SAN DIEGO--(BUSINESS WIRE)--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.
The SCLERADEC II trial is enrolling a similar population of patients as the U.S. pivotal STAR trial sponsored by Cytori. The STAR trial is an eighty patient randomized, double blind placebo controlled trial of a single dose of the ECCS-50 therapeutic compared to placebo. Details of the STAR trial including inclusion and exclusion criteria can be found at the following link: https://clinicaltrials.gov/ct2/show/NCT02396238?term=Cytori&rank=5
Full details of the SCLERADEC-II trial can be found on clinicaltrials.gov (NCT02558543).
About Scleroderma
Systemic sclerosis (SSc) or scleroderma is a rare disease characterized by cutaneous and visceral fibrosis and obliteration of the lumen of small vessels which results in ischemia. The prevalence in Europe is approximately 100,000 patients and in the US is approximately 50,000 patients.
The hand manifestations of scleroderma are common, occurring in approximately 90% patients with scleroderma and lead to impaired hand function and diminished quality of life. Hand involvement is the result of fibrosis and ischemia and may cause diminished mobility and progress to fixed flexion contractures of the digits.
About Cytori Therapeutics, Inc.
Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information: visit www.cytori.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, without limitation, those regarding site initiation, patient screening, enrollment and treatment, and conduct of our clinical trials generally, as well as product safety and efficacy and potential benefits of our products, and use of clinical data to seek regulatory approvals, are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, risks related to our history of operating losses, the need for further financing and our ability to access the necessary additional capital for our business, inherent risk and uncertainty in the protection intellectual property rights, regulatory uncertainties, risks in the conduct of clinical trials, risks in the collection and results of clinical data, final clinical outcomes, dependence on third party performance, performance and acceptance of our products in the marketplace, as well as other risks and uncertainties described under the heading "Risk Factors" in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
