Stemedica Cell Technologies today announced positive results from its Phase I/IIa clinical study for the treatment of ischemic stroke, and plans to begin a Phase IIb trial, after the expected meeting with the FDA in the first half of 2019.
A San Diego clinical-stage biopharmaceutical company developing allogeneic progenitor cell and protein therapeutics for use in treating underserved medical conditions, said in a statemend on Monday that, in a multi-center, open-label Phase I/IIa study, ischemic tolerant mesenchymal stem cells (itMSCs) achieved safety, tolerability, and preliminary efficacy objectives.
Craig Carlson, Chief Executive Officer of Stemedica reminds that about 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. He noted that 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,” he said in the statement.
“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.
Nikolai Tankovich, M.D., Ph.D., President and Chief Medical Officer of Stemedica added: “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. 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.”
Stemedica plans to begin a Phase IIb trial, after the expected meeting with the FDA in the first half of 2019.