Tetra's PPP003 cannabinoid drug receives Orphan Drug Designation for the Prevention of Proliferative Vitreoretinopathy
OTTAWA / ACCESSWIRE / April 15, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX-V:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, is pleased to announce that it has received U.S. Food and Drug Administration (FDA) Orphan Drug Designation for its synthetic cannabinoid PPP003 (HU308) in the prevention of proliferative vitreoretinopathy.
Proliferative vitreoretinopathy (PVR) is a vision-threatening condition that develops in approximately 10% of patients who undergo reparative primary retinal detachment surgery and in about 50% of patients with open globe injury. PVR is defined as the growth of membranes on both surfaces of the detached retina and on the posterior surface of the detached vitreous gel.
The pathophysiology of PVR includes the formation of a subretinal or epiretinal membrane (ERM) that can subsequently contract, causing a new retinal detachment or failure of a surgically corrected detachment. The standard of care involves repeat surgery but unfortunately the outcome is not always successful as surgical intervention does not address the inflammatory basis of the condition and increases the risk of serious ocular infection (e.g. endophthalmitis). "Our research in an experimental model of PVR has demonstrated that the synthetic cannabinoid, PPP003, can prevent this condition through activation of the type 2 cannabinoid receptor. If Tetra's clinical trial can successfully demonstrate prevention of PVR in humans, PPP003 would become the first prescription eye medication approved for this condition," commented Dr. Melanie Kelly CSO, Tetra Bio-Pharma Inc.
"We are very pleased to have received this new Orphan Drug Designation (ODD) from the FDA. Tetra now has 3 drugs that obtained Orphan Drug status from the FDA! This new designation is a direct result of Tetra's acquisition of Panag Pharma Inc and its solid intellectual property and scientific advancement in cannabinoid treatment of ophthalmic conditions. This includes USA and European granted patents making Tetra a world leader in cannabinoid ophthalmic drug development," said Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra Bio-Pharma. Dr. Chamberland further added, "Tetra will be requesting a Type B meeting with the US FDA to discuss the clinical development program for this Orphan Drug indication. The Company will provide an update to shareholders once the meeting is confirmed."
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX-V:TBP) (OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed and approved, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies. Could we work in "existing regulatory standards of safety and clinical evidence for pharmaceutical products".
For more information visit: www.tetrabiopharma.com