Vitality Biopharma Taking Cannabinoid Research To The Next Level

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Sales of both medical marijuana and adult legal marijuana are soaring. Total marijuana sales in 2014 were less than $5 billion. A story in USAToday notes the number is expected to approach $23 billion in 2020 (1) due to decriminalization and the increasing recognition of its therapeutic utility within the medical community. Twenty-nine states plus the District of Columbia have medical or legalized marijuana laws in place (2). Millions of Americans use marijuana to provide symptom relief from dozens of indication, including cancer, glaucoma, Parkinson's, multiple sclerosis, epilepsy, seizures, wasting syndrome, Crohn's disease, PTSD, and chronic pain.

There are three cannabinoid products approved in the U.S. These products hold the same therapeutic potential as marijuana, yet IMS Health estimates sales totaled only $133 million in 2014. Sales are restrained by several well-known limitations, including poor oral bioavailability, erratic pharmacokinetics, inconvenient administration, short duration of action, poor tolerability, and psychoactive side effects. 

California-based Vitality Biopharma, Inc. (VBIO) has a proprietary glycosylation technology for producing cannabinoid prodrugs. The technology was crafted by the company's research with Stevia and natural sweeteners in 2015; and to date, Vitality has produced more than 25 novel cannaboside molecules; several composition of matter patent applications are pending. Below is an introduction to Vitality Bio, a look at the company's pipeline and the medical marijuana industry, and why investors should put this name on their radar.

Medical Marijuana - Not Just Smoke

The medical benefits of marijuana, or more specifically, cannabinoids, are real. I'm an ardent user of the NCBI's PubMed website. I'm on it every day. There is no shortage of literature supporting the medical benefits of cannabinoids. Hundreds of peer-reviewed publications exist concluding there is a therapeutic benefit in the treatment of mental health disorders like PTSD (3), movement disorders like Parkinson's (4), Huntington's (5), and restless leg (6), or in other neurological conditions like epilepsy (7), multiple sclerosis (8), and traumatic brain injury (9). However, the most common uses of synthetic cannabinoids or medical marijuana are in glaucoma (10) and in chronic and neuropathic pain (11). In fact, so accepted is the antiemetic effect of medical marijuana that it is now common practice for many terminally ill cancer patients (1213).

Cannabis sativa is a mixture of a number of compounds, including tetrahydrocannabinol (THC) and cannabidiol (CBD). Studies show that THC activates pathways in the central nervous system which work to block pain signals from being sent to the brain. Manzanares et al notes, "The discovery of cannabinoid receptors, their endogenous ligands, and the machinery for the synthesis, transport, and degradation of these retrograde messengers, has equipped us with neurochemical tools for novel drug design. Agonist-activated cannabinoid receptors, modulate nociceptive thresholds, inhibit release of pro-inflammatory molecules, and display synergistic effects with other systems that influence analgesia, especially the endogenous opioid system. Cannabinoid receptor agonists have shown therapeutic value against inflammatory and neuropathic pains, conditions that are often refractory to therapy" (14). For example, cannabis has been shown to be especially effective against neuropathic pain refractory to other medications (15). Cannabinoids may also be helpful in helping patients with insomnia (16) and inflammatory bowel disease (17).

Cancer patients find significant utility in the use of cannabis, not only because of the antiemetic effects but also because THC may have broad antitumor activity (18). Two synthetic cannabinoid products, AbbVie's Marinol® (dronabinol) and Valeant/Meda's Cesamet® (nabilone) are approved in the U.S. by the FDA as antiemetic agents for cancer patients undergoing chemotherapy.

In the U.S., 29 states and Washington, DC allow for the use of medical or recreational marijuana in adults. The increasing number of states allowing either medical or recreational marijuana use is leading to a boom in sales growth for the industry. ArcView Market Research forecasts legal use of marijuana will hit $22.8 billion in 2020. Marijuana Business Daily projects the full economic impact of marijuana decriminalization, which includes sales of both marijuana and peripherals, could hit $44 billion by 2020 (19).

Marijuana Stocks - Why You Should Care

The growth of the marijuana industry warrants investor attention. Marijuana is no longer illegal in the majority of states in the U.S. and a recent poll by Quinnipiac University found that 89% of responders supported the use of medical marijuana; 54% support full legalization in the U.S. (20). If ArcView Market Research is correct and the marijuana industry hits nearly $23 billion in sales in 2020, this would be one of the largest and fastest-growing segments of the U.S. pharmaceutical industry. Marijuana stocks are also hot right now. According to the website,, a basket of 23 North American stocks in the marijuana industry is up 181% over the past twelve months.

The website lists 198 stocks that are involved in the marijuana economy, which includes some mid-size biotech players like GW Pharmaceuticals Plc (GWPH) and Insys Therapeutics Inc. (INSY), to dozens of nano-cap OTC stocks (21). I believe the true value for investors is in biopharma research and finding potential U.S. FDA approvable indications for cannabinoid compounds, although producers and marijuana-tech companies also offer exciting areas for growth (22).

Many marijuana companies are penny-biotech stocks that have no real future or ability to compete. It's an area where I have been previously hesitant to spend a lot of time because of the speculative nature of most of these companies. To be a true player, the company must have a proprietary technology and intellectual property, an experienced management team, and the necessary financial resources to advance internal candidates.

That being said, unicorns do exist! Nasdaq-listed GW Pharmaceuticals is perhaps the most widely known and advanced company focusing on cannabinoids. The company has one approved product on the market called Sativex® (nabiximols) for spasticity associated with multiple sclerosis, and in March 2016, management announced positive Phase 3 data on Epidiolex® (cannabidiol) for the treatment of Dravet syndrome, a rare and debilitating type of epilepsy for which there are currently no treatments approved in the U.S. In the Phase 3 study, Epidiolex achieved the primary endpoint of a significant reduction in convulsive seizures assessed over the entire treatment period compared with placebo (p=0.01) (23). GW Pharma's stock is up 260% since that release. Epidiolex has both Orphan Drug Designation and Fast Track Designation from the U.S. Food and Drug Administration (FDA). Other late-stage indications for Epidiolex include Lennox-Gastaut syndrome (LGS), Tuberous Sclerosis Complex (TSC) and Infantile Spasms (IS).

In Search Of Unicorns - Vitality Biopharma (VBIO)

Vitality Bio has developed a new class of cannabinoid prodrugs, known as cannabosides, to overcome the limitations of raw Cannabis sativa or synthetic cannabinoids. Cannabosides are "prodrugs", which means that they are medications or compounds that, after administration, are converted within the body into pharmacologically active drugs. Cannabosides are more stable and soluble than cannabinoids, which results in less risk of non-psychotropic cannabidiol (CBD) being converted to psychotropic THC or otherwise degraded in the acidic stomach environment. Vitality Bio creates the cannaboside prodrugs through enzymatic glycosylation, a process perfected in 2015 when the company focused on enzymatic taste modification technologies originally developed for
Stevia sweeteners.

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Angry Old Lady 4 years ago Member's comment

Lol, that's a relief Jason Napodano. Glad to know it's not you. Though I have never received any such calls. Has any investors other than Logical One claimed to have?

Bill Johnson 4 years ago Member's comment

Logical One 's accusations about this stock are very disconcerting! Jason Napodano, as the author of this piece, do you have anything else to say about $VBIO?

Jason Napodano 4 years ago Author's comment

I can't control what others do. It certainly isn't me making random phone calls to people.

Logical One 4 years ago Member's comment

Sounds like a scam. I have received several calls by foreign sounding telemarketers trying to get me to buy this stock. They started when it was 1.45. Today's call was that the 'inside scoop' is that they will be bought out soon by a pharma company. Hope it takes off so I can short the heck out of it

Jason Napodano 4 years ago Author's comment