SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics, Inc. (NASDAQ: CYTX) today reports new data demonstrating a single administration of Cytori Cell Therapy™ (ECCS-50) achieved a sustained improvement in hand dysfunction at two years in patients with scleroderma. Scleroderma is a rare autoimmune disease that results in hardening of tissue from a buildup of fibrotic tissue in the fingers, skin and other organs and tissues.
The trial findings were presented by trial co-principal investigator Dr. Guy Magalon on February 20, 2016 at the 4th Systemic Sclerosis World Congress in Lisbon, Portugal. Cytori will host an investor conference call at 8:30 a.m. Eastern Time today, February 22, 2016, to discuss two year follow up results from the SCLERADEC I trial. In general, the data showed a sustained two year improvement in hand symptoms and function across multiple endpoints in patients with scleroderma following single administration of Cytori Cell Therapy™ (ECCS-50).
Major findings at 24 months following single administration of Cytori Cell Therapy™ (ECCS-50):
- Hand dysfunction assessed by the validated Cochin Hand Function Score (CHFS), showed a 62% reduction in hand dysfunction at two years (p<0.001).
- Raynaud’s Condition Score, a patient-reported measure of the severity and frequency of Raynaud’s Phenomenon, decreased by an average of 89% over baseline at two years (p<0.001).
- Hand pain, as measured by the standard 100mm Visual Acuity Score, and the Scleroderma Health Assessment Questionnaire (SHAQ) score at two years both showed improvement of 50% over baseline (p=0.01 and p<0.001 respectively).
- Improvement of 20 % in grip strength and 330% in pinch strength at two years (p=0.05 and p=0.004 respectively)
- Continued reduction in the number of ulcers from 15 at baseline to 9 at one year and 6 at two years.
“Hand dysfunction in scleroderma is both disabling and hard to treat,” said Dr. Guy Magalon, who presented these data on behalf of the team at Assistance Publique-Hôpitaux de Marseille (APHM). “The standard treatments we rely on for these patients are often not effective or are poorly tolerated because of side effects. The broad efficacy signals along with a very favorable safety profile makes ECCS-50 one of the more promising new therapeutic options for these difficult to treat patients.”
SCLERADEC-I led by Principal Investigators Pr. Brigitte Granel and Pr. Guy Magalon and the Cell Therapy Department of APHM by the team of Pr. Florence Sabatier, is a 12 patient, French, single center study aimed at measuring for the first time the safety, tolerability and potential efficacy of Cytori’s ECCS-50 locally injected in patients with hand disability due to scleroderma. Scleroderma has orphan designation in Europe.
“The scientific findings of sustained symptomatic and functional improvement coupled with the direct patient feedback we have received from other scleroderma patients treated apart from this trial leads us to be optimistic about the potential for ECCS-50 to help patients worldwide,” said Dr. Marc Hedrick, President and CEO of Cytori Therapeutics Inc. “The follow on approval trials, STAR and SCLERADEC II are enrolling, our EU compassionate use (or Managed Access) program has launched and we remain on track to submit to US FDA in mid-2017.”
Results at 12 months of follow-up for this trial were published in the August 2015 edition of Rheumatology. The data indicated that a single administration of ECCS-50 was safe and that treated patients exhibited significant improvements in hand symptoms, function and Raynaud’s Phenomena through one-year post-treatment.
Management Conference Call Webcast
Cytori will host a management conference call at 8:30 a.m. Eastern Time today to further discuss the two year follow up results of the SCLERADEC I trial. The webcast will be available live and by replay two hours after the call and may be accessed under "Webcasts" in the Investor Relations section of Cytori's website. If you are unable to access the webcast, you may dial in to the call at +1 (877) 402-3914, Conference ID: 56735683.
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, statements regarding the safety and efficacy, timing for regulatory approvals and market opportunities for our cell therapy, 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, inherent risk and uncertainty in the protection intellectual property rights, regulatory uncertainties, risks in the conduct of clinical trials and clinical trial results, risks in the collection 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.