Viralytics (ASX:VLA) has announced positive data from the CANON clinical trial of its lead drug candidate, CAVATAK, at the 31st Annual European Association of Urology (EAU) Congress in Germany.
Data were presented by Professor Hardev Pandha, University of Surrey and Principal Investigator of the CANON study, at the late breaking news session of the conference.
Professor Pandha provided commentary on the data from 14 patients on the Phase 1 CANON clinical trial, a two stage study expected to enrol approximately 25 non-muscle invasive bladder cancer (NMIBC) patients.
In the first stage, 9 patients were treated by intravesicular administration of monotherapy CAVATAK. In the second stage, to date, 5 patients have received a subtherapeutic dose of the chemotherapy, mitomycin C, plus CAVATAK intravesically prior to routine surgical removal of the tumour tissue.
The company said the study has generated evidence of CAVATAK targeting of tumour cells with viral replication and tumour cell death following either single or multiple administrations of CAVATAK to patients.
"Anti-cancer activity including viral induced tumour inflammation has been demonstrated in both the monotherapy and combination therapy arms of the study," said the company. "A complete response has been observed in one out of the 3 patients in the highest dose cohort of the monotherapy. To date the intravesicular administration of CAVATAK has been generally well tolerated with no Grade 2, 3 or 4 product-related adverse events."
According to Professor Pandha, “I am very encouraged by the CAVATAK tumour targeting and anti-cancer activity observed in the CANON study. The observed tumour targeting and viral replication seen in this study is likely to provide a strong signal in generating a local and systemic anti-tumour immune response. There is an urgent need for new agents in the treatment of NMIBC and there is considerable potential for CAVATAK in this setting.”