Viralytics trial shows Cavatak well-tolerated

By Dylan Bushell-Embling
Monday, 12 November, 2012

Viralytics (ASX:VLA) has published results from a phase I trial of its Cavatak oncolytic virus in solid tumours which have given it the confidence to proceed to phase II.

The company has presented a poster on the safety and tolerability trial at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.

The phase I dose escalation study in stage IV patients with solid tumours shows that the treatment candidate was well tolerated when delivered intravenously. But no objective response was recorded at the phase I dose levels.

Cavatak is a proprietary formulation of coxsackievirus A21, is a naturally occurring common cold like virus shown in pre-clinical studies to stimulate in vitro and in vivo oncolytic activity across a range of cancers.

The virus achieves this by binding to the N-terminal domain of surface expressed ICAM-1 – which is present on the surface of cancers including melanoma, breast and prostate cancers – triggering cytosis in the cells.

The results of the phase I trial fulfilled the criteria required for Viralytics to advance to a phase II trial under its IND application for the treatment with the US FDA.

Viralytics revealed it has so far dosed 13 patients in the phase II melanoma trial, with three of these demonstrating immune-related progression free survival at six months.

The primary objective of the trial is progression-free survival in 12-14 of a targeted 63 melanoma patients.

Viralytics also holds the patents to EVATAK, its proprietary formulation of Echovirus Type 1 (EV1). EVI uses a different cell surface receptor to bind and infect cancer cells.

Viralytics (ASX:VLA) shares were trading 9.5% lower at 38c as of 3pm on Monday. But the price remains well above the six-month average following a significant spike in October.

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