News is outStem Cell Therapeutics Corp. Corporate Update
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CALGARY, ALBERTA--(Marketwire - June 25, 2010) - Stem Cell TherapeuticsCorp. ("SCT" or the "Company") (TSX VENTURE:SSS) announces thefollowing updates:
Ongoing Stroke Trial Analysis
On May 25, 2010, the Company announced top-line results for themodified REGENESIS-Phase IIb stroke trial, a placebo controlled, doubleblinded, 3:1 randomized clinical study that enrolled 96 patients withacute ischemic stroke between August 2009 and January 24, 2010. SCTreported that the top-line analysis for this clinical trial ofNTx(R)-265 in acute stroke showed that there was substantialimprovement in the primary efficacy endpoint (absolute change in NIHSS)in both placebo treated patients and those receiving NTx(R)-265, withno statistical differences between the groups.
After further analysis of the trial results, management has been unableto determine a definitive explanation for the unexpectedly largeplacebo effect encountered in the modified REGENESIS-Phase IIb stroketrial. Further analysis has, however, indicated that some of thesecondary endpoints that were also measured as part of the trialdemonstrate a trend that shows greater efficacy in those patients whoreceived the NTx(R)-265 therapy versus those who were given theplacebo. None of these secondary endpoints had sufficient patientpopulations 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 aresubject to validation in the final report which is expected to becompleted by the end of August.
In light of these positive trends, and the excellent safety profile forNTx(R)-265 as demonstrated by the modified REGENESIS-Phase IIb stroketrial, management of the Company believes that it would be worthwhileto proceed to an end-of-Phase II meeting with the FDA in which theywill seek approval to proceed with a Phase III stroke study forNTx(R)-265. Management's objective is to have such meeting in Octoberof this year. There can be no assurance that the FDA will grantapproval for a Phase III stroke trial.
Cost Cutting Program
Even if the Company is successful in obtaining FDA approval to conducta Phase III stroke trial for NTx(R)-265, the Company's ability tocontinue further stroke studies is uncertain at this time due to itslimited capital and the failure to meet the primary efficacy endpointin the modified REGENESIS-Phase IIb stroke trial. Accordingly, theBoard of Directors has decided to implement a cost-cutting program topreserve as much capital as possible while management pursues theend-of-Phase II meeting with the FDA. As part of this program, theemployment contracts for each of the senior officers of the Company(CEO, CFO, VP Product, Development and VP, Commercial Planning) havebeen terminated effective June 30, 2010. Alan Moore, the current CEO,and Barry Herring, the current CFO have agreed to stay on with theCompany in their current capacities on a consulting basis for thefollowing six months to assist the Company in its attempt to maximizethe value of its intellectual property. The Company has made a similarconsulting offer to Alan Davidoff, the current VP, Product Developmentand expects to have a response next week. Also, as part of the costcutting program, other staff positions will be eliminated or reduced,certain external research and service contracts will be terminated, andthe Company will significantly reduce the size of its office space. Theestimated cost of effecting the employee terminations and othercutbacks discussed above is approximately $540,000. Managementestimates that after giving effect to the cost cutting program, theCompany will have a cash balance of approximately $1.4 million at theend of 2010, with little or no severance, lease or other contractualobligations at such time. The Board believes that taking these stepsnow will put the Company in the strongest financial position toconsider and pursue strategic alternatives for maximizing futureshareholder value.
Board of Directors
Bob Rieder resigned as a director of the Company effective June 24,2010. The remaining Board members have verbally indicated theirintention 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 onpursuing the end-of-Phase II meeting with the FDA for the NTx(R)-265stroke therapy, as discussed above. This is expected to be a low-costinitiative. At the same time, management and the Board will reviewalternatives for pursuing the traumatic brain injury ("TBI") andmultiple sclerosis ("MS") study opportunities that have been discussedin the past. The focus in this regard will be to determine the best wayto finance such studies through to their completion. In addition to theforegoing, management and the Board will also consider other strategicalternatives for the Company. This might involve the engagement of afinancial advisor and/or the appointment of a Special Committee of theBoard. No such steps have been taken at this time as the currentpriority is to implement the cost cutting program described above andallow management to begin pursuing the initiatives discussed in thispress release. Further updates will be announced as developmentswarrant.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is apublic biotechnology company (TSX VENTURE:SSS) focused on thedevelopment and commercialization of drug-based therapies to treatcentral nervous system diseases. SCT is a leader in the development oftherapies that utilize drugs to stimulate a patient's own resident stemcells. The Company's programs aim to repair brain and nerve functionlost due to disease or injury. The Company's extensive patent portfolioof owned and licensed intellectual property supports the potentialexpansion into future clinical programs in numerous neurologicaldiseases 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 StatesSecurities Act of 1933, as amended, or the securities laws of anystate, 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 applicableexemption from U.S. registration requirements is available.
Except for historical information, this press release may containforward-looking statements, which reflect the Company's currentexpectation 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 actualresults to differ materially from those in the forward-lookingstatements. Such risks and uncertainties include but are not limitedto, changing market conditions, the successful and timely completion ofclinical studies, the establishment of corporate alliances, the impactof competitive products and pricing, new product development,uncertainties related to the regulatory approval process and otherrisks detailed from time to time in the Company's ongoing quarterly andannual reporting.
FOR FURTHER INFORMATION PLEASE CONTACT:
Stem Cell Therapeutics Corp.
Alan Moore, PhD
President and CEO
403-245-5495 ext.224
amoore@stemcellthera.com
or
Stem Cell Therapeutics Corp.
Angelika Goncalves DaSilva
Operations Manager
403-245-5495 ext. 221
adasilva@stemcellthera.com
www.stemcellthera.com