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Canadian biotech Stem Cell Therapeutics Corp. (SCT, Calgary, Alberta) said on May 14 that the U.S. Food and Drug Administration (FDA) has verbally informed the company that it had removed a clinical hold placed on the company’s therapeutic regimen targeting the treatment of stroke.
The FDA hold was placed on NTx-265 on September 18, 2008.
Lifting the clinical hold allows SCT to begin recruiting patients under an amended protocol using NTx-265 for the company’s Phase IIb clinical trial treating acute ischemic stroke.
“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,” CEO Alan Moore said in a statement.
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.
Encouraging clinical results from SCT’s BETAS Phase IIa stroke trial were presented at the International Stroke Conference in February 2009, showing clinically relevant recovery in 12 of 12 patients who received the complete treatment.
Stem Cell Therapeutics is developing drug-based therapies to treat central nervous system diseases.
Contact: http://www.stemcellthera.com
Contact the reporter: jessica.brown@datatrendspublications.com
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