Enrollment Completed in ADRESU Clinical Trial of Cytori Cell Therapy™ for Stress Urinary Incontinence
March 28 2018 - 12:00PM
Cytori Therapeutics, Inc. (NASDAQ:CYTX) announced today that
full enrollment has been reached in the ADRESU
investigator-initiated clinical trial of Cytori Cell Therapy™ for
men with stress urinary incontinence as a complication of prostate
intervention. A total of 45 patients, all treated in Japan,
were enrolled in this potential approval trial.
ADRESU is an investigator-initiated, multicenter, 45 patient,
open-label, single arm clinical trial of Cytori’s ECCI-50 cellular
therapeutic, comprised of Celution®-prepared autologous Adipose
Derived Regenerative Cells (ADRCs) and Adipose Cells. The
ADRESU trial was based on a promising pilot trial with short-term
data of 11 patients published in the International Journal of
Urology in 2014 and long-term data of 14 patients presented at
the International Continence Society in 2017, which “demonstrated
that transurethral injection of autologous ADRCs can be a safe and
effective treatment modality for postprostatectomy incontinence”.
Details of the ADRESU protocol and trial can be found
on BMC Urology, clinicaltrials.gov and
the University Hospital Medical Information Network
website.
The primary endpoint for the ADRESU trial is the percentage of
patients who experience greater than 50% reduction in urinary
leakage volume from baseline (as measured by the weight of
unintended urinary leakage over 24 hours) at 52 weeks after
treatment. A number of other key secondary endpoints are also being
assessed. If the primary endpoint is successfully achieved, the
data may be used to seek approval of ECCI-50 for this
indication.
The trial costs are substantially supported by the Japan Agency
for Medical Research and Development, an independent administrative
agency of the Government of Japan, with additional support from
Cytori. The trial is sponsored by the lead institution,
Nagoya University.
“Cytori would like to thank the investigators and patients
participating across the 4 sites involved in this clinical trial:
Nagoya University, Shinshu University, Kanazawa University and
Dokkyo University,” said Dr. Marc H. Hedrick, President and
CEO of Cytori Therapeutics. “If the trial successfully meets
key endpoints, Cytori intends to seek marketing approval and
reimbursement for this cellular therapeutic product in Japan.”
Use of Cytori Cell Therapy™ is growing in Japan, primarily for
aesthetic, breast and osteoarthritis indications. Japan’s
groundbreaking Regenerative Medicine Law, enacted in November 2014,
provides companies such as Cytori that offer regenerative medicine
such as Cytori Cell Therapy, expedited pathways to the market.
Since 2008, Cytori’s Japanese subsidiary has built an
installed customer base of 77 centers using its regenerative
medicine products and has shown double digit growth in utilization
over the preceding 3 years.
“Prostatic disease, including prostate cancer and benign
prostatic hyperplasia is very common among aging males,” said Dr.
Momokazu Gotoh, Professor and Chairman of the Department of
Urology at Nagoya University and Principal
Investigator for the ADRESU trial. “Urinary incontinence, as a
complication of prostatic intervention, is difficult to treat and
limited treatment options are available. Most patients resort to
wearing a diaper to manage the leakage. Cytori Cell Therapy would
be the first approved therapy for this indication in Japan.”
About ADRESU InvestigatorsThe ADRESU trial is
being led by Dr. Momokazu Gotoh at Nagoya University, Aichi,
Japan. The other participating investigators and institutes
include Dr. Kazutaka Narimoto at Kanazawa University Hospital
(Ishikawa, Japan), Dr. Osamu Ishizuka at Shinshu University
Hospital (Nagano, Japan) and Dr. Tomonori Yamanashi at Dokkyo
Medical University (Tochigi, Japan).
About Male Stress Urinary
IncontinenceMale stress urinary incontinence is a
post-surgical complication of radical prostatectomy and surgeries
for benign prostatic hyperplasia with limited treatment options,
representing an unmet medical need. In 2016, the Ministry of
Health, Labor and Welfare (MHLW) reported approximately 20,000
prostate cancer surgeries and 22,000 benign prostatic hyperplasia
procedures performed at Diagnostic Procedure Combination (DPC)
participating hospitals.
About Cytori Cell Therapy™ Cytori is
developing cell therapies that harness the unique attributes of
adipose-derived regenerative cells (ADRCs), which are living cells
that are present in an adult human’s own adipose tissue.
Cytori Cell Therapy™ is a suspension of ADRCs that are
manufactured from a single lipoaspirate (material removed via
liposuction, a procedure in which fat is removed from under the
skin by suction). The process concentrates ADRCs intended for
autologous re-implantation subcutaneously into the digits. The
resultant cell suspension contains critical cells naturally
occurring in the patient’s own tissue. Preparation of autologous
ADRCs for subcutaneous delivery involves no cell culture and can be
prepared and re-implanted into the same patient within 4 hours
About Cytori Therapeutics, Inc.Cytori is a
therapeutics company developing regenerative and oncologic
therapies from its proprietary cell therapy and nanoparticle
platforms for 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. Cytori Nanomedicine™ is developing liposome encapsulated
therapies for regenerative medicine and oncologic indications. For
more information, visit www.cytori.com.
Cautionary Statement Regarding Forward-Looking
StatementsThis 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.
Investor Contact:Tiago GiraoCytori
Therapeutics, Inc. 1-858-458-0900 ir@cytori.com
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