Stem Cell Therapeutics Corp. Announces The FDA Has Lifted Its Clinical Hold On The Phase IIb Stroke Trial

Main Category: Stroke
Also Included In: Clinical Trials / Drug Trials;  Regulatory Affairs / Drug Approvals;  Stem Cell Research
Article Date: 15 May 2009 - 0:00 PDT

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Stem Cell Therapeutics Corp. ("SCT" or "the Company") (TSX VENTURE:SSS) is pleased to announce the U.S. 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 as follows:

"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."

About REGENESIS

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.

Source
Stem Cell Therapeutics Corp.