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Tetra Bio-Pharma Provides PPP003 Inflammatory Cytokine Reduction Drug Program
Tetra Bio-Pharma Provides PPP003 Inflammatory Cytokine Reduction Drug Program.
About this update from Tetra Bio-pharma Inc.
[{"type":"text","content":"OTTAWA, ON / ACCESSWIRE / May 6, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSXV:TBP)(OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, is pleased to announce that it has now completed the modifications to the nonclinical safety program of PPP003 to ensure the launch of a Phase 1 trial in healthy volunteers later this year and subsequently be able to initiate a Phase 2 trial in patients with COVID-19 immediately after.The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the Covid-19 (or SARS-2 Coronavirus) at this time. As with any new drug candidate, PPP003 has not been shown to be safe or effective in the prevention or treatment of inflammatory cytokine conditions. Dr. Melanie Kelly, Ph.D., Chief Scientific Officer, Tetra Bio-Pharma has read and approves of the scientific disclosure in this news release.Tetra's drug development program for PPP003 was adjusted to support a Clinical Trial Application (CTA) in Canada and an Investigational New Drug (IND) application in the USA for an intravenous sterile finished drug product. The nonclinical safety studies required to support a CTA/IND in healthy volunteers for a new molecular entity (NME) include: drug metabolism, pharmacokinetics, cardiovascular and respiratory safety pharmacology, genetic toxicology and repeat dose toxicology in accordance with the regulatory requirements. The intention is to have completed these CTA/IND-enabling studies to allow initiation of the Phase 1 single ascending and multiple ascending dose with complete cardiovascular assessment by late calendar Q3 2020.Once human studies begin, the research and development team will continue to advance the nonclinical safety studies to ensure readiness for an eventual Phase 2 trial in patients with moderate to severe COVID-19. In parallel, Tetra will complete the nonclinical safety studies required to support a new drug submission/application in Canada/USA. These latter studies include longer term repeat dose toxicology, teratology and fertility and early embryonic toxicology.The phase I study will enroll approximately 100 healthy volunteers and will be conducted at one clinical site located in Montreal, Quebec. The study will include standard safety assessments, pharmacokinetics and ca...