Approval of cannaboside pharmaceutical research included review by FDA and California Research Advisory Panel
LOS ANGELES, CA–(Dec 21, 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 that it has received approval from both the U.S. Drug Enforcement Agency (DEA) and the State of California Research Advisory Panel which permits the Company to scale up activities at its facilities used for the development of novel cannabinoid pharmaceutical prodrugs.
Vitality has been working with the DEA to ensure adequate on-site measures are in place to prevent diversion of Schedule I controlled substances. As a component of this process, Vitality’s preclinical studies for its proprietary prodrugs of CBD and THC were reviewed and approved by the U.S. Food & Drug Administration (FDA). The California Research Advisory Panel, a part of the California Attorney General’s Office, has also granted Vitality a research permit to conduct cannabinoid pharmaceutical development activities that are designed to enable regulatory approval of first-in-man clinical trials.
Despite cannabis attaining legal status within the State of California and in many other states across the U.S. for medical and recreational purposes, pharmaceutical research and development continues to be closely regulated by the DEA and FDA. Vitality’s work is focused on developing a novel class of THC and CBD prodrugs that reduce or avoid psychoactive side effects through targeted prodrug technology.
“We are excited to scale up our research and to aggressively pursue clinical testing of our compounds, and this approval greenlights that work,” said Dr. Brandon Zipp, Director of R&D, and Scientific Co-founder of Vitality Biopharma. Robert Brooke, the Company’s CEO, further states that, “There are surprisingly few companies in the United States that are properly licensed and developing differentiated cannabinoid pharmaceutical products. We are very proud of our team’s work to enable this milestone, and believe that recent discoveries have provided us with a very unique opportunity.”
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.