Stem Cell Therapeutics Corp. Announces Outcome of End of Phase II Meeting With FDA and Provides a Corporate Update & 2011/12 Mil
23 December 2010 - 9:41AM
Marketwired
Stem Cell Therapeutics Corp. (TSX VENTURE: SSS) ("SCT" or the
"Company") announced today that on Monday Dec 20, 2010 SCT met with
the U.S. Food and Drug Administration ("FDA") and participated in
an End of Phase 2 (EOP2) meeting. The outcome of the meeting
discussion clarified the regulatory path forward for the NTx®-265
program, regarding minimum steps necessary to submit a marketing
application for NTx®-265 in acute ischemic stroke. The next steps
for SCT are to design a path forward to advance the NTx®-265
program, based on the valuable information gained from the
REGENESIS-LED trial and this FDA meeting.
Discussions between SCT and FDA included a review of safety and
exploratory efficacy data accumulated during phase 2 trials: BETAS,
REGENESIS and REGENESIS-LED. Further discussion focused on the path
of development for NTx®-265 and included potential pivotal trial
designs, efficacy endpoints and statistical analysis options. SCT
expects to receive the official FDA minutes of the meeting in the
New Year. After the FDA minutes are received, SCT will determine
the most strategic path forward for the NTx®-265 program, then work
to implement that plan. Further detailed announcements are
anticipated after that date.
The purpose of this type of meeting is to assess the project's
data to date and to discuss parameters for proceeding to pivotal
studies (Phase 3). Meeting discussion evaluates FDA's view of the
future clinical plan, including protocol design details and the
adequacy of current studies to support the future studies. An EOP2
meeting is also useful to identify any additional information FDA
thinks necessary to support a marketing application for the uses
under investigation.
SCT's was pleased with the positive and constructive outcome of
this meeting.
During 2010 SCT has undergone considerable changes, including
re-evaluation of programs and company structure. As a result of the
changes the company has emerged revitalized with a strong focus on
building a business aimed at translating the company's broad
intellectual property portfolio into business opportunities and
strategic alliances.
SCT's revitalized focus for 2011-2012 is to direct carefully
managed finances, personnel and time toward the following programs
and creating value for our various stakeholders.
The following are general timelines for key milestones of SCT's
three clinical programs:
Ischemic Stroke:
-- Q1, 2011 - Receive FDA minutes from End of Phase 2 meeting
-- H1, 2011 - Plan and initiate the next stroke study
-- H2, 2011 - Initiate enrollment in Stroke Study
-- Q1, 2012 - Optional interim analysis of Stroke Study
-- Q4, 2012 - Complete Enrollment in Stroke Study
Traumatic Brain Injury (TBI):
-- Q1, 2011 - Continue enrollment in Phase IIa Trial
-- Q4, 2011 - Report top line data
Multiple Sclerosis (MS):
-- H1, 2011 - Complete strategic analysis to advance this program.
An SCT-supported Investigator-Initiated study is currently
enrolling patients in its 10 patient traumatic brain injury (TBI)
Phase IIa trial. This trial is being conducted at Foothill Medical
Center, Calgary Canada and is designed to characterize the safety
of hCG and EPO in traumatic brain injury. SCT will update our
stakeholders as this trial progresses.
The Company has received considerable support from its various
stakeholders. SCT will start fiscal 2011 with approximately
$2,865,000 in cash and cash equivalents. This capital has enabled
SCT to advance program plans for future activities. As Fiscal 2011
opens, SCT will be working on the initiation, enrollment and
completion of clinical trials, continuing to strategically evaluate
programs and reviewing new opportunities. The company anticipates
announcements regarding these activities throughout 2011.
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. SCT'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, multiple sclerosis, Huntington's disease, Alzheimer's
disease, and ALS.
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.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Contacts: Stem Cell Therapeutics Corp. Allen Davidoff, PhD CSO
403-245-5495 ext.226 adavidoff@stemcellthera.com Stem Cell
Therapeutics Corp. Michael Cook CFO 403-245-5495 ext.229
mcook@stemcellthera.com Stem Cell Therapeutics Corp. Angelika
Goncalves DaSilva Operations Manager 403-245-5495 ext. 221
adasilva@stemcellthera.com www.stemcellthera.com
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