SAN DIEGO & TOKYO--(BUSINESS WIRE)--Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today that on May 18, 2016, an update regarding the French SCLERADEC I and II clinical trials investigating the use of Cytori Cell Therapy in the treatment of scleroderma-related hand dysfunction will be delivered at the 104th Annual Meeting of the Japan Society of Aesthetic Surgery in Tokyo, Japan.
Professor Guy Magalon, the SCLERADEC-I principal investigator, is scheduled to present, “New Strategy and Possibility for Using ADRCs for Treating Scleroderma,” in the International Invited Lecture session on May 18th at the ANA Intercontinental Tokyo in Room A from 10:45 to 11:45 am.
Scleroderma has been designated as an intractable disease in Japan, estimated to affect 27,800 people.† A study from Japan in 1991 shows that a high number of these patients have hand symptoms. Specifically, 98% exhibit Sclerodactyly (thickening and tightness of the skin in fingers, often leading to ulceration of the fingers) and 95% exhibit Raynaud’s Phenomenon.‡ Pre-clinical and clinical studies suggest that adipose-derived regenerative cells, or ADRCs, may promote angiogenesis, modulate inflammation and reduce/remodel fibrosis. In addition, Dr. Magalon reported that the open-label SCLERADEC I trial showed a sustained benefit over a two-year period using ADRC therapy prepared by Cytori’s Celution® System. Dr. Magalon will detail those findings in Japan at this presentation.
“Hand involvement is common in scleroderma and few effective medical options exist,” said John Harris, Vice President and General Manager, Cell Therapy. “We are very grateful that Dr. Magalon is here in Japan highlighting the results of this seminal work. The timing coincides nicely with our development and partnering plans here in Japan that have the goal of bringing Cytori’s novel ECCS-50 therapy for hand scleroderma to the market.”
Cytori’s U.S. FDA approved Phase III STAR trial is currently enrolling and thus far, is 75% of the way toward complete enrollment. The trial is scheduled to complete enrollment by mid-June, which is ahead of original schedule. The STAR trial follows the French SCLERADEC-I pilot trial, led by Drs. Magalon and Granel, which was performed at the Assistance Publique Hôpitaux de Marseille. One year post-treatment results were published in the August 2015 edition of the journal Rheumatology. Data recently presented at the Systemic Sclerosis World Congress indicated that a single administration of ECCS-50 therapy could be performed safely and that treated patients exhibited significant improvements in hand symptoms, function and Raynaud’s Phenomena through 2 years following treatment.
† Japan Ministry of Health, Labor and Welfare
‡ Tamaki T, Mori S, Takehara K. “Epidemiologic study of patients with systemic sclerosis in Tokyo.” Arch Dermatol Res 1991;283(6):366 –71.
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 statements regarding clinical trial enrollment and clinical trial results, and partnering and product introduction plans are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. These risks and uncertainties are 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.