Invion Limited (ASX: IVX) has received ethical approval from the St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC) to commence the Phase I/II non-melanoma skin cancer (NMSC) trial for its lead drug candidate INV043.
INV043 is a novel photosensitiser developed in Australia for use in Photodynamic Therapy (PDT).
As part of the standard procedure following HREC approval, Invion has notified the Therapeutics Goods Administration (TGA) on the trial via its Clinical Trial Notification (CTN) submission.
Invion has now completed all necessary regulatory processes to undertake its skin cancer trial and patient screening, treatment and follow-up are expected to commence from October 2024. The trial will be conducted at Veracity Clinical Research in Brisbane, Queensland, a leading dermatology clinical research site in Australia, and the principal investigator is Dr Lynda Spelman.
Skin cancer is one of the world’s most common cancers and NMSC makes up over 98% of all skin cancers1 with the global treatment market to hit US$21.1 billion by 2032.
The primary endpoints of this open label trial focus on safety and secondary / exploratory endpoints include dose optimisation and efficacy signals.
As an adaptive trial design, additional cohorts of patients may be added to evaluate other safety aspects of the treatment if required, as well as dose optimisation and efficacy endpoints. As such, the total number of patients can range between 18 and 174, and the number of treatment cycles and the length of the study can vary because of this.
Veracity will select male and female patients over the age of 18 with non-metastatic cutaneous squamous cell carcinoma (SCC) and basal cell carcinoma (BCC), although other NMSCs may be approved on a case-by-case basis. Other screening criteria include size and location of the lesion.
“We are excited to reach this major milestone in our non-melanoma skin cancer clinical trial and look forward to starting patient screening, treatment and follow up starting next month,” Executive Chair and Chief Executive Officer of Invion, Thian Chew, said.
“Our next-generation PDT has the potential to become an important alternative treatment for this and other cancers as it overcomes many key shortcomings of current standard of care. Preclinical studies have shown INV043 to have a solid safety profile and strong efficacy against multiple cancers without scarring.”
The trial will be conducted under International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) good clinical practice (GCP) and ISO 14155 standards.
