08 September 2021 | Wednesday | News
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The Company’s Clinical Trial Protocol was approved by the Alfred Ethics Committee and allows for the immediate start of the human trial.
“We are elated to have received approval to begin our Phase 1 clinical trials for our pharmaceutical compound, it’s time we had a treatment in the pipeline for this unmet need and I am proud to be a part of it.” commented Jacob VanLandingham, Executive Vice President of Drug Development of Odyssey Group International, Inc.
The Phase 1 clinical trial is designed to test for drug safety, tolerability, and concentrations in both the blood and urine as dosing escalates. The study is randomized, double-blinded, and placebo controlled. The initial approved study will be a single 1-day dose for each subject but will graduate to single doses for 5-days upon secondary approval. PRV-002 toxicology studies have shown it to be tolerated three times a day for 14-days. There will be six cohorts with eight subjects in each. Trial data will be reported and approved for continuation after each cohort is completed.
In preclinical animal studies, nasal administration of PRV-002 has shown rapid, broad brain biodistribution and simultaneously reduced swelling, inflammation and oxidative stress with positive safety data. Phase 1 trials will be managed by Avance, Inc. and Nucleus Network, Inc., two highly regarded Contract Research Organizations.
Phase 1 trials will be managed by Australia’s premium biotech Clinical Research Organization, Avance Clinical Pty Ltd, and Phase I Clinical Trial Site, Nucleus Network, Inc.
“Avance Clinical has an international reputation for first pass approvals and we are pleased to be able to deliver for Odyssey on their Clinical Trial Design and IND-enabling studies needed to gain the Ethics Committee approval. Odyssey and their concussion drug, PRV-002 have met the strict standards set by the Ethics Committee to now move into the clinic.” said Dr Jorgen Mould, Principal Scientific and Regulatory Affairs Specialist at Avance Clinical.
Nucleus Network has a long history of managing successful Phase 1 clinical trials and will be administering PRV-002 to establish drug dosing and safety margins in the coming months. It is expected that Odyssey’s unique breath-propelled drug-device combination will promote enrollment at the clinical trial site. This will be one of the first studies to define the pharmacokinetics of this administration route which is specifically designed to target the central nervous system.