Vitality Biopharma (“Vitality”) (OTCQB: VBIO) is a cure development company, dedicated to unlocking the power of cannabinoid “prodrugs” as a means to treat serious neurological and inflammatory disorders. We are interested in drug approvals first and foremost, but our overarching mission is to improve the lives of patients afflicted with devastating neurological and inflammatory conditions, such as multiple sclerosis. We aim to go beyond providing symptomatic relief to patients afflicted with these disorders, such as treatment of muscle spasticity in multiple sclerosis, and to instead identify combination treatments that treat the underlying cause of disease and hold the potential to help patients recover lost function.
Prodrugs are medications or compounds that, after administration, are converted within the body into a pharmacologically active drug, which may already have a long history of clinical investigation and use. Because the reference drug already has independent verification of its safety and efficacy, the prodrug may be approved rapidly through demonstrating similar bioavailability or bioequivalence, and at the same time a prodrug can be far more marketable due to its ability to eliminate unwanted side effects or undesirable commercial aspects. A classic prodrug example is Aspirin, acetylsalicylic acid, which was first made by Felix Hoffmann at Bayer in 1897 and is a synthetic prodrug of salicylic acid. As of 2015, there were approximately 15 prodrugs that had been classified as blockbusters, defined as having annual sales in excess of $1 billion.
One of the most hotly pursued cannabinoids for pharmaceutical purposes is cannabidiol, which is non-psychotropic, and has demonstrated therapeutic effects in clinical trials for serious neurological conditions including rare seizure disorders and for alleviating symptoms of multiple sclerosis. Our prodrugs could exert the same beneficial therapeutic effects, but with notable improvements, such as a better tasting formulation that enables improved patient compliance, better oral bioavailability that provides safer and more reliable dosing, or a delayed release mechanism that enables patients using these medications to have long-lasting, overnight relief. Given that we have recently filed intellectual property applications including strong composition of matter claims for more than 30 cannabinoid prodrugs, including versions of THC, CBD, and CBDV, we have demonstrated the ability to create a proprietary prodrug of every significant cannabinoid pharmaceutical available today.
Cannabosides – A New Class of Cannabinoid Pharmaceuticals
Vitality Biopharma has developed a new class of cannabinoid prodrugs, known as cannabosides, which upon ingestion can enable the selective delivery of THC and cannabidiol (CBD) to the gastrointestinal tract. Site-specific delivery could enable oral drug formulations of cannabinoids to provide therapeutic benefits while reducing or avoiding the systemic delivery of THC into the bloodstream. Currently, high concentrations of psychoactive THC in the brain limit the dose of cannabinoids that can be used elsewhere in the body for treatment of pain and inflammation.
Independent clinical trial results suggest that cannabinoids will help induce remission in Crohn’s disease patients, and that the vast majority of inflammatory bowel disease patients experience symptomatic relief, including more than 75% of patients who report improvement in visceral pain and abdominal cramping. Approximately 1.4 million Americans are affected by inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis. Most patients are diagnosed before age 30 and require life-long treatment.
In addition to providing targeted delivery, cannabosides could enable a better tasting formulation for improved patient compliance, better oral bioavailability that provides safer and more reliable dosing, and a delayed release mechanism that enables patients using these medications to have long-lasting, overnight relief.A prodrug is a medication or compound that, after administration, is metabolized (i.e., converted within the body) into a pharmacologically active drug. Prodrugs are often designed to improve bioavailability when a drug itself is poorly absorbed from the gastrointestinal tract, or to overcome other issues that make molecules unappealing candidates for future development efforts. A prodrug may for instance be used to selectively target a specific tissue or organ, such as the brain or gut, which enables the drug to have a more targeted effect. Prodrugs have been around for a while, with Aspirin, acetylsalicylic acid, first made by Felix Hoffmann at Bayer in 1897, a classic example of a synthetic prodrug of salicylic acid. As of 2015, there were approximately 15 prodrugs that had been classified as blockbusters, defined as having annual sales in excess of $1 billion.
Cannabosides – A Novel Class of Cannabinoid Prodrugs
Novel cannabinoid glycoside compositions of matter have reliably lead to dramatic improvements in drug solubility and stability, as evidenced below.
Patents are pending for more than 20 novel cannabinoid glycoside prodrugs (including prodrug versions of of CBD, THC, CBDV, and more).
As federal restrictions on medical research in this field are beginning to relax, and as interest from the public continues to mount, there is a striking increase in the number of clinical trials being sponsored by academic investigators for use of cannabinoids to treat lucrative, large market disease indications. Given our ability to rapidly create proprietary prodrug versions of each these cannabinoids, we stand to benefit from emerging data, and increasing recognition from the medical community of the potent pain relief and anti-inflammatory effects of cannabinoids.
Studies have shown that cannabinoids can be far more potent than opiates for pain relief, and far more potent than aspirin or corticosteroids for providing anti-inflammatory effects. Specifically, cannabinoid drugs can be nearly 10 times as potent as opiates for pain relief, including morphine. Studies have also shown they can be 20 times as potent as aspirin, and twice as potent as corticosteroids for treating inflammation.
Our compounds take advantage of a targeted-release mechanism where microbial enzymes present in the intestines will enable a very site-specific localized release of compounds including THC, CBD, and many of the other known cannabinoids. Because of this, we could provide targeted relief of inflammatory bowel diseases (IBD) such as Crohn’s disease or ulcerative colitis, simply by enabling larger doses of cannabinoids to be delivered.
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Through extensive research in the natural sweetener industry, we pioneered industrial-scale processes to modify stevia to make it taste better. This process is known as glycosylation, which involves adding additional glucose molecules to it, and it modifies both the taste and solubility of it. Over the last 10 years or so, it has become appreciated within the pharmaceutical industry that glycosylation could act to generate new natural product libraries with improved drug properties. This process for modifying natural products to make them more useful is often called glycorandomization, or glycodiversification.
Using the same technology, we’ve now been able to produce and characterize more than 20 novel cannabinoid glycosides, or “cannabosides”, which are novel cannabinoid prodrug pharmaceuticals. As an example, one of the most hotly pursued cannabinoids for pharmaceutical purposes is cannabidiol, which is non-psychotropic, and has potential therapeutic effects in a wide variety of serious neurological and inflammatory conditions. Our prodrugs could exert the same beneficial therapeutic effects, but with notable improvements, such as site-specific delivery that avoids or reduces psychoactivity, a better tasting formulation for improved patient compliance, better oral bioavailability that provides safer and more reliable dosing, and a delayed release mechanism that could enable long-lasting, overnight relief.
Vitality has filed intellectual property applications including strong composition of matter claims for prodrugs of THC, CBD, and CBDV, creating proprietary prodrugs of every significant cannabinoid pharmaceutical available today.
Company News & Media
|Sep 13, 2016 ||Vitality Biopharma Develops Cannabinoid Alternatives to Opiate Prescription Pain Medications ||Press Release |
|Sep 12, 2016 ||Vitality Biopharma to Present at Rodman & Renshaw 18th Annual Global Investment Conference ||Press Release |
|Aug 24, 2016 ||Vitality Biopharma Announces Expansion of Prodrug Pharmaceutical Portfolio ||Press Release |
|Aug 17, 2016 ||Vitality Biopharma Begins Trading Under New Stock Symbol "VBIO" ||Press Release |
|Jul 27, 2016 ||Vitality Biopharma Advances Cannabosides for Treatment of Inflammatory Bowel Disease ||Press Release |
|Jul 19, 2016 ||Vitality Biopharma Name Change and Corporate Actions Receive Shareholder Approval ||Press Release |
|Jun 1, 2016 ||Vitality Biopharma to Present at LD Micro and BIO Conferences ||Press Release |
|May 9, 2016 ||Launch of Vitality Biopharma for Cannabinoid Prodrug Pharmaceutical Development ||Press Release |
|Sep 3, 2015 ||Stevia First Corp. to Present at Rodman & Renshaw 17th Annual Global Investment Conference ||Press Release |
|Aug 25, 2015 ||Stevia First Corp. Launches Campaign to Divorce Sports World From Sugary Beverages ||Press Release |
In the News
Vitality Biopharma, Inc.
1901 Avenue of the Stars
Los Angeles, California
Telephone: (530) 231-7800
Fax: (866) 293-0655