Cytori Therapeutics Cell Therapy Leads To Improved Function And Reduced Scar Tissue In A Urinary Injury Model

SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today the publication in The Journal of Urology of a preclinical study applying Adipose-Derived Regenerative Cells (ADRCs) prepared using Cytori Cell Therapy in a large animal model of urethral injury.

“This important safety and proof of concept preclinical study will be useful in forthcoming regulatory submissions in the US, Europe and Japan.”

The results show that delivery of the cell therapy product immediately after injury resulted in a >50% decrease in fibrotic scar tissue from 17% of total urethral surface area in the control to 7% in the treated group (p=0.05) 30 days following treatment. The study further reported that delaying delivery of the cell therapy product until 30 days after injury—a time at which urethral fibrosis was well-established—led to >10-fold decrease in injured surface area (from 13% of the urethra in the control group to 1% in the treated group; p<0.05) at 60 days after injury (30 days after treatment). ADRC-treatment was also associated with a statistically significant increase in the maximum pressure generated by the urethra, an important component of urinary sphincter function.

This study was led by Drs. Giles Karsenty and Romain Boissier of Aix-Marseille University in Marseille, France supported by the team of Pr. Florence Sabatier of the Cell Therapy Department of Hôpital de le Conception, Assistance Publique-Hôpitaux de Marseille.

“These now published findings support the use of either immediate or delayed application of Cytori Cell Therapy to help reduce injury and scarring,” said Dr. Marc Hedrick, President and CEO of Cytori. “This important safety and proof of concept preclinical study will be useful in forthcoming regulatory submissions in the US, Europe and Japan.”

Data from this preclinical study supported the company’s recently enrolled the STAR clinical trial, an FDA-approved, 88 patient, multi-center, randomized controlled Phase III trial of Cytori Cell Therapy for the treatment of hand dysfunction and Raynaud’s Phenomenon in patients with scleroderma as well as the investigator-initiated, ADRESU urinary incontinence trial currently enrolling in Japan. A reduction in cutaneous fibrosis as measured by the modified Rodnan Skin Score (mRSS) of the hand was also noted in the previous published SCLERADEC I clinical trial.

Links:

Boissier et al (2016) “Histologic and urodynamic effects of autologous stromal vascular fraction extracted from fat tissue with minimal ex vivo manipulation on a porcine model of intrinsic sphincter deficiency.” J Urol pii: S0022-5347(16)30555-9. doi: 10.1016/j.juro.2016.04.099. [Epub ahead of print]

The ADRESU Trial

The STAR Trial

The SCLERADEC I Trial

The SCLERADEC II Trial

About Cytori

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 statements regarding clinical trial results and related benefits of Cytori Cell Therapy, and possible benefits of preclinical study data to Cytori (including its pipeline and prospects) are all 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 preclinical and clinical trials and the results of such trials (including risks that further studies may not support efficacy or safety of Cytori Cell Therapy) are 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.