By GREGORY ZELLER //
A research effort stretching from Florida to Long Island to Canada’s Alberta province will determine if compounds derived from marijuana can be effective treatments for concussions.
Calgary-based R&D firm Scythian Biosciences has agreed to fund a University of Miami study, to be conducted by the university’s The Miami Project to Cure Paralysis and Miller School of Medicine, exploring cannabinoid-based methods of reducing post-concussion brain cell inflammation, which causes headaches and other neurological complications.
Scythian Biosciences is owned by investment banker Jonathan Gilbert, who partners in Great Neck-based fitness-nutrition enterprise Decision Nutrition with his wife, Keren Gilbert, among other ventures.
The Canadian research firm – which acquired western-Canadian cannabinoid producer Go Green BC Medical Marijuana in 2015 – is not supplying that kind of green for the project, but it’s ponying up plenty of the other: Scythian Biosciences will pay the University of Miami $16 million over the course of the five-year study.
Gilbert said the first tranche has already been paid and he is “engaged” with a Toronto-based group that may fund the rest.
The company is also sharing the science behind one of its two pending patents, both written by Chief Operating Officer David Schrader, a corporate attorney with a biochemistry degree from Johns Hopkins University. A per Schrader’s patent, University of Miami researchers will be testing a compound that combines CBD, a cannabinoid derivative of hemp, with a chemical that disrupts nerve-cell receptors.
Gilbert launched his Canadian R&D firm in 2014, first as Valens Agritech Canada and then Spartan Cannabis Corp. An early deal referencing the “Valens” name fell through and “Spartan Cannabis” never really clicked – “We found having the word ‘cannabis’ in the name of the parent company was actually limiting,” Gilbert noted – so the CEO and his partner, Canadian investment banker Mo Fazil, went with “Scythian,” a reference to the Fourth Century BC Iranian/Eurasian nomadic tribe believed to be the first cannabis users.
Now, just 25 dope centuries later, Scythian Biosciences is looking to rewrite the concussion-treatment textbook by leveraging the medical marijuana boom. It’s a high-profile mission with billion-dollar ramifications, and Gilbert believes his company has the science to succeed.
Studies have shown cannabinoids are effective for treating pain and other symptoms associated with glaucoma, epilepsy, depression and a host of other conditions, all with few side effects – and Scythian Biosciences believes it can achieve similar results for patients with sustained brain injuries, according to its CEO.
“There is currently no pharmaceutical treatment for concussions,” Gilbert told Innovate LI. “When you got to the emergency room with a concussion, they basically tell you to go home and rest, and maybe give you some ibuprofen.
“We are in a white space here,” he added. “That’s what makes this so unbelievably compelling.”
Scheduled to begin in January, the Miami team – led by Gillian Hotz, director of the University of Miami’s concussion program – will first study the compound’s effects on laboratory rats, tweaking doses and other clinical factors. (And no, the rats won’t develop the munchies or get deep into the symbolism of “The Lamb Lies Down on Broadway.” The compound’s cannabinoid derivative contains no tetrahydrocannabinol, better known by its stage name THC, marijuana’s main mind-altering agent.)
Researchers hope to then move into a human pilot study that would administer the compound to a small control group and two patient groups – one with chronic brain injuries, one with acute brain injuries – and assess their cognitive functions.
Assuming positive results, they’ll then seek an FDA-approved clinical trial featuring hundreds of patients, ultimately aiming for a therapeutic treatment that could involve a pill, an inhalable vapor or some other delivery system.
Scythian Biosciences, meanwhile, will wait out those patents – the second involves cannabinoid-derived treatments for gastrointestinal disorders – and pursue funding opportunities. It’s also awaiting a license to distribute medical marijuana in Canada, the second leg of what Gilbert described as a “bifurcated business model.”
But its concussion-related mission is the startup’s main vertical, and has already attracted some major-league support. Behind Gilbert, Fazil and Schrader is a directors board rich with scientific and business acumen, including Peter Levy, a Harvard-educated attorney and former president of New Jersey biotherapeutics innovator Myos Corp., and Maghsoud Dariani, a cofounder and vice president of Celgene Corp., a New Jersey biotech focused on cancer-fighting pharmaceuticals.
Also on board are Rutgers University neurologist Thomas Zimmerman and Bart Oates, the former Super Bowl-winning center of the New York Giants, now a member of the New Jersey Bar Association.
“What I have is an all-star advisory team that has catapulted me into a new stratosphere, allowing me to walk in confidently to investment firms and ask for tens of millions of dollars for research and development funding,” Gilbert noted.
The participation of Oates – who is also president of the New York/New Jersey Chapter of the National Football League Alumni Association – is especially telling, according to the CEO, who noted both the NFL Alumni and the World Boxing Association have already signed on as program partners.
“The NFL Alumni Association has an obvious interest in concussions,” Gilbert said. “It’s nice to have their endorsements, but I also plan on approaching the leagues themselves. This is a problem that the NFL and the [National Hockey League] need to address and take seriously.”
Of course, as endless headlines and federal studies show, the problem is hardly limited to professional athletics, adding some serious social heft to the Scythian Biosciences/University of Miami collaboration.
“It’s a pervasive problem, and not only for professional football and hockey players,” Gilbert said. “This is an equal-opportunity injury that goes right to the playground and the girls’ lacrosse team.
“Our goal is to have a commercialized drug that treats concussions, and solves a traumatic brain injury problem that is not being adequately addressed.”