10:34 AM EST - Revive Therapeutics Ltd. : Provided a corporate update on its cannabinoid pharmaceuticals program specifically as it relates to the clinical development of Cannabidiol (“CBD”) in the treatment of rare diseases and the Company’s novel drug delivery technology. Revive has built a portfolio of U.S. Food and Drug Administration (“FDA”) orphan drug designations for CBD that support the long-term potential of cannabinoid prescription medicines for rare diseases and disorders, which the Company believes has been validated by the FDA approval of the GW Pharmaceuticals plc EPIDIOLEX® product and the recently announced acquisition of GW Pharmaceuticals by Jazz Pharmaceuticals for $7.2 billion. For its rare disease cannabinoid product pipeline, Revive was granted in the past by the FDA two orphan drug designations for CBD in the treatment of autoimmune hepatitis, a rare liver disease, and CBD in the prevention of ischemia and reperfusion injury (“IRI”) resulting from solid organ transplantation, such as liver, kidney, heart and lung. Revive recently entered into a clinical trial agreement with The Trustees of Indiana University (“TIU ”) to develop and manage a proposed Phase 2 clinical study entitled, “Use of Cannabidiol as an adjunct therapy for difficult to treat autoimmune hepatitis.” TIU and the Company are in the process of completing the protocol and study documents for submission of a pre-Investigational New Drug (“IND”) meeting with the FDA. Upon the receipt of permission from the FDA to proceed with the study under an IND, the Company will proceed to evaluate a potential study with CBD for ischemia/reperfusion injury and other liver diseases. Revive Therapeutics Ltd.
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