Cytori ATHENA Trial Results Support Symptomatic Benefit From Cytori Cell Therapy

SAN DIEGO–(BUSINESS WIRE)–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.