Cytori Therapeutics Inc (NASDAQ:CYTX) announced that the first patient has been enrolled and treated in the SCLERADEC-II trial, a late phase, follow-on European clinical trial designed to determine the efficacy and safety of Cytori Cell Therapy™ in patients with hand dysfunction associated with scleroderma.
SCLERADEC-II is a multicenter, double blind, placebo controlled trial of a single administration of Cytori Cell Therapy (ECCS-50). The trial will enroll up to 40 patients randomized in a 1:1 fashion to either active or placebo control. The primary endpoint is the Cochin Hand Function Score at 3 months following treatment. Key secondary endpoints include Raynaud’s Condition Score, SHAQ, Pain, modified Rodnan Skin Score, capillaroscopy and functional hand assessment. Placebo patients will be eligible for cross over to the active arm after 6 months with their respective cryopreserved cells. If the trial endpoint is successfully achieved, this trial may be used to seek European marketing approval of Cytori Cell Therapy for this indication, which has been designated by the European Commission as an orphan medicinal product for treatment of scleroderma.
This trial is a follow on trial to the twelve patient SCLERADEC-I pilot trial which was published in the August 2015 edition of the journal Rheumatology. One year follow up of patients treated in this open label trial suggested that a single administration of ECCS-50 was safe and that treated patients exhibited significant improvements in hand symptoms and function.
“The sustained safety and benefit across a number of concordant endpoints in patients that received cell therapy in the SCLERADEC-I trial after 12 months of follow-up was very encouraging. This suggests the possibility that Cytori Cell Therapy may be a useful therapeutic option for patients who suffer from scleroderma,” said Dr. Brigitte Granel, North Hospital, Assistance Publique Hôpitaux de Marseille and the Principal Investigator on both the SCLERADEC I and SCLERADEC II trials, conducted by Marseille University Hospital. “We are hopeful that SCLERADEC II will substantiate these findings and help support product approval in Europe.”
The trial is sponsored by the Assistance Publique Hôpitaux de Marseille, Marseille, FR and conducted under an approval from the French national regulatory agency, Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM), and supported by Cytori. (Original Source)
Shares of Cytori Therapeutics closed last Friday at $0.39. 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 $0.38 and its 200-day moving average is $0.59.
On the ratings front, Roth Capital analyst Joseph Pantginis reiterated a Buy rating on CYTX, with a price target of $4, in a report issued on September 11. The current price target represents a potential upside of 925.6% from where the stock is currently trading. According to TipRanks.com, Pantginis has a total average return of -4.9%, a 33.7% success rate, and is ranked #3727 out of 3788 analysts.
Cytori Therapeutics Inc is engaged in the development of novel treatments for cardiovascular disease and soft tissue injuries and burns.