Former NHL player and two-time Stanley Cup winner Daniel Carcillo was a headlining speaker at last week’s Wonderland: Miami psychedelic conference, where he and Mike Tyson spoke of how psychedelics have helped them overcome struggles and symptoms associated with traumatic brain injury (TBI).
Carcillo joined The Dales Report team aboard the Maryam in Miami following his on-stage discussion for an in-person interview with Nicolle Hodges and yours truly.
Step One: Getting Better
Before Wesana Health Holdings Inc. (CNSX: WESA; OTCMKTS: WSNAF) was founded, a lot of things had to happen, said Carcillo, who went through every treatment option in the book (and some experimental ones) prior to learning about psilocybin.
“I really wasn’t in much control, and first and foremost, it was [about] getting better,” he said.
Carcillo took his treatment into his own hands, spending significant time researching, reading academic papers, speaking with pathologists, and visiting brain banks and concussion clinics before landing on a routine that has dramatically improved his quality of life.
“It’s allowed me the ability to be able to lessen my anxiety, lessen my depression, not suffer from suicidal ideation, be more creative, have better access to my brain, and then build a team around me that’s going to help me realize my dream, which is to get an FDA-approved pharmaceutical for traumatic brain injury and for concussion survivors.”
The Regulatory Path: What Drug Development Looks Like
Carcillo spelled out the complicated work of drug development and onerous FDA approval processes for TDR viewers (and hosts): it all starts with a novel innovation, which must first be tested in an animal model.
“You can do a tail suspension test for depression and anxiety and administer your medication to that animal. If your animal doesn’t die, and you show that your medication had an effect on the anxiolytic or anti-depressant properties of mice or rats, then they will allow you to proceed into preclinical work,” he said.
Preclinical work involves toxicology and safety studies, and must be completed before applying for an indication, or an IND (investigational new drug) with the FDA.
“If you do all the things that satisfy them, then they can sit down with you and give you direction,” he said. Carcillo’s team has already requested a meeting with the FDA and he anticipates it will take place in Q1 of 2022.
Once the FDA is satisfied with the results of the work, they provide approval that allows study to progress to phase one, which moves the drug from animal models to ones involving healthy humans. Phase two involves a closer look at the desired indication.
“If you have depression, or TBI, then you start treating people with that specific indication that you want to treat in phase two,” he said. Phase three is a more robust iteration of phase two.
The Benefit of a Novel Compound
One thing Carcillo noted about the space is that many companies seem to be “racing” to complete phase 2b studies, and they are strictly using psilocybin, whereas Wesana is focused on a novel drug.
“That advantage is 20 years of exclusivity, as opposed to six with data exclusivity for a new indication,” he said.
Given the lack of options for people suffering from TBI and the effects of concussion, and that the leading cause of death in people with TBI is suicide, the need for a new treatment option is dire.
“There are no approved pharmaceuticals to treat concussion or TBI. The treatment right now is being sold as a lifetime treatment,” Carcillo said.
“What’s so exciting about psychedelics is all I kept hearing in these clinics is ‘neuroplasticity;’ reopening critical areas of the brain that are shut down, either due to emotional or physical trauma,” he said.
“That is exactly what some of these compounds do.”
The Need to “Go Through The S**t”
As more and more companies seem to be interested in developing drugs that take out the possibility of a ‘bad’ trip, Carcillo said something on stage at Wonderland that the audience seemed to appreciate: bad trips shouldn’t be avoided, but embraced, like a “secret sauce” to healing.
“I truly believe that for every disease, there’s a cure in nature. Psilocybin is one of those cures,” he says. “I think one of the most crucial points to this therapy is facing your problems or demons or depression, or in my case, suicidal ideation, head on [and] going through it. How long is a bad trip that’s beneficial?”
Watch our full discussion with Carcillo in the video above, where we go on to discuss ethics, plant sanctity, and the insatiable drive for capital in a growing industry.