Viralytics’ Cavatak well-tolerated intravenously

Viralytics (ASX:VLA) says a phase I study of intravenous delivery of Cavatak - a virotherapy cancer treatment candidate - has met its primary end point of patient tolerability.

Of the 10 late-stage melanoma, prostate, breast or colorectal cancer patients involved in the study, eight were evaluable for assessment by the end of the trial. None experienced any treatment-related serious adverse events.

Participants received a single IV infusion (or two infusions in the case of one patient) at various doses. No patients demonstrated an objective response at this dose level, but two subjects displayed stable disease at day 84.

Study investigator Winston Liauw, an associate professor at St George Hospital’s Cancer Care Unit, said the results bode well for future trials.

“Single-dose intravenous administration of Cavatak was well tolerated, demonstrated secondary replication, presence inside some cancer tissue and provided evidence for some stable disease,” he said.

Viralytics also released the results of lab studies evaluating the use of Cavatak in combination with popular chemotherapy drug docetaxel in lung cancer cell lines.

Cavatak was either moderately or strongly synergistic with docetaxel compared to either product alone in the cell lines tested. Docetaxel also had no negative effect on the rate of Cavatak replication.

On the strength of these results, Viralytics now plans to move on to a UK-based phase I/II multi-dose clinical trial of intravenous delivery of Cavatak.

This study - which, subject to approvals, will commence in 2H13 - will first involve using Cavatak as a monotherapy in late-stage melanoma, non-small cell lung, metastatic bladder and castrate-resistant prostate cancer.

The second stage will then evaluate Cavatak in conjunction with docetaxel or carboplatin in the cancer type for which Cavatak demonstrates the most promise.

Viralytics is also currently involved in a separate US phase II trial involving intratumoural injection of Cavatak to treat melanoma. This trial has generated some positive early results.

Cavatak is a modified version of coxsackievirus type 21A, which binds to the ICAM-1 cell receptor strongly expressed in a range of cancer types.

Viralytics shares were trading 6.25% lower at $0.30 as of around 1.30 pm on Tuesday.