United Abroad

U.S. Companies Turn Eyes to Israel
for Cannabis Research


Innovations in cannabis abound in the U.S. as state legalization becomes a reality, but there is a limit to what can be researched under federal prohibition. How can you fully test a drug that isn’t federally legal? Take your research to a country that has openly studied medical cannabis for decades — Israel.
“Israel has one of the oldest regulated cannabis programs in the world with a strong emphasis on patient data and clinical trials,” said Saul Kaye, founder and CEO at iCAN Israel-Cannabis. “This has given Israel a lead of at least 10 plus years in the industry and the ability to do things that aren’t able to be done in the U.S.”

Kaye leads the team at iCAN, a group of dedicated professionals from diverse backgrounds that work together to create a global network for the cannabis industry. They host the annual CannaTech conference in Tel Aviv, Israel, a live event experience that showcases global leaders whose expertise spans the fields of science, finance, medicine, government policy, agriculture and entrepreneurship.
“In the U.S., there is still a federal ban on cannabis research, meaning that all clinical trials must be conducted elsewhere,” Kaye said. “Israel’s clinical trial environment has been a driver for the pharma and biotech industries as it is more cost effective to do them in Israel rather than the U.S. anyway,” he added. “Israel’s reputation as a leader in biotechnology and medical research, together with our prowess in agriculture and conservation, has put Israel ahead of the rest of the world in the cannabis space.”
Federal prohibition in the U.S. has actively blocked decades of research and funding from the hands of eager scientists who want to study cannabis as medicine. A spokeswoman from the U.S. National Institute on Drug Abuse, Shirley Simson, told “The New York Times” back in 2010, “Our focus is primarily on the negative consequences of marijuana use. We generally do not fund research focused on the potential beneficial medical effects of marijuana.” Other agencies reportedly followed their lead.
Israel, however, has no such hang ups with a phenomenon that truly began within its borders. In 1964, Israeli scientists Raphael Mechoulam and Yechiel Gaoni were the first to isolate THC, the chemical component that causes a high. In 1993 Israel became one of the first countries to legalize cannabis for medicinal use when Mechoulam discovered the reason humans get high: the compounds in cannabis mimic the compounds in our brains. Since then, Israel has allowed the full research and development of cannabis medicine.

According to iCAN’s research, U.S. firms have invested more than $50 million to license Israeli medical marijuana patents, cannabis agro-tech startups, and firms developing delivery devices such as inhalers.
But that opportunity to conduct research hasn’t alone earned Israel the title of being the global leader in cannabis research, according to Dr. Reggie Gaudino, vice president of Science, Genetics and Intellectual Property at Steep Hill lab, a California-based cannabis testing company. “There’s a little known fact that there’s a system of reciprocity for clinical trials in Israel,” he said.

Companies that progress through stage two or three of clinical trials in Israel can then file a transfer document with the FDA, Gaudino said. All the data is then accepted as if it had been done in the U.S. “It makes it a pretty easy way to get pre-legalization cannabis studies done and have that data automatically count in the [U.S.] later,” he said.

A quick breakdown of what these clinical trials are for all pharmaceuticals: stage one trials start with 20-to-100 healthy volunteers, or people with a specific condition, to determine the medicine’s safety and dosage, according to the Drug Development guidelines from the U.S. Food and Drug Administration.
If it’s determined to be safe, the medicine goes into stage two trials, which involve several hundred participants, to determine any side effects and how well the drug works. That can take anywhere from several months to two years, according to the FDA. If it passes that stage, it goes into stage three trials, which are conducted over a period of one-to-four years and include 300-to-3,000 volunteers (with a specific condition or disease).

Steep Hill is one of many companies that is extending operations into Israel. They recently formed a partnership with Dr. David Meiri to be part of a research and development facility in Israel, Gaudino said. Meiri heads the Laboratory of Cancer Biology and Cannabinoid Research at Technion, the Israel Institute of Technology, and was the first scientist to receive an official license from the Israeli government to study cannabis. Steep Hill will be bringing its expertise to assist with Meiri’s research.
Steep Hill and Meiri’s team first formed their partnership through CannaTech’s Tel Aviv conference. This event helps Israel attract American companies and others from around the world that have a thirst for studying cannabis. Meiri’s lab is investigating the therapeutic potential of phytocannabinoids, the unique active compounds of cannabis. He’s also collaborating with cannabis growers, clinicians and major manufacturers and distributors of medical cannabis to revolutionize cannabis treatment. Meiri is operating the “Cannabis Database Project” and his lab is currently involved in seven clinical trials covering diverse aspects of cannabis treatments in areas such as: colon disease, pain prevention, cancer treatment, and epilepsy.

“The goal is for us to be essentially the chemistry arm of his research,” Gaudino said. “We know there are 144 cannabinoids and over 500 active compounds, of which there are many terpenes, and there’s other minor compounds like flavonoids, iso-flavonoids.”

“All of those molecules have some sort of biological activity, we know that from the study of other plant organisms. Then you add to that the accumulation of hundreds and hundreds of biologically active compounds in cannabis, a higher number than occur in almost any other plant,” he added, “The question becomes: what is this plant useful for? What can be done? That’s why people think it’s the miracle cure. It certainly has a lot of compounds that act in a lot of different systems,” Gaudino said.

Plant extracts are analyzed by Meiri’s team and used in vitro or in clinical trials, Gaudino said. That means having real people try the medicine. Once the trial’s outcome is determined, they compare the results to the chemical profile for all those compounds. “In doing so, you get to see the differences the strains have in terms of their chemical profile, and you can correlate that to the efficacy of different things.”

Steep Hill isn’t alone in its desire to connect with investors and partners at events like CannaTech. Kaye of iCAN said the science and research opportunities at the international event attracts many types, though the people most interested are investors looking for protectable intellectual property, and revenue — “Israel offers that,” he said.
“We have successfully created the highest end cannabis ecosystem in the world, and we are very proud of the diverse range of communities that we can impact,” he said.

Emerald contributor since December 2016


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