Stem Cell Therapeutics Corp. Corporate Update
June 25 2010 - 8:30AM
Marketwired
Stem Cell Therapeutics Corp. ("SCT" or the "Company") (TSX VENTURE:
SSS) announces the following updates:
Ongoing Stroke Trial Analysis
On May 25, 2010, the Company announced top-line results for the
modified REGENESIS-Phase IIb stroke trial, a placebo controlled,
double blinded, 3:1 randomized clinical study that enrolled 96
patients with acute ischemic stroke between August 2009 and January
24, 2010. SCT reported that the top-line analysis for this clinical
trial of NTx®-265 in acute stroke showed that there was substantial
improvement in the primary efficacy endpoint (absolute change in
NIHSS) in both placebo treated patients and those receiving
NTx®-265, with no statistical differences between the groups.
After further analysis of the trial results, management has been
unable to determine a definitive explanation for the unexpectedly
large placebo effect encountered in the modified REGENESIS-Phase
IIb stroke trial. Further analysis has, however, indicated that
some of the secondary endpoints that were also measured as part of
the trial demonstrate a trend that shows greater efficacy in those
patients who received the NTx®-265 therapy versus those who were
given the placebo. None of these secondary endpoints had sufficient
patient populations to demonstrate statistically significant
differences; nevertheless the trends are considered by management
to be encouraging. Analysis of the trial results is ongoing and all
calculations are subject to validation in the final report which is
expected to be completed by the end of August.
In light of these positive trends, and the excellent safety
profile for NTx®-265 as demonstrated by the modified
REGENESIS-Phase IIb stroke trial, management of the Company
believes that it would be worthwhile to proceed to an end-of-Phase
II meeting with the FDA in which they will seek approval to proceed
with a Phase III stroke study for NTx®-265. Management's objective
is to have such meeting in October of this year. There can be no
assurance that the FDA will grant approval for a Phase III stroke
trial.
Cost Cutting Program
Even if the Company is successful in obtaining FDA approval to
conduct a Phase III stroke trial for NTx®-265, the Company's
ability to continue further stroke studies is uncertain at this
time due to its limited capital and the failure to meet the primary
efficacy endpoint in the modified REGENESIS-Phase IIb stroke trial.
Accordingly, the Board of Directors has decided to implement a
cost-cutting program to preserve as much capital as possible while
management pursues the end-of-Phase II meeting with the FDA. As
part of this program, the employment contracts for each of the
senior officers of the Company (CEO, CFO, VP Product, Development
and VP, Commercial Planning) have been terminated effective June
30, 2010. Alan Moore, the current CEO, and Barry Herring, the
current CFO have agreed to stay on with the Company in their
current capacities on a consulting basis for the following six
months to assist the Company in its attempt to maximize the value
of its intellectual property. The Company has made a similar
consulting offer to Alan Davidoff, the current VP, Product
Development and expects to have a response next week. Also, as part
of the cost cutting program, other staff positions will be
eliminated or reduced, certain external research and service
contracts will be terminated, and the Company will significantly
reduce the size of its office space. The estimated cost of
effecting the employee terminations and other cutbacks discussed
above is approximately $540,000. Management estimates that after
giving effect to the cost cutting program, the Company will have a
cash balance of approximately $1.4 million at the end of 2010, with
little or no severance, lease or other contractual obligations at
such time. The Board believes that taking these steps now will put
the Company in the strongest financial position to consider and
pursue strategic alternatives for maximizing future shareholder
value.
Board of Directors
Bob Rieder resigned as a director of the Company effective June
24, 2010. The remaining Board members have verbally indicated their
intention to remain on the Board until at least the end of
2010.
Outlook for Remainder of 2010
During the next six months, management will focus its efforts on
pursuing the end-of-Phase II meeting with the FDA for the NTx®-265
stroke therapy, as discussed above. This is expected to be a
low-cost initiative. At the same time, management and the Board
will review alternatives for pursuing the traumatic brain injury
("TBI") and multiple sclerosis ("MS") study opportunities that have
been discussed in the past. The focus in this regard will be to
determine the best way to finance such studies through to their
completion. In addition to the foregoing, management and the Board
will also consider other strategic alternatives for the Company.
This might involve the engagement of a financial advisor and/or the
appointment of a Special Committee of the Board. No such steps have
been taken at this time as the current priority is to implement the
cost cutting program described above and allow management to begin
pursuing the initiatives discussed in this press release. Further
updates will be announced as developments warrant.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp.
is a 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 brain and
nerve 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, multiple sclerosis, Huntington's disease, Alzheimer's
disease, and ALS.
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, including specifically estimated expenses and future
cash balances, involve risk and uncertainties, which may cause the
Company's actual results to differ materially from those in the
forward-looking statements. Such risks and uncertainties include
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. Alan Moore, PhD President
and CEO 403-245-5495 ext.224 amoore@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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