THC safety record and prior FDA approval propels Vitality’s prodrug as targeted treatment for pediatric IBD without drug psychoactivity
LOS ANGELES, CA – (January 3, 2018) — 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, today introduced its lead cannabinoid drug formulation VITA-100 as a non-psychoactive prodrug of THC.
Vitality Biopharma has developed a new class of cannabinoid prodrugs, known as cannabosides, which enable targeted delivery of THC to the large intestine. THC has been previously reviewed and approved by the U.S. Food & Drug Administration (FDA) under the name dronabinol, and has been established as safe and effective for use with appetite stimulation and for treatment of nausea and vomiting. Vitality’s cannabosides could enable oral delivery of large concentrations of cannabinoids in order to provide therapeutic benefits while reducing or eliminating psychoactivity by limiting entry of THC into the bloodstream or brain.
Vitality is focusing initial clinical development efforts on VITA-100, a proprietary THC cannabinoid drug formulation, and plans to complete a first-in-man clinical study in the first half of 2018. The treatment indications the Company plans to evaluate in Phase 2 trials include inflammatory bowel disease (IBD), irritable bowel syndrome, and narcotic bowel syndrome, a severe form of opiate-induced abdominal pain.
Independent clinical trial results suggest that THC can help induce remission in drug-resistant Crohn’s disease and that the vast majority (75% or more) of IBD patients report improvement in visceral pain and abdominal cramping with cannabinoid treatment. More than 1.4 million Americans have been diagnosed with IBD, which includes Crohn’s disease and ulcerative colitis. Most IBD patients are diagnosed before age 30 and require life-long treatment.
“As independent clinical studies are demonstrating the therapeutic effects of THC, we are well positioned with our VITA-100 gut-restricted prodrug formulation,” said Robert Brooke, CEO and Co-Founder of Vitality Biopharma. “Many parents, pediatric gastroenterologists, and affected adults are eagerly seeking a treatment option that provides therapeutic effects without the resulting psychoactivity. In developing a THC prodrug, we will also benefit from a robust track record of safety and history of FDA drug approvals.”
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.
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