New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
August 12, 2014
11:20 EDTCYTXCytori Therapeutics reports publication of six month data from scleroderma study
Cytori Therapeutics (NASDAQ: CYTX) today announced that six month outcomes from a 12 patient independent investigator-initiated study using Cytori Cell Therapy to treat scleroderma have been published in the Annals of Rheumatic Disease. Data from the study indicated that treatment with Cytori Cell Therapy was safe and well tolerated through six months. In addition, the data indicated an approximately 50% average improvement across four key, validated endpoints used to assess the clinical status in patients with systemic scleroderma with impaired hand function at two months, with benefits sustained through six month follow-up. “After six month follow up, we are encouraged by the results that have been seen by the investigators in France...The investigators in Marseille have continued to follow the patients and are considering a larger, controlled study based on these positive outcomes,” said Dr. Steven Kesten, Chief Medical Officer, Cytori.
News For CYTX From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
October 23, 2014
09:04 EDTCYTXOn The Fly: Pre-market Movers
Subscribe for More Information
October 22, 2014
18:19 EDTCYTXCytori Therapeutics receives FDA approval to resume ATHENA trial enrollment
Cytori Therapeutics has received notification from the FDA that Cytori has provided additional information sufficient to support continuation of enrollment in its ATHENA cardiovascular trials. The FDA has agreed that the submitted data and protocol amendments support the fact that there are no subject protection concerns that preclude continuation of the trials. The ATHENA trials have enrolled a total of 31 patients thus far but enrollment was stopped last May by the company based on meeting the trials’ internal stopping rules related to potential cerebrovascular events affecting both cell and placebo treated patients. Based on consultation with the FDA, Cytori initiated a thorough safety review consisting of evaluating each adverse event in all of its previous and ongoing cardiovascular trials and conducted additional testing of its product and cellular output. In addition, Cytori implemented several protocol changes to enhance the safety of the trial procedures for patients. The FDA response to Cytori’s submission was received on October 22.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use