Source – https://pilotonline.com/news/local/health/article_0dc5c548-138f-11e9-bd40-7be70021dc07.html
Eighteen months after receiving a broad federal license for importing medical cannabis, a Norfolk research company is about to embark on a series of critical studies into a variety of medical and mental disorders, diseases and conditions.
Sanyal Biotechnology is already considering proposals for research campuses and planning its first clinical trial for this summer. The new venture potentially opens the door to significantly expanding national research being done on the medical benefits of cannabis.
It brings the company one step away from its main focus: pharmaceutical drug screening through preclinical trials of liver diseases, obesity and diabetes. But Rebecca Caffrey, co-founder and CEO of Sanyal, said the research possibilities with cannabis extracts are endless.
She said the federal license is the broadest ever issued to a U.S. company and allows it to import high-quality cannabis extracts not available in the U.S. Cannabis available for federal research in the U.S. is of notably lower quality than what is available outside the country, she said.
Access to the higher-quality imports allows Sanyal to ensure better quality control and significantly expand American research, which has been under tight control of the federal government.
Sanyal, which operates out of Eastern Virginia Medical School, received the license from the Drug Enforcement Administration in 2017. It cannot import cannabis flowers or buds but can receive organic extracts, such as THC, which produces a “high,” and cannabidiol (CBD) for preclinical and clinical trials.
It has taken years to get the needed state and federal licenses, but the company is now ready to develop a clinical research facility. It’s still sifting through the flood of proposals from other companies that want to invest in a facility but hopes to have a decision this quarter, said Sanyal cannabis consultant James Lee.
There’s no assurance that Hampton Roads would be on the list of potential spots for the research headquarters. Lee would not disclose which companies have approached Sanyal or how much their investment would be, but said there was a proposal in New York that the company was seriously considering.
Bids from interested investors have arrived from all over the nation with offers to build up to nine-acre research campuses, Lee said. But even if the headquarters went elsewhere, Sanyal still expects to have a substantial presence here.
“What we’re going to do is we’re looking at running a 200-person clinical trial here in Hampton Roads,” he said. “We’re looking for the proper space to build a (15,000-square-foot) satellite facility down here.”
Caffrey said she would like Sanyal to stay in Virginia, but it might not be possible, depending on which proposal they choose.
“I would like to maintain a presence here that doesn’t preclude me from having operations elsewhere, too,” she said.
The first clinical trial will most likely be focused on suboxone supplements. Suboxone reduces symptoms of opiate addiction and withdrawal.
“We literally might be able to use medical cannabis to get out of this public health crisis that’s killing our people because of prescription pain pills that are pushing them to heroin,” Caffrey said. “To me, it’s this huge irony that this drug that everyone has said is so bad for so long might end up saving a lot of lives and solving that societal problem.”
Other trials could include studies on PTSD, insomnia or depression.
Sanyal’s pursuit of a DEA license began when Ontario, Canada-based Revive Therapeutics requested a liver study using CBD on Sanyal’s lab mice.
It originally applied for a license allowing Sanyal to only import cannabis extracts from Canada, and Caffrey assumed a narrow license would be granted. Instead, she said she was surprised when the company got a nearly “unrestricted” license that left importing opportunities open to more than just Canadian exports.
Getting the license took a year of paperwork, background checks and inspections of the company’s facility, as well as applying for needed state and federal licenses that would allow the research.
“We didn’t originally plan to do clinical trials on people, but there’s this huge unmet need and it’s so hard for American researchers to do research…” Caffrey said. “American researchers and American doctors have really been cut out of the loop because the government puts so many hurdles to be able to do preclinical research on mice or research on humans for all these different conditions.”
Caffrey said the federal government’s strict hold on trials has allowed other countries to get “way ahead” of the U.S. Now that Sanyal has a license to import material for trials, foreign companies have become interested in hiring the company to perform research with their compound products.
But don’t expect any giant shipments of cannabis extracts into Norfolk. Caffrey said she is permitted to only import a DEA-approved amount for each study.
Caffrey said she has kept frequent contact with the DEA as they worked to get the operation up and running. Staying in line with federal regulations is her priority, since cannabis is still federally illegal.
“I tell them (the DEA) all the time, ‘I’m going to be bothering you so much because I have questions,’ ” she said. “I don’t look good in orange. It’s not my color.”