One Year Follow Up of Cytori Cell Therapy™ in Investigator Erectile Dysfunction Trial

Data suggests safety and potential sustained efficacy in post prostatectomy patients  failing pharmacologic intervention


SAN DIEGO, May 10, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) announces one year follow up data of  ADRCs (Cytori Cell Therapy™) treatment in post prostatectomy erectile dysfunction. The related abstract and presentation will occur at the 2017 American Urological Association Annual Meeting, May 12-16 in Boston. The abstract is currently available in the Journal of Urology (online).

The investigator initiated, open label, Phase I, single arm pilot trial studied 21 men with post prostatectomy erectile dysfunction with insufficient clinical effect after maximal pharmacologic intervention. The abstract reports that following a single administration of Cytori Cell Therapy™, eight of 14  (57%) of subjects with urinary continence at baseline recovered their erectile function and could implement sexual intercourse after 6 months with the effect sustained to 12 months after treatment. This was associated with a modest but statistically significant sustained improvement in the patient’s IIEF-5 score, a widely used measure of male sexual function. Efficacy was solely demonstrated in patients that were continent at inclusion of the trial. No serious adverse events and 8 minor events related to the liposuction were reported.

This data follows previously published six month follow-up from the same trial on a smaller subset of 17 men with erectile dysfunction following radical prostatectomy (publication available here).

In addition to this study in erectile dysfunction, Cytori Cell TherapyTM is currently being studied in the ADRESU trial in Japan for male urinary incontinence following prostatic surgery.  This investigator initiated, phase III, multicenter, 45 patient trial of Cytori’s ECCI-50 cellular therapeutic 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 Japanese Ministry of Health Labour and Welfare website

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 encapsulated therapies for regenerative medicine and oncologic indications. 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 and presentation of clinical data, 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 conduct of investigator-initiated clinical trials, protection of intellectual property rights, regulatory uncertainties, 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.

 


            

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