Positive data from bladder cancer trial


Tuesday, 15 March, 2016


Immunotherapy developer Viralytics (ASX:VLA) announced positive data from a clinical trial of its lead drug candidate, CAVATAK, at the 31st Annual European Association of Urology Congress held in Munich. The data was presented by principal investigator Professor Hardev Pandha, from the University of Surrey, and covered the 14 patients with non-muscle invasive bladder cancer (NMIBC) so far enrolled in the Phase 1 CANON clinical trial.

In the first stage of the trial, nine patients were treated by intravesicular administration of monotherapy CAVATAK — an investigational novel cancer immunotherapy based on a bio-selected common cold virus that has been shown to preferentially infect and attack cancer cells. In the second stage, five patients have so far received a subtherapeutic dose of the chemotherapy mitomycin C, plus CAVATAK intravesically, prior to routine surgical removal of the tumour tissue.

The study is said to have generated evidence of CAVATAK targeting of tumour cells with viral replication and tumour cell death following either single or multiple administrations of the drug to patients. Anticancer activity including viral-induced tumour inflammation has been demonstrated in both the monotherapy and combination therapy arms of the study.

A complete response has been observed in one out of the three patients in the highest dose cohort of the monotherapy. The intravesicular administration of the drug has so far been generally well tolerated with no Grade 2, 3 or 4 product-related adverse events.

“The observed tumour targeting and viral replication seen in this study is likely to provide a strong signal in generating a local and systemic antitumour immune response,” said Professor Pandha. “There is an urgent need for new agents in the treatment of NMIBC and there is considerable potential for CAVATAK in this setting.”

The study is expected to eventually enrol around 25 patients. The poster detailing the results so far can be found on the Viralytics website.

Viralytics (ASX:VLA) shares were trading 5.11% higher at $0.72 as of around 12.30 pm on Tuesday.

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