BARDA Funded Study Published in the Journal “Burns”
SAN DIEGO, June 28, 2018 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (Nasdaq:CYTX) announced today the publication of preclinical data from a study using intravenous delivery of Cytori Cell Therapy™ in a model of large burn injury representative of patients being recruited in the ongoing RELIEF clinical trial. This study was performed with support from the Biomedical Advanced Research and Development Authority (BARDA) as a component of the preclinical data supporting the FDA approved United States RELIEF Trial.
In the study described in this publication, Adipose Derived Regenerative Cells (ADRCs), the active component of Cytori Cell Therapy™, were delivered by intravenous injection in a porcine model of mixed full-and partial thickness burn injury covering approximately 20% of total body surface area in which full thickness burns were treated with a meshed autologous split-thickness skin graft. All animals received skin grafting procedures, burn dressings, and other supportive care commonly used in burn centers around the USA.
No serious adverse events related to ADRC infusion were noted in any of the animals. Delivery of ADRCs appeared to be safe with none of the systemic safety parameters worsened compared to the control group. Importantly, skin graft healing was significantly faster in ADRC-treated animals such that five days after treatment wounds in animals treated with ADRCs were 27.1±11.8% epithelialized compared to only 1.1±1.1% in control animals (p<0.05). Skin barrier function (ability to prevent water loss) was 20-fold greater in ADRC-treated wounds than in controls on Day 9 after treatment (32.8±6.3 vs. 157.8±57.3 g/m2/h, respectively; p=0.01). Skin biological elasticity was also significantly greater in ADRCs-treated animals compared to those treated with LR (0.50±0.1 vs. 0.44± 0.02, respectively; p=0.017). Similar improvement in healing was also evident in donor sites (epithelialization 52.8% vs. 33.1% on Day 5 post-treatment) and partial thickness burn (epithelialization 81.8% vs. 59.8% on Day 18 post-treatment).
Overall, the results of this study showed that healing of skin grafts occurred more rapidly in ADRC-treated animals than in controls with more rapid formation of new skin (epithelialization), earlier restoration of skin function (ability to resist water evaporation), and improved skin elasticity.
The paper entitled “Preclinical Assessment of Safety and Efficacy of Intravenous Delivery of Autologous Adipose-Derived Regenerative Cells (ADRCs) in the Treatment of Severe Thermal Burns using a Porcine Model” was published today in the journal Burns and is now available online.
The findings from this preclinical study have been incorporated into the design of the RELIEF clinical trial of Cytori Cell Therapy™ which is also funded by BARDA. The RELIEF trial is designed to assess Cytori Cell Therapy in human patients with substantial thermal burn injury using several of the end points used in this preclinical study including epithelialization, skin barrier function, and skin elasticity.
“Healing of meshed skin grafts remains an important clinical problem in burn care,”said Dr. John Fraser, Chief Scientist at Cytori. “We look forward to adding to the number of clinical sites already recruiting patients for the RELIEF trial and to assessing clinical data from RELIEF which applies the same treatment approach to treat very similar wounds.”
The treatment of thermal burns remains a critical unmet medical need. Despite standard of care primarily consisting of dressings, skin grafts and skin substitutes, patients frequently suffer from slow healing, pain, scarring, skin contracture and reduced range of motion.
Autologous cell therapies such as those offered by Cytori have the potential to improve the quality and rate of wound healing and reduce scarring. In a mass casualty event, the U.S. Government Accountability Office estimates that as many as 10,000 patients could require thermal burn care. The limited number of specialist surgeons and burn centers in the U.S. creates a public health need for a burn wound therapy that can be quickly and broadly applied by non-specialist medical personnel following such an event. Therefore, autologous Cytori’s Cell Therapy represents a novel medical countermeasure not only to address these challenges but also to promote wound healing and tissue repair and improve casualty care.
The RELIEF trial is designed to assess safety and feasibility of intravenous delivery of Cytori Cell Therapy™ as an adjunct to usual care in patients with thermal burn injuries covering between 20% and 50% of their body surface area. Subjects will have at least one deep partial or full thickness burn wound that is to be treated with a meshed autologous split thickness skin graft. Subjects will be randomized (1:2) to receive either usual care alone or usual care supplemented with Cytori Cell Therapy. While primarily focusing on safety and feasibility, the RELIEF trial is also designed to assess a series of parameters related to skin graft healing. The trial is approved to enroll up to 15 patients in up to 10 U.S. sites. The trial has been initiated at two sites. Cytori anticipates adding additional sites at a cadence of approximately one per month.
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 using technology that allows Cytori to use the benefits of its encapsulation platform to develop novel therapeutic strategies and reformulate other drugs to optimize their clinical properties. 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. These statements are subject to risks and uncertainties that could cause Cytori’s actual results and financial position to differ materially. Such statements, including, without limitation, statements regarding Cytori Cell Therapy’s potential to provide benefits across multiple disease states, the conduct of the RELIEF trial and the anticipated number of additional RELIEF trial sites, are 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 conducting clinical trials and studies and the results of such trials and studies (including risks that further trials and studies may not support efficacy or safety of Cytori Cell Therapy), risks associated with clinical use of Cytori Cell Therapy in trials and studies not controlled by Cytori, risks to Cytori’s intellectual property portfolio are described under the heading "Risk Factors" in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. Cytori assumes 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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