FDA Grants IND Approval for Phase IIa Clinical Trial Using …

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SAN DIEGO and Epalinges, Switzerland June 9, 2015 Stemedica Cell Technologies, Inc. received the FDAs investigational new drug (IND) approval for a United States-based, Phase IIa clinical study using its allogeneic stem-cell therapy to treat subjects with mild to moderate dementia due to Alzheimers disease (AD), the sixth leading cause of death in the United States. The study is sponsored by Stemedica International, S.A. and will start at the University of California, San Diego (UCSD) under Principle Investigator Douglas Galasko, M.D. and expand to other sites. Stemedica International will provide management and financial support for this clinical trial. The clinical trial is titled "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 was approved based on the excellent safety profile of Stemedicas cGMP-manufactured, hypoxically-grown stem cells and on solid pre-clinical data obtained by Stemedica International in cooperation with the cole Polytechnique Fdrale de Lausanne of Switzerland and with a grant from the Swiss government, said Lev Verkh, Ph.D. Stemedicas Chief Regulatory & Clinical Development Officer. He continued We are very proud of Stemedicas clinical program under U.S. INDs for several indications including ischemic stroke, acute myocardial infarction, chronic heart failure, cutaneous photoaging and Alzheimers disease. At the studys conclusion we will understand if our approach is efficacious versus placebo in subjects with Alzheimers-related dementia, as evidenced by neurologic, functional, and psychiatric endpoints.

Stemedicas bone marrow-derived, allogeneic itMSCs are unique because they are grown under hypoxic conditions that more closely resemble the environment in which they live in the body. Compared to other MSCs, itMSCs secrete higher levels of growth factors usually associated with angiogenesis and healing. Stemedica Internationals AD stem cell therapies feature itMSCs, neural stem cells (NSCs) and stem cell factors, which are described in Stemedica Internationals U.S. Patent application #20140286910.

Promising results were achieved during a three-year, intensive, pre-clinical research project supported by a grant from the Swiss Commission for Technology and Innovation (CTI). The research was conducted at the Laboratoire dOptique Biomedicale headed by Professor Theo Lasser at cole Polytechnique Fdrale de Lausanne (EPFL) in Switzerland.

Stemedica Internationals pre-clinical research was led by Chief Scientist Tristan Bolmont, Ph.D. To evaluate the impact of an intravenous delivery of human mesenchymal stem cells on amyloid pathology, the well-established APPPS1 transgenic mouse model of Alzheimers disease was used. Intravenous delivery of itMSC safely reduced cerebral Abeta pathology in APPPS1 animals analyzed one week after the last injection. Both aged and young APPPS1 mice exhibited significantly decreased Abeta amyloidosis following the itMSC treatments. Concomitantly, microglial activation was diminished in aged and young itMSC-treated APPPS1 mice. No increase of vascular amyloid or manifestation of microhemorrhages was observed following the repeated intravenous itMSC delivery. Biodistribution analysis revealed that intravenously delivered itMSC migrate to the brain and could be detected in this organ with the highest value at one hour post-delivery, decreasing after one day and subsequently dropping below detection level at one week after the injection.

According to Alzheimers Disease International, nearly 44 million people have Alzheimers or a related dementia. Alzheimers and dementia are most common in Western Europe followed closely by North America. The global cost of Alzheimers and dementia is estimated to be $605 billion USD, which is close to 1% of the worlds gross domestic product.

We are very excited to take this next step in developing 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 Our upcoming Phase IIa clinical trial will enable us to make progress towards determining if our stem cell treatment may be able to halt or slow down the progression of Alzheimer's disease and other forms of dementia.

About Stemedica Cell Technologies, Inc. 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 and Alzheimers disease. Stemedicas 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 http://www.stemedica.com.

About Stemedica International S.A. Founded in Epalinges, Switzerland, in 2008, Stemedica International S.A. is a global biotechnology company that develops therapeutic applications for the treatment and prevention of Alzheimers 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 an exclusive license to manufacture and distribute the parent companys allogeneic, ischemia-tolerant mesenchymal stem cell (itMSC) and ischemia-tolerant neural stem cell (itNSC) lines and stem cell factors for Alzheimers 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 http://www.stemedica-intl.com

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