The Pharmaceutical Companies Exploring Cannabis as a Cancer Treatment
The market for medical cannabis has been growing tremendously over the past decade, and that growth is expected to continue. In 2020, the market size was estimated at $13.4 billion, and is forecasted to reach $44.4 billion by 2025. This growth is driven by more people turning to cannabis for common ailments like insomnia, anxiety, stress, and pain. Medical cannabis use is also strongly associated with treating the side effects of chemotherapy or the symptoms of cancer. This application, along with use for treating AIDS patients, led to the first wave of state laws allowing cannabis use. The growth of the market has galvanized several pharmaceutical companies to enter the cannabis space and develop standardized products for specialized purposes. Some of these companies are exploring a new, groundbreaking use for medical cannabis – directly treating cancer.
The potential for cannabinoids, the isolated components of cannabis, to treat cancer has been known for quite some time. In 1974, researchers with the University of Virginia showed that tetrahydrocannabinol (THC), the psychotropic component of cannabis, slowed lung tumor growth in mice. Since then, dozens of preclinical studies (using cultured cells or animal models, not people) have revealed how THC and cannabidiol (CBD), the most well-known nonpsychotropic cannabinoid, kill numerous types of cancer cells or shrink tumors in animals. A review article published in July 2020 by researchers with Dalhousie University in Canada summarized the evidence for CBD – “Treatment with CBD exhibited a multitude of beneficial anti-cancer effects in lung, breast, colon, prostate, melanoma, leukemia, cervical, brain, neuroblastoma and multiple myeloma cancer cells.” Studies showing how THC inhibits breast, brain, lung, skin, liver, pancreatic, prostate, colon, cervical, and oral cancer cells were also analyzed. Given the strength and depth of this evidence, it is not surprising that pharmaceutical companies are looking into using cannabinoids to treat cancer in humans.
Just because something works in test tubes and animals does not mean it will work in humans. Thankfully, emerging evidence suggests cannabis can indeed exert some level of anticancer effect in real patients. GW Pharmaceuticals, a UK-based pharmaceutical company that was recently acquired in May 2021 by Jazz Pharmaceuticals, has been studying the potential of cannabinoids to treat glioblastoma for many years. Glioblastoma is an especially severe form of brain cancer that even with standard treatment (chemotherapy and radiation) has a median survival time of only about 15 months. This aggressiveness makes the results of GW’s double-blind, placebo-controlled trial testing a cannabis-derived THC/CBD product in concert with chemotherapy (temozolomide [TMZ]) against glioblastoma even more impressive. The trial, published February 2021, found that 83.3% of patients who received THC/CBD along with the TMZ chemotherapy were still alive after 1 year, compared to 44.4% who received TMZ and a placebo. Moreover, after two years, the median overall survival was estimated to be 21.8 months in the cannabis group and 12.1 months in the placebo group.
These stark improvements can most reasonably be explained by the cannabinoids working alongside the chemotherapy to inhibit progression of the cancer. Indeed, preclinical evidence clearly shows that both THC and CBD synergize with TMZ. For example, a 2011 study by researchers with Complutense University in Spain stated that, “Treatment with TMZ and submaximal doses of THC and CBD produced a strong antitumoral action in both TMZ-sensitive and TMZ-resistant tumors.
While GW Pharmaceuticals is the only company to have completed human trials, many other companies have completed preclinical studies and are preparing for human research. Interestingly, although THC and CBD have attracted most of the attention as anticancer compounds derived from cannabis, a company called Flavocure Biotech, located in Maryland, is looking at an entirely different type of molecule. In addition to cannabinoids, cannabis also contains flavonoids, which are found in a wide variety of plants and impart color to flowers, in addition to serving a wide variety of protective biological functions. In a 2019 study, funded by Flavocure Biotech and the National Institutes of Health, and conducted by researchers with Dana-Farber Cancer Institute at Harvard Medical School, a specific cannabis-derived flavonoid called FBL-03G was shown to kill pancreatic cancer cells and delay tumor progression in mice. This study was apparently used to support the Food and Drug Administration’s designation of FBL-03G (also known as Caflanone) as an orphan drug to treat pancreatic cancer. While such designation is not formal marketing approval or an endorsement of effectiveness, it incentivizes drug development for rare diseases, and is only granted if there is legitimate scientific rationale for a therapy’s potential effectiveness. The fact the FDA has granted orphan drug designation (ODD) to Caflanone is a testament to the real potential of this compound to treat pancreatic cancer.
Several other companies have received ODD for using cannabis-derived products to treat cancer. Not surprisingly, GW Pharmaceuticals has ODD for treating glioma (glioblastoma is an advanced form of glioma). Benuvia Therapeutics, located in Arizona, also has an ODD listing for CBD to treat glioblastoma specifically. The status of their work on this application is unclear, and the company seems more focused on other non-cannabinoid products.
Axium Pharmaceuticals is a small pharmaceutical company in North Carolina, which also received an ODD for CBD and THC to treat glioblastoma in January 2018. Their current work is unclear and they do not appear to have a website, but the fact they obtained an ODD suggests they have some concrete work underway.
Diverse Biotech in Pennsylvania was granted an ODD for the use of CBD to treat glioblastoma in April 2020. A post on their website dated March 2020 stated they had signed a partnership with Duke University Medical Center to further explore CBD for this purpose. Professor Steve Keir of Duke University commented, “We are excited to be collaborating with Diverse Biotech and to evaluate their cannabidiol compounds in our [glioblastoma] models. One of the main goals of our lab is to find new therapies that might improve the outcomes for patients living with this disease. Preclinical testing of novel agents is the first step in this process.”
The above examples primarily concerned glioblastoma, but a Canadian pharmaceutical company called Tetra Bio-Pharma is interested in the use of THC to treat hepatocellular carcinoma, the most common form of liver cancer. They received their ODD for this purpose in November 2019. According to their pipeline page, the company has apparently not made much progress on further testing. However, a May 2021 article reported that the first patient had entered their clinical trial for testing THC and CBD against breakthrough cancer pain, indicating they are moving forward with using cannabinoids for other cancer applications.
Can-Fite BioPharma is an Israeli firm primarily working with single-target synthetic drugs. They are also pursuing the use of CBD and THC to treat liver cancer, and their initial preclinical experiments demonstrated inhibition of liver cancer cell growth with a 5:1 CBD:THC ratio. While the timeline of future research is unclear, the company has filed patent applications related to this discovery.
Cannabics Pharmaceuticals is a Maryland-based pharmaceutical company that conducts research and development activities in Israel. They have an especially strong focus on using cannabinoids to treat cancer, as their homepage immediately links to more information about their goals to develop a cannabinoid-based drug for treating colorectal cancer. A March 2021 press release described how their drug candidate RCC-33 resulted in 35% prolonged survival in mice inoculated with human colorectal cancer cells. While the composition of RCC-33 is unclear, it is described as nonpsychoactive, and thus is either CBD-rich or contains other cannabis constituents aside from THC.
Apollon Formularies is a UK-based pharmaceutical company with most of its operations apparently being carried out by its affiliate in Jamaica known as Apollon Formularies Jamaica Limited. They are federally licensed in Jamaica to cultivate, manufacture, and sell medical cannabis products. A May 2021 press release announced they had worked with a company called Aion Therapeutics to demonstrate that combining medical cannabis formulations and medicinal mushroom formulations (non-psychedelic) resulted in nearly 100% destruction of HER2+ breast cancer cells in preclinical studies. The CEO of Apollon Jamaica, Paul Burke, stated that he wants to “bring these formulations to market as quickly as possible” to help women in Jamaica who cannot afford conventional treatments. A further press release on June 14, 2021 announced that Apollon had signed a long-term lease for its first International Cancer Institute in Jamaica and is moving forward on getting it ready to begin treating patients.
Enveric Biosciences, located in Florida, is focused on exploring the therapeutic utility of cannabinoids for radiation dermatitis and chemotherapy-induced peripheral neuropathy, as well as directly treating glioblastoma. An April 2021 article reported the company was preparing to conduct a Phase 1/2 clinical study in Israel with CBD and other cancer drugs against glioblastoma; they already have preliminary approval and are awaiting final approval from an Israeli hospital and the Ministry of Health.
Pascal Biosciences has locations in both the United States and Canada and is also focused predominantly on using cannabinoids to treat glioblastoma. However, they are unique for their research into combining cannabinoids with immunotherapy drugs to enhance their effectiveness. The cannabinoid products appear to be semi-synthetic and not just pure extracts of the cannabis plant. The company plans to enter human clinical studies for glioblastoma sometime in 2021. A September 2020 press release announced that Pascal was planning to begin safety testing for their immunotherapy drug, although the exact timeline was not noted.
It is truly extraordinary how many pharmaceutical companies are pursuing the use of cannabinoids to treat cancer. This unprecedented interest is a testament to the strength of the scientific evidence and the real potential for efficacy. While cannabis-based pharmaceutical options for cancer treatment will inevitably emerge, patients must always have access to the full-spectrum THC-rich and CBD-rich products of their choosing through local medical cannabis programs. It would not be good for patients or society at large for pharmaceutical cannabis products to be the only options. Nonetheless, it is excellent that so many companies are involved in researching cannabis for cancer, as this work will accelerate the production of clinical trial data and further the discovery of effective protocols for cancer treatment.