Cytori Therapeutics, Inc. (CYTX)

[Paulness]

NEWS -- Cytori and BARDA Execute $13.4 Million Contract Option for Burn Clinical Trial

Date : 05/31/2017 @ 9:00AM
Source : GlobeNewswire Inc.
Stock : Cytori Therapeutics (MM) (CYTX)

SAN DIEGO, May 31, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (CYTX) (“Cytori” or the “Company”) today announced that the Company and the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response (ASPR), have executed a contract option valued at approximately $13.4 million.

The executed option will fund the Company’s RELIEF trial, a U.S. pilot clinical trial of Cytori Cell Therapy™ (DCCT-10) in thermal burn injury as the next step in development of Cytori technology as a medical countermeasure for thermal burn injury. The present option increases the overall BARDA commitment to Cytori technology to approximately $34.6 million thus far.

Patients with large burns frequently require treatment with an autologous skin graft. Unpublished preclinical data generated by Cytori under its BARDA-funded development program indicate that intravenous delivery of Cytori Cell Therapy was associated with increased formation of new skin (epithelialization) and earlier restoration of the barrier function of the newly-formed skin (1). The RELIEF trial will apply the same approach in the clinic.

“Cytori continues to develop Cytori Cell Therapy technology as a multiuse platform for use in both the routine clinical setting and in the event of a mass casualty emergency,” said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. “There are several published reports indicating clinical benefit of Cytori Cell Therapy in chronic wound healing. This trial provides Cytori the opportunity to extend these reports by assessing utility of intravenous administration in an acute traumatic situation.” (2)

The RELIEF trial will 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 (STSG). 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 will also assess a series of parameters related to skin graft healing. The trial is approved to enroll up to 30 patients in up to 10 U.S. sites with study initiation expected to occur in Q4 2017.

This project with BARDA was initiated to evaluate Cytori Cell Therapy as a potential medical countermeasure that could be used to treat thousands of patients with a combination of burn and radiation injury following detonation of an improvised nuclear device in a major USA metropolitan area. The first step towards achievement of this goal was completed in pre-clinical studies which reported that intravenous delivery of Cytori Cell Therapy improved healing of full thickness burn wounds complicated by radiation injury (linked here).

The RELIEF clinical trial represents the next step in this path. The original contract with BARDA retains two as-yet unfunded options valued at up to $68 million. The first of these options is written to support a pivotal clinical trial that could potentially follow RELIEF and lead to FDA approval of Cytori Cell Therapy as a treatment for thermal burn injury. The second option addresses additional preclinical work targeting application in thermal burn and radiation injury.

BARDA is developing medical countermeasures for use following a mass casualty disaster involving burns to address the ill-preparedness of the current healthcare system to deal with very large numbers of patients requiring treatment for thermal burns, particularly those complicated by concomitant radiation exposure. According to the American Burn Association, there were approximately 450,000 burn injuries in 2013 that required medical treatment in the United States, with approximately 40,000 requiring hospitalization. In a mass casualty event, the 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. Current standard of care for large burns consists of dressings, skin grafts and skin substitutes. Despite these treatments, patients with severe burns commonly suffer from prolonged pain, aggressive scarring, skin contracture and reduced range of motion. Cellular therapeutics such as those offered by Cytori may have the potential to improve the quality and rate of wound healing and reduce scarring and also can be deployed in a cost effective manner, even in mass casualty situations.

1. Data from Cytori Study

2. Published reports of use of Cytori Cell Therapy™ in chronic wounds include, but are not limited to:

Akita et al (2012) Radiat Prot Dosimetry 151 (4): 656-660
Cervelli et al (2011) Stem Cell Res 6 (2) 103-11
Daumas et al (2016) Curr Res Trans Med 65 (1) 40-43
Mizushima et al (2016) Surg Today 46 (7) pp. 835-42
Iddins et al (2016) Health Phys. 111(2):112–116; 2016

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 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, but not limited to, statements regarding Cytori’s use of BARDA funding; the possibility that pilot trial costs exceed the BARDA funding (in which case Cytori will be responsible for such costs); conduct of the RELIEF clinical trial; potential benefits of Cytori Cell Therapy™ (including its potential cost and clinical benefits, and its future availability as a medical countermeasure for thermal burn injury); potential patient populations requiring thermal burn care; and potential additional BARDA funding of Cytori’s development program, are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include: a possible adverse decision by BARDA to delay, suspend or reduce funding of Cytori’s proposed RELIEF clinical trial or other development efforts under its contract with BARDA or other changes in BARDA’s funding and procurement priorities that may adversely affect our thermal burn injury program; BARDA’s sole discretion in determining funding timing and amounts; BARDA’s ability to reduce, modify or terminate its contract (and contract options) with us if it determines it is in the government’s best interests to do so; the risk that Cytori is unable to complete development work necessary to receive BARDA funding; the risks that quality of data supporting IDE approval and execution of BARDA contract options is deemed insufficient; risks in the collection and results of clinical data; risks associated with final clinical outcomes; regulatory risks and uncertainties; risks related to dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" section 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 contained in this press release to reflect events, trends or circumstances after the date of this communication.

Cytori Therapeutics, Inc.
Tiago Girao, 1.858.458.0900
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