SAN DIEGO and TOKYO, March 28, 2018 (GLOBE NEWSWIRE) — 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 Investigators
The 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 Incontinence
Male 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 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.
Cytori Therapeutics, Inc.