Stem Cell Therapeutics Corp. (SCT) announced it has received a No Objection Letter (NOL) from Health Canada for the company supported, investigator-led phase IIa, single centre, open label study to characterize the safety of human Chorionic Gonadotropin (hCG) & Erythropoietin (EPO) in severe traumatic brain injury (TBI) patients . Dr David Zygun, MD, MSc, FRCPC, Assistant Professor in the Departments of Critical Care Medicine, Clinical Neurosciences and Community Health Sciences, University of Calgary, Foothills Medical Centre, Calgary Health Region, will be the Principal Investigator for this phase IIa TBI trial.
Dr. Alan Moore, president and CEO, commented: "We are pleased to receive the go-ahead from Health Canada for this TBI clinical trial using the same drug regimen as in the modified REGENESIS phase IIb acute ischemic stroke study to treat TBI patients. TBI represents such a huge unmet medical need as currently there are no marketed products available to treat TBI, leaving patients with lifelong disabilities. As the therapeutic regimen for TBI is the same one being used in our phase IIb acute ischemic stroke trial, we anticipate this TBI trial to expand our existing safety database for NTx-265 as well as efficacy measures."
The protocol of the phase IIa TBI study has been reviewed by Health Canada. Approval by the University of Calgary's Office of Medical Bioethics is pending and once received will permit TBI patient enrolment in the phase IIa TBI study at the Calgary Foothills Medical Centre.
"The development of a new therapeutic regimen to treat traumatic brain injury is urgently warranted. TBI is common and is the single most important injury contributing to traumatic mortality and morbidity. Severe traumatic brain injury comprises only 10% of all brain injuries, but contributes the greatest proportion of deaths, disability, and cost related to brain injuries both in Canada and around the world. Using rigorous methodology, we hope to ultimately translate initial discoveries from the laboratory of Dr. Samuel Weiss at the University of Calgary into improvements in TBI patient outcomes. This initial safety assessment is an essential component of the process that will lead to larger efficacy trials," commented Dr. David Zygun, Principal Investigator.
Traumatic injury to the head resulting from automobile accidents, concussive explosions or serious athletic impact to the head represents serious events that cause loss of independence and demand intense medical intervention with recovery periods that often persist for months or years. At present there are 10 million TBI survivors worldwide, and the Centers for Disease Control and Prevention estimates that at least 5.3 million Americans are currently living with long-term or lifelong disabilities related to TBI. A therapy that induces improved neurological recovery or functional recovery after an acute injury would increase patient independence, decrease rehabilitation time and cost, and represent a new important scientific advancement and medical development.
The NTx-265 regimen is similar to that used in the REGENESIS phase IIb stroke program. The objectives of the regimen are to stimulate the growth and differentiation of new neurons to replace the brain cells that were lost or damaged by the severe brain injury, and importantly, to direct functional recovery of motor, visual and cognitive capacity.
Stem Cell Therapeutics Corp. is a public biotechnology company focused on the development and commercialization of drug-based therapies to treat central nervous system diseases. SCT is a leader in the development of therapies that utilize drugs to stimulate a patient's own resident stem cells.