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Press Release

STAR Trial Data Accepted for Presentation at Systemic Sclerosis World Congress


Posted on: 07 Nov 17

SAN DIEGO, Nov. 07, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (Nasdaq:CYTX) (“Cytori” or “the Company”) announced today that its U.S. STAR clinical trial assessing the safety and efficacy  of Habeo™ Cell Therapy for hand dysfunction due to systemic scleroderma (SSc) has been accepted for presentation at the 5th Systemic Sclerosis World Congress on February 15-17, 2018 in Bordeaux, France.

The presentation will include a full data analysis, beyond the top-line results previously reported by the company in July and October 2017, specifically:

  • While there were trends toward greater improvement in the primary endpoint, Cochin Hand Function Score [CHFS], for Habeo compared to placebo at 24 and 48 weeks, for both time points these differences did not achieve statistical significance of p≤0.05.
  • The pre-specified analysis of 51 subjects with diffuse SSc showed a clinically meaningful treatment benefit at 48 weeks in both the CHFS (improvement of 12.0 points for Habeo compared to 6.6 in the placebo group) and in a secondary endpoint, the Health Assessment Questionnaire Disability Index [HAQ-DI] (improvement of 0.21 points compared with 0.04 in the placebo). These differences approached or achieved statistical significance (p=0.069 and p=0.044, respectively).

Subsequent data analysis of these and other key endpoints in patients with diffuse SSc are also consistent with a treatment effect:

  • Responder analysis for the HAQ-DI score at 48 weeks, based on published minimal clinical important differences, showed that 63% of patients in the Habeo group had a clinically-important improvement compared with only 26% of patients in the placebo group (p=0.019)
  • A standardized measure of health-related quality of life, EQ-5D, showed that 50% of patients in the placebo group exhibited clinically-important worsening at 48 weeks compared to only 3% in the Habeo group (p=0.0002).
  • Patients in the Habeo group, compared to the placebo group, also exhibited a reduced number of new ulcers over the 48 week study period (mean 1.72/patient compared with 3.74/patient in the placebo group; p=0.178), delayed time to first new ulcer (p=0.116), and greater improvement in hand mobility at 48 weeks, as measured by 2nd-4th corner distance of right hand (~5.5 mm increase vs. ~0.6 mm decrease, respectively; p=0.135).

The full data set will be presented at the 5th Systemic Sclerosis World Congress on February 15-17, 2018.

STAR was a randomized, placebo-controlled, double-blind, parallel group, U.S. clinical trial intended to study the safety and efficacy of Habeo Cell Therapy in 88 subjects with hand dysfunction due to scleroderma at 19 U.S. centers.  Cytori is currently working with statisticians and study investigators in preparation for publication of these results in a peer-reviewed journal.

About Scleroderma

Scleroderma is a rare and chronic connective tissue disease generally classified as an autoimmune rheumatic disorder. The word “scleroderma” is derived from two Greek words: “sclera,” which means hard, and “derma,” meaning skin, as hardening of the skin is one of the most visible manifestations of the disease. An estimated 300,000 Americans have scleroderma, about one-third of whom have the systemic form of the disease, known as systemic sclerosis (SSc). SSc is further sub-classified as diffuse cutaneous and limited cutaneous SSc. Patients with diffuse cutaneous SSc have more severe disease with significant hand dysfunction and internal organ involvement. Diffuse scleroderma accounts for between one-third and one-half of all cases of systemic sclerosis.1,2

SSc contributes to hand impairment through inflammatory arthritis or inflammation of the joints, joint contractures, Raynaud’s Phenomenon (RP, skin discoloration resulting from narrowing of the blood vessels in response to cold, emotional upset, or stress), digital ulcers, puffy hands and skin fibrosis over the fingers and hands, and calcinosis (calcium deposits in the soft tissues of the hand). These manifestations, which often coexist, can contribute to difficulty with occupational activities and activities of daily living, which can impair quality of life. Whereas current treatment recommendations focus on management of internal organ involvement, there is little treatment available for hand impairment.

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking statements regarding events, trends and business prospects, which may affect Cytori’s future operating results and financial position. These statements are subject to risks and uncertainties that could cause Cytori’s actual results and financial position to differ materially. Some of these risks and uncertainties include: the risk that the cost and other negative effects related to the workforce reduction may be greater than anticipated; the risk that Cytori may not realize the benefits expected from the workforce reduction or other cost control measures; the risk that Cytori may need additional funds to conduct its operations, and that investors may not agree with the manner in which Cytori allocates its resources; unexpected or unfavorable clinical data, and the risk that regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Cytori, request additional information, have additional recommendations or change their guidance or requirements; the timing, success and cost of Cytori’s research and development and related strategy and decisions; Cytori’s ability to comply with the terms of its credit agreement and the potential for acceleration of amounts owed to its secured lender; the potential for litigation or other disagreements with third parties; and other risks and uncertainties described under the “Risk Factors” section in Cytori's Securities and Exchange Commission filings on Form 10-K and Form 10-Q. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this communication.

1http://www.scleroderma.org/site/PageNavigator/patients_whatis.html#.WWZdOYjyvGh

2 Arthritis Rheumatism Vol 48, (8), August 2003, pp 2246–2255 DOI 10.1002/art.11073

Investor Contact:
Tiago Girao
ir@cytori.com
Cytori Therapeutics, Inc. 
1-858-458-0900

GlobeNewswire
globenewswire.com

Last updated on: 07/11/2017

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