- Published: 18 September 2008
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Stem Cell Therapeutics Corp. Receives Letter From Health Canada and Verbal Request From FDA to Place a Clinical Hold on Its REGENESIS Phase IIb Stroke Trial in Canada and the US, Respectively
The rationale provided for this change in clinical status is that data from an unrelated foreign clinical trial in stroke using EPO has shown a safety concern that is being reviewed by the FDA
Stem Cell Therapeutics Corp. ("SCT")(TSX VENTURE: SSS) has received a letter from Health Canada and a verbal request from the U.S. Food and Drug Association (FDA) calling for a temporary 'full clinical hold' on its currently enrolling REGENESIS Phase IIb stroke trial in Canada, and to not begin recruiting in the U.S., respectively. Additionally, Health Canada has requested that recruitment not begin in the recently announced traumatic brain injury trial. The reason for these requests was that a trend in data found from an unrelated foreign stroke trial has reported safety results that require further analysis.
Dr. Alan Moore, President and CEO, commented as follows:
"While we are disappointed with the clinical hold status, we recognize and support this action to protect patient safety when concern is raised. At this time, the FDA has given every indication that this is a temporary hold. Both regulatory agencies are evaluating the data from this unrelated trial and are working to expediently understand if a safety issue can be confirmed and define the patient population affected within this study in question. Health Canada's clinical hold is anticipated to be released once additional analysis has been completed. Unfortunately, we have been provided with limited information regarding the data, specific trial and trial results in question. We are diligently doing everything we can to provide current safety data from the BETAS trial to assure the regulatory agencies that the company's NTx(TM)-265 is safe in patients with acute ischemic stroke."
Dr. Steven C. Cramer and Dr. Michael Hill, Co-Principle Investigators for the REGENESIS Phase IIb stroke trials, commented as follows:
"We understand the requested action from Health Canada and the FDA and we agree that patient safety is critical. A key point to note is that the independent Data Safety and Monitoring Board recently reviewed the REGENESIS trial and authorized the continuation of the trial as there was no safety signal. We look forward to the REGENESIS trial starting again after the unrelated study data is reviewed. We also take note that the BETAS Phase IIa stroke trial found no safety concerns in the 15 stroke patients who received the same hCG and EPO regimen."
About REGENESIS: NTx(TM)-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 regimen 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 functional recovery of motor, visual and cognitive capacity after acute ischemic stroke. Animal studies have shown a significant recovery in motor function after receiving the NTx(TM)-265 regimen 24-48 hours post stroke. Encouraging clinical results from SCT's Phase IIa BETAS stroke trial were presented at the International Stroke Conference in February 2008, showing clinically relevant recovery in 8 of 8 patients who received the complete regimen. SCT is recruiting patients for the multi-centre, double-blind, placebo-controlled Phase IIb REGENESIS study for NTx(TM)-265 with primary endpoints of efficacy and safety.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is a Canadian public biotechnology company (TSX VENTURE: SSS) focused on the development and commercialization of drug-based therapies to treat central nervous system diseases. SCT is a leader in the development of therapies that utilize drugs to stimulate a patient's own resident stem cells. The Company's programs aim to repair neurological 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 and multiple sclerosis.
For further information on Stem Cell Therapeutics Corp., visit www.stemcellthera.com.
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SOURCE: Stem Cell Therapeutics Corp.