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Biotech firm set to start modified Phase II stroke trial


Calgary-based Stem Cell stem cell

In living organisms, an undifferentiated cell that can produce other cells that eventually make up specialized tissues and organs. There are two major types of stem cells, embryonic and adult.
 Therapeutics Corp. (TSX TSX Toronto Stock Exchange (TSE before April, 2002)
TSX Transfer from Stack Pointer to Index
TSX True Space Extension
: V.SSS SSS
abbr.
sick sinus syndrome
, Stock Forum) announced Thursday that it has decided to start the modified Phase IIb REGENESIS clinical stroke trial as soon as possible, with the goal of completing patient enrollment by the end of 2009.

The move follows an announcement last week that the U.S. Food and Drug Administration was lifting the clinical hold placed on the company’s NTx(R)-265 Phase IIb stroke trial last September, as well as encouraging results from the Phase IIb patients enrolled prior to the clinical hold, says the biotech firm.

"Before starting the modified REGENESIS Phase IIb study, we un-blinded results from the seven patients who were enrolled in the halted Phase IIb trial. Although these results are not statistically significant, due to the small number of patients, they are encouraging and consistent with the Phase IIa results announced in February of this year. We were also pleased to see that there were no adverse health effects among the patients who received the treatment, which is also consistent with our findings in the Phase IIa trial. All of this has reinforced our confidence in NTx(R)-265 and we are excited to proceed with the testing of our treatment for stroke patients," says Alan Moore

For other people named Alan Moore, see Alan Moore (disambiguation).


Alan Moore (born November 18, 1952[7] in Northampton) is an English writer most famous for his influential work in comics, including the acclaimed graphic novels
, the company’s president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. .

Stem Cell Therapeutics notes that the results of the Phase IIb trial from the seven patients indicated an improvement in the treated group as compared to the placebo group.

The Company also announced Thursday that Robert W. Rieder, chairman and CEO of Cardiome Pharma has been elected to SCT's Board of Directors, and W. Dalton Dietrich has joined SCT's Scientific Advisory Board.

Shares of Stem Cell Therapeutics climbed 10.5% to 10.5 cents Thursday.

The company also reportedly held its AGM AGM annual general meeting

AGM n abbr (= annual general meeting) → AG f

AGM n abbr (= annual general meeting) → JHV f 
 on Wednesday, after which Stockhouse member rjc2827 provided the following comments on the company’s Bullboard:

The May 20, 2009 AGM was a “good news” AGM

For starters, we’re getting a PR tomorrow morning with the results of the “orphaned” 7 patients that were enrolled in the Phase IIb stroke Trial that was halted. This trial was basically identical to the 12 patient Phase IIa Trial that had such great results, except that this one was a randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 double blind Trial. When it was halted, 7 patients had been enrolled … 2 treated with our hCG + EPO EPO

see erythropoietin.

EPO Erythropoietin, see there
, and the other 5 with a placebo (basically salt water). The 2 treated patients did better than the 12 did in the Phase IIa Trial. This is good. The 5 placebo patients did less well than we had assumed that untreated patients would do. This is good for us statistically. The patient count is way way way too small to give us a free pass to an Approval, but I think that the results are great[sic]. (for the full post, click here.)

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Author:Buzz on the Boards
Publication:Stockhouse
Date:May 21, 2009
Words:468
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