First medical product cleared in U.S. for use on certain injuries caused by sulfur mustard

The U.S. government reached a milestone in its long-standing efforts to defend the country against potential use of chemical weapons:  the first U.S. Food and Drug Administration (FDAclearance of a product to manage certain blister injuries caused by sulfur mustard, commonly known as mustard gas.

“Our top priority is saving lives during national emergencies. To do so, we must make safe and effective medical products for all the illnesses and injuries stemming from the serious health security threats confronting our nation,” said Robert Kadlec, M.D., Assistant Secretary for Preparedness and Response (ASPR) at U.S. Department of Health and Human Services. “This product clearance is the latest step in delivering on that promise to the American people.”

The ASPR’s Biomedical Advanced Research and Development Authority (BARDA) provided technical expertise and funding to support the studies necessary to show that the product, Silverlon, is appropriate for use on first- and second-degree skin burns caused by exposure to sulfur mustard.

“Chemical weapons like sulfur mustard cause horrific, painful, and life-altering injuries, yet in the 100-year history of sulfur mustard use, no medical countermeasures existed – until now,” added BARDA Director Rick Bright, Ph.D. “At BARDA, we are excited to have supported the first cleared product for use on skin injuries caused by sulfur mustard. This clearance exemplifies BARDA’s ongoing commitment to our partners and the nation as we seek out promising technologies and products to improve our nation’s health security and protect Americans.”

Argentum Medical, LLC, has received FDA clearances for multiple indications for Silverlon since 2003 and in that time the wound dressing has been used extensively by the U.S. military to treat burn and blast wounds. Silverlon dressings also are used widely by the healthcare and first responder communities.

“The FDA plays an important role in preparing our nation for a range of threats, including chemical, biological, radiological, and nuclear threats, providing guidance and support for the development of medical countermeasures that can be used safely, effectively and reliably during public health emergencies,” said Acting FDA Commissioner Ned Sharpless, M.D. “The expanded indication for this first-of-its-kind wound contact dressing to include management of certain injuries caused by sulfur mustard vapor exposure demonstrates our commitment to working closely with our federal partners, including BARDA, to expedite the availability of medical countermeasures essential for managing responses to chemical weapons attacks in both civilian and battlefield settings.”

BARDA’s support for this additional indication began in 2013 as part of the federal government’s effort to repurpose approved drugs and medical products to save lives and reduce injury in an attack on the United States.

This multi-purpose approach has proven to be cost-effective in preparing mass casualty emergencies from chemical, biological, and radiological agents. Repurposing products in widespread use additionally ensures first responders have a familiar product to use in a time of crisis. 

Beginning in 2015, BARDA used Project BioShield authorities and the Project BioShield Special Reserve Fund to purchase Silverlon for the Strategy National Stockpile as part of BARDA’s burn countermeasure program. BARDA continues to work with Argentum on studies necessary for FDA clearance of Silverlon for use on radiation burns.

Silverlon is a silver-plated nylon dressing available commercially and used widely to aid in the management of acute skin wounds and first- and second-degree thermal burns. The silver plating helps kill bacteria within the dressing, and one dressing can be used for up to seven days. This allows for fewer dressing changes, which reduces the burden on caregivers and minimizes the pain and damage that would occur if the wound was disturbed.

Sulfur mustard was first used as a chemical weapon in World War I and can be released into the air, food or water. More recently the chemical was used in the Iran-Iraq war and in the Syrian Civil War.

DARPA Awards Grant to ASU for Fight Against WMDs

Arizona State University has announced that it has been selected by the U.S. Defense Advanced Research Projects Agency (DARPA) to build a field-deployable, point-of-care device that will determine in 30 minutes or less if a person has been exposed to weapons of mass destruction or their precursors. The DARPA award, worth up to $38.8 million over four years in phases and options, will build on the university’s growing capabilities in developing molecular diagnostics for applications in defense and human health.

The device will be capable of detecting the health effects of a number of substances associated with weapons of mass destruction, including biological agents, radiation, chemicals, and explosives. 

Arizona State University has been selected to participate in DARPA’s Epigenetic CHaracterization and Observation (ECHO) program. According to DARPA, the “ECHO program has two primary challenges: to identify and discriminate epigenetic signatures created by exposure to threat agents; and to create technology that performs highly specific forensic and diagnostic analyses to reveal the exact type and time of exposure.” (Epigenetic changes are chemical modifications that affect genes, altering their expression while leaving the genetic code intact. Epigenetic changes can occur as natural responses to the environment but can also signal exposure to toxic agents or disease pathogens.)  

pigenetics is coming into its own in the 21st century. DARPA describes the epigenome as “biology’s record keeper,” explaining that “though DNA does not change over a single lifetime, a person’s environment may leave marks on the DNA that modify how that individual’s genes are expressed. This is one way that people can adapt and survive in changing conditions, and the epigenome is the combination of all of these modifications. Though modifications can register within seconds to minutes, they imprint the epigenome for decades, leaving a time-stamped biography of an individual’s exposures that is difficult to deliberately alter.”

Sethuraman Panchanathan, ASU Knowledge Enterprise executive vice president and chief research and innovation officer, said the project fits with the university's mission.

“ASU has long been committed to working across disciplines, often in tandem with corporate partners and government entities, to identify, address and solve global grand challenges,” Panchanathan said. “We’re proud to utilize our innovative approaches to advance our military’s capability in this critical capacity. Warfighting technology of the future will increasingly rely on the ability to rapidly develop and deploy highly integrated, responsive technologies like the ECHO project. Much like ASU, DARPA is committed to making strategic investments in breakthrough technologies. This partnership to advance our country’s national security priorities is a direct reflection of that shared vision.”

The technology under development may eventually enable simple, low-cost monitoring of epigenetic changes, which could be used as a powerful diagnostic method to detect a broad range of human diseases.

The new Translational Center for Molecular Diagnostics within ASU’s Biodesign Virginia G. Piper Center for Personalized Diagnostics brings together a proven team that includes molecular assay development, bioinformatics, machine learning, biosignature identification and automated assay development. ASU’s approach engages experts both within ASU and externally to leverage maturing technologies that are ready to make an impact in the field.

While available technologies can identify the physical presence of weapons of mass destruction and chemical precursors, current techniques for determining the source of life-threatening substances have proven unsatisfactory at identifying people engaged in the production of toxic agents. The ECHO program assesses the impacts of exposure on the human body. This epigenetic signature provides a persistent indicator of historical exposures.

The ASU team, led by Joshua LaBaer, executive director of the Biodesign Institute and director of the Center for Personalized Diagnostics, and co-principal investigator Vel Murugan, aims to develop a technology that will use a single drop of blood to quickly read a person’s epigenetic “fingerprint.” The fingerprint will identify signatures that indicate if the individual has ever been exposed to materials associated with producing weapons of mass destruction.

The ASU project will be known as DEPICT-Diagnostic Epigenetics of Infectious agents and Chemical Toxicity. During the project, researchers will apply novel approaches to identify changes in global epigenetic signatures and implement unique bioinformatics and machine learning tools to identify epigenetic biomarkers that will quickly and accurately reveal the nature and severity of exposures.

In keeping with their high-risk, high-reward approach to innovation, DARPA envisions the same technology being used to rapidly diagnose patients and troops who may have been exposed to threat agents or who may be suffering from infections.

“ECHO technology could open up new sources of forensic evidence and make battlefield collection of evidence safer, more efficient and more accurate,” Eric Van Gieson, ECHO program manager, said in DARPA’s original announcement of the program. “Additionally, by making it possible to deploy an analytical capability to vastly more locations, we would enhance our ability to conduct global, near-real-time surveillance of emerging threats.”

According to LaBaer, this project builds on the team’s previous success with a $36 million Biomedical Advanced Research and Development Authority (BARDA) project during which his team created a bio-dosimeter that can detect the level of exposure to an unanticipated radiologic or nuclear event. ASU’s prior experience in assay development and translation to industry will be fundamental to the development of this new platform.

“Imagine U.S. intelligence has identified a WMD threat and a suspect, but needs a way to quickly verify if the suspect is the perpetrator,” LaBaer said. “The current approach just isn’t effective. Medical personnel would identify traces of biological or chemical agents on the suspect’s clothing or hair, a slow and unreliable process requiring lab analysis. Now, consider the same situation in which the agent in the field can obtain a small blood sample and check epigenetic markers in real time to begin piecing together evidence.”

Co-principal investigator Murugan said that the molecular diagnostics team at the Biodesign Institute is driven by the idea their work will save lives.

“We continue to work with institutions across the U.S. and our partners around the world to develop technologies that will protect our warfighters, as well as our fellow citizens,” Murugan said. “The assays and platform that we will develop have the potential to become useful beyond detecting WMD exposures — ultimately, leading to a non-invasive diagnostic test for chronic illnesses such as cancer, diabetes and heart diseases.”

The project will require experts from various disciplines, including epigenomics, genomics, proteomics, single-cell genomics, microfluidics, toxicogenomics, assay development, process optimization, QA/QC, bioinformatics, machine learning algorithm development, instrument design and manufacturing, as well as chemical, biological, radiological and nuclear defense.

The ASU team includes researchers Chad Borges, Michael J. Fiacco, Robert McCulloch, Paul R. Hahn, Jin Park and Mitch Magee.

Jennifer Blain Christen, assistant professor at ASU’s Ira A. Fulton Schools of Engineering and an expert in microfluidics, will be part of an independent advisory panel.

As envisioned by DARPA, the ECHO diagnostic platform could meet the needs of many organizations, including Special Operations Command, Biomedical Advanced Research and Development Authority, U.S. Army Medical Research and Materiel Command, and Joint Program Executive Office for Chemical and Biological Defense.

The interdisciplinary team includes SRI International, Gryphon Scientific, Columbia University, Northern Arizona University and Washington University in Saint Louis.

 

Ebola Outbreak 2018 - Present Health Information Guide

In response to the WHO declaring the Ebola outbreak in the DRC a Public Health Emergency of International Concern (PHEIC), the U.S. National Library of Medicine has made available to all the Ebola Outbreak: 2018-Present Health Information Guide. 

The guide can be found here and contains all the information and links one might need when requiring more information on Ebola.

The PHEIC declaration was made following a meeting of the International Health Regulations (2005) Emergency Committee for Ebola virus disease in the Democratic Republic of the Congo on 17 July 2019, and includes advice for affected countries, neighboring countries, and all states. The statement can be read here 

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