US-based oncolytic immunotherapy developer Genelux has started dosing patients in a Phase II clinical trial (VIRO-15) of its clinical-stage candidate GL-ONC1 to treat recurrent ovarian cancer.
GL-ONC1 is an attenuated therapeutic vaccinia virus, which is a non-pathogenic virus altered by the firm to enhance safety, tumour selectivity and anti-tumour activity.
Designed to enrol up to 40 subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer, the open-label Phase II trial will assess intraperitoneal GL-ONC1 administered in bolus infusions on two consecutive days.
The trial is being conducted at Florida Hospital Cancer Institute (FHCI) in Orlando, US and led by gynaecologic oncologist Dr Robert Holloway.
Genelux intends to later expand the trial to additional centres in the country.
The trial will monitor progression-free survival as the primary endpoint, while its secondary endpoints include occurances of adverse events, anti-tumour and objective responses, disease control rate and overall survival.
Genelux president and CEO Thomas Zindrick said: “Exciting data provided Genelux with insights on optimising parameters to launch our Phase II trial, which is an important milestone in the clinical advancement of GL-ONC1.”
The Phase II trial is based on favourable results obtained during a previous Phase Ib trial performed in patients suffering from platinum-resistant/refractory ovarian cancer.
As a monotherapy, GL-ONC1 was found to have achieved objective and tumour-specific T-cell responses with a quality of life benefit during the Phase Ib trial.
According to other clinical study results from more than 100 patients, GL-ONC1 is well-tolerated and demonstrated documented clinical benefits.
Image: Ovarian cancer as seen on CT. Photo: courtesy of James Heilman.