Viralytics - Targeted Cancer Treatment

Phase I Melanoma Intratumoural Trial

In January 2010 the Company released the final results of its Phase I intratumoural trial in late stage melanoma patients. This trial was to assess the safety and tolerability of two doses of CAVATAK™ when injected directly into a solid tumour. The trial was successfully completed with the treatment being well tolerated and none of the patients exhibiting any product-related serious adverse events. In addition to assessing product safety of CAVATAK™ in humans, a secondary objective of the trial was to look for any signs of clinical benefit, both with respect to the injected tumours and any distant tumours in the body that might have been infected by CAVATAK™ resulting from the systemic release of virus from injected tumours. In this trial, the injected tumours of 36% of patients actually reduced in size, and the size of injected tumours of a further 22% of patients remained stable. In addition, measurement of distant tumours in patients showed that the overall disease was stabilised in two of the patients. All patients in the trial had late stage disease and previously had failed or rejected standard therapies.

a) Reduction=decrease in longest diameter ≥20% (calipers) or visual tumour flattening
b) Reduction= transient decrease in volume ≥25% (ultrasound)
c) Stable= decrease in tumour volume of <25% or <20% increase in tumour volume (ultrasound)
d) Progressive= increase in tumour volume of >20% (ultrasound)

The study conclusions supported the development of CAVATAK™ towards a Phase II trial, where repeated dosing over a longer period of time and more extensive measurements of clinical outcomes will be used to establish the efficacy of CAVATAK™ in treating melanoma.

The successful conclusion of  the Phase I trial has led to the successful Investigational New Drug (IND) application with the FDA, for the Phase II study in the USA.

Phase I Stage IV Solid Tumour Intravenous Trial

Viralytics is also conducting an intravenous (IV) trial in Stage IV solid tumour cancer patients bearing ICAM-1 to assess the safety of CAVATAK™ when administered at high doses directly into the bloodstream rather than injected into the tumour. 

Viralytics believe that patients with metastases could benefit greatly from the intravenous administration of CAVATAK™ because it effectively disseminates through the body.  To date eight patients have received CAVATAK™ intravenously and a final patient is required to register for this trial to complete the 9 patient study.