Enrollment Begins in Cytori Phase III/Pivotal ADRESU Urinary Incontinence Trial
SAN DIEGO–(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.
Contacts
Cytori Therapeutics, Inc.
Tiago Girao, +1 (858) 458-0900
ir@cytori.com
