- 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).
- 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 2 nd-4 th corner distance of right hand (~5.5 mm increase vs. ~0.6 mm decrease, respectively; p=0.135).
Cautionary Statement Regarding Forward-Looking StatementsThis 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. 1 http://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 Giraoir@cytori.comCytori Therapeutics, Inc. 1-858-458-0900