- Results of the study are supportive of advancing clinical program -
- Plans are underway to conduct Phase IIb trial following consultation with the FDA
SAN DIEGO -- Stemedica Cell Technologies, Inc., a clinical-stage biopharmaceutical company developing allogeneic progenitor cell and protein therapeutics for use in treating underserved medical conditions, today announced positive results from its Phase I/IIa clinical study for the treatment of ischemic stroke.
In a multi-center, open-label Phase I/IIa study, ischemic tolerant mesenchymal stem cells (itMSCs) achieved safety, tolerability, and preliminary efficacy objectives. The data demonstrated that itMSCs administered intravenously appeared to be safe and well tolerated. No serious adverse events or clinically significant changes in lab and imaging measurements were reported. Results of the study are supportive of advancing the clinical program.
"We are excited to move our ischemic stroke program forward," said Craig Carlson, Chief Executive Officer of Stemedica. "Approximately 800,000 people in the U.S. suffer strokes each year and 87% of all strokes are ischemic strokes, costing the U.S. an estimated $34 billion each year in health care services, medicines, and missed days of work.1 There are currently no treatments approved by the FDA to reduce the severity of neurological disabilities resulting from ischemic stroke. Stemedica's itMSCs have the potential to address this significant and unmet need."
"Stemedica's Phase I/IIa clinical results demonstrated product safety as well as preliminary efficacy results indicating potentially significant clinical benefits for patients with ischemic stroke," said Dr. Michael Levy, principal investigator in the study, Chief of Pediatric Neurosurgery at Rady Children's Hospital-San Diego, and Clinical Professor of Surgery at UC San Diego School of Medicine.
"The positive results of this clinical trial give Stemedica important insight into how our hypoxia-induced cGMP-manufactured itMSCs perform within an ischemic environment of stroke brain tissue as it relates to safety and potential efficacy," stated Nikolai Tankovich, M.D., Ph.D., President and Chief Medical Officer of Stemedica. "These results are also interesting in light of the fact that patients enrolled in the study had a minimum post-stroke time of 6 months at baseline with some patients having suffered a stroke more than 20 years prior to treatment."
Following a meeting with the FDA anticipated in the first half of 2019, Stemedica plans to initiate a Phase IIb trial. Detailed safety data and clinical results from the Phase I/IIa study with itMSCs will be published and presented at a future medical conference.
Phase I/IIa Study Design
The Phase I/IIa, multi-center, open-label, two-part study assessed the safety, tolerability, and preliminary efficacy of a single intravenous dose of itMSCs to subjects with ischemic stroke. In the first part of the study, 15 subjects received intravenously one dose of 0.5 million cells per kilogram of itMSCs (n = 5), 1.0 million cells per kilogram of itMSCs (n = 5), or 1.5 million cells per kilogram of itMSCs (n = 5). In the second part of the study, 21 subjects received 1.5 million cells per kilogram of itMSCs. The primary endpoint was the safety of treatment with itMSCs during the twelve-month study period as determined by the incidence and severity of adverse events, clinically-significant changes on clinical laboratory tests, vital signs, physical and neurologic examinations. Additional information about the trial can be found at www.clinicaltrials.gov with Clinical Trial Identifier NCT01297413.
About Ischemic Stroke
Ischemic Stroke is a sudden neurological deficit caused by the occlusion of an artery delivering blood to the brain. When this happens, a part of the brain is deprived of oxygen and nutrients. This deprivation results in a cerebral infarction, which provokes neurological damages that result in severe disabilities or death if it lasts more than several minutes or hours. It is characterized by a quick onset, instantaneously or within minutes, and typically affects one half of the body with hemiplegia and unilateral blindness but also speech impairment.
About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of allogeneic progenitor cell, protein and combination therapeutics for underserved medical conditions. Stemedica has developed a proprietary manufacturing technology platform that produces allogeneic progenitor cell products with intellectual property protection under a low-oxygen, low-tension environment in a cGMP-compliant manufacturing facility. The company's lead drug candidate, itMSCs, is an allogeneic progenitor cell therapy currently in clinical development for the treatment of ischemic stroke and Alzheimer's disease. The company's second drug candidate, ischemia-tolerant neural progenitor cells, or itNSCs, is an allogeneic cell therapy currently in development. In addition, Stemedica is developing progenitor multi-cell therapy (itMSCs and itNSCs) for ischemic stroke, Alzheimer's disease, and central and peripheral neurological diseases. Also in pre-clinical development is combination therapy using progenitor cells and proteins for Alzheimer's disease. More information on Stemedica may be found at www.stemedica.com.
"Stemedica Cell Technologies" and the Stemedica logo are registered trademarks of Stemedica Cell Technologies, Inc.
This press release contains forward-looking statements, including statements related to our business strategy, timeline and other goals and market for our anticipated products, plans and prospects; statements about our ability to obtain regulatory approval; and statements about potential benefits of our drug product candidates and our technologies.
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process; our ability to obtain and maintain regulatory approval of our drug product candidates; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; our ability to successfully commercialize our drug product candidates and the timing of commercialization activities; the rate and degree of market acceptance of our drug product candidates; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. These forward-looking statements speak only as of the date hereof. Stemedica disclaims any obligation to update these forward-looking statements.
1 Benjamin EJ, Blaha MJ, Chiuve SE, et al. on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2017 update: a report from the American Heart Association. Circulation. 2017;135:e229-e445.
Stemedica Cell Technologies, Inc.
Executive Vice President, Strategy and Business Development
Stemedica Cell Technologies, Inc.
Senior Vice President, Corporate Administration and Investor Relations