Cytori Reports Interim Data on U.S. Phase II Osteoarthritis Trial
Data suggest beneficial effect of ECCO-50 for knee osteoarthritis:
full data set expected Q3 2016
SAN DIEGO–(BUSINESS WIRE)–Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today the top-line
data as part of the pre-specified partial unblinding of 24 week follow
up data from the company’s ACT-OA trial. The trial is a U.S. phase II
randomized, double-blind, placebo controlled trial designed to evaluate
the safety and feasibility at 48 weeks of a single intra-articular knee
injection of the ECCO-50 cellular therapeutic in patients with chronic
knee pain due to osteoarthritis.
“Key endpoints and trends observed thus far suggest that a beneficial
effect may be attributable to a single intra-articular administration of
ECCO-50 in patients with osteoarthritis of the knee,” said Dr. Marc H.
Hedrick, President and CEO of Cytori Therapeutics. “The full 48 week
data set is the next important milestone in this program. While we
continue to move our clinical pipeline along, the company will remain
intensely focused on bringing to market our lead therapeutic for
scleroderma which is currently in phase III.”
The primary goal of the ACT-OA trial is to help determine: (1) safety
and feasibility of ECCO-50 for osteoarthritis, (2) provide dosing
guidance and (3) explore key trial endpoints useful for a phase III
trial. As a proof of concept trial, ACT-OA was not sized or powered for
statistical significance in any of the endpoints.
The purpose of the interim 24 week partial unblinding in this trial is
to provide early data that will facilitate key regulatory and business
development discussions and provide better understanding of the
therapeutic mechanism of action that may impact other clinical programs.
The interim analysis pre-specifies the evaluation of a number of patient
reported outcomes important in patients with osteoarthritis of the knee.
A total of 94 patients were treated in the trial (30 received a low dose
of ECCO-50 [20 million cells], 31 received a high dose of ECCO-50 [40
million cells] and 33 received placebo). Patients, providers and Cytori
personnel remain blinded to individual patient treatment allocation and
patient subgroup outcomes.
The interim top-line data show the following:
-
The randomization is relatively balanced among the three treatment
groups: low dose, high dose and placebo. -
Intra-articular application of a single dose of ECCO-50 appears to be
safe and feasible in an outpatient day-surgery setting. No
complications occurred related to the fat harvest, cell processing or
cell delivery. -
A significant placebo response was observed, similar to that
demonstrated in other OA trials. -
The pre-specified primary endpoint, pain on walking at 12 weeks, as
measured by a single question from the Knee Injury and Osteoarthritis
Outcome Score (KOOS) did not obtain statistical significance. -
Key secondary endpoints include the total and sub-scores of the KOOS,
patient assessment of knee pain, knee stability, osteoarthritis
activity and osteoarthritis damage, use of as-needed pain medication,
pain while walking 50 feet and health status as measured by the SF-36.
Consistent trends were observed suggesting improvement in the cell
treated group relative to the placebo group at the 12 and 24 week time
periods for patient reported outcomes. - Both high dose and low dose of ECCO-50 performed similarly.
In the 3rd quarter, following full unblinding of the data,
the Company will be able to more fully evaluate the data, including 48
week follow up, patient subset analyses, and the effect on knee
cartilage as measured by magnetic resonance imaging results changes
between baseline and 48 weeks.
In summary, patterns of response are suggestive of a beneficial effect
attributable to a single intra-articular administration of ECCO-50 in
patients with osteoarthritis of the knee. The full 48 week data are
expected to be available for review during the third quarter of this
year, which will more fully inform further development decisions,
including phase III trial design, cell dose, administration protocol,
inclusion/exclusion criteria, selection of primary and secondary
endpoints and sample size. Further details of the trial can be found on clinicaltrials.gov
(NCT02326961).
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 (i) clinical performance of our
technology, including its safety, efficacy and feasibility, (ii) our
clinical pipeline, including our focus on bringing our scleroderma
therapeutic to market, and (iii) review and publication of our study
data (including anticipated 48 week 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 of
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.
Contacts
Cytori Therapeutics, Inc.
Tiago Girao, +1 (858) 458-0900
ir@cytori.com
