Paradigm Biopharmaceuticals Ltd. reported that the first subjects have been randomized and dosed in the United States (U.S.) in the PARA_OA_002 pivotal clinical trial, evaluating injectable pentosan polysulfate sodium (PPS/Zilosul®) for the treatment of pain associated with knee osteoarthritis (kOA). The first subject randomization was confirmed at Northwestern University, Chicago, by Lead Investigator, Dr. Thomas Schnitzer MD, Ph.D.
The global pivotal Phase III, PARA_OA_002, study is currently screening and enrolling subjects in eight sites across Australia and 21 of the 56 selected sites in the U.S. Clinical trial site activation has been a critical focus for Paradigm from the start of the calendar year to enable a large pool of potential candidates to be identified across the activated sites and begin the screening process. Site activations in the U.S. will continue, and UK and EU sites are also being initiated throughout CY22.
“To have our first subjects randomized in the U.S. is an important milestone in the OA clinical program. The Paradigm clinical team has been working tirelessly to initiate and activate sites throughout the U.S., and we are seeing a large number of subjects entering the screening phase throughout the U.S. We look forward to continuing the strong momentum in the Phase III program and reporting important recruitment milestones to our shareholders,” said Dr. Donna Skerrett, Paradigm’s Chief Medical Officer and Interim CEO.