Singapore: Australia based drug discovery company, Viralytics, has recieved UK Medicines and Healthcare Products Regulatory Agency (MHRA) approval to undertake a Phase 1 clinical trial of CAVATAK in patients with non-muscle invasive bladder cancer (NMIBC), also known as superficial bladder cancer.

The Phase 1 trial is a two-part, open-label, dose-escalation study designed to evaluate the safety and tolerability of CAVATAK administered alone, as well as in combination with the standard chemotherapy, mitomycin C, in patients with NMIBC.

This trial, referred to as the CANON (CAVATAK in Non-muscle invasive bladder cancer) study, will be undertaken by Professor Hardev Pandha, director of the Surrey Cancer Research Institute at the University of Surrey as part of its ongoing research collaboration with Viralytics investigating CAVATAK's oncolytic activity in bladder cancer. CAVATAK is a novel cancer immunotherapy based on a proprietary cold virus that has been shown to preferentially infect and attack cancer cells.

In preclinical studies, the combination of CAVATAK and mitomycin C synergistically enhanced the cancer-killing activity in bladder cancer cell lines. In both the first and second stage of the trial, biopsies of the tumour tissue will be taken to assess the response to CAVATAK administration.

"Based on the significantly increased oncolytic activity of the CAVATAK/chemotherapy combination observed in bladder cancer cell cultures, we are excited to further explore this treatment in human trials, said Professor Pandha. "There is an urgent need for improved therapies for bladder cancer, and this combination appears promising."

According to Dr Malcolm McColl, chief executive officer, Viralytics, "The approval is a significant milestone for Viralytics, which is pursuing the development of CAVATAK as a treatment for a variety of cancers, including late-stage melanoma, prostate and lung cancer. Success in this setting would further broaden the commercial opportunity for CAVATAK, either as a monotherapy or in combination with other treatments."