AUSTIN, Texas, Aug. 27, 2020
AUSTIN, Texas, Aug. 27, 2020 /PRNewswire/ -- Direct Biologics, LLC announces a rapid acceleration of the investigational use of ExoFlo™ for treatment of COVID-19 as new mechanisms of SARS-CoV-2 have been revealed. Published in Lung Cellular and Molecular Physiology in August, a recent research collaboration by bioinformatics experts in the United States and Poland suggests that the SARS-CoV-2 viral genome may be binding to specific human microRNA (miRNA) in the manner of an epigenetic "sponge"— essentially inhibiting normal downstream processes and facilitating viral hijacking and/or immune evasion.
"These findings are highly interesting and pertinent to our research," states Dr. Vik Sengupta, Chief Medical Officer, "especially since the authors' exomic analysis reveals the depletion of multiple miRNA targets. These data complement our recent findings that ExoFlo contains multiple miRNA that may specifically inhibit the SARS-CoV-2 viral invasion and modulate the systemic hyperinflammatory response, known as Cytokine Storm."
Dr. Sengupta further elaborates that ExoFlo may have other therapeutic mechanisms, stating that "In April 2020, we already treated 24 patients with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS), reversing hypoxia in 17 out of the 24 patients, who were then discharged within 5-6 days. Our results suggest that ExoFlo may be fortifying host immunity by reconstituting T-cells and downregulating inflammation."
Tim Moseley, Chief Scientific Officer, states that "Consistent with our clinical findings, we have obtained new in vitro data showing that ExoFlo promotes a non-inflammatory T-regulatory phenotype." If the mechanisms are confirmed, both Dr. Sengupta and Dr. Moseley add, the implication is that ExoFlo may remain effective against SARS-CoV-2 even as the viral genome inevitably mutates in the coming months, a process that some scientists predict could render other countermeasures, like convalescent plasma and vaccination, ineffective.
"The potentiality of ExoFlo is beyond compelling at this point," Joe Schmidt, Co-Founder and President of Direct Biologics, LLC declares, emphasizing the company's priorities of accelerating clinical research efforts. He went on to say, "Our investigators are days away from enrolling critically ill patients across the U.S in EXIT COVID-19 — an FDA-approved multi-center, phase II clinical trial. This may be a landmark study both domestically and internationally, and we are ready to scale."
Co-Founder and Chief Executive Officer Mark Adams concludes, "Speaking as a resident in the state of Texas, I have struggled with the knowledge that a potential lifesaver is stored in our warehouse as the death toll climbs daily. The Institute for Health Metrics and Evaluation's latest COVID-19 forecasts indicate that the U.S. will exceed 300,000 deaths by Dec. 1, 2020 — therefore, I do not think that we can afford to be complacent for even one day in our ongoing fight against COVID-19. Our physicians and scientists are convinced that it will take many different therapies to eradicate COVID-19, not just vaccines. We must find and make available multiple treatments that will benefit our elderly patients in nursing homes and other high risk, immunocompromised populations, as there will be thousands of patients who will become critically ill with ARDS before 2021, even after vaccines become widely available. Here at Direct Biologics, we are working around the clock to prepare for the inevitable increase in COVID-19 cases this winter."
ExoFlo is an investigational new drug that has not been approved or licensed by FDA. It is an allograft extracellular vesicle product isolated from human bone marrow mesenchymal stem or stromal cells (MSCs). ExoFlo provides signaling proteins that have been shown to modulate inflammation and may stimulate bioactivity and direct cellular communication.
About Direct Biologics
Direct Biologics, LLC, is headquartered in Austin, Texas, with an R&D facility located at the University of California, and an Operations and Order Fulfillment Center located in St. Louis, Missouri. Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medical products, including a robust line of extracellular vesicle-based biological products. The Company was created to expand the science of cutting-edge biologic technologies. Direct Biologic's management team holds extensive collective experience in biologics research, development, and commercialization, making the Company a leader in the evolving, next-generation segment of the biotherapeutics industry. Direct Biologics is dedicated to pursuing additional clinical applications of ExoFlo through the FDA's investigational new drug application process. For more information, visit http://www.directbiologics.com.