Wednesday, July 27, 2016
STEMEDICA BEGINS FIRST CLINICAL TRIALS IN THE U.S. USING ADULT ALLOGENEIC STEM CELLS TO TREAT ALZHEIMER’S DISEASE
Initial Sites Are Emory University and University of California, Irvine
San Diego, California, and Lausanne, Switzerland
Stemedica Cell Technologies, Inc. and its subsidiary, Stemedica International S.A., a leader in the development of innovative stem cell-based treatments for Alzheimer’s disease (AD), are pleased to announce the opening of enrollment into a new study at Emory University in Atlanta and University of California, Irvine (UCI). The study is 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.”
The study will enroll approximately 40 subjects diagnosed with mild to moderate dementia due to Alzheimer’s disease (AD) at least 3 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.
“This study is based on exciting preclinical data which demonstrated that intravenous administration of Stemedica stem cells resulted in a delay of accumulation of plaque formation and also in the reduction of plague in an animal Alzheimer’s model. This exciting data has been presented at several international meetings,” says Lev Verkh, PhD, chief regulatory & clinical development officer at Stemedica Cell Technologies. “We are also encouraged by an excellent safety profile of our cells as demonstrated in several ongoing clinical trials conducted by Stemedica and Stemedica affiliates under U.S. Investigational New Drug (IND).”
“As we begin the enrollment process at Emory and UCI, we get closer to reaching our vision for an effective treatment for this devastating disease,” says Nikolai Tankovich, MD, PhD, president and chief medical officer of Stemedica Cell Technologies and executive chairman of Stemedica International.
Ihab Hajjar, MD, associate professor of medicine and neurology at Emory University School of Medicine and an investigator for the Emory Alzheimer’s Disease Research Center, is the Principal Investigator at Emory for this trial. “Since therapeutic options for Alzheimer’s disease are limited, stem cells may offer new ways to manage this illness. This study’s main goal is to demonstrate the safety of using stem cells in AD, and we are pleased to be a site for this Stemedica International trial.”
Aimee Pierce, MD, assistant clinical professor of neurology at UCI and Principal Investigator at UCI for this trial states, “We are constantly looking for new ways to safely treat our patients with Alzheimer’s disease. Our research team looks to build on the prior experience of the phase IIa clinical trial testing allogenic stem cells in ischemic stroke.”
More information about this clinical trial, including enrollment details, can be found at https://clinicaltrials.gov/ct2/show/NCT02833792?term=stemedica&rank=1.
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Stemedica Cell Technologies, Inc. is a global biopharmaceutical company that manufactures best-in-class allogeneic adult stem cells and stem cell factors. The company is a government licensed manufacturer of cGMP, clinical-grade stem cells currently used in US-based clinical trials for acute myocardial infarction, chronic heart failure, cutaneous photoaging, ischemic stroke, traumatic brain injury and Alzheimer’s disease. Stemedica’s products are also used on a worldwide basis by research institutions and hospitals for pre-clinical and clinical (human) trials. Stemedica is currently developing additional clinical trials for other medical indications using adult, allogeneic stems cell under the auspices of the FDA and other international regulatory institutions. The company is headquartered in San Diego, California and can be found online at www.stemedica.com.
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.
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.
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