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Enrollment Begins in Cytori Phase III/Pivotal ADRESU Urinary Incontinence Trial

2015年09月03日 PM08:00
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SAN DIEGO

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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20150903005467/en/

CONTACT

Cytori Therapeutics, Inc.
Tiago Girao, +1 (858) 458-0900
ir@cytori.com

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