One of the few manufacturers in the world that meets the high-quality research standards in the U.S. and Europe for medicinal cannabinoid (CBD) is collaborating with University of Miami Miller School of Medicine researchers, providing the company’s product for groundbreaking studies.
Israel-based BOL Pharma is shipping its CBD product to the Miller School researchers who are the first in the United States to receive it, and are using it to conduct animal and eventually human clinical trials studying CBD’s effect on symptoms of concussion and mild traumatic brain injury (mTBI).
A barrier to conducting research on CBD is obtaining CBD that’s high quality and manufactured with Good Manufacturing Practices (GMP), according to Gillian A. Hotz, Ph.D., professor at the Miller School and director of the UHealth Concussion Program.
“Manufacturing plants that meet regulatory standards for CBD research don’t exist in the U.S.,” Dr. Hotz said. “We are the first academic research center to be able to import CBD from a GMP facility, which is critically important for allowing the drug to be used in humans. Without the CBD from BOL Pharma, we would not be able to transition our work from animal studies to human use. This work is so important because treatments for concussion and mTBI are vitally needed.”
BOL Pharma is the only Israeli company to comply with international regulations and the first medicinal CBD manufacturer to obtain approval for exporting medical cannabis products, according to Tamir Gedo, Ph.D., BOL Pharma’s CEO. BOL Pharma has a $150 million manufacturing facility in Israel. The CBD made there is 98% pure, and includes no tetrahydrocannabinol (THC).
“This is a breakthrough for the University of Miami Miller School of Medicine, as it allows the University to conduct its programs in-house instead of running experiments overseas,” said Boaz Hirshberg, M.D., BOL Pharma’s chief medical officer and head of global development. “This is the first shipment of cannabinoid-based active pharmaceutical ingredient to the U.S. It is a cumulation of years of scientific and clinical research, and is a breakthrough for our company. Israel is at the forefront of the life sciences industry, in terms of regulation, research and product development. We are proud to be one of a select number of countries that comply with those strict medical criteria that can export and trade cannabis worldwide.”
CBD is widely used. Yet, high-quality research to support its safety and efficacy is lacking.
“Performing research in leading U.S. universities will allow us to fully elucidate the benefits as well as the risks and inform the U.S. public, regulators, and physicians on best use practices. Importing CBD for research at the University of Miami is the first step in this essential process,” Dr. Hirshberg said.
Dr. Hotz and colleagues are conducting animal studies looking at CBD safety. The University of Miami Health System’s expert neuroscience team includes Dr. Hotz along with colleagues Dalton Dietrich, Ph.D., Helen Bramlett, Ph.D., Michael Hoffer, M.D., and Bonnie Levin, Ph.D. The team is currently conducting pre-clinical studies looking at CBD safety and preparing protocols and outcome measures for an eventual clinical trial.
“This work is important for two reasons,” said Dr. Hoffer. “One, it can lead to a safe oral medicine that reduces the impact of mTBI/concussion, which is one of the most frequent traumatic medical conditions in the world, and two, it can provide scientific evidence for the efficacy of CBD.”
Dr. Hotz added, “We are hopeful that the animal and eventual human studies on CBD will result in a CBD pill that safely treats symptoms of mild brain injury and concussion, including headache, anxiety, depression and pain.”
Miller School researchers plan to finish the pre-clinical work this year and start a clinical trial on humans with concussion and mTBI in the beginning of 2021.
“This is so exciting because research on CBD and brain injury has never been done,” Dr. Hotz said. “Clinical trials should have been done with CBD years ago, but regulatory barriers have limited our ability to study CBD’s effect on humans. Now, thanks to having a high-quality drug to study, we can move forward.”