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Cytori ATHENA Trial Results Support Symptomatic Benefit From Cytori Cell Therapy

PSTV | May 6, 2016

Cytori ATHENA Trial Results Support Symptomatic Benefit From Cytori Cell Therapy

Cytori Therapeutics, Inc. (NASDAQ:CYTX) announced today the presentation of six and twelve month data from the ATHENA Trials at the annual meeting of The Society for Cardiovascular Angiography and Interventions. The ATHENA trials are two prospective, randomized (2:1, active : placebo), double-blind, controlled, parallel group trials (ATHENA and ATHENA II) each assessing Cytori Cell Therapy® [ATHENA: 20 million cells, 28 patients; ATHENA II: 40 million cells, 3 patients]. The objective of the ATHENA program was assessment of safety and feasibility of Cytori Cell Therapy using the Celution® System automated on-site manufacturing of the cellular therapeutic and intramyocardial delivery for treatment of chronic ischemic heart disease with left heart failure.

On the treatment day, patients underwent fat harvest via small volume lipoharvest followed by cell processing, electromechanical mapping of the left ventricle with subsequent injection of cells (or placebo) into viable myocardium intramyocardial.

A total of 31 patients (17 Cytori Cell Therapy, 14 placebo) were randomized prior to termination of enrollment, with 28 patients having 6 month or longer follow-up data. Trial enrollment was terminated prematurely due to the prolonged period of enrollment required. Enrollment was prolonged due to challenges in identifying suitable patients who met all inclusion/exclusion criteria and two trial enrollment delays related to safety reviews during the trial. ATHENA and ATHENA II trial data were combined for analyses.

Top line 12 month data revealed:

Improvements in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) total score (a validated questionnaire for disease specific health related quality of life) were observed in the Cytori Cell Therapy group relative to the placebo group. The mean (95% CI) between group differences (Cytori Cell Therapy minus placebo) for the change from baseline were as follows: 3 months = -4.7 (-20.3, 10.9) (p=0.54), 6 months = -9.4 (-22.5, 3.8) (p=0.154) and 12 months = -16.3 (-31.7, -1.0) (p=0.038).
The SF-36 (a validated questionnaire for generic health related quality of life) results showed trends toward improvement in the Cytori Cell Therapy group relative to the placebo group, with several domains associated with nominal p-values less than 0.05.
At 6 months post-treatment, incremental treadmill testing, left ventricular ejection fraction, left ventricular end-systolic volume and left ventricular end-systolic volume showed no relevant differences between groups. As per the protocol, echocardiogram and treadmill testing were not conducted at 12 month post-treatment.
Heart failure hospitalizations were reported by investigators in 3/17 (17.6%) and 5/14 (35.7%) of cell treated and placebo treated groups respectively.

Regarding safety, 18 of 31 patients (58.1%) were reported to have at least one serious adverse event during the trial (Cytori Cell Therapy 9/17 (52.9%), placebo 9/14 (64.3%)). Two non-cell related fatal events occurred during the trial in the Cytori Cell Therapy group (myocardial ischemia – day 2 post-procedure, decompensation of heart failure – day 291 post-procedure) with none in the placebo group.

“The ATHENA data suggest that a small volume fat harvest, followed by automated local processing, and intramyocardial delivery of autologous Cytori Cell Therapy is feasible and may be associated with symptomatic benefit in these patients. Although the sample is size is limited, the findings support feasibility and scalability for use of Cytori Cell Therapy for treatment of ischemic heart disease,” said Dr. Tim Henry, Director, Division of Cardiology, Cedars-Sinai Heart Institute, Los Angeles and one of the coordinating investigators for the ATHENA trials.

About Cytori Therapeutics, Inc.

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, clinical performance of our technology, including its safety and feasibility, and publication of our study 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 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.