In 2019 a flavonoid of cannabis – Caflanone (FBL-03G) – was granted Orphan drug status by the United States Food and Drug Administration. Now, trials using the flavonoid to treat pancreatic cancer are anticipated to begin in the spring.
Flavocure, a drug discovery and development company, was granted Orphan drug status to its lead drug candidate, the cannabis flavonoid Caflanone (FBL-03G), by the United States Food and Drug Administration (FDA), following the successful demonstration of its therapeutic efficacy in tumour progression in animals with pancreatic cancer.
The company is now on track to begin clinical trials for treating pancreatic cancer with Caflanone in the spring. The research has received strong endorsements from Harvard University, the Pancreatic Cancer Network and others.
Medical Cannabis Network spoke to Co-Founder & Executive Vice Chairman, Clark Swanson, about Caflanone and the upcoming pancreatic cancer trials.
Caflanone (FBL-03G) research
Flavocure’s research into Caflanone is progressing at a rapid pace and will be entering Phase 1/2 of clinical trials later this year.
Swanson said: “We are very excited about this stage of the company’s growth and pioneering new immunotherapies. During the third quarter of this year, we received an Orphan Drug designation for FBL-03G from the FDA. This provides us with many distinct advantages.
“Research continues at Harvard Medical School, an institution credited with development and collaboration of some of the world’s most successful drugs. 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.”
Black Swan: a rare Jamaican cannabis strain
Flavonoids are found in all types of plants and all strains of cannabis contain flavonoids, which account for their variety of taste and colour, depending on which flavonoids they contain. Currently, around 6000 flavonoids have been found throughout nature.
Caflanone, or FBL-03G, has been derived from an endemic strain of cannabis sativa found in Jamaica called Black Swan.
Swanson said: “The company Chairman, Hon. Dr Henry Lowe PhD. has been a pioneer of phytomedicine (medicine from plants) for decades, and a world renown research scientist. He has studied cannabis since 1974 and authored many books on the subject.
“Although some people don’t know where their drugs come from, it may surprise them to learn that many of them come directly from plants. Vincristine, for example, is a plant alkaloid, from periwinkle. It is among the most commonly used cancer drugs today.
“Dr Lowe discovered a rare strain of cannabis endemic to Jamaica. The strain has been labelled as “Black Swan” due to its high flavonoid rich spectrum. Typically, a cannabis plant flavonoid content is far less than 1%, averaging less than 0.14%. As such, Caflanone from cannabis for pharmaceutical purposes has been manufactured by way of a proprietary synthetic schema.
“Although you may frequently read about noteworthy scientists like Dr Mechleoum synthesis of CBD and THC as groundbreaking, Dr Lowe and his team of research scientists have done something equally challenging – produced commercial kilogramme quantities of cannabis derived flavonoids.
“To address the commercial viability of Flavocure, this was a huge step in the process and the schema remains classified. From Black Swan we anticipate the development of other new drugs yet to be discovered by researchers. Flavocure has isolated this strain and our work on the plant derived molecules continues.”
Treating pancreatic cancer with cannabis
In pre-clinical studies, conducted at Harvard Medical School, Caflanone exhibited successful results in difficult to treat animal models of pancreatic cancer.
Flavocure initially developed Cresorol – another flavonoid from the same Black Swan strain of cannabis – for treatment of acute myeloid leukaemia (AML), which also received Orphan Designation by the FDA, however, it acts on different mechanisms than Caflanone.
Swanson said: “These two flavonoids have the potential to be very effective when used in combination.
“We have preliminary evidence that Flavocure’s drug pipeline can become a new standard of care for patients suffering from pancreatic cancer. The pipeline also holds potential for AML as we have seen results in vivo which exceed the standard of care today by comparison.
“However, our focus today is on the pancreatic cancer trials, enrolling patients suffering from pancreatic cancer.”
The trials for Calanone are expected to begin in Spring 2020, says Swanson, however, recruitment has not yet begun.
He said: “Recruitment will begin the first quarter of 2020. 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.
“If the research translates into the clinic, Flavocure may be in the unique position to offer patients with a new way to treat cancer. We are optimistic that the trials will be successful, and thus far research has shown that Caflanone (FBL-03G) to be non-toxic. This is a departure from most drugs in clinical trials which typically carry risk for toxicity and side effects.”