Cytori Reports Sustained Benefit of Cell Therapy in Erectile Dysfunction Trial
July 09 2018 - 12:00AM
Cytori Therapeutics, Inc. (Nasdaq:CYTX) announced publication in
the peer-reviewed journal, Urology, of “A 12-Month Follow-up After
a Single Intracavernous Injection of Autologous Adipose-derived
Regenerative Cells in Patients with Erectile Dysfunction Following
Radical Prostatectomy: An Open-label Phase I Clinical Trial”.
The trial of Adipose-Derived Regenerative Cells (ADRCs) or
Cytori Cell Therapy™ in erectile dysfunction (ED) following radical
prostatectomy was performed by investigators from the Danish Centre
for Regenerative Medicine and Odense University Hospital, Odense,
Denmark.
In the trial, 21 patients with ED after radical prostatectomy
(RP), with no signs of recovery following conventional therapy,
received a single intra-cavernous injection of autologous ADRCs.
Six men were incontinent, and 15 were continent at inclusion.
Safety and efficacy (sexual function) were evaluated over 12 months
through assessment of adverse events and use of validated
questionnaires including the International Index of Erectile
Function-5 (IIEF-5) and Erection Hardness Score (EHS).
The mean age at baseline was 60.2 years (range 46-69). The
approach was deemed safe with no serious adverse events reported.
At 12 months following treatment with cell therapy, erectile
function assessed using the IIEF-5 showed a statistically
significant improvement from a median baseline score of six to a
median of eight; p=0.004. Subset analysis of the 15 patients with
urinary continence at baseline, showed substantially greater
improvement from a median baseline score of six to 13; p=0.012.
At 12 months after surgery, median EHS was unchanged in the
combined group of 21 patients. However, patients in the continent
subset exhibited statistically significant improvement in EHS from
a baseline median score of one to a median of two at 12 months;
p=0.03. Further, 53.3% or eight out of 15 continent patients
reported recovered function sufficient for completion of
intercourse.
ED and urinary incontinence are serious issues for many men
following RP. Cytori Cell Therapy™ is being used to address both of
these medical problems. Thus, in addition to the work published in
this report, the company has fully enrolled the Autologus Aipose
Derived Regenerative Cells for the Treatment of Male Stress Urinary
Incontinence (ADRESU) trial of Cytori Cell Therapy™ in men with
stress urinary incontinence following RP. 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) one year following treatment. Data from ADRESU are
anticipated in the first half of 2019.
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 ADRCs and
Adipose Cells. The ADRESU trial was based on a promising pilot
trial with short-term data of eleven 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.
About CytoriCytori 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 encapsulated therapies for regenerative
medicine and oncologic indications using technology that allows
Cytori to use the benefits of its encapsulation platform to develop
novel therapeutic strategies and reformulate other drugs to
optimize their clinical properties. 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.
These statements are subject to risks and uncertainties that could
cause Cytori’s actual results and financial position to differ
materially. Such statements, including, without limitation,
statements regarding Cytori Cell Therapy’s potential to provide
benefits across multiple disease states, the conduct of the ADRESU
trial and timing of anticipated trial data, are subject to risks
and uncertainties that could cause our actual results and financial
position to differ materially. These risks and uncertainties, which
include inherent uncertainties in conduct of clinical studies and
trials and the results of such trials (including risks that further
studies may not support efficacy or safety of Cytori Cell Therapy),
risks associated with clinical use of Cytori Cell Therapy in
studies and trials not controlled by Cytori, risks to Cytori’s
intellectual property portfolio are described under the heading
"Risk Factors" in Cytori's Securities and Exchange Commission
Filings on Form 10-K and Form 10-Q. Cytori assumes no
responsibility to update or revise any forward-looking statements
to reflect events, trends or circumstances after the date they are
made.
CONTACTCYTORI THERAPEUTICS
Tiago Girao+1.858.458.0900 ir@cytori.com
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