Cytori Therapeutics, Inc. (CYTX)

[Paulness]

NEWS -- Cytori to Expand Scleroderma Focus to Broader Hand Therapy Franchise Under the Habeo™ Cell Therapy Brand

Date : 01/10/2017 @ 9:30AM
Source : GlobeNewswire Inc.
Stock : Cytori Therapeutics (MM) (CYTX)

Cytori Therapeutics, Inc. (NASDAQ:CYTX), as part of its corporate update at the Biotech Showcase, announced its intention to broaden its investigation of the ECCS-50 formulation of Cytori Cell Therapy® to include secondary Raynaud’s phenomenon (RP) beyond scleroderma, a problem that affects over one million patients worldwide. Habeo Cell Therapy (formerly ECCS-50) is the new brand name of Cytori Therapeutics’ hand therapy franchise.

“Pilot trial data suggest that our ECCS-50 cellular therapeutic may help to address Secondary RP symptoms and other autoimmune and inflammatory conditions of the hand,” said Dr. Marc H. Hedrick, Cytori President and Chief Executive Officer. “Our plan is to leverage published and ongoing preclinical and clinical data to expand our investigation of ECCS-50 to a much larger patient population with secondary RP under the new Habeo brand name.”

In addition to its substantial contribution to the disease burden of scleroderma, RP is a source of significant morbidity in several more common autoimmune and inflammatory conditions including rheumatoid arthritis, systemic lupus erythematosus (lupus), and Sjogren’s syndrome. The worldwide prevalence of moderate-to-severe RP in these three diseases alone exceeds one million patients, providing an estimated peak annual revenue potential of $1.6 billion.

“Habeo, pronounced ‘habeo,’ means ‘to hold’ in Latin,” explained John Harris, Vice President & General Manager, Cell Therapy. “The name embodies the promise that we believe Cytori Cell Therapy holds for patients with a number of disorders that affect the hand by potentially improving function, reducing pain, and restoring activities of daily living.”

Broadening of clinical interest to secondary RP in other autoimmune and inflammatory diseases is based in large part on 36-month follow-up data from the investigator-initiated, 12-patient, open-label SCLERADEC I trial, which reported a 90 percent reduction in the Raynaud’s Condition Score, a clinically validated scale for determining the degree of difficulty experienced by patients with RP. Earlier limited published data has also reported improvement in vascular architecture, hand color, and other direct and indirect indicators of vascular function. Cytori’s internal preclinical data provide further support for a potential role of Habeo Cell Therapy in the stabilization of the vascular endothelium, an important contributor to the vascular dysfunction found in patients with RP.

RP is a key secondary endpoint in the STAR clinical trial, Cytori’s randomized, double-blind, placebo-controlled Phase 3 clinical trial in patients with scleroderma. Cytori anticipates unblinding of the trial data in mid-2017. The combination of the anticipated US-based STAR data with clinical data from the completed SCLERADEC I pilot trial, anticipated clinical data from the ongoing SCLERADEC II trial in Europe, the accumulated preclinical data, patient advocacy awareness, extensive market analysis, and Cytori’s intellectual property position provide compelling support for continued research, development and commercial planning of Habeo Cell Therapy in Secondary RP.

About Cytori Therapeutics

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 http://www.cytori.com.

• About the STAR Trial — The STAR trial is a Phase 3, US-based, multi-center (19 sites), randomized, controlled trial of Cytori Cell Therapy™ in 88 patients with hand dysfunction and Raynaud’s phenomenon associated with scleroderma. Enrollment was completed in mid-2016. Data unblinding and analysis will commence once the last enrolled subject has competed their 48-week follow-up visit, anticipated to be in mid-2017.
• About the SCLERADEC I Trial — The SCLERADEC I trial was a single-center, open-label study of the use of Cytori Cell Therapy (Habeo) in 12 patients with scleroderma. Short- (6-month) and long-term (24-month) results of the trial have been published in the peer-reviewed literature. Cytori recently released preliminary top-line data from 36 months of follow-up that indicated general persistence of the apparent benefit. Cytori anticipates publication or presentation of these data in the first half of 2017.
• About the SCLERADEC II Trial — The SCLERADEC II trial is a multi-center, randomized, double-blind, placebo-controlled trial of Cytori Cell Therapy (Habeo) in up to 40 patients with hand dysfunction associated with scleroderma. Enrollment in this trial is ongoing at three centers in France. Completion of enrollment is anticipated in mid-2017 with data unblinding and analysis estimated to occur by the end of 2017. Subjects assigned to the control arm of this study have their cell therapy product stored (cryopreserved) and will be given the opportunity to receive their cells once the study is unblinded.

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 potential benefits of Habeo Cell Therapy for patients with Secondary RP (including the potential to improve function, reduce pain, and restore activities of daily living), Cytori’s plan to leverage existing preclinical and clinical data to investigate possible use of Habeo Cell Therapy in Secondary RP, and projected availability of clinical data, 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 conduct of clinical trials (including risks associated with conduct of investigator-initiated trials) and clinical trial results, risks in the collection of clinical data, final clinical outcomes risks (including continued access to capital necessary to initiate, run and complete development and clinical programs for Secondary RP), risk regarding protection of intellectual property rights, regulatory uncertainties, risks regarding dependence on third party performance, competitive risks (including potential introduction of superior alternative therapeutic approaches to scleroderma and Secondary RP), and 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 unless we have an obligation under U.S. Federal securities laws to do so.

Cytori Therapeutics, Inc.
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