OyaGen, Inc. announces a compound in development with broad antiviral activity against coronaviruses

[PeteS in CA]

http://www.oyageninc.com/wordpress/wp-content/uploads/2020/03/OyaGen-Press-for-03102020.pdf

OyaGen, Inc. announces a compound in development with broad antiviral activity against coronaviruses including SARS-CoV-2

Rochester, NY (BUSINESS WIRE)
OyaGen, Inc. The company announced today new unpublished results from collaborative research with the National Institute of Allergy and Infectious Diseases’ Integrated Research Facility at Fort Detrick, MD, suggesting strong dose-dependent antiviral activity of its lead compound OYA1 against live SARS-CoV-2, the causative agent for COVID-19, based on in cell culture infectivity studies.

About OYA1. OYA1 has broad-spectrum antiviral activity in laboratory-based assays against the coronaviruses SARS-CoV-2 and MERS-CoV and also is a dual targetspecific antiviral against filoviruses such as Ebola virus. OYA1 was strongly more effective than a positive-control compound, chlorpromazine HCl, at inhibiting SARSCoV-2 from replicating in cell culture. OYA1 had prior FDA approval as an investigational new drug for treating cancer in the 1960s but was abandoned for a lack of efficacy. Studies at that time demonstrated safety in nonhuman primates and human adults when dosed daily or weekly. Side effects may include cardiac toxicity in children when dosed every day.

[jmyrlefuller]

So how long will it take to roll it out? I'm getting frustrated at the slow bureaucratic process here.

[PeteS in CA]

So how long will it take to roll it out? I'm getting frustrated at the slow bureaucratic process here.

FDA testing and approval takes months. That's reality in the US, and there are valid reasons for it (google "Thalidomide" and "DES" for a couple of well-known examples). In the case of this drug, there is at least some safety testing already done, so that will shorten the process. But reality is that we are at least several months away from treatment(s) being approved, and probably on the order of a year from a vaccine being released.

[DB]

FDA testing and approval takes months. That's reality in the US, and there are valid reasons for it (google "Thalidomide" and "DES" for a couple of well-known examples). In the case of this drug, there is at least some safety testing already done, so that will shorten the process. But reality is that we are at least several months away from treatment(s) being approved, and probably on the order of a year from a vaccine being released.

Stuff like this could have all sorts of long term issues.

I would think a traditionally made vaccine targeting a specific virus would have much less likelihood of going wrong if testing were cut short. The primary issue would be it not working and therefore being a waste of time and money. Not what health harm it might cause.