsidiary of Stemedica Cell Technologies, Inc., a global biotechnology company that manufactures adult allogeneic stem cells. Stemedica International has the worldwide rights to manufacture and distribute the parent company’s allogeneic, ischemia-tolerant mesenchymal stem cell (itMSC) and ischemia-tolerant neural stem cell (itNSC) lines and stem cell factors for Alzheimer’s disease and vascular dementia indications. The company also has Swissmedic licenses to import, export and distribute Stemedica Cell Technologies’ cell lines worldwide for human use in approved clinical trials. Manufactured in compliance with cGMP standards, the stem cell lines have a unique, proprietary technology based on the expansion of cells in constant hypoxia, which provides critical benefits in terms of safety, efficacy and scalability. For more information, visit www.stemedica-intl.com.
About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a specialty biopharmaceutical company that manufactures best-in-class, allogeneic, adult stem cells and stem cell-derived factors. The company is a government-licensed manufacturer of cGMP, clinical-grade stem cells currently used in clinical trials in the United States under FDA Investigational New Drug (IND) approval for chronic heart failure, cutaneous photoaging, ischemic stroke and Alzheimer’s disease. Stemedica’s products are also used by research institutions and hospitals outside of US under the auspices of international regulatory authorities for pre-clinical and clinical (human) trials. Stemedica is developing clinical trials for other indications using its adult, allogeneic stem cells. The company has headquarters in San Diego, California, and can be found online at www.stemedica.com.
Forward Looking Statements
This press release may contain forward-looking statements. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance and you are cautioned not to place undue reliance on these forward-looking statements. These statements reflect the views of Stemedica as of the date of this press release with respect to future events and, except as required by law, it undertakes no obligation to update or revise publicly any forward looking statements, whether as a result of new information, future events or otherwise after the date of this press release.
Media and Business Contact
David Cheatham
Stemedica International S.A.
+41 (0)78 794 7232
dcheatham@stemedica.com
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