Stem Cell Therapeutics Corp announced that the US Food and Drug Administration (FDA) has provided a verbal confirmation to remove its clinical hold placed on NTx-265 on September 18, 2008. This will allow SCT to commence the recruitment of patients under an amended protocol using NTx-265 for the company's phase-IIb clinical trial treating acute ischemic stroke.
Dr Alan Moore, president and CEO, commented, "We are very pleased that our series of collaborative meetings with the FDA has resulted in this positive development. We are expecting to receive written notification from the FDA in the near future following which we will finalize the plans for our stroke trial. We will issue another press release once this has been determined."
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.
Stem Cell Therapeutics Corp is a Canadian public biotechnology company focused on the development and commercialization of drug-based therapies to treat central nervous system diseases.