Approval of Vitality research program and manufacturing operations through May 2019
LOS ANGELES, June 20, 2018 — 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 Administration (DEA) and the State of California Research Advisory Panel which permits the Company to continue development of its novel cannabinoid pharmaceutical prodrugs.
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 the U.S. Food and Drug Administration (FDA). Vitality initially worked with the DEA to ensure adequate on-site measures are in place to prevent diversion of Schedule I controlled substances, the most regulated tier of controlled substances in the US. In addition, the California Research Advisory Panel, a part of the California Attorney General’s Office, also approved Vitality’s cannabinoid pharmaceutical development activities.
Vitality Biopharma’s operations are in compliance with federal controlled substance regulations and are enabling development of a novel class of cannabinoid prodrugs that avoid psychoactivity. The Company’s lead compound VBX-100 is a proprietary prodrug of THC that is targeted to the gastro-intestinal tract, meaning it reduces or avoids entry of THC into the bloodstream or brain. VBX-100 is produced on-site using an enzymatic biosynthesis process and will be produced according to cGMP pharmaceutical standards for use within clinical trials across the United States.
“Our biocatalysis and drug manufacturing capabilities have advanced rapidly over the past 18 months, and we’re excited to continue this work with oversight from DEA, the State of California, and also the FDA,” said Dr. Brandon Zipp, Director of R&D, and Scientific Co-founder of Vitality Biopharma.
Robert Brooke, CEO and Co-founder of Vitality Biopharma adds that, “Our team first pioneered a novel biosynthesis process for our cannabinoid prodrugs, and now they’ve successfully scaled it in a way that could enable widespread supply for clinical trials and even commercialization. This puts us in an enviable position within our industry, and we look forward to seeing what else can be achieved in the months and year ahead.”
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.