Thursday, April 16, 2020
It’s a long and expensive process between a medication being developed and brought to market, but with a global pandemic claiming victims by the thousands daily just in the United States, the Food and Drug Administration might provide some flexibility to companies that could offer something promising against COVID-19.
That could happen as early as summer with the anti-viral drug Vicromax. It’s being supported for imminent clinical testing by the Mayo Clinic as a major step toward FDA approval—the drug already having completed two initial testing phases.
While summer approval would be too late for many patients, Vicromax and drugs like it could prepare the nation for the next version of the coronavirus.
“All the experts seem to agree this will be a seasonal issue,” says Andrew Filler, a patent lawyer who is aiding Connecticut-based BioSig Technologies Inc. in the drug’s development. “The government may want to stockpile this drug for the near future. The next season could be this fall.
Legal details of approval
Well before the leaves turn color, Filler hopes to have helped BioSig’s subsidiary company, ViralClear, secure a foundational IP position for Vicromax as it commences clinical trials as early as next month.
A board member as well as IP adviser to the company, Filler actually is general counsel of the California-based Sherpa Technology Group that aids corporate clients in assembling and monetizing a patent portfolio. BioSig being a Sherpa client, Filler helped it acquire the rights to Vicromax from Trek Therapeutics, a Cambridge, Massachusetts, company that lacked the infrastructure to further develop it.
“All the experts seem to agree this will be a seasonal issue. The government may want to stockpile this drug for the near future. The next season could be this fall.”
Now, Filler says, there’s optimism that Vicromax could be used in combination with other drugs that together show effectiveness against COVID-19 and its inevitable mutations.
Assessing the potential of this combo has been outsourced to one of BioSig’s majority-owned subsidiaries, NeuroClear Technologies Inc., noted for its innovations in bioelectronic medicine.
“Stopping the COVID-19 pandemic and preventing similar viral threats in the future must be the number-one priority of all of us in the healthcare community,” BioSig Chairman and CEO Kenneth L. Londoner said in a recent statement. “This very promising anti-viral is the result of tireless efforts by an accomplished group of pharmaceutical industry veterans, and we are doing everything in our power to ensure it gets tested and brought to market as soon as possible.”
And that necessitates all hands on deck.
Filler helped ready BioSig for this mission long before COVID-19 became a pandemic. Founded in 2009, the company was big on innovation but short on patents. Filler brought in Sterne Kessler Goldstein and Fox, a leading patent firm in Washington D.C., and together they helped secure six patents and filed for more than 20 more on BioSig’s Pure EP™ System, positioning the company to attract partners such as the Mayo Clinic that now could make a big difference against the virus.
Filler emphasizes that it’s more a question of when, not if, the next coronavirus strikes.
Over 200 versions of varying severity exist of that virus. Previous deadly outbreaks included SARS in 2003 and MERS in 2012, though the common flu also kills hundreds of thousands of immuno-compromised people each year. But he’s optimistic about BioSig finding an Achilles heel in coronavirus.
“This drug has a broad spectrum that attacks the underlying mechanism of viral replication” Filler says of Vicromax. “It could potentially be used against all coronaviruses. It’s a very broad drug that also has adaptability in animals. Remember, a tiger got COVID-19.”
That 4-year-old Malayan tiger, Bronx Zoo resident Nadia, had developed a dry cough, along with some other big cats, but is expected to recover.