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Vitality Biopharma, Inc. (OTCQB: VBIO) Breaking News - November 9, 2016

 


 

Vitality Biopharma Announces International Patent Filing for Cannabinoid Pharmaceuticals
 

Once concluded, IP protection extends to 2035 or longer in USA and all major markets worldwide
 

LOS ANGELES, CA -- (Marketwired) - November 9, 2016 -  Vitality Biopharma, Inc. (OTCQB: VBIO) ("Vitality Biopharma," "Vitality," or the "Company") a corporation dedicated to the development of cannabinoid prodrug pharmaceuticals, and to unlocking the power of cannabinoids for the treatment of serious neurological and inflammatory disorders, today announced the filing of an international PCT patent application, a milestone in its development of a platform of cannabinoid pharmaceuticals.

The Patent Cooperation Treaty (PCT) is an international patent law treaty, which provides a unified procedure for filing patent applications to protect inventions in each of its member states. Vitality Biopharma’s patent filing includes details that were previously submitted in three separate U.S. provisional applications, and includes 79 patent claims and almost 200 individual compounds, including novel glycoside prodrugs of the most abundant phytocannabinoids, THC and cannabidiol (CBD), as well as a variety of other phytocannabinoids and endocannabinoids. The patent application includes additional compounds, such as vanilloids, a class of molecules that could provide sustained pain relief through targeting of the TRPV1 receptor, and enzymatic biosynthesis methods that the Company uses internally for drug manufacturing.

There are 151 member countries within the PCT worldwide, so near global patent coverage can be obtained through successful patent prosecution in the U.S., Japan, Europe, Canada, Australia, New Zealand, China, Brazil, Russia, India, and many other countries. The original priority date for this filing was September 22, 2015, therefore coverage of any underlying patent claims would extend for 20 years until 2035 in the United States, and may be subject to patent term extensions that would enable years of additional protection.

“This is a significant milestone enabled by our team’s discovery and production of a versatile new portfolio of cannabinoid pharmaceuticals,” said Robert Brooke, Chief Executive Officer of Vitality Biopharma. “The clinical data emerging on the use of cannabinoids for inflammatory bowel disease, opiate addiction, and many other serious disorders is inspiring, and our team is now working internally and through collaborators to develop key therapeutic applications for our compounds.”

About Vitality Biopharma (OTCQB: VBIO) - Vitality Biopharma is dedicated to unlocking the power of cannabinoids for the treatment of serious neurological and inflammatory disorders. For more information, visit: www.vitality.bio. Follow us on Facebook, Twitter and LinkedIn.

Notice Regarding Forward-Looking Statements - This news release contains "forward-looking statements" as that term is defined in Section 27(a) of the United States Securities Act of 1933, as amended and Section 21(e) of the Securities Exchange Act of 1934, as amended. Statements in this press release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such factors include, among others, the inherent uncertainties associated with new projects and development stage companies. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K for the most recent fiscal year, our quarterly reports on Form 10-Q and other periodic reports filed from time-to-time with the Securities and Exchange Commission.

Contact
Vitality Biopharma
Investor Relations
info@vitality.bio
1-530-231-7800
www.vitality.bio
Source: Vitality Biopharma, Inc.

____________________________________________
Recent Vitality Biopharma News:
 

Vitality Biopharma Reports on Initial Cannabinoid Drug Formulation Studies
 

Water solubility significantly improved more than 100-fold, enabling novel pharmaceutical applications
 

LOS ANGELES, CA -- (Marketwired) --  Vitality Biopharma, Inc. (OTCQB: VBIO) ("Vitality Biopharma," "Vitality," or the "Company") a corporation dedicated to the development of cannabinoid prodrug pharmaceuticals, and to unlocking the power of cannabinoids for the treatment of serious neurological and inflammatory disorders, today announced results of recent drug formulation studies that documented substantial modifications to key physiochemical properties of cannabinoids through the production of cannaboside prodrug pharmaceuticals.

Vitality Biopharma has demonstrated through internal drug formulation studies that cannabosides have versatile physical properties, enabling various compounds to be produced as liquids, solids, powders, as well as foams. The most convenient method of delivering pharmaceuticals is through oral delivery, and most oral cannabinoid medicinal products today must be delivered using oil-based liquid solutions or sprays. Because cannabinoid oils often include harsh organic solvents such as ethanol and propylene glycol, they can act as irritants when used repeatedly. This limits the amount of cannabinoids that can be delivered orally, and also reduces product appeal, especially for pediatric applications.

Vitality's formulations now deliver water solubility documented as high as 500mg/ml, or roughly 50% of the mass-to-volume ratio, which represents more than a 100-fold improvement over the reported water solubility of most cannabinoids such as THC and cannabidiol (CBD). This improved solubility represents a novel ability to produce concentrated liquid cannabinoid solutions that can be delivered orally, for maximum convenience, and further, it enables alternative methods of administration such as topical, rectal, or intravenous drug formulations.

A primary target of cannaboside prodrugs is for the treatment of inflammatory bowel disease, an autoimmune condition where an individual's immune system attacks their intestines, rectum, and other parts of their digestive tract. This disease afflicts 1.4 million Americans and often affects children, with most patients receiving their diagnosis prior to age 30. As with epilepsy, dramatic clinical trial results have been documented through the use of cannabinoids, including an ability to induce remission of Crohn's disease. Large state-funded and independently-managed clinical trials are now underway to further document and analyze these therapeutic effects, and many states have now approved medical marijuana for the treatment of inflammatory bowel disease, including Colorado, California, Ohio, and more than a dozen others. Vitality Biopharma's cannabinoid prodrugs enable the targeted delivery of cannabinoids directly to the site of disease, enabling larger drug concentrations to be used while simultaneously reducing or avoiding psychoactivity altogether. This could lead to their widespread use as pharmaceuticals that provide the same therapeutic benefits as medical marijuana, or more, and yet do so without any debilitating or unwanted side effects.

About Vitality Biopharma (OTCQB: VBIO) Vitality Biopharma is dedicated to unlocking the power of cannabinoids for the treatment of serious neurological and inflammatory disorders. For more information, visit: www.vitality.bio. Follow us on Facebook, Twitter and LinkedIn.

Notice Regarding Forward-Looking Statements This news release contains "forward-looking statements" as that term is defined in Section 27(a) of the United States Securities Act of 1933, as amended and Section 21(e) of the Securities Exchange Act of 1934, as amended. Statements in this press release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such factors include, among others, the inherent uncertainties associated with new projects and development stage companies. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K for the most recent fiscal year, our quarterly reports on Form 10-Q and other periodic reports filed from time-to-time with the Securities and Exchange Commission.

Contact Vitality Biopharma Investor Relations info@vitality.bio
1-530-231-7800
www.vitality.bio

Source: Vitality Biopharma, Inc.


Vitality Biopharma Develops Cannabinoid Alternatives to Opiate Prescription Pain Medications

 

Cannabosides Enable Targeted Pain Relief and Avoid Psychoactivity of THC Through Site-Specific Delivery

LOS ANGELES, CA -- (Marketwired) -- 10/19/16 -- Vitality Biopharma, Inc. (OTCQB: VBIO) ("Vitality Biopharma," "Vitality," or the "Company") a corporation dedicated to the development of cannabinoid prodrug pharmaceuticals, and to unlocking the power of cannabinoids for the treatment of serious neurological and inflammatory disorders, wishes to advise that a recent article written by Robert Brooke, Company CEO, sheds new light on key factors in the fight against the increasing epidemic of prescription painkiller related deaths.

In his article, Mr. Brooke notes, "Opiates are one of the key classes of drugs we're seeking to replace, or to make far less necessary, as our proprietary cannabosides could provide a potent alternative form of pain relief and help avoid, or greatly reduce, the use of opiates for the treatment of many conditions including inflammatory bowel disease (where 70% of patients now regularly receive opiates upon hospitalization)."

The statistics are startling, as last year there were 47,055 Americans that died from drug overdoses, and opioids were involved in 61% of these cases. Since 2013, the rates of drug-overdose deaths have exceeded the number of deaths from car accidents. This is not uniquely an American problem, but the U.S. uses an astonishing 80% of the world's opioids, while representing only 4.6% of the world's population. The New England Journal of Medicine has just written that the rising death toll has been rivaled in modern history only by that at the peak of the AIDS epidemic in the early 1990s.

On Friday, the Washington Post reported that an Arizona-based maker of fentanyl, the drug most commonly reported in many of these deaths, just donated $500,000 to oppose legalization of medical marijuana. This at a time when studies have shown that today about 75% to 86% of heroin users started with prescription opioid pain relievers. So the first exposure to opiates is far more likely to come not from heroin (as was overwhelmingly true in the 1960's), but rather from prescription drugs.

To find out more about Vitality Biopharma and its development of cannaboside pharmaceuticals, please visit www.vitality.bio and to read Mr. Brooke's article "What We Should Know About Opiates and Prescription Drug Abuse," please visit the CEO Blog at www.vitality.bio/investors/news.

About Vitality Biopharma (OTCQB: VBIO) Vitality Biopharma is dedicated to unlocking the power of cannabinoids for the treatment of serious neurological and inflammatory disorders. For more information, visit: www.vitality.bio. Follow us on Facebook, Twitter and LinkedIn.

Notice Regarding Forward-Looking Statements This news release contains "forward-looking statements" as that term is defined in Section 27(a) of the United States Securities Act of 1933, as amended and Section 21(e) of the Securities Exchange Act of 1934, as amended. Statements in this press release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such factors include, among others, the inherent uncertainties associated with new projects and development stage companies. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K for the most recent fiscal year, our quarterly reports on Form 10-Q and other periodic reports filed from time-to-time with the Securities and Exchange Commission.

Contact Vitality Biopharma Investor Relations info@vitality.bio
1-530-231-7800
www.vitality.bio

Source: Vitality Biopharma, Inc.

 

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About Vitality Biopharma, Inc.

 

Vitality Biopharma is developing proprietary cannabinoid pharmaceuticals for treatment of serious neurological and inflammatory disorders, such as inflammatory bowel disease and multiple sclerosis.

Meeting Pharmaceutical Market Demands

Vitality is developing proprietary cannabinoid pharmaceuticals that are compliant with FDA and DEA regulations. Oral cannabinoid pharmaceuticals are a convenient and desirable option for patients and physicians, and they could help realize the full therapeutic potential of cannabinoid medicines.

A Low-Cost, Low-Risk Regulatory Strategy

Oral prodrugs enable a regulatory strategy with lower risk that is akin to specialty pharmaceutical development. The company benefits from existing clinical studies of cannabinoids demonstrating their effectiveness in treating in IBD, MS, pain, epilepsy, and additional disease indications.

Healthcare & Life Sciences Expertise

Senior management is entrepreneurial with a track record in healthcare and drug development. Laboratory and manufacturing operations are based in Northern California, and the R&D team includes passionate scientists, medical advisers, and regulatory affairs specialists.

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.

TEAM

Robert Brooke
CEO, Co-founder

Former hedge fund analyst at Bristol Capital for over 50 direct healthcare investments; Experienced biotech entrepreneur, Founder of Genesis, now Lion Biotech (NASDAQ:LBIO), Co-Founder of Intervene Immune. B.S. in Electrical Eng., Georgia Tech; M.S. in Biomedical Eng., UCLA.

Richard McKilligan, JD, MBA
Controller

Ex-Morgan, Lewis, & Bockius LLP, State Bars in CA and NY, CPA (inactive). JD from Cornell, MBA from Univ of Chicago, BS in Accounting from Univ of Illinois.

Avtar Dhillon, MD
Chairman & Co-founder

Chairman, Inovio Pharmaceuticals, Oncosec Medical, and Arch Therapeutics. Raised $200M in public markets over last 10 years. Former venture capitalist and family physician for over 10 years.

Anthony Maida, PhD, MBA
Director, Chair of Audit Committee

Senior Vice President, Clinical Research, Northwest Bio. MBA, MA in Toxicology, PhD in Immunology.

Brandon Zipp, PhD

Director of R&D, Scientific Co-founder
10 years research experience with glucosyltransferase enzymes. Developer of UGT biosynthesis platform. Ph.D., Biochem & Molecular Biology, Univ. of California Davis.

Our Technology
A Breakthrough in Glycosylation

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.

SOURCE: vitality.bio




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