UK-based PsiOxus Therapeutics (PsiOxus) has started its Octave trial of paclitaxel combined with the oncolytic virotherapy enadenotucirev to treat patients with ovarian cancer.
The trial is designed to evaluate the safety, tolerability and efficacy of intraperitoneal enadenotucirev when combined with intravenous paclitaxel.
The company noted that in earlier Phase I trials enadenotucirev has been shown to selectively infect cancer cells when administered by intravenous infusion.
Platinum-resistant ovarian cancer patients are being enrolled in the Octave trial at clinical centres in the UK and Spain.
Patients in Phase Ia received intra-peritoneal enadenotcuriev on its own. The trial’s Phase Ib component will now examine the combination with intravenous paclitaxel.
Last year, the European Medicines Agency (EMA) awarded enadenotucirev orphan drug status when combined with paclitaxel to treat epithelial ovarian cancer in Europe.
Pre-clinical trials have shown the combination to be successful in models of platinum-resistant ovarian cancer, and to have potentially improved efficacy over monotherapy alone.
PsiOxus CEO Dr John Beadle said: "This marks an important milestone in the development of enadenotucirev for ovarian cancer. The combination with paclitaxel will bring together two agents with very different, but complementary, mechanisms of action.
"This combination has the potential to offer patients an improved therapeutic benefit in a disease population where there is a high unmet need."
The company has also started its Spice trial to evaluate a therapy combining Merck’s Keytruda (pembrolizumab) and EnAd.
Currently being conducted in the US, the trial is to evaluate enadenotucirev’s ability to reverse resistance to checkpoint inhibitors for certain tumour types, including metastatic colorectal cancer.
Image: Micrograph of a mucinous ovarian carcinoma. Photo: courtesy of Nephron.