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NEWS -- Cytori Cell Therapy™ Clinical Trial Results

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Paulness   Thursday, 01/31/19 09:02:26 AM
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NEWS -- Cytori Cell Therapy™ Clinical Trial Results in Crohn’s Disease
  • 80% of Treated Patients with Clinical Response at 48 weeks, Published in Gastroenterology
SAN DIEGO, Jan. 31, 2019 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (CYTX) announces the publication of results from a pilot investigator-initiated clinical trial of Cytori Cell Therapy™ for the treatment of refractory perianal fistula in patients with Crohn’s Disease. These findings were published online this month in the journal Gastroenterology1, a publication of the American Gastroenterological Association.

Highlighted results from this study:
  • 10 patients were treated with a single administration of Cytori Cell Therapy™. No significant safety concerns were noted as part of the therapy.
  • 80% of patients exhibited a clinical response at 48 weeks; 60% of patients were deemed in combined remission with no evidence of leakage by clinical examination or MRI.
  • 76% of treated external fistula openings showed complete re-epithelialization or an absence of drainage at week 48
  • >50% decrease in mean Perianal Crohn’s Disease Activity Index (PDAI) 2 at 48 weeks (7.3 points at baseline to 3.4 points at 48 weeks). Mean PDAI score at 12 and 48 weeks after treatment (3.8 points and 3.4 points respectively) was below the threshold score of 4 that indicates active disease, requiring medical or surgical treatment.
The treatment approach involved a single administration of an average dose of 23 M freshly prepared autologous adipose-derived regenerative cells (ADRCs) into the fistulous tract in combination with an autologous adipose micrograft. Cytori Cell Therapy™ was prepared using Cytori’s Celution® 800/CRS System, similar to the product that was recently approved as a Class III medical device in Japan.

Crohn’s Disease (CD) is a rare, chronic idiopathic inflammatory bowel disease condition with no cure that is characterized by flares and remission across the entire gastrointestinal tract from the mouth to the anus. Perianal fistulas are a common in CD (26% of patients within 20 years of CD diagnosis) and typically complex (70-80% of perianal fistulas). These fistulas cause pain, depression, a decreased quality of life, and an increased risk of anal epithelia carcinoma. Management of these fistulas has improved over the last 20 years, but even with the latest combined medical and surgical approaches, healing rates have only approached 50%.

CD can affect people of all ages, though onset is most common in late adolescence and early adulthood, and has a prevalence of up to 0.2% (201 existing cases per 100,000 population) and incidence of 0.015% (14.6 new cases per 100,000 population) according to the CDC.

The study was conducted by a team of investigators from the Departments of Gastroenterology, Digestive Surgery, Plastic Surgery, and Cell Therapy of the Assistance Publique Hôpitaux de Marseille (APHM), Aix Marseille University, France. Cytori Cell Therapy has also been evaluated in clinical studies at this Institution for scleroderma and vocal cord scarring. Data from these studies are expected in 2019.

Cytori’s Cell Therapy products may have broad applicability across a range of diseases and conditions. It has been evaluated in both pre-clinical and clinical research studies and cited in over 65 publications. References to these studies can be found on Cytori’s website.

1 "Long-term safety and efficacy of local microinjection combining autologous microfat and adipose-derived stromal vascular fraction for the treatment of refractory perianal fistula in Crohn's disease” Serrero et al Gastroenterology. 2019 Jan 18. pii: S0016-5085(19)30092-7

2 The perianal disease activity index (PDAI) score includes the evaluation of 5 elements: fistula discharge, pain and restriction of activities, sexual activity restriction, type of perianal disease, and degree of induration. A PDAI score >4 suggests active fistula drainage or local inflammation, with an accuracy of 87%. This score has been validated in several clinical trials.

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 http://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, and product approvals, 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.

Investor Contact:

Tiago Girao
Cytori Therapeutics, Inc.

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