San Diego, California, January 27, 2016
Stemedica Cell Technologies, Inc. announced completion of enrollment into "A Phase I/IIa, Multi-Center, Open-Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects with Ischemic Stroke." This study focused on patients who were at least six months post-stroke with significant functional or neurologic impairment (defined as confined to a wheelchair or required to have home nursing care or assistance with the general activities of daily living). In addition, inclusion criteria specified that patients have no substantial improvement in neurologic or functional deficits for the two months prior to enrollment in the study.
The primary goal of this study is to evaluate the safety and tolerability of Stemedica's ischemia-tolerant allogeneic mesenchymal bone marrow cells (itMBMC) administered intravenously. Patient status is assessed at specified time points over a period of 12 months using the following assessment scales: National Institutes of Health Stroke Scale (NIHSS), Mini Mental Status Exam (MMSE), Barthel Index (BI) and The Geriatric Depression Scale (GDS). This study was conducted at three clinical sites: the University of California, San Diego; Mercy Gilbert Medical Center, Arizona; and University of California, Irvine.
Phase I of this trial was a dose-escalation study evaluating three doses of stem cells, with five subjects per dose receiving itMBMC based on weight: 0.5, 1.0 and 1.5 million mesenchymal cells per kilogram body weight. At the completion of the treatment of each dose cohort, a safety review was conducted by a Data Safety Monitoring Board (DSMB) prior to treatment at the next dose level. Fifteen patients were treated in Phase I of this study and the DSMB unanimously recommended continuing the study into Phase IIa. An additional 21 patients were treated at a dose of 1.5 million cells per kilogram body weight.
Of the 36 patients treated in this study, 14 patients have already completed a 12 month follow-up. Only one mild adverse event was attributed to the investigational product. There were no serious adverse events or deaths in the study attributed to the product. No clinically-significant changes in laboratory or imaging results were reported. Although the cells are allogeneic (not the patient's own cells but from a healthy donor), the laboratory findings did not indicate an immune response and no immunosuppressive drugs were used in the clinical study.
The majority of patients experienced improvement of their conditions in comparison to the baselines as assessed by the NIHSS, MSE, BI and GDS scales.
"These findings represent a significant milestone in the clinical development of Stemedica's ischemia-tolerant allogeneic mesenchymal bone marrow cells for the treatment of the chronic phase of stroke," said Lev Verkh, Ph.D., Chief Regulatory and Clinical Development Officer of Stemedica. He continued, "We observe the same clean safety profile of our product in other ongoing clinical trials in patients with chronic heart failure and in patients with photoaged skin. Stemedica is planning to present its stroke data to the FDA for a fast-track designation."
"Stem cells have the potential to be a valuable addition to current stroke treatments," said Nikolai Tankovich, M.D., Ph.D., President and Chief Medical Officer of Stemedica. "We are happy with the continued progress of Stemedica's Phase I/IIa ischemic stroke trial and are making plans for a Phase IIb study."
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 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.
Forward Looking Statements
This press release may contain forward-looking statements regarding the business strategy of Stemedica Cell Technologies, Inc. and its subsidiaries ("Stemedica"), including statements regarding Stemedica's future clinical studies and planned regulatory activities. These statements relate to future events and involve known and unknown risks, uncertainties and other factors that could cause actual levels of activity or performance to differ materially from those expressed or implied by 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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