What To Know
- Concurrent with our intent to be a leader in the emerging blood purification industry, COVID-19 has revealed the strengths and weaknesses of government preparedness initiatives that were in place at the outset of the pandemic.
- In the past year, the results from a series of in vitro blood purification studies have validated the ability of Sigyn Therapy to extract viral pathogens (including COVID-19), gram-negative and gram-positive bacterial toxins, hepatic toxins, cytovesicles and pro-inflammatory cytokines from human blood plasma.
James A. Joyce – CEO, SIGYN THERAPEUTICS
On March 24, 2020, the U.S. Department of Health and Human Services (HHS) declared that the emergence of COVID-19 justified the Emergency-Use Authorization (EUA) of drugs, biological products, and medical devices to combat the pandemic.
Within a month of the HHS declaration, The U.S. Food and Drug Administration (FDA) awarded an EUA to industry colleagues at Terumo BCT, ExThera Medical Corporation, CytoSorbents, Inc., and Baxter Healthcare Corporation. The therapeutic products from these organizations were not drug or biological agents, they were blood purification technologies.
In connection with these EUA awards, FDA published a statement that blood purification devices may be effective at treating certain patients with confirmed COVID-19 by reducing various pathogens, cytokines, and other inflammatory mediators from the bloodstream.
At Sigyn Therapeutics, we are advancing a dual-function blood purification technology designed to address pathogen sources of life-threatening inflammation in concert with the broad-spectrum elimination of cytokines and other inflammatory mediators. We call this technology Sigyn Therapy.
In the past year, the results from a series of in vitro blood purification studies have validated the ability of Sigyn Therapy to extract viral pathogens (including COVID-19), gram-negative and gram-positive bacterial toxins, hepatic toxins, cytovesicles and pro-inflammatory cytokines from human blood plasma.
Concurrent with our intent to be a leader in the emerging blood purification industry, COVID-19 has revealed the strengths and weaknesses of government preparedness initiatives that were in place at the outset of the pandemic.
In this regard, the development, clinical testing, market clearance, and global delivery of multiple vaccines that protect against severe COVID-19 infection is unprecedented. Less than one year after the HHS mandate, vaccines from Janssen, Moderna, and Pfizer-BioNTech were cleared under Emergency Use Authorization. Beyond the ongoing need to protect against COVID-19, the business environment for protective vaccines should continue to be robust as a confluence of global warming, urban crowding, and intercontinental travel are likely to fuel a continuance of future pandemics.
Inversely, 5.5 million COVID-19 deaths and the shutdown of global economies have exposed the futility of aligning post-exposure antiviral drugs with emerging pandemic threats. Especially, if preventive messenger RNA (mRNA) vaccines can be delivered to the marketplace at a pace that precedes the development of a post-exposure antiviral drug. Between the EUA clearance of the blood purification and vaccine technologies referenced above, Remdesivir (Gilead Sciences, Inc.), a drug repurposed from the Ebola 2014 outbreak, was the sole antiviral to be cleared under EUA.
Prior to COVID-19, pathogen-specific antiviral drug agents had been market cleared to treat fewer than 5% of the 300+ viruses that were already known to be infectious to humans. Regardless of this statistic and the resources of large pharmaceutical organizations, COVID-19 has demonstrated that preventative vaccine countermeasures can be developed and delivered at a pace that precedes the advancement of post-exposure antiviral drugs that have been clinically proven to reduce mortality.
As a result, the business environment for post-exposure therapies will shift toward broad-spectrum countermeasures that can address different strains, species, and families of viral pathogens in concert with reducing the circulating presence of inflammatory mediators that induce sepsis, which is the leading cause of viral infection deaths. As such mechanisms remain beyond the reach of drug therapies, medical device countermeasures are likely to be required.
An increasing emphasis should be placed on blood purification technologies as post-exposure countermeasures to treat hospitalized patients with severe infections. A properly designed blood purification device can perform functions that are beyond the reach of drugs and will have broad commercial applications beyond the treatment of pandemic viruses.
About the author:
James “Jim” Joyce has 30+ years of diverse public market experience, which includes two decades of public company CEO and Corporate Board leadership roles. He is also an inventor or co-inventor underlying 18 pending or issued patents.
Prior to establishing Sigyn Therapeutics, Mr. Joyce was the founder and former Chairman and CEO of Aethlon Medical, a therapeutic technology company that he navigated from single shareholder start-up to Nasdaq-traded Company with 8000+ shareholders. During his tenure at Aethlon, Mr. Joyce oversaw the development of the Hemopurifier®, a first-in-class blood purification technology to address life-threatening viruses and cancer-promoting exosomes. Under his leadership, the Hemopurifier® became the first therapeutic candidate to be awarded two FDA “Breakthrough Device” designations and was the first and only device to receive “Emergency Use Authorization” (EAU) approval from both the FDA and Health Canada to treat Ebola virus. Time Magazine named the Hemopurifier® one of the “11 Most Remarkable Advances in Healthcare” and designated the device to its “Top 25 Best Inventions” award list. The Hemopurifier® has since been cleared by the FDA to treat severe COVID-19 infections in a clinical setting.
Under Mr. Joyce’s leadership, the Hemopurifier® was the subject of two Department of Defense (DOD) contract awards and a National Cancer Institute (NCI) contract. Mr. Joyce led the completion of approximately $100 million of equity financings on behalf of Aethlon Medical and established preclinical and clinical collaborations with more than twenty government and non-government research institutes.
Based on the use of the Hemopurifier® to treat HIV and Hepatitis-C infected individuals in India, Mr. Joyce was the recipient of the “Spirit of India Award” sponsored by the Bill & Melinda Gates Foundation and awarded each year by the American India Foundation to the American business leader who has demonstrated a commitment to accelerate social and economic change in India.
Mr. Joyce testified before Congress and lobbied Capitol Hill to promote the Hemopurifier® as a broad-spectrum countermeasure against bioterror and pandemic threats, which contributed to expanding the government-wide definition of treatment countermeasure to be inclusive of medical devices under U.S. law.
Mr. Joyce is also the founder and former Executive Chairman of Exosome Sciences, Inc. (ESI), a company focused on the discovery of exosomal biomarkers to diagnose and monitor cancer and neurological disorders. Inspired by the death of a former teammate, Mr. Joyce established a collaboration with the Boston University CTE Center to test his hypothesis that circulating exosomes transported tau protein cargos (exosomal tau or TauSome) that could provide a basis for a non-invasive blood test to diagnose and monitor neurological tauopathies, including chronic traumatic encephalopathy (CTE) and Alzheimer’s disease. As a result, ESI was invited to participate in the first NIH funded clinical study of CTE, which revealed TauSome levels to be approximately 9x higher in 78 former NFL players as compared to the same age group control subjects. The study results (co-authored by Mr. Joyce) were published in the Journal of Alzheimer’s Disease. Follow-on clinical studies are being conducted. Mr. Joyce established a collaboration with the Boston University Alzheimer’s Disease Center that also demonstrated TauSome levels to be significantly elevated in diagnosed Alzheimer’s patients.
Prior to founding Aethlon Medical and Exosome Sciences, Mr. Joyce operated James Joyce & Associates. He was the founder and former CEO of Mission Labs, Inc. and a principal at London Zurich Securities. Upon graduating from the University of Maryland, Mr. Joyce was first employed as a member of the Denver Broncos Football Club of the National Football League.
