Dec 21, 2020

Dr. Ellie Soheili is Principal Investigator and Internal Medicine Resident at Larkin Community Hospital, South Miami FL Larkin Community Hospital is a general medical-surgical-psychiatric and teaching hospital. This 146-acute-care-bed hospital is located in South Miami, Florida. It is accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). A TARGETED GENE THERAPY FOR COVID-19 INDUCED ARDS “Thousands of patients worldwide still die every day of severe COVID-19. The EUA for DeltaRex-G establishes a precedent for patients with severe COVID-19 (Right to Try Law of 2018).” — Ellie Soheili, MD LOS ANGELES, CA, USA, December 21, 2020 / EINPresswire.com / — The Aveni Foundation ( www.avenifoundation.org ), in collaboration with Larkin Community Hospital , South Miami FL, Drs. Ellie Soheili and George Yatzkan, is proud to announce that the USFDA has granted Emergency Use Authorization (EUA) for DeltaRex-G, a disease-targeted gene therapy, for the treatment of a patient with severe COVID-19 infection. According to Dr. Soheili, Principal Investigator at Larkin Community Hospitals ( www.larkinhospital.com ), “Thousands of patients worldwide still die every day of COVID-19 related ARDS. The Emergency Use Authorization of DeltaRex-G establishes a precedent for many patients with severe COVID-19 who have run out of therapeutic options ( Right to Try Law of 2018)". Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 causes life threatening complications including Cytokine Release Syndrome (CRS) or Cytokine Storm and Acute Respiratory Distress Syndrome (ARDS). However, these complications are believed to be caused not just by the virus itself, but by an exaggerated immune reaction to the infection. The overactive (bad) immune cells are thought to make certain proinflammatory chemicals (cytokines) that cause raging fevers and damage to the lungs and other organs. Over 1000 clinical trials are on-going to diagnose, prevent, treat, and improve the aggressive nature of COVID-19. DeltaRex-G is the first and only disease-targeted gene therapy with the potential of effectively treating cytokine storm and ARDS and increasing survival of COVID-19 patients. “DeltaRex-G is currently being developed for cancer but there are striking similarities between the pathologic features of ARDS of COVID-19 and lung cancer that has led us to believe that DeltaRex-G could work as a treatment for severe COVID-19 as well”, said Dr. Erlinda M. Gordon, President of the Aveni Foundation. Common features include (1) presence of abnormal Signature (SIG) proteins in the damaged lung environment of COVID-19 and the tumor microenvironment of lung cancer, and (2) presence of rapidly dividing cells (overactive immune cells in ARDS and cancer cells in lung cancer). DeltaRex-G is a disease-targeted gene therapy that (a) displays a SIG-binding peptide on its surface for targeting sites of injury, and (b) encodes a designer killer gene for eradicating rapidly dividing cells. When injected intravenously, the DeltaRex-G nanoparticles seek out and accumulate in areas of pathology where SIG proteins are abnormally found, in the vicinity of overactive immune cells or cancer cells. Mechanistically, DeltaRex-G would then enter the bad immune cells and kill them, hence, reducing cytokine storm and the severity of ARDS. From our experience in 5 Phase 1 and 2 US-based clinical trials for metastatic cancer, we have shown that intravenous DeltaRex-G has minimal, if any, systemic toxicity. According to Dr. Gordon, Emergency Use Authorization of DeltaRex-G for ARDS opens the door to its potential use in autoimmune disorders wherein a person’s own immune cells recognize “self” as foreign, and attack “self” causing debilitating disease. These autoimmune disorders include lupus, rheumatoid arthritis, myasthenia gravis, Parkinson’s disease, psoriasis, lichen planus and atopic dermatitis. For further information, please visit our websites: www.avenifoundation.org , contact Dr. Gordon at egordon@avenifoundation.org ● Click on the DONATE button at www.avenifoundation.org ● Send a check to: Aveni Foundation, 2811 Wilshire Blvd., Suite 414 Santa Monica CA 90403 ● Wire funds to: Chase Bank, Account Name: Aveni Foundation, Routing No: 322 271 627 Checking Acct. No. : 317 312 673, SWIFT CHASUS33 Written by: Dr. Don A. Brigham, retired US Marine Corps Officer Erlinda M Gordon