Vitality Biopharma has appointed Tracy Rockney, co-founder and chief operating officer at OneSource Regulatory, to the position of senior regulatory advisor. She will be responsible for the regulatory development of the company’s cannabosides-based prodrug candidate VB100 for inflammatory bowel disease (IBD).
Based in Los Angeles, Vitality Biopharma is focused on the development of new drugs that can use cannabinoids to treat serious neurological and inflammatory disorders. They use a new class of cannabinoid prodrugs, known as cannabosides. Upon ingestion, these prodrugs can selectively deliver THC and cannabidiol (CBD) to the gastrointestinal tract.
The company’s new cannabosides prodrug not only allows a targeted delivery, but it also can provide a way of achieving the therapeutic benefits of cannabinoids without the systemic delivery of psychoactive compounds. This characteristic may overcome the most common limitation of this class of drugs, which is the brain overflow with psychoactive compounds.
A previous clinical trial (NCT01040910) showed that cannabinoid-derived compounds can help induce remission in Crohn’s disease patients. These results were true even in heavily medicated patients, and on those who did note respond to treatments with corticosteroids or immunomodulators. Also, the use of these compounds can promote symptoms relief for IBD patients, with great improvement of visceral pain and abdominal cramping.
Vitality Biopharma anticipates starting the Phase 1/2 clinical trials for its cannaboside candidate VB100 for treatment of IBD in 2017.
The company expects that with Rockney’s experience in the licensing process of drugs for IBD, she can advance this prodrug candidate for a future use in a clinical setting.
“We’re very excited to have Tracy join our team, as a regulatory leader with a clear track record of innovation and success with development of new drugs for gastrointestinal disorders,” said Vitality Biopharma CEO Robert Brooke in a press release.
Formerly working at Shire Pharmaceuticals, Rockney was responsible for the company’s Gastrointestinal Business Unit, and Regulatory Advertising and Promotion. Leading negotiations with the U.S. Food and Drug Administration (FDA) for Lialda, she made possible the commercialization of what is now considered the clinical standard-of-care drug for the treatment of IBD.