Cytori Therapeutics, Inc. Release: Scleroderma Therapy Benefit Sustained At One Year Follow Up

SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics (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 [http://rheumatology.oxfordjournals.org/content/early/2015/09/08/rheumatology.kev323.abstract].

“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”

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.”

About Cytori

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 conduct of our clinical trials, including Scleredec II, and the possible benefits of Cytori 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, 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.