Crucial life-saving initiative led by Dr. Steven Quay for clinical trials on the safety and efficacy of a combination of FDA-approved drugs (nebulized Heparin-N-acetylcysteine in COVID-19 Patients by Evaluation of pulmonary function (HOPE))

SEATTLE, March 30, 2020 (GLOBE NEWSWIRE) — Physician-scientist and inventor Dr. Steven Quay, MD, PhD, is announcing a new combination treatment with the potential to improve pulmonary function and reduce or eliminate mechanical ventilation in patients with the coronavirus infection. The treatment uses two drugs previously approved by the FDA for other conditions: nebulized (inhaled as a fine mist) heparin combined with N-acetylcysteine (NAC), termed “H-NAC.” Dr. Quay is making this new clinical trial protocol (called the COVID-19 HOPE Trial) available for use by the worldwide medical community. Starting today, doctors around the world are invited to directly download the protocol free of charge at www.DrQuay.com.

“Given the rapid growth in the number of new COVID-19 cases worldwide, and especially in the U.S., I made the decision to make the HOPE Trial documents immediately available,” said Steven Quay, M.D., Ph.D. “From my experience having invented seven FDA-approved pharmaceuticals over my career, it is my reasoned opinion that this has a high likelihood of success and should be quick to test given that these drugs are widely available. Nebulized H-NAC could become a valuable new tool for frontline COVID-19 treatment, as it should reduce or eliminate the need for a mechanical ventilator.”

“I have known Steve for over a decade as a creative, diligent, and talented scientist and the COVID-19 HOPE Trial protocol he has developed and recommended is a truly creative approach to the treatment of patients in this pandemic,” said Dr. James Woolliscroft, M.D., Lyle C. Roll Professor of Medicine, Professor of Internal Medicine and Professor of Learning Health Sciences, and Former Dean, The University of Michigan Medical School. “As we search for therapies to meet this unprecedented clinical challenge, the importance of testing potential interventions is great as hundreds of thousands of people around the world are infected.”

At the request of the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, and the National Institutes of Health, the protocol has been provided to the Infectious Disease Clinical Research Consortium in the United States.

The basis for Dr. Quay’s recommendation for this new potential treatment is four-fold:

• The SARS-CoV-2 virus has a Spike Protein on its surface that potentially interacts with three molecules on the surface of lung cells: heparin sulfate, furin, an enzyme for protein processing, and angiotensin converting enzyme 2 (ACE), a cell surface receptor. These interactions are needed for the virus to infect cells.

  Like a vaccine which teaches the immune system to make antibodies to block these same interactions and prevent an infection, Dr. Quay expects H-NAC to also interfere with these interactions, based on an understanding of the genetics of the virus and the biophysics and biochemistry of the Spike Protein, and the surface of cells in the lungs, heart, and other organs which are attacked by this virus.

• Laboratory experiments with the current coronavirus, SARS-CoV-2, and previous human coronaviruses show that both drugs separately can interfere with infection in vitro.
• Twelve clinical trials in over 780 patients have been conducted with either nebulized heparin alone or in combination with NAC for the treatment of pulmonary damage in burn patients and in patients with Adult Respiratory Destress Syndrome. These trials showed efficacy, as measured by improved lung function and reduced need for mechanical ventilation, and demonstrated safety, with only clinically minor adverse events seen.
• Both drugs are currently FDA-approved for use by injection, are widely available, and are reasonably priced. NAC is also FDA-approved in an inhalation formulation for a wide range of pulmonary conditions, although not for COVID-19 patients.

About the COVID-19 HOPE Study

Heparin was discovered in 1918 and is an FDA-approved injectable product and used as an anticoagulant (blood thinner). Side effects at high doses include bleeding. It is on the World Health Organization’s List of Essential Medicines, the safest and most effective medicines needed in a health system. The wholesale cost in the developing world, when used to prevent blood clots, is between $10 and $40 per month.

N-acetylcysteine (NAC) is a medication that is used to treat acetaminophen overdose, and to loosen thick mucus in individuals with cystic fibrosis or chronic obstructive pulmonary disease. It can be taken intravenously, by mouth, or nebulized, i.e., inhaled as a mist.

The COVID-19 HOPE Clinical Trial protocol can be quickly adapted for clinical trials by institutions worldwide and contains most information that would be necessary to secure both Institutional Review Board (Institutional Ethics Committee) and governmental agency approvals to quickly begin conducting clinical studies.

The COVID-19 HOPE Clinical Trial protocol is available to physicians at: COVID-19 HOPE Trial

About Steven Quay, M.D., PhD.

Steven Quay is the founder, Chairman, and CEO of Seattle-based Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions.

Dr. Quay received his M.D., M.A. and Ph.D. from The University of Michigan, was a postdoctoral fellow at MIT with Nobel Laureate H. Gobind Khorana, a resident at the Harvard-Massachusetts General Hospital, and was on the faculty of Stanford University School of Medicine for almost a decade. He has over 300 published contributions to medicine which have been cited over 9,700 times.

Dr. Quay has founded six pharmaceutical startups, invented seven FDA-approved medicines, and holds 87 U.S. patents. Over 80 million people have benefited from the drugs he has invented. His current passion is the prevention of the two million yearly breast cancer cases worldwide. A TEDx talk he delivered on breast cancer prevention, “How to Be Smart If You’re Dense,” has been viewed over 200,000 times.