Possible dip & rip in the making, Close watch.
$CYTX 1.11 0.00 0.00 244,994 0.43 0.4399
Cytori Therapeutics Files 8K - Other Events >CYTX
1 hour 11 minutes ago - DJNF
Cytori Therapeutics Inc. (CYTX) filed a Form 8K - Other Events - with the U.S Securities and Exchange Commission on July 24, 2017.
On July 24, 2017, Cytori Therapeutics, Inc. (the "Company" or "Cytori"
announced top-line, preliminary data from its Phase III pivotal STAR trial of Habeo(tm) Cell Therapy(tm) in patients with scleroderma. The U.S. multi-center STAR trial enrolled and evaluated 88 patients with scleroderma, including 51 patients within the diffuse cutaneous subset and 37 with limited cutaneous scleroderma. While the primary endpoint did not reach statistical significance at 24 or 48 weeks, the trial data reported clinically meaningful improvement in the primary and secondary endpoints of both hand function and scleroderma-associated functional disability, for Habeo treated patients compared to placebo, in a subgroup of patients with diffuse cutaneous scleroderma.
In the combined study population, the primary endpoint, specifically mean improvement in the Cochin Hand Function Score, did not show statistical difference between treated patients and those receiving placebo at 24 weeks and 48 weeks as determined by both analysis of covariance and mixed model repeated measure analysis. The Raynaud's Condition Score, a secondary endpoint, improved in both the treatment and placebo group but was not statistically different between the Habeo-treated and placebo groups.
However, in the pre-specified subgroup analysis of patients with diffuse cutaneous scleroderma, a more severe form of the disease, improvements in the Cochin Hand Function Score and the Health Assessment Questionnaire-Disability Index (HAQ-DI), a measure of functional disability and an important secondary endpoint, met or exceeded the published criteria for minimally important clinical differences in these measures (6.5 points for Cochin 1, 0.22 points for HAQ-DI 2).
Endpoint
Timepoint
Habeo /
Placebo /
p value /
All Subjects
n=48
n=40
CHF - mean improvement
weeks
11.5 / 11.8
10.2 / 9.8
0.442 / 0.3943
weeks
/ 11.3
8.9 / 8.51
0.2989 / 0.2650
HAQ-DI - mean improvement
weeks
The full text of this SEC filing can be retrieved at: http://www.sec.gov/Archives/edgar/data/109598...170724.htm
Any exhibits and associated documents for this SEC filing can be retrieved at: http://www.sec.gov/Archives/edgar/data/109598...-index.htm
Public companies must file a Form 8-K, or current report, with the SEC generally within four days of any event that could materially affect a company's financial position or the value of its shares.
(END) Dow Jones Newswires
July 24, 2017 08:01 ET (12:01 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
$CYTX 1.11 0.00 0.00 244,994 0.43 0.4399
Cytori Therapeutics Files 8K - Other Events >CYTX
1 hour 11 minutes ago - DJNF
Cytori Therapeutics Inc. (CYTX) filed a Form 8K - Other Events - with the U.S Securities and Exchange Commission on July 24, 2017.
On July 24, 2017, Cytori Therapeutics, Inc. (the "Company" or "Cytori"
announced top-line, preliminary data from its Phase III pivotal STAR trial of Habeo(tm) Cell Therapy(tm) in patients with scleroderma. The U.S. multi-center STAR trial enrolled and evaluated 88 patients with scleroderma, including 51 patients within the diffuse cutaneous subset and 37 with limited cutaneous scleroderma. While the primary endpoint did not reach statistical significance at 24 or 48 weeks, the trial data reported clinically meaningful improvement in the primary and secondary endpoints of both hand function and scleroderma-associated functional disability, for Habeo treated patients compared to placebo, in a subgroup of patients with diffuse cutaneous scleroderma. In the combined study population, the primary endpoint, specifically mean improvement in the Cochin Hand Function Score, did not show statistical difference between treated patients and those receiving placebo at 24 weeks and 48 weeks as determined by both analysis of covariance and mixed model repeated measure analysis. The Raynaud's Condition Score, a secondary endpoint, improved in both the treatment and placebo group but was not statistically different between the Habeo-treated and placebo groups.
However, in the pre-specified subgroup analysis of patients with diffuse cutaneous scleroderma, a more severe form of the disease, improvements in the Cochin Hand Function Score and the Health Assessment Questionnaire-Disability Index (HAQ-DI), a measure of functional disability and an important secondary endpoint, met or exceeded the published criteria for minimally important clinical differences in these measures (6.5 points for Cochin 1, 0.22 points for HAQ-DI 2).
Endpoint
Timepoint
Habeo /
Placebo /
p value /
All Subjects
n=48
n=40
CHF - mean improvement
weeks
11.5 / 11.8
10.2 / 9.8
0.442 / 0.3943
weeks
/ 11.3
8.9 / 8.51
0.2989 / 0.2650
HAQ-DI - mean improvement
weeks
The full text of this SEC filing can be retrieved at: http://www.sec.gov/Archives/edgar/data/109598...170724.htm
Any exhibits and associated documents for this SEC filing can be retrieved at: http://www.sec.gov/Archives/edgar/data/109598...-index.htm
Public companies must file a Form 8-K, or current report, with the SEC generally within four days of any event that could materially affect a company's financial position or the value of its shares.
(END) Dow Jones Newswires
July 24, 2017 08:01 ET (12:01 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
1
I'm in it to win it!
NASDAQ DIP and RIP
Here is the best word that describes what i do here.
Intuitive;
means having the ability to understand or know something without any direct evidence or reasoning process.
I was born with it, I'm truly blessed!
Alway's searching for winners'
NASDAQ DIP and RIP
Here is the best word that describes what i do here.
Intuitive;
means having the ability to understand or know something without any direct evidence or reasoning process.
I was born with it, I'm truly blessed!
Alway's searching for winners'
