Vitality Biopharma: A Small-Cap THC Drug Stock That May Stop IBD

  MIAMI, FLORIDA - 10/02/2018 (PRESS RELEASE JET)

As public opinion and thoroughly-researched clinical trials continue to support the medicinal use of cannabis, an investment into an emerging cannabis-focused stock is no longer the gamble it was during the initial boom of Colorado's recreational legalization in 2014. Skepticism over the safety and effectiveness of cannabinoid-based treatments has waned as clinical data demonstrate several promising medical applications of the compounds, proving its ability to relieve chronic pain and illness with minimal to no side effects compared to most traditional pharmaceutical options.

Now, having overcome significant barriers to entry, one company in particular, Vitality Biopharma (OTC:VBIO), sits well-positioned within the short list of companies capable of delivering this promising medical breakthrough to a significant and segmented group of patients, and at the same time exploit a considerable opportunity to treat unmet medical needs.

Pro-Active Legislation May Offer VBIO A Lucrative Market Opportunity

With legislation seemingly becoming more lenient by the day, evidenced further by Canada's recent federal legalization of cannabis (which has also caught the investment attention of Coca-Cola (NYSE: KO)), a pro-drug focused company, Vitality Biopharma (VBIO), is well-placed to earn substantial rewards from being an early innovator in the pharmaceutical cannabis sector.

While two other companies in the sector, GW Pharma (NasdaqGM: GWPH) and Arena Pharmaceuticals (NasdaqGS: ARNA) get much investor attention, VBIO is differentiating itself by focusing on the development of novel cannabinoid prodrugs that have the unique capacity to enable therapeutic use of THC without any psychoactivity through targeted delivery.  With these novel compounds, VBIO is intent on first treating Inflammatory Bowel Disease (IBD) and Narcotic Bowel Syndrome (NBS), a severe form of opiate-induced abdominal pain.

With a keen focus on a select range of diseases and ailments that can benefit significantly from prodrug applications, VBIO is hoping to gain quick traction and potential market exclusivity thanks to the high barriers to entry that surround the industry. And, after analyzing the data published from the company's recent development reports, it is clear that VBIO is on the right track to becoming a breakthrough cannabinoid pharmaceutical developer.

VBIO Prodrug To Target The IBD and NBS Market

Despite years of research and trials, the current standard of care for both IBD and NBS has not made significant advances in addressing and treating the painful and debilitating symptoms associated with each condition. Moreover, in the past decade, there has been little progress in finding a treatment capable of providing any substantial and sustained measure of symptom relief, and even less success in finding a solution to address the long-term treatment of these conditions.

With few options, many patients with these diseases are prescribed opiates or steroids, both of which are well-known to create additional and potentially severe medical complications including addiction. However, with little choice available, physicians are almost compelled to treat the painful symptoms of the diseases, knowing that they can't provide a meaningful option to eradicate the root causes of the syndromes. And, as patients endure symptoms that include unbearable abdominal pain, infection, bloody stools, and severe joint pain, the market is clearly long overdue for a new treatment option. Hence, the niche for VBIO is ready for the taking.

Seizing Prodrug Opportunity For Unmet Medical Needs

Taking advantage of a significant treatment and market opportunity, VBIO is developing novel cannabinoid prodrug treatments that can effectively ease symptoms associated to IBD and NBS while also targeting the underlying causes.

Vitality is actively advancing two drugs in its clinical development pipeline, VBX-100, and VBX-210, and also has additional cannabinoid formulations under active research. From their focus toward IBD and NBS, VBIO is looking to capture a substantial portion of a market where an estimated 81% of current opiate users have functional bowel disorders and more than 58% of patients struggle with chronic abdominal pain. Moreover, the market opportunity grows even more, with up to 10% of this selected population having potential to develop NBS. Now, although 10% of a patient population may not sound like a significant opportunity, it poor quality of life and drug overdose deaths afflict more than 61% of this subsection. Thus, if VBIO is successful at developing effective treatments, as they believe they will, they can save thousands of lives and untold amounts of emotional pain for patients, families, and friends.

Understandably, opiates and steroids are not an adequate solution in addressing the underlying issues at hand with these ailments, they only mask the symptoms for the short term. Beyond those limitations, the additional side effects caused by these medications can introduce even more complications to the patient. For example, in a 2014 clinical study designed to research the diagnosis and treatment of NBS, patients were enrolled in an opioid detoxification trial in hopes of improving their NBS symptoms. The study did show a reduction in pain symptoms; however, over half of the enrolled patients returned to regular opiate use within three months of completing the trial.

Notably, patients have expressed their concerns about having only a "band-aid" solution to their chronic ailment, especially when the temporary relief may lead to addiction problems for them in the long run. And, these days, few can argue with the opiate epidemic. With just 4.6% of the world's population, the United States accounts for 80% of the world's opiate prescriptions, and since 2013, the yearly number of drug overdose deaths has actually exceeded the number of deaths from car accidents.

Yet, as big pharma continues to push opiates on patients, they remain mostly silent on the ramifications of their use. Hence, it becomes the responsibility of patients, informed advocates, and promising research companies like VBIO to demonstrate clear and scientifically-supported value in alternative treatments like VBX-100 and to prove its ability to address both the symptoms and root causes of the diseases targeted.

VBIO Shows Life-Changing Potential Behind Cannabinoid Therapy

Maintaining control of its assets through the research, development, and manufacturing process, VBIO is conducting independent clinical trials to validate the known benefit offered by their prodrug treatments when compared to the current standard of care.

One of the most promising reports released by VBIO was centered on a 13-year-old boy with Crohn's disease. The boy was initially diagnosed with Crohn's disease at age 9 and continuously found himself in and out of the hospital over the next four years. Placed on a treatment regimen that included the use of alpha inhibitors, a morphine drip, and additional medications like sulfasalazine, Lialda, CANASA, and azathioprine, the disease was not once observed to enter any state of disease remission. During this time, the patient missed an average of 25 days of school per year as his symptoms of agonizing stomach pain, anemia, bloody diarrhea, and stunted growth continued to worsen.

Having exhausted some of the newest and most advanced treatments hospitals had to offer, the frustrated and desperate family of the patient learned of another Crohn's patient named Coltyn Turner, who had recently been treated with cannabis-based compounds at the Mayo Clinic and reported a complete clinical remission following completion of the trial. Taking notice of these encouraging results, the family received approval for treatment in 2016 under the California Compassionate Use Act and started their son on a treatment regimen of three daily doses of chocolate bar edibles dosed with 3mg of THC and 3mg of CBD.

THC Produced A Life-Changing Effect For Crohn’s Patient 

Within only thirty days, the patient, who had shown nearly complete resistance to every pharmaceutical treatment on the market, had already achieved clinical disease remission. Moreover, after sixty days of cannabinoid-based therapy, the calprotectin levels of the patient decreased to less than 100 mcg/g, along with the associated serum erythrocyte sedimentation rate dropping by a notable 88%. Also important to know from a regulatory and future approval perspective, this cannabinoid treatment did not cause any additional side effects or adverse reactions.

Now, only two years later, the patient had stopped all infliximab treatments, showed no signs of Crohn's disease symptoms, and been declared to be in complete remission. The boy, who was painfully bed-ridden for years despite the best treatment medical practitioners had to offer, had a healthy weight and height, a normal appetite, attended school regularly, and had remained in remission for over a year since beginning therapy.

Are cannabinoids a miracle drug for IBD? Data suggests it may be. And, with that in mind, investors that are looking for exposure into this emerging treatment may be right on target in considering VBIO as their vehicle to invest in the sector.

Cannabinoid Treatment Is Game-Changing Option

Those just reading about the results from the Crohn’s study may be thinking, if the results from cannabinoid therapy and treatment is proving to be so useful, does not produce any adverse side effects, and has been shown to place a severe disease into remission, then why aren’t top medical professionals paying closer attention to the benefits of cannabinoids?

To answer this question, there are a few factors at play, but number one can be attributed to the ever-changing regulatory status of cannabis in the US and the rest of the world. Marijuana, which remains federally illegal and a Schedule 1 drug under the DEA (meaning no accepted medical value), has been difficult or even impossible to study until the easing of laws over the past 8-10 years. Before 2006, obtaining a green-light to move ahead with THC based research was incredibly difficult, and historical data actually shows that studies intended to measure the potentially harmful effects of cannabis were more likely to be approved than studies of its medical benefits.

However, as more opportunities arise to study and demonstrate the positive contributions of marijuana and its many compounds on treating pain and other conditions, researchers are supporting the idea that a Schedule 1 drug designation may be based on outdated and scientifically unsupported claims. Further, as lawmakers evaluate the benefits of cannabinoids to address significant medical needs, VBIO is leveraging the positive clinical data that exists and ongoing research to support the idea that THC prodrug treatments can result in a substantially improved quality of life for patients with inflammatory diseases.

The Importance of VBIO's Prodrug Technology

Building upon independent clinical data supporting THC’s therapeutic benefits, VBIO is firmly focused on the utilization of prodrugs to effectively target and enhance the effectiveness of THC in treating inflammatory diseases like IBD and NBS without any psychoactive effects. For those new to the term, a prodrug is a pharmacologically inactive medication that is metabolized into an active form within the body. In other words, a prodrug formulation is often used when targeting a specific area, allowing the drug to get delivered to the treatment area with fewer off-target or adverse effects.

VBIO is already showing that when used in prodrug form, they are effectively able to deliver THC based drugs into a specified area while preventing the systemic delivery into the bloodstream and brain, eliminating the possibility of the psychoactive effects, or "high", associated with cannabis (specifically THC, the primary psychoactive substance in marijuana). This achievement and milestone cannot be understated, as this means that while competing companies will be forced to limit the amount of THC used due to the potential psychoactive effects, VBIO can instead maximize the power of its compounds through its use of proprietary formulations.

An Emerging And Promising Future For VBIO

Vitality Biopharma is not only emerging as a viable contributor in the medical cannabinoid sector, but they are funding trials independently, conducting their own research, and developing products that may offer significant therapeutic benefit over existing treatments and products marketed by competing pharmaceutical companies. In other words, as other companies are quick to partner and dilute potential windfalls, VBIO is aware of the power in their IP and not willing to dilute its value with early partnerships.

Notably, as legislative hurdles continue to become less restrictive, the market environment has created a significant opportunity for innovative companies, manufacturers and investors to take advantage of the potentially life-changing benefits of cannabinoid therapy. As one example, take a look at one of VBIO's competitors – GW Pharma's (GWPH) $4.6 billion market cap that can be attributed mainly to its recent FDA approval of Epidiolex. Taking into consideration that the company only recorded $14.2 million in 9-month revenues, along with a loss of more than $180 million during the same period, the facts suggest that investors are primarily focused on the exciting potential and benefits of cannabinoid therapy to gain widespread adoption within the medical sector. And, at current price levels, VBIO is getting overlooked.

The clinical data for cannabinoid therapy is compelling, and it is evident that VBIO is well aware of its opportunities and sits ideally positioned to take full advantage of the growing investor interest in the sector. VBIO is intent to capitalize on opportunities presented from its extensive IP portfolio covering a novel class of prodrugs that also include more than 20 patent applications. For those investors who prefer to be at the forefront of medical innovation, Vitality Biopharma (VBIO) is an emerging growth stock opportunity whose unique THC prodrug treatments could position them to fill an important niche in what is already a multi-billion dollar market for IBD therapeutics.

This story also appeared on Soulstring Report