Enrollment Begins in Cytori Phase III/Pivotal ADRESU Urinary Incontinence Trial
September 03 2015 - 7:00AM
Business Wire
Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced that the
first patient has been enrolled and treated in the ADRESU trial, a
late phase, physician-initiated Japanese clinical trial to study
the efficacy and safety of Cytori Cell Therapy™ in men with urinary
incontinence after prostatic surgery for prostate cancer or benign
prostatic hypertrophy.
ADRESU is a multicenter, 45 patient open label controlled trial
of the ECCI-50 cellular therapeutic and is based on promising pilot
trial data published in the International Journal of Urology in
2014. Details of the pilot trial can be found on clinicaltrials.gov
and the MHLW website. The primary endpoint for the ADRESU trial
will be the number of patients who experience reduction of urinary
leakage volume (as measured by the weight of diaper pads used over
24 hours) 52 weeks after treatment. If the endpoint is successfully
achieved, the data will be used to seek approval of Cytori Cell
Therapy for this indication. The trial costs are substantially
supported by Japan’s Ministry of Health, Labour and Welfare, with
additional support by Cytori. The trial is sponsored by Nagoya
University.
“Cytori is committed to the goal of obtaining the first approval
for a cellular therapeutic product since the new Regenerative
Medicine Law was implemented in November 2014,” said Dr. Marc H.
Hedrick, President and CEO of Cytori Therapeutics. “The
administration of Prime Minister Abe has made a substantial
commitment of Japanese resources to this field and we feel likewise
committed to this important market.”
Cytori has been commercially active in the Japanese market since
2008 through its Japanese subsidiary and has had a full-time office
and in-country leadership in Japan since 2005. Over that period of
time, Cytori has built a user base of approximately 50 sites,
including both hospitals and individual clinics. Many users are in
leading academic institutions throughout Japan, such as Nagoya
University.
Dr. Momokazu Gotoh, Professor and Chairman of the Department of
Urology at Nagoya University and Principal Investigator on the
ADRESU trial, said, “Prostatic disease is a very common cancer in
aging males. Incontinence after prostatic manipulation or surgery
is notoriously hard to treat and physicians have little to offer
these patients beyond adult diapers and psychological support.
Cytori Cell Therapy technology performed well in the pilot trial
and holds promise as an effective therapy for this indication.”
The ADRESU trial was based on preliminary safety and efficacy
data published in 2014 in the International Journal of Urology.
Following enrollment and assessment of the results of the trial,
Cytori and Nagoya University intend to file for medical device
approval for the therapy, which in Japan is typically combined with
reimbursement.
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, conduct of clinical trials involving
our technology, clinical performance, product approvals and product
reimbursement, 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150903005467/en/
Cytori Therapeutics, Inc.Tiago Girao, +1 (858)
458-0900ir@cytori.com
Cytori Therapeutics (NASDAQ:CYTX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cytori Therapeutics (NASDAQ:CYTX)
Historical Stock Chart
From Apr 2023 to Apr 2024