Stem Cell Therapeutics Corp. Receives Letter From Health Canada and Verbal Request From FDA to Place a Clinical Hold on Its REGE
September 18 2008 - 8:00AM
Marketwired
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.
These securities have not been registered under the United
States Securities Act of 1933, as amended, or the securities laws
of any state, and may not be offered or sold within the United
States or to, or for the account or benefit of U.S. persons unless
an applicable exemption from U.S. registration requirements is
available.
Except for historical information, this press release may
contain forward-looking statements, which reflect the Company's
current expectation regarding future events. These forward-looking
statements involve risk and uncertainties, which may cause but are
not limited to, changing market conditions, the successful and
timely completion of clinical studies, the establishment of
corporate alliances, the impact of competitive products and
pricing, new product development, uncertainties related to the
regulatory approval process and other risks detailed from time to
time in the Company's ongoing quarterly and annual reporting.
The TSX Venture Exchange does not accept responsibility for the
adequacy or accuracy of this release.
Contacts: Stem Cell Therapeutics Corp. Alan Moore, PhD President
and CEO (403) 245-5495 ext.224 Email: amoore@stemcellthera.com Stem
Cell Therapeutics Corp. Chloe Douglas-Crampton Investor Relations
(403) 245-5495 ext. 221 Email: crampton@stemcellthera.com Website:
www.stemcellthera.com
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