During safety pharmacology screening Vitality’s THC prodrug demonstrates no signs of adverse or off-target effects
LOS ANGELES, CA – August 21, 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 during a recent in vitro safety pharmacological screening study its lead drug candidate VBX-100 demonstrated no signs of adverse pharmacological effects, affirming its potential for widespread clinical use as a GI-targeted prodrug of THC.
“With the positive safety profile seen in this study, our glycosylation platform clearly has succeeded in creating THC prodrugs with reduced potential for adverse or off-target effects,” said Dr. Brandon Zipp, Director of Research and Development and Scientific Co-founder of Vitality Biopharma.
An industry standard study design was used for safety pharmacology screening of human receptor and transporter proteins, in work based upon the analysis of key drug safety targets recommended by four major pharmaceutical companies. As a GI-targeted prodrug of THC, VBX-100 is intended to be functionally inert after ingestion and until it is activated in the lower gastrointestinal tract. Once the VBX-100 prodrug releases THC, it can exert therapeutic effects and data indicates there is minimal systemic absorption. As a result, there is minimal entry of THC into the bloodstream or brain, avoiding psychoactivity, while also avoiding the adverse systemic effects of currently marketed immunosuppressants.
Vitality has filed for intellectual property protection on more than 100 different glycoside prodrugs, including VBX-100, a THC prodrug that is being developed for treatment of inflammatory bowel disease, irritable bowel syndrome, and narcotic bowel syndrome, a severe form of opiate-induced abdominal pain.
VBX-100 is an oral prodrug of Δ9-tetrahydrocannabinol (THC) that must be activated in the intestines to release THC in a controlled manner. In the safety pharmacology screening study where it was tested alongside THC, Vitality’s VBX-100 prodrug demonstrated greatly reduced pharmacological activity against established safety targets, demonstrating a superior safety profile and clear potential for use as a THC prodrug. THC is best known as an agonist of the cannabinoid receptors, including CB1 and CB2, and it was found to modulate the activity of these receptors as well as a wide variety of additional human receptors and transporters.
Robert Brooke, CEO and Co-founder adds that, “As our team rapidly advances VBX-100 through the final stages required for first-in-human clinical studies in the U.S., these results are quite important and an early indicator that our THC prodrugs may be very well tolerated in future clinical trials.”
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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