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Cytori to conduct burn clinical trial under HHS contract.

SAN DIEGO, Calif., May 31, 2017 -- Cytori Therapeutics, Inc. (CYTX) will conduct a clinical trial in thermal burn injury under a contract option with 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).


The money 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 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Unpublished preclinical data generated by Cytori under its BARDA-funded development program indicate that intravenous delivery of Cytori Cell Therapy was associated with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.

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 CEO Marc Hedrick. "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."

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 percent and 50 percent 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 launched to test whether Cytori Cell Therapy 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 U.S. metropolitan area.

The first step toward achievement of this goal was completed in preclinical studies that reported that intravenous delivery of Cytori Cell Therapy improved healing of full thickness burn wounds complicated by radiation injury.

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 counter-measures 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.

Next-Generation Celution Technology

In related news, Cytori said it plans to introduce its next-generation Celution technology, available for pre-orders effective June 1, 2017, with first product shipments anticipated to begin in Q3.

The next-generation Celution technology incorporates new hardware and enChanced software that substantially improves performance and maintains compliance with evolving global medical device and cell therapy standards.

Cytori will offer the new technology through chargeable upgrades to its existing global Celution user base (where available) and as a standard feature set for Celution Systems purchased by new customers.

This technology builds on nearly market experience, thousands of single-use procedure sets sold, clinical trials and cent research and development.

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Publication:Stem Cell Business News
Geographic Code:9AZER
Date:Jun 12, 2017
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