Update of QBiotics Group human oncology clinical trials
11 December 2022
QBiotics Group Ltd (QBiotics) reports that the trial site at the Melanoma Institute of Australia for a Phase I/IIa clinical trial with intratumoural tigilanol tiglate in combination with a check point inhibitor drug treating late-stage melanoma is in the process of closing.
CEO and Managing Director Dr Victoria Gordon commented “We are disappointed with the site closure and as with all of our clinical programmes, we are currently reviewing the melanoma programme with a view of focusing our resources and effort to achieve identified milestones for the company.”
QBiotics has received Clinical Trial Authorisation (CTA) from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA). This regulatory authorisation is an important step in QBiotics’ work to elevate the standard of care for patients with head and neck cancers and provides a critical pathway to conduct head and neck trials in the United Kingdom. MHRA approval enables QBiotics to open trial sites across the United Kingdom for QB46C-H08, a Clinical Phase II trial to assess the efficacy of intratumoural tigilanol tiglate in patients with a broad range of solid tumours of the head and neck region. This follows the established QB46C-H08 Australian trial site, which opened in early November, to recruit patients under a Clinical Trial Notification.