Cytori Therapeutics Inc (NASDAQ:CYTX) announced the publication today of the results from the 12 month clinical follow up of patients enrolled in the Scleradec-I clinical trial from hand dysfunction common in patients with the rare disease scleroderma. The Scleradec-I trial, an investigator-initiated, open-label 12 patient trial, was led by Dr. Brigitte Granel and Dr. Guy Magalon from the Assistance Publique des Hôpitaux de Marseille. The manuscript was published in the journal Rheumatology.
The publication documented that a single treatment with Cytori Cell Therapy™, known as ECCS-50, provided prolonged improvements in patients with impaired hand function due to scleroderma. Specifically, hand function assessed using the validated clinical measure known as the Cochin Hand Function Scale and overall health status using the Scleroderma Health Activity Questionnaire improved from baseline by an average of 51.3% and 46.8%, respectively, at 12 months (p=0.001 for both). Raynaud’s Condition Score, which measures the incidence and severity of Raynaud’s phenomena, was reduced by 63.2% from baseline at 12 months (p<0.001). Other key findings include a 30.5% improvement from baseline in grip strength (p=0.002) and 34.5% improvement from baseline in pain (p=0.052).
Relative to the data measured in these patients at 6 months after treatment, the 12 month data included evidence of on-going benefit across a number of endpoints. For example, fibrosis of the hand, an important pathophysiologic feature of the disease, was assessed using the modified Rodnan Skin Score and declined by 22.9% relative to baseline (p=0.014). Similarly, capillaroscopic assessment of vascular suppression improved by 35% compared to baseline (p=0.001).
The follow on European Phase III trial known as Scleradec II is a larger, randomized, controlled trial designed to substantiate these findings and is anticipated to begin before the end of the year.
Based in part on the preliminary 6 month data from this study, Cytori has received FDA IDE approval for the STAR trial, a pivotal (Phase III) clinical trial of Cytori Cell therapy for the treatment of hand dysfunction and Raynaud’s phenomena in patients with scleroderma. This 80 patient, multi-center, randomized, double-blind placebo-controlled trial began enrolling in August of 2015.
“The observation that the improvement in hand function and Raynaud’s phenomena that was seen at 6 months, persists to at least 12 months with a single administration of Cytori Cell Therapy should provide added optimism on the outlook of this therapy for patients and their families,” said Dr. Steven Kesten, Chief Medical Officer, Cytori Therapeutics. “The prolonged benefit across a number of concordant endpoints in these patients is very encouraging. The recent start of the STAR trial brings us a step closer to understanding what role Cytori Cell Therapy may have in scleroderma.” (Original Source)
Shares of Cytori Therapeutics closed yesterday at $0.409. CYTX has a 1-year high of $1.47 and a 1-year low of $0.29. The stock’s 50-day moving average is $0.40 and its 200-day moving average is $0.74.
On the ratings front, Cytori has been the subject of a number of recent research reports. In a report issued on August 10, Roth Capital analyst Joseph Pantginis reiterated a Buy rating on CYTX, with a price target of $4, which represents a potential upside of 878.0% from where the stock is currently trading. Separately, on June 15, 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 -2.3% and -10.3% respectively. Pantginis has a success rate of 38.0% and is ranked #3479 out of 3752 analysts, while Kolbert has a success rate of 32.2% and is ranked #3737.
Cytori Therapeutics Inc is engaged in the development of novel treatments for cardiovascular disease and soft tissue injuries and burns.