OCTAVE is a phase I/II clinical trial to assess the safety and efficacy of its oncolytic vaccine enadenotucirev (previously known as ColoAd1) in platinum-resistant ovarian cancer patients at multiple UK cancer centres, beginning this month. Enadenotucirev has shown potent, broad-spectrum, anti-cancer activity pre-clinically and is also in phase I/II clinical trials in patients with colorectal tumours.
The OCTAVE study will examine the safety, tolerability, pharmacokinetics and efficacy of administering the vaccine directly into the abdomen of cancer patients, where ovarian cancer tends to recur (a process known as intra-peritoneal or IP delivery). The phase I component of the study will determine the dose of enadenotucirev to be used alone or in combination with paclitaxel. The phase II component will be an open label dose expansion of the combination regimen of enadenotucirev and paclitaxel to determine whether this combination has a risk benefit profile that supports further investigation in the treatment of patients with platinum-resistant epithelial ovarian cancer.
Dr Iain McNeish, MD, Professor of Gynaecological Oncology at the Institute of Cancer Sciences at the University of Glasgow, is the principal investigator of the OCTAVE study. The trial is co-funded by a £1.7 million grant awarded to PsiOxus by the UK government-backed Biomedical Catalyst. This programme is designed to deliver growth to the UK life sciences sector and run jointly by the UK’s innovation agency, the Technology Strategy Board, and the Medical Research Council.PsiOxus CEO Dr John Beadle commented: “Our enadenotucirev oncolytic vaccine has enormous potential to treat a broad spectrum of solid cancer types and starting this OCTAVE study is a key milestone as we progress towards demonstrating its effectiveness in a second form of cancer with a very significant unmet medical need.”
Enadenotucirev was originally developed using a directed evolution process, with the aim of generating an entirely novel virus with optimised cancer-lytic properties. It has been shown to have little or no activity in normal cells whilst keeping a very high level of anti-cancer potency. As well as assessing how effective intraperitoneal enadenotucirev is for treating ovarian cancer, PsiOxus is also carrying out clinical studies evaluating its safety and efficacy via intravenous injection in patients with colorectal cancer. The phase I/II EVOLVE study (EValuating OncoLytic Vaccine Efficacy) is currently underway and has shown some promising early results.
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