High On Israel

Jerusalem — Six months of Palestinian terror attacks didn’t discourage scores of medical cannabis experts and investors from flocking to Israel last week for a medical cannabis (marijuana) conference.

Israel’s 2nd CannaTech conference, which focused on “accelerating cannabis innovation,” attracted participants from dozens of countries eager to capitalize on the country’s research and know-how, as well as Israeli growers, researchers and entrepreneurs eager to collaborate.

Though much better known for its high-tech and military expertise, “Israel is at the forefront of cannabis-related research and how it interacts with our bodies,” said John Kagia, director of industry analytics for New Frontier, a U.S.-based cannabis industry data collection company. “Israeli researchers have been instrumental in helping shape our understanding of cannabis’ therapeutic applications.”

Few people outside the industry know that Rafael Mechoulam, an Israeli pioneer in medical cannabis research, isolated THC, the main psychoactive chemical in cannabis, in 1964 at the Weizmann Institute, or that the ground-breaking clinical trial based on his discovery demonstrated — 35 years ago — that cannabis can alleviate epileptic seizures.

“Unfortunately, no one was interested then,” Mechoulam, now in his 80s and conducting research at the Hebrew University, told The Jewish Week. “Till this day children continue to have epileptic attacks” that could be alleviated with cannabis.

It took nearly another three decades for GW Pharmaceuticals, a British company, to build on Mechoulam’s research (with his active participation) and develop the experimental Epidolex, which The New York Times this week hailed as the first cannabis-based medication to reduce convulsive seizures in clinical trials.

In the years since Mechoulam’s breakthrough, Israeli researchers have conducted clinical trials to determine cannabis’ ability to ameliorate the side effects of chemotherapy and bone marrow transplants. Other trials have focused on post-traumatic stress disorder (PTSD) and gastrointestinal diseases.

Meanwhile, Israeli start-ups have developed medical marijuana that doesn’t lead to a high, and the world’s first metered dose cannabis inhaler. Hebrew University, it was announced during the conference, plans to establish Israel’s first academic cannabis research center. And Israeli agricultural researchers are growing a variety of cannabis strains they hope will ease a number of ailments.

These innovations and human trials have been facilitated by an Israeli policy that permits researchers to obtain cannabis plants, despite the fact that cannabis possession for “entertainment” purposes is strictly illegal.

Tamir Gedo, CEO of B.O.L Pharma, which calls itself Israel’s leading medical cannabis producer and drug development facility, said he and other Israeli cannabis entrepreneurs and researchers, “want to build Israel as a hub to conduct clinical trial research” for researchers and companies that can’t conduct trials at home due to their governments’ regulations.

“There are more than 280 [cannabis-related] pre-clinical trials [including animal testing] being conducted in the U.S. and a similar number being conducted in other Western countries,” Gedo said, referring to non-human trials that test for feasibility and drug safety.

But U.S. researchers can rarely carry out the next level.

“While the FDA “highly supports” conducting medical trials using the cannabis plant, Gedo said, the Drug Enforcement Administration “is suppressing them.”

The DEA has authorized just one institution to distribute cannabis plants to researchers, he said, but the supply is grossly inadequate.

To date, only one major cannabis-based clinical trial — for Epidiolex — has been completed in a U.S. hospital, and only after Stage I and II trials held elsewhere were proved safe and effective.

“In Israel you can conduct clinical trials,” Gedo noted. “The regulations are more liberal. The Ministry of Health will examine [any] protocol if your research makes sense. In the last quarter of 2015 there were more than 30 clinical trial applications and I believe half were approved. This is a huge number when talking about a country like Israel.”

The need for overseas clinical trials is greater than ever before, the entrepreneur said, because the FDA has recently cracked down on companies that make unsubstantiated medical claims.

“In the past two months, the FDA issued eight warning letters to companies that market cannabis products using medical claims. Some of those products were taken off the shelves. The only way to make a medical claim is by conducting a clinical trial,” Gedo said.

Clinical trials performed in Israel are recognized by the FDA, and U.S-based trials are recognized by Israel’s Ministry of Health.

Asked how Israel can benefit financially, Gedo said that foreigners conducting trials in Israel would hold all the rights to the “intellectual property” garnered in Israel and that in return, “we will ask them to produce their product in Israel” using Israeli-grown cannabis.

Kagia believes medical cannabis is finally on the public’s radar.

“Just in the last year The New York Times, Financial Times, USA Today and many other papers have done in-depth stories on the industry. It’s part of a broader social awakening that the stigma so long related to the plant is unfounded.”

Kagia believes Hebrew University, will add to the field’s credibility and “further cement Israel’s position as a world leader in cannabis research.”

Jeffrey Friedland, CEO of Intiva, which is based in Colorado, said he has invested in two Israeli cannabis-focused companies.

“The real money is based on real science,” he said. While 23 or 24 states now allow medical marijuana, Friedland said, “physicians are frustrated. They don’t feel right telling patients, ‘Take two tokes and call me in the morning.’ There’s no dosage information, no data. There’s not enough science to back it up.”

While cannabis research is still in its early stage, Friedland said, “Israel is light years ahead of the rest of the world.”