Stem cell stimulation therapy NTx-265 to treat traumatic brain injury gets Canadian approval: Stem Cell Therapeutics

NTx-265, a new therapy regimen to stimaulate patients’ own stem cells to deal with severe traumatic brain injury by Stem Cell Therapeutics Corp has been given a No Objection Letter (NOL) by Health Canada.

Health Canada has given approval for Stem Cell Therapeutics’ 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.

NTx-265, is a regimen of two approved and marketed drugs (human chorionic gonadotropin (hCG) & erythropoietin (EPO)) targeting the treatment of stroke. The therapy works by stimulating the growth and differentiation of new neurons to replace the brain cells that are lost or damaged by the stroke and importantly, to direct motor, visual and cognitive recovery after acute ischemic stroke. Our approach avoids surgical transplantation of stem cells; instead we use drugs to stimulate the body’s own existing adult stem cells.

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.

64 patients have been enrolled to-date in our modified REGENESIS Phase IIb acute ischemic stroke study.

The studies are currently underway in trial sites in India, Canada and the U.S.

tem Cell Therapeutics anticipates Phase IIb patient enrollment to be complete by the end of Q1 2010 and for top-line data to be available after the 90-day patient assessment review period is complete, approximately by the end of Q2 2010.

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.

“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,” stated Dr Alan Moore, president and CEO.

traumatic brain injury represents such a huge unmet medical need as currently there are no marketed products available to treat TBI, leaving patients with lifelong disabilities, he added.

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.

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.

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.

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.

StemCell 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.