Coronavirus R&D Pipeline
Researchers at OyaGen & Others Push Forward
by Jeannie Wraight
Each day, hospitalizations due to COVID-19 dramatically increase as the virus sweeps across the U.S. and the globe. The number of confirmed cases today will be a fraction of those on the day this article is published. As we wait for the development of an effective preventive vaccine, those who are already sick are in dire need of therapeutics that will provide the best chance of survival. Yet a drug shown in the lab to kill SARS-CoV-2, the virus that causes COVID- 19, is being ignored.
COVID-19 is a particular concern for people living with HIV who are immune-compromised. The CDC states that people who have a low CD4 count or who are not on suppressive antiretroviral therapy need to take special care to prevent exposure to the virus. Those leading the Presidential efforts including Dr. Anthony Fauci, Director of the National Institutes of Health, Dr. Deborah Birx, the United States Global AIDS Coordinator and CDC director Dr. Bob Redfield are all well known figures in the field of HIV. Yet, little information has been offered in regard to whether a combination of HIV- specific co-morbidities and various levels of being immune-compromised may affect a person with HIV’s response to COVID- 19.
As stay-at-home directives begin to be lifted throughout many states, doctors and researchers search for potential treatments to treat the sick. Laboratory studies conducted at OyaGen in Rochester, New York, in collaboration with Fort Detrick, Maryland, tested a chemical compound OYA1 against SARS CoV-2. Results showed the drug to have strong dose-dependent anti-viral activity against the virus indicating OYA1 successfully prevented the virus from replicating.
OYA1 had been approved by the FDA as an investigational drug in the sixties for the treatment of cancer. Although it proved not to be effective in cancer, safe dosing was determined in both nonhuman primates and humans.
OyaGen anticipates the regulatory approval to test OYA1 in Phase I clinical trials may require that nonhuman primate testing be redone. However, these expensive and time-consuming studies will prevent this experimental treatment from being available for clinical trials at a time when an antiviral treatment is desperately needed.
Dr. Harold Smith, the drug discoverer and CEO of OyaGen, stated in regards to OYA1 and the cell culture study, “We will not know if OYA1 is a treatment solution, or if it is the best immediate treatment method until it is tested in COVID-19-infected patients. As OyaGen’s press release stated, clinical trials in the late 1960s demonstrate do-no-harm dosing of OYA1 in women, men and children and the number of days that people can be safely dosed. OyaGen working with NIAID/NIH discovered that at very low doses, OYA1 stopped the spread of SARS-CoV-2 2 (the virus that causes COVID-19) and MERS (the coronavirus outbreak in 2012) under experimental conditions where cells were grown in dishes and different amounts of live virus was added directly to those cells. Based on safety in humans and efficacy against the virus, OYA1 could be fast-tracked to testing in infected people. The low dose efficacy of OYA1 in the lab also suggests cost-effective scaling up for manufacturing of OYA1 doses for clinical testing. But everything is speculation until we have the opportunity to evaluate OYA1 by human testing.“
OYA1 was also tested against MERS-COV and Ebola and shown to have broad spectrum antiviral activity, an attribute particularly important as the world faces the ever increasing possibility of viral outbreaks and the need for short-term and long-term treatment solutions.
Several drugs that have shown to be safe and are FDA-approved for other indications are being studied in people battling COVID-19. Remdesivir, a broad-spectrum antiviral medication, has been shown to be 30% effective in treating COVID-19 patients and has been given limited FDA approval for COVID-19. Hydroxycholoroquine, an anti-malaria medication touted by President Trump, has been shown to have problematic risks and has been abandoned by many leading physicians. Two HIV antiretroviral therapies, lopinavir and ritonavir, were studied by doctors in China but were found to show no benefit. .
The numbers we are seeing and expect to see for some time in emergency rooms throughout the U.S. will undoubtedly include some people living with HIV who fit the criteria for being at high risk. As the virus increasingly spreads to nations entering winter in the southern hemisphere, large populations of HIV-positive people, some without access to a continuum of care, will be adversely affected by COVID-19. An effective treatment to prevent escalating numbers of deaths is essential. Only human studies will show if OYA1 is effective in treating COVID-19. In a time of crisis, a drug shown to prevent replication in laboratory experiments with proven safety data should be given a second and serious look by the FDA.
Jeannie Wraight is the former editor-in-chief and co-founder of HIV and HCV Haven (http://www.hivhaven.com) and a blogger and writer for TheBody.com. She is a member of the Board of Directors of Health People, a community-based organization in the South Bronx and an advisor to TRW (Teach me to Read and Write), a community-based organization in Kampala, Uganda. She lives with her husband in New York City.