SCHOHARIE COUNTY -- A treatment developed by a Schoharie County researcher that’s shown effectiveness against COVID-19 is days away from entering an important clinical trial that could be the next step forward.
John McMichael, Ph.D, president and CEO of Beech Tree Labs, developed treatment across multiple lines (TML) more than two decades ago, and it’s passed two phase-2 trials from the U.S. Food and Drug Administration as a treatment for herpes infections.
Recently, physicians in the Beech Tree Labs network have begun using TML as an off-label therapy for coronavirus patients, and it’s shown strong results with all reported patients recovering within 48 hours.
“Our anecdotal work, not under any trial conditions, shows that people usually get better, certainly within 48 hours,” McMichael, who holds Ph.Ds in both immunology and virology, said in a phone interview Tuesday. He lives in Schoharie County. The company's main lab is in Rhode Island.
Beech Tree Labs has partnered with Poplar Healthcare in Memphis, Tennessee to conduct a double-blind, placebo-controlled study to prove its effectiveness under clinical conditions.
“We just wanted to see if it would work with coronavirus,” McMichael said. “It appears it does, but now we have to prove it with this double-blind, placebo-controlled trial. We want to get going in the next few days.”
In support of McMichael’s efforts, state Assemblyman Chris Tague, R-Schoharie, sent a letter to President Donald Trump and the White House Coronavirus Task Force to inform them of TML’s potential and seek an expedited review and approval of the drug.
“In this time of crisis, it’s imperative we seek every possible manner to fight the virus,” Tague said in a news release. “To that end, I feel that the breakthrough Dr. McMichael has had with TML is a very hopeful avenue to helping those afflicted by COVID-19. It is my hope that by bringing all the resources to the Coronavirus Task Force, along with the attention of President Trump, we will be able to accelerate any investigation to cure the virus.”
In the letter, Tague writes of TML’s effectiveness as an “off label” treatment and urged the White House “to do everything prudently possible to relax bureaucratic requirements and expedite the testing and approval of this potentially life-saving treatment. In the instances where TML was provided ‘off label’ to patients, the process was simple — a few drops on the tongue, no side effects, with symptoms resolved in as little as four hours. Simply put, to know that such a miraculous medication exists, one that has the potential to save thousands of lives, and not do everything in our power to immediately get it into the hands of those who need it the most, would be immoral.”
While McMichael said the process was currently in a stage with “nothing dramatic happening — a lot of paperwork to be done to remain in compliance with the FDA to get this pilot trial started,” he thanked Tague and others for helping to spread the word.
McMichael also acknowledged that he understands the stress regulatory agencies are under at this time.
“I’m sure these regulatory folks and the people from the medical community at the federal and state level are overwhelmed,” he said, “not only with the people that are ill but also just with all the folks that claim to have a cure or something that they want to have evaluated. They have a lot of work to sift through what’s legitimate and what’s not, and so forth. We’re moving ahead — never as fast or as streamlined as you’d hope, but moving ahead — toward this pilot study that we should have kicked off within the next two days, and we’ll see where it goes from there.”
Should TML pass its upcoming short pilot trial — a “dangerous assumption,” McMichael said — things could then proceed to an official phase-3 trial with the FDA, which would be the final step before the drug could go to the market.
If that happens, McMichael said the best plan would be for Beech Tree Labs to partner with a larger pharmaceutical company that has the infrastructure and resources to produce on a large scale.
“That’s not us,” he said. "We have neither the infrastructure nor the resources for the infrastructure, nor, really, the interest. We would want to partner with a bigger company that does that all the time.”