Paradigm Biopharmaceuticals Ltd (ASX:PAR) has activated the first UK site in a Phase 3 study assessing the effect of Zilosul® on osteoarthritis, beginning the screening and recruitment process after receiving regulatory and ethics approval from the UK.
This first site is at the University of Leeds, led by investigator professor Hemant Pandit, and Paradigm is planning to open a total of seven sites in the UK in the coming months.
Canada Health has also given regulatory approval for the trial, although ethics approval is still pending. Paradigm expects to activate up to 10 clinical sites in Canada once such approval has been received.
Approval received from four jurisdictions
“I am pleased we are moving forward with regulatory approval within another planned jurisdiction for the global phase 3 program,” Paradigm Biopharmaceuticals chief medical officer Dr Donna Skerrett said.
“The interaction with Health Canada was positive throughout the regulatory process and the company looks forward to announcing anticipated ethics approval and subsequent participant recruitment in Canada.
“Equally, the achievement by the Paradigm team to activate participant recruitment in the UK highlights Paradigm's ongoing execution of activities for this global phase 3 trial in knee OA.”
Paradigm has now secured regulatory approval from four major jurisdictions for its Phase 3 trial; the US Food and Drug Administration (FDA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada, and the Australian Therapeutic Goods Administration (TGA).