Cytori Therapeutics Inc (NASDAQ:CYTX) announced the launch of its U.S. phase III/pivotal trial to study the efficacy of its ECCS-50 cellular therapeutic in patients with scleroderma associated hand dysfunction.
In July 2015, Cytori received follow-on U.S. FDA investigational device approval for recent updates to the Celution® System, which is being used in the STAR trial. The updates include recent technologic advances such as enhanced software code that substantially improves the efficiency of the bedside therapeutic manufacturing process for ECCS-50.
Currently three U.S. centers have been initiated. Cytori anticipates that the majority of investigational sites will be active byOctober 2015. Screening of patients has begun and it is expected that the first U.S. patients will be treated this month. A variety of promotional activities for the STAR trial will begin after Labor Day; however, the STAR microsite is currently active at:http://www.startrial-us.com/. Enrollment duration is expected to be approximately 1 year.
“Hand involvement creates one of the most significant quality-of-life issues faced by people living with scleroderma, causing pain and significant disability,” commented Robert Riggs, Chief Executive Officer of the Scleroderma Foundation, Inc., the leading patient advocacy and research nonprofit organization for the scleroderma community. “It’s exciting to see a therapy advance through clinical trials that is intended to address this debilitating and disfiguring manifestation of scleroderma.” More information on the Scleroderma Foundation can be found at the following link:http://www.scleroderma.org/site/PageServer#.VcJOjUu3bfM
STAR is an eighty patient randomized, double blinded controlled trial of a single dose of the ECCS-50 therapeutic compared to placebo. Details of the trial including inclusion and exclusion criteria can be found at the following link:https://clinicaltrials.gov/ct2/show/NCT02396238?term=Cytori&rank=5
The STAR trial was predicated on promising data from the European phase II/pilot trial named SCLERADEC which was published in 2014 (Granel et al. Annals of Rheumatic Diseases) and reported data suggesting that the treatment was safe and potentially effective in improving certain hand symptoms in patients with scleroderma. The data can be found at the following link: http://ard.bmj.com/content/early/2014/08/10/annrheumdis-2014-205681.full.
Subsequent follow up of the SCLERADEC patients at 12 months revealed that the beneficial effect of Cytori’s ECCS-50 therapy in scleroderma was found to persist beyond 12 months and that data has been accepted for publication and is currently in press. (Original Source)
Shares of Cytori Therapeutics closed yesterday at $0.42. CYTX has a 1-year high of $1.89 and a 1-year low of $0.36. The stock’s 50-day moving average is $0.51 and its 200-day moving average is $0.76.
On the ratings front, Cytori has been the subject of a number of recent research reports. In a report issued on June 15, Roth Capital analyst Joseph Pantginis maintained a Buy rating on CYTX, with a price target of $6, which implies an upside of 1327.6% from current levels. Separately, on the same day, Maxim Group’s Jason Kolbert reiterated a Buy rating on the stock and has a price target of $7.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joseph Pantginis and Jason Kolbert have a total average return of 3.7% and -7.0% respectively. Pantginis has a success rate of 42.5% and is ranked #896 out of 3727 analysts, while Kolbert has a success rate of 33.7% and is ranked #3693.
Cytori Therapeutics Inc is engaged in the development of novel treatments for cardiovascular disease and soft tissue injuries and burns.