U.S. Food and Drug Administration (FDA) has provided a verbal confirmation to Stem Cell Therapeutics Corp.(SCT) to commence the recruitment of stroke patients under an amended protocol using NTx®-265 for the Company’s Phase IIb clinical trial for the acute ischemic stroke treatment.
The company is expecting the written approval from FDA in near future. After receiving the approval they will finalize the plans for the stroke trial.
SCT’s encouraging clinical results from BETAS Phase IIa stroke trial showing clinically relevant recovery in 12 of 12 patients who received the complete treatment, were presented at the International Stroke Conference in February 2009.
SCT is a leader in the development of therapies that utilize drugs to stimulate a patient’s own resident stem cells.
NTx®-265 is SCT’s lead therapeutic regimen of two approved and clinically well-defined drugs, human Chorionic Gonadotropin (hCG) and Erythropoietin (EPO), targeting the treatment of stroke.
The twin objectives of the treatment are to stimulate the growth and differentiation of new neurons to replace the brain cells that were lost or damaged by the stroke, and importantly, to direct motor, visual, and cognitive recovery after the acute ischemic stroke.
The Company’s programs aim to repair brain and nerve function lost due to disease or injury.
The Company’s extensive patent portfolio of owned and licensed intellectual property supports the potential expansion into future clinical programs in numerous neurological diseases such as traumatic brain injury, multiple sclerosis, Huntington’s disease, Alzheimer’s disease, and ALS.
For further information on Stem Cell Therapeutics Corp., visit www.stemcellthera.com.