Cytori ATHENA Trial for Chronic Ischemic Cardiovascular Disease

Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that the results from the ATHENA Trials have been published and are now available online in Catheterization and Cardiovascular Interventions, a leading international journal covering the broad field of cardiovascular diseases and the official journal of The Society for Cardiovascular Angiography and Interventions that has over 4,300 interventional and invasive cardiologist members in over 70 countries.

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: 40 million cells, 28 patients; ATHENA II: 80 million cells, 3 patients]. The objective of the ATHENA program was assessment of safety and feasibility of Cytori Cell Therapy using the Celution® System for 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.

Thirty-one 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 prior to the planned target (45 patients per trial) due to the prolonged period of enrollment and safety reviews. ATHENA and ATHENA II trial data were combined for analyses.

The key results were as follows:

• 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)
  • 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 12 months, New York Heart Association class improved in 57% of ADRC-treated patients compared to 15% of placebo patients. The corresponding values for the Canadian Cardiovascular Society class were 67% and 27%.
• Echocardiogram and treadmill testing was performed at baseline and 6 months post-treatment. The mean change from baseline to 6 months in maximum oxygen consumption was 45.4±222 mL/min (ADRC, n=15) vs. -9.5±137 mL/min (placebo, n =10) [mean (95% CI) between group difference = 54.9 (-109, 219), p=0.495]. Left ventricular ejection fraction, left ventricular end-systolic volume and left ventricular end-systolic volume showed no relevant differences between groups.
• Heart failure hospitalizations were reported in 3/17 (17.6%) and 5/14 (35.7%) of cell treated and placebo treated groups respectively. Central adjudication of these events showed the respective numbers to be 2/17 (11.7%) and 3/14 (21.4%).

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%)). Major Adverse Cardiovascular Events (MACE) occurred in 6/17 (35.3%) of ADRC patients and 3/14 (21.4%) of placebo patients. Two fatal events were reported during the trial with both occurring in the Cytori Cell Therapy group (myocardial ischemia – day 2 post-procedure, decompensation of heart failure – day 291 post-procedure).

The authors stated “… it appears feasible to harvest, process on-site, and deliver autologous ADRCs on the same day to patients with severe ischemic cardiomyopathy. ADRC delivery was associated with signals of benefit on both patient reported outcomes and ischemic burden.”

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, statements regarding clinical performance of our technology, including safety, feasibility and possible benefits associated with its use, 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.

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