Viralytics wins nod for phase I Cavatak trial
Viralytics (ASX:VLA) has won approval to commence a phase I trial of cancer treatment Cavatak in non-muscle invasive bladder cancer.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the CANON trial, which will be conducted at the Surrey Cancer Research Institute at the University of Surrey.
The two-part, open-label dose escalation study is expected to commence in the first quarter of 2015. Its lead investigator will be professor Hardev Pandha, the institute’s director.
The trial will be conducted in two stages, with the first stage designed to evaluate Cavatak delivered as a monotherapy directly into the bladder. During the second stage, mitomycin C will be added.
In preclinical studies, Cavatak and mitomycin C demonstrated superior cancer-killing activity in bladder cancer cell lines than Cavatak alone.
“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,” Pandha said.
“There is an urgent need for improved therapies for bladder cancer, and this combination appears promising.”
Viralytics recently revealed that Cavatak demonstrated improved anticancer activity during lab studies involving combining the candidate with immune checkpoint inhibitors Ipilimumab or Pembrolizumab.
Viralytics (ASX:VLA) shares were trading 3.39% higher at $0.305 as of around 2 pm on Friday.
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