FDA Lifts Clinical Hold on Stem Cell Therapeutics' Phase IIb Stroke Trial
Thu, 05/14/2009 - 4:43am
Stem Cell Therapeutics Corp. has revealed that the 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."