Tag: coronavirus

Results Support Development of AT-H201 for COVID-19 Patients

SEATTLE, May 20, 2020 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19, today announced the successful results from in vitro testing of AT-H201, Atossa’s proprietary COVID-19 drug candidate. The preliminary study results show that AT-H201 inhibits SARS-CoV-2 infectivity of VERO cells in a laboratory culture, which are the standard cell types being used to study infectivity of the coronavirus. SARS-CoV-2, sometimes called the coronavirus, is the COVID-19 infectious agent.  

AT-H201 is designed to act as a “chemical vaccine” by binding to the surface of the coronavirus and inhibiting the ability of the virus to enter a cell (“viral infectivity”). Significant findings from the testing include:

• AT-H201 components inhibited SARS-CoV-2 from infecting VERO cells in a laboratory culture.
   
• This is the first submicromolar inhibitor of SARS-CoV-2 identified to date in published literature, meaning that a relatively small amount of the drug is necessary to result in an anti-viral effect.
   
• Testing was also performed on remdesivir, an anti-viral medication being studied by others for use in COVID-19 patients, and the generic anti-malaria drug hydroxychloroquine, which is also being studied by others in COVID-19 patients. In these laboratory tests, the components of AT-H201 were found to be at least four-times more potent than remdesivir and at least twenty-times more potent than hydroxychloroquine. Potency was measured by microscopic examination of the cytopathic effect caused by SARS-CoV-2 in VERO cells.

“These results support the continued development of AT-H201 for COVID-19 patients and beginning studies in the clinical setting,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “We look forward to reporting progress in clinical studies.”

The testing was conducted on behalf of Atossa by a leading academic research institute. Atossa plans to publish a manuscript of these test results. Successful in vitro tests do not guarantee similar results from in vivo studies, including in human clinical trials. Additional safety and efficacy studies must be successfully completed and regulatory approvals must be obtained before AT-H201 may be commercialized.

ABOUT ATOSSA THERAPEUTICS

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com.

FORWARD-LOOKING STATEMENTS

Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with any variation between interim and final clinical results, whether in vitro test results will also be achieved in in vivo studies, including human clinical studies, actions by and interactions with the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence human clinical studies of AT-H201, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa’s products, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others such as patent rights, and other risks detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.

Company Contact:
Atossa Therapeutics, Inc.
Kyle Guse, CFO and General Counsel
Office: 866 893-4927
kyle.guse@atossainc.com

Investor Relations Contact:
Core IR
Office:(516) 222-2560
ir@atossainc.com

Source: Atossa Therapeutics, Inc.

Study Designed to Evaluate Atossa’s Combination Therapy AT-H201 to Reduce Patient Time on a Ventilator

SEATTLE, April 27, 2020 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need, today announced that it has contracted with NYC Health + Hospitals/Metropolitan in New York City to conduct the NY HOPE Study of Atossa’s proprietary combination drug therapy called AT-H201. The NY HOPE Study will evaluate AT-H201 in COVID-19 patients on ventilators with the goal of reducing the amount of time on ventilators.

“We are honored to be working with NYC Health + Hospitals/Metropolitan and Dr. Getaw Hassen, who are on the front lines of this unprecedented health crisis,” stated Dr. Steven Quay, President and CEO of Atossa Therapeutics. “The NY HOPE Study is a vital step in developing this new therapy for critically ill COVID-19 patients.”

“Managing patient care and ventilator use has become a major challenge,” commented Getaw Hassen, M.D., Ph.D., Emergency Physician, at NYC Health + Hospitals/Metropolitan and the principal investigator of the NY HOPE Study. “We have an urgent need for a therapy to reduce reliance on ventilators and we are looking forward to playing a key role in what could be a much-needed solution for our sickest COVID patients.”

The NY HOPE Study will assess the safety and efficacy of AT-H201 administered via inhalation in COVID-19 patients on mechanical ventilation support. Subject to FDA and IRB input, the study is currently designed as follows: Thirty-nine patients will be enrolled in the active treatment group and compared to the outcomes of 66 patients in a matched retrospective control group. Patients will be dosed with AT-H201 each day in addition to the standard of care, while on mechanical ventilation for up to seven days and will be followed up during hospitalization and for 28 days after discharge. The primary objectives are to determine the number of ventilator-free days after patients are removed from ventilators following the initial airway intervention; oxygenation levels; and survival rates.

Secondary efficacy endpoints include a variety of lung function parameters and time in ICU. Secondary safety endpoints include markers of coagulation and system function.

The NY HOPE Study is currently pending IRB approval and will not commence without IRB and all necessary regulatory approvals, including FDA. Atossa has filed comprehensive provisional patent applications related to AT-H201.

About Atossa’s COVID-19 HOPE Program

Atossa’s COVID-19 program is called “COVID-19 HOPE,” which is an acronym for AT-H201 in COVID-19 patients for Pulmonary Evaluation. The intended primary function of the drug combination AT-H201 is to essentially mimic the function of the antibodies formed from a vaccine by blocking the ability of the virus to enter the target cells; a vaccine that may not be available for more than a year. There are five known key steps the coronavirus must take to signal the cell to open up and let the virus in. AT-H201 is being designed to function like a “chemical vaccine” by blocking all five of those steps, similar to what antibodies would be expected to do when a vaccine is administered. With AT-H201, the virus should be unable to enter the cell because its “keys” that would otherwise open the door into the cell surface, are disabled. Atossa expects that its AT-H201 drug combination can be developed more quickly than a traditional vaccine.

The NY HOPE Study is a critical step in determining safety and efficacy of AT-H201 and in bringing this new therapy to the market.

About the Inventor, Dr. Steven Quay

AT-H201 was invented by Dr. Steven Quay. 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 companies, invented seven FDA-approved medicines, and holds 87 U.S. patents.

About Atossa Therapeutics

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need. Atossa’s current focus is on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com.

About NYC Health + Hospitals/Metropolitan

NYC Health + Hospitals/Metropolitan is the community hospital of choice for residents of East Harlem, northern Manhattan and neighboring communities. NYC Health + Hospitals/Metropolitan provides culturally sensitive primary and specialized medical care to patients of all ages regardless of national origin, immigration status, or ability to pay. Since its founding in 1875, the hospital has been affiliated with New York Medical College, representing the oldest partnership between a hospital and a private medical school in the United States. NYC Health + Hospitals/Metropolitan is part of the NYC Health + Hospitals public health care system. For more information, please visit www.nychealthandhospitals.org/metropolitan.

Forward-Looking Statements

Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with any variation between preliminary and final clinical results, actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence studies, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa’s products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others, such as patent rights, potential market sizes for Atossa’s drugs under development and other risks detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form10-K and 10-Q, each as amended and supplemented from time to time.

Company Contact:
Atossa Therapeutics, Inc.
Kyle Guse, CFO and General Counsel
Office: 866-893-4927
kyle.guse@atossainc.com

Investor Relations Contact:
Scott Gordon
Core IR
377 Oak Street
Concourse 2
Garden City, NY 11530
Office:516-222-2560
scottg@corprominence.com

SEATTLE — The fatality rate for COVID-19 victims on ventilators has been 50% or higher.

So, at Atossa Therapeutics in Seattle, Dr. Steven Quay is getting a drug combination ready for a clinical trial in a hard-hit hospital back east.

“There’s a side port on the ventilator where you can put medication for these patients … basically they can breathe a mist while they are on the ventilator and the goal is to get them off the ventilator and once you are off the ventilator you’ll have an improved clinical course.

Quay is CEO of Seattle’s Atossa Therapeutics. He’s says he’s invented seven FDA approved drugs for other illnesses.

Called H-NAC, the drug would put a coating over the parts of the virus that help them replicate so quickly, rendering it ineffective, similar to what a vaccine does.

“We want to teach the immune system to coat the virus with antibodies, I’m coating the virus … with these two already FDA approved drugs,” he said.

Source:
https://www.kiro7.com/news/local/seattle-doctor-developing-treatment-sickest-covid-19-patients/OO4DJZ7BHBCUPI5FRPB3ZMW5KQ/

U.S. Physician Scientist Dr. Steven Quay, MD, PhD offers his predictions based on COVID-19 case growth model and firsthand eye witness to Taiwan’s coronavirus best practice policies, many of which are mirrored in the U.S. Administration’s policies

SEATTLE, April 17, 2020 (GLOBE NEWSWIRE) — Physician-scientist and inventor Dr. Steven Quay, MD, PhD announced today that his proprietary model of COVID-19 case growth predicts that the United States as a whole will be able to declare a SARS-CoV-2 “cease fire” on April 23, 2020, although individual states will continue to battle the pandemic. His model has successfully predicted a similar success in nine European countries, some of which are beginning to successfully reopen their economies.

He also believes the ‘Opening Up America Again’ initiative will be successful based on his firsthand witnessing of Taiwan’s policies and practices. Many of the Administration’s initiatives have been successfully used by Taiwan to contain the virus and then permit the country to return to near normal. Taiwan is considered to have the most successful SARS-CoV-2 response in the world, with a total of 395 cases and 6 deaths. The case rate in Taiwan is 17 per million population compared to Spain and Italy where there have been 3956 and 2794 cases per million (CPM), respectively.  

“The timing of the Administration’s ‘Opening Up America Again’ initiative is prescient,” stated Dr. Quay. “Within the last 48 hours my model predicted that on April 23rd the U.S. would cross the threshold seen in all other countries that defines a cease fire against SARS-CoV-2. A cease fire is defined as a time when exponential growth has ended and daily case velocity is negative. With that achievement the country can begin to turn to the process and steps needed to restart the economy. Here in Taiwan, schools, businesses, restaurants, and public transportation are all operating in a near normal condition as governmental policies have worked to stop the virus and reduce infectivity. I believe the Administration’s plan announced yesterday will do the same for the United States in due course, as each state tailors its response to circumstances in their respective areas.”

“In looking at the three phase approach of the Administration, the decision to put these tools in the hands of the state governors will be critical to success,” Dr. Quay added. “Clearly Hawaii and Montana, with under 400 cases per million population are at a different place in the battle than New York and New Jersey, with 11,530 and 8,480 CPM population, respectively.”

“The U.S. economy is the largest in the world and generates $56 billion USD every day when it is fully functioning. To facilitate the ‘Opening Up America Again’ initiative in a manner that prioritizes public health first and foremost while returning America to work as fast as possible, the model is a tool to help guide timing and decisions for our nation’s governors,” continued Dr. Quay. “I stand ready to help in the analysis and interpretation of COVID-19 public health data at the county, state, regional, or national level and to work with U.S. officials in any manner I can to help translate Taiwan’s SARS-CoV-2 best-practices to the U.S. environment.”

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 seeking to discover and develop innovative medicines in areas of significant unmet medical need. Atossa’s current focus is on breast cancer and COVID-19, with the recent announcement of the COVID-19 HOPE drug development program.

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.

Public Relations Contact:
Dunn Pellier Media| t: (310) 362-6131 ext. 943
11620 Wilshire Blvd| 9th Floor, Los Angeles, CA 90025
melissa@dunnpelliermedia.com
nicole@dunnpelliermedia.com

Source: http://www.globenewswire.com/news-release/2020/04/17/2018068/0/en/COVID-19-Cease-Fire-for-the-United-States-on-April-23-2020-and-successful-Opening-Up-America-Again-initiative-predicted.html

Source: https://wjla.com/news/coronavirus/two-fda-approved-drugs-could-help-fight-covid-19

Source: https://video.foxnews.com/v/6147410883001#sp=show-clips

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“Things will go back to normal by April 21st, Easter”

FALSE. Using the DTFG tool I developed and explained in a March 21 blog (Predicting the COVID-19 Future) the United States will have approximately 1.7 million cases by mid-May. At that point the growth of new cases will be at a still significant but steady, daily increase. 

---

“If you can hold your breath for 10 seconds, you don’t have CV”

PARTIALLY TRUE. See this blog to learn the full truth: The Eleven Second Home COVID-19 Test. 

---

“You can’t get coronavirus in hot climates, cold weather, or snow kills coronavirus, hot baths kill coronavirus in your body”

FALSE, FALSE. Every region, from equatorial Africa to Artic Scandinavia, has COVID-19, laboratories store viruses in the cold to preserve them, and if baths could kill germs, antibiotics would have never been the miracle drugs of the 20th century that they were. 

---

“You can get coronavirus from a mosquito bite”

FALSE. Malaria and many other diseases are contracted by a mosquito bite but not SARS-CoV-2. Someday, unfortunately when a large percentage of the world’s population has the virus, there will be a small future risk that a mosquito can travel from an infected to a non-infected patient and cause the disease. 

---

“You can’t transmit coronavirus if you have no symptoms”

FALSE, DANGEROUSLY SO. As I write this Q&A on April 4th, there are 1.2 million COVID=19 patients in the world. That means there are 240,000 patients with the virus who have absolutely NO symptoms. 

The first example from the medical literature I read that taught the consequences of this false statement was about a 36-year old man who in December 2019 had visited Wuhan, China, where the pandemic began. He returned home two days later, and never had any symptoms at any time…ever. His wife became ill two days after his return home and one week later she was hospitalized in the intensive care unit with a machine helping her to breathe. The medical article ended without saying whether she lived or died. 

---

“Coronavirus is only infecting and killing elderly people with underlying conditions”

FALSE (Infection) AND TRUE (Mortality). On March 5th, a medical paper was published (1) about children with COVID-19. In the small study of 20 cases, the children were between six months and six years of age. There were more boys than girls (just like in adults), 65% had a cough and/or fever when first seen by the doctor, and 65% had a “certain” history of contact with an infected person. All twenty survived and at the time of this writing I am unaware of a child under age 10 years who has died. 

While most deaths are in the elderly (the death rate above 70 years of age is 12-24%), the death rate for men and women age 50-59 year is about 1.3%. (2) 

No one in their 50s thinks they are elderly! 

---

“Children can’t get the coronavirus”

FALSE. See previous answer. 

---

“Pneumonia vaccines are effective in preventing CV”

FALSE. Neither the influenza nor pneumonia vaccines provide any protection. 

In 2003 an “ancestor” of this 2019 virus infected about 8,000 patients worldwide (2003 Coronavirus Epidemic). A group of Beijing medical scientists performed a thoughtful experiment and examined the blood of survivors of the 2003 epidemic to see if the antibodies they had developed 17 years earlier would recognize this new virus, a “great-grand child” of the 2003 virus. (3) 

Unfortunately there was limited cross-reactivity, providing no new knowledge towards the quest for a vaccine. 

---

1 Pediatr Pulmonol. 2020 Mar 5. doi: 10.1002/ppul.24718.
2 Lancet Infect Dis 2020 Published Online March 30, 2020 https://doi.org/10.1016/ S1473-3099(20)30243-7
3 Nat Commun. 2020 Mar 27;11(1):1620. doi: 10.1038/s41467-020-15562-9

“Dr. Quay, thank you for taking some time from your work today to answer a few questions people have. Let me jump right in:”

---

“Things will go back to normal by April 21st, Easter”

FALSE. Using the DTFG tool I developed and explained in a March 21 blog (Predicting the COVID-19 Future) the United States will have approximately 1.7 million cases by mid-May. At that point the growth of new cases will be at a still significant but steady, daily increase. 

---

“If you can hold your breath for 10 seconds, you don’t have coronavirus”

PARTIALLY TRUE. See this blog to learn the full truth: The Eleven Second Home COVID-19 Test. 

---

“You can’t get coronavirus in hot climates, cold weather, or snow kills coronavirus, hot baths kill coronavirus in your body”

FALSE, FALSE, FALSE, FALSE. Every region, from equatorial Africa to Artic Scandinavia, has COVID-19, laboratories store viruses in the cold to preserve them, and if baths could kill germs, antibiotics would have never been the miracle drugs of the 20th century that they were. 

---

“You can get coronavirus from a mosquito bite”

FALSE. Malaria and many other diseases are contracted by a mosquito bite but not SARS-CoV-2. Someday, unfortunately when a large percentage of the world’s population has the virus, there will be a small future risk that a mosquito can travel from an infected to a non-infected patient and cause the disease. 

---

“You can’t transmit coronavirus if you have no symptoms”

FALSE, DANGEROUSLY SO. As I write this Q&A on April 4th, there are 1.2 million COVID=19 patients in the world. That means there are 240,000 patients with the virus who have absolutely NO symptoms. 

The first example from the medical literature I read that taught the consequences of this false statement was about a 36-year old man who in December 2019 had visited Wuhan, China, where the pandemic began. He returned home two days later, and never had any symptoms at any time…ever. His wife became ill two days after his return home and one week later she was hospitalized in the intensive care unit with a machine helping her to breathe. The medical article ended without saying whether she lived or died. 

---

“Coronavirus is only infecting and killing elderly people with underlying conditions”

FALSE (Infection) AND TRUE (Mortality). On March 5th, a medical paper was published (1) about children with COVID-19. In the small study of 20 cases, the children were between six months and six years of age. There were more boys than girls (just like in adults), 65% had a cough and/or fever when first seen by the doctor, and 65% had a “certain” history of contact with an infected person. All twenty survived and at the time of this writing I am unaware of a child under age 10 years who has died. 

While most deaths are in the elderly (the death rate above 70 years of age is 12-24%), the death rate for men and women age 50-59 year is about 1.3%. (2) 

No one in their 50s thinks they are elderly! 

---

“Children can’t get the coronavirus”

FALSE. See previous answer. 

---

“Pneumonia vaccines are effective in preventing coronavirus”

FALSE. Neither the influenza nor pneumonia vaccines provide any protection. 

In 2003 an “ancestor” of this 2019 virus infected about 8,000 patients worldwide (2003 Coronavirus Epidemic). A group of Beijing medical scientists performed a thoughtful experiment and examined the blood of survivors of the 2003 epidemic to see if the antibodies they had developed 17 years earlier would recognize this new virus, a “great-grand child” of the 2003 virus. (3) 

Unfortunately there was limited cross-reactivity, providing no new knowledge towards the quest for a vaccine. 

---

1 Pediatr Pulmonol. 2020 Mar 5. doi: 10.1002/ppul.24718.
2 Lancet Infect Dis 2020 Published Online March 30, 2020 https://doi.org/10.1016/ S1473-3099(20)30243-7
3 Nat Commun. 2020 Mar 27;11(1):1620. doi: 10.1038/s41467-020-15562-9

Who thinks getting medical advice from politicians is a good idea, regardless of which political party they belong to?

Here is what the doctors at the FDA are sayinging about respirators, face masks, and where we are TODAY.

Be safe, take care, Dr. Quay

https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/faqs-shortages-surgical-masks-and-gowns?utm_campaign=2020-03-03%20Face%20Masks%20and%20Respirators%20update-COVID-19&utm_medium=email&utm_source=Eloqua#kn95

The humans are winning in every country!

In previous posts I described my proprietary method of deciding who is winning the pandemic, the virus or the humans. You can go back there and see the math behind the method. Briefly, it calculates the number of days for a ten-fold increase in cases in a country (DTFG) and then uses ranges for the resulting number for the referee to make the call as to who’s winning and who’s losing, and where the game is tied or a stalemate.

Today I want to see what progress, if any, has been made by the humans in the last seven days, a week.

Twitter version: Every country improved!

The way to read this chart is, first colored column, where each country was on March 23rd. Next column is where each country was on March 30, seven days later. The fraction in that third column is the DTFG for the 23rd slash the DTFG for the 30th. If the number is getting larger with time, a country is making progress.

So here we go:

China and South Korea have declared victory and their numbers keep getting bigger. Why keep counting their numbers? Because the way the math works, if the virus starts sneaking back the first sign will be this number starts getting smaller: finally, an early warning system!

Next we have the ‘humans winning’ category. This went from only two countries to five. And in every country, the DTFG number is larger now than a week ago. Good job!

Next are six countries that were at a stalemate with the virus a week ago and, although they are still at a stalemate, their DTFG has increased. They are making progress. You can see just how much progress they made in a week and since they have to get above 15 to get the green flag, make a game of it and guess which country will be winning by this time next week and which ones won’t quite be there.

Finally, a week ago five countries were losing to the virus and today only one is, the US. The other four have transitioned to being at a stalemate, which must be a wonderful feeling for them. As for the US. I project we will cross over to a stalemate sometime within the next 96 hours. (The details were the US was at about 9.6 which I rounded up and could have made it yellow but I didn’t and kept it in the red zone to be conservative).

Don’t worry, I will keep track of the US progress for you and will report as soon as the referee gives the US the yellow flag, saying the game is finally tied in the US.