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Vitality Submits Requests Orphan Drug Designation from FDA for THC Prodrug

January 17, 2018

 

LOS ANGELES, Jan. 17, 2018 (GLOBE NEWSWIRE) -- Vitality Biopharma, Inc. (OTCQB:VBIO) (“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, is pleased to announce it has submitted an orphan drug designation request for VITA-100 to the U.S. Food & Drug Administration (FDA)

 

Upon approval, VITA-100 would be designated as an orphan drug for the treatment of pediatric ulcerative colitis (UC), a form of pediatric inflammatory bowel disease. The U.S. Orphan Drug Act (ODA) of January 1983 is meant to encourage development of drugs for rare diseases, and review by the FDA’s Office of Orphan Products Development can expedite the evaluation and eventual market approval of products that demonstrate significant promise for the treatment of these conditions.

 

Vitality Biopharma’s gut-targeted cannabosides enable delivery of THC without psychoactivity or intoxication, which may enable more widespread use of cannabinoids for treatment of pediatric digestive disorders. The Company has already completed studies that demonstrate the efficacy of cannabosides for treatment of preclinical models of colitis. Cannabosides were able to reduce weight loss, decrease damage to the colon, and markedly improve gastrointestinal health compared to the placebo controls.

 

“In young children, ulcerative colitis can often be hyperactive and difficult to control using existing FDA-approved medications,” said Robert Brooke, CEO and Co-Founder of Vitality Biopharma. “Given the mounting clinical data documenting use of cannabinoids for treatment of gastrointestinal disorders, we are very excited about the potential of VITA-100 and our cannabosides platform to provide a meaningful impact for these patients, helping them to stabilize their disease and avoid debilitating surgeries.”

 

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.

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