The FDA has granted Orphan Drug status to a synthetic cannabis flavonoid, derived from a rare strain of Jamaican ganja, that can help treat pancreatic cancer.
Most research into the medical properties of cannabis have focused on individual, well-known cannabinoids like THC and CBD. But last summer, a study published in the Frontiers in Oncology journal reported that cannflavin B — a flavonoid, not a cannabinoid — can help kill pancreatic cancer cells. This is an especially exciting development, since pancreatic cancer is one of the deadliest forms of this disease, with a bleak 8 percent survival rate.
In this study, researchers found that cannflavin B can cause cancer cells to essentially commit suicide, while also enhancing the effectiveness of standard chemotherapy and radiation therapies. Flavocure Biotech Inc, the company that funded this research, is not interested in using natural cannabis to fight cancer, however. Instead, they have used cannflavin B to help develop an anti-cancer drug known as Caflanone, or FBL-03G.
This fall, the Food and Drug Administration (FDA) granted Caflanone Orphan Drug status, allowing Flavocure to launch their next phase of trials to investigate the efficacy of this new drug. Orphan Drug status is reserved for new drugs that can treat illnesses affecting fewer than 200,000 US patients annually.
“Research continues at Harvard Medical School, an institution credited with development and collaboration of some of the world’s most successful drugs,” said Flavocure Co-Founder & Executive Vice Chairman Clark Swanson to the Medical Cannabis Network. “Investigational New Drug (IND) enabling studies are essentially complete now, and we are confident in the results and the much-anticipated clinical stage of our company’s drug development.”
Although the company is working to create a synthetic cannabis-derivative, the initial discovery of this cancer-fighting flavonoid came from a unique strain of Jamaican ganja. Swanson explained that Flavocure chairman Dr. Henry Lowe PhD “discovered a rare strain of cannabis endemic to Jamaica. The strain has been labeled as ‘Black Swan’ due to its high flavonoid-rich spectrum.” Naturally-grown Black Swan plants only have an average of 0.14 percent flavonoid content, however, so the company chose to recreate a synthetic version of the natural compound.
Swanson told Medical Cannabis Network that his company is now focusing on the new pancreatic cancer trials, which are set to begin later this spring. “Recruitment will begin the first quarter of 2020,” Swanson explained. “At this time, we plan to carry out a multisite study. We anticipate East and West Coast, USA. No further details are available at this time.”