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(July 09, 2018)
Benefit Observed at 12 months Postoperatively Following Single Administration
SAN DIEGO, July 09, 2018 (GLOBE NEWSWIRE) -- 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.
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 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.
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