Viralytics cleared to begin UK cancer trial


By Dylan Bushell-Embling
Wednesday, 11 September, 2013

Viralytics (ASX:VLA) has secured final approval for a UK phase I/II clinical trial of its Cavatak oncolytic virus in various cancer types.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has signed off on Viralytics’ STORM (Systemic Treatment Of Resistant Malignancies) trial.

The study is expected to commence soon. It will be conducted across three cancer centres in the UK. The trial will assess the effectiveness of multiple intravenous doses of Cavatak in patients with late-stage melanoma, prostate, lung or metastatic bladder cancers.

The first stage of the trial will involve Cavatak as a monotherapy, and this will be used to identify the most promising cancer target.

In the second stage, Cavatak will be administered in combination with chemotherapy drugs docetaxel or carboplatin/paclitaxe as a treatment for the chosen target.

The trial’s lead investigators are Professor Hardev Pandha of the University of Surrey; Professor Kevin Harrington of the Institute of Cancer Research and The Royal Marsden, London; and Professor Alan Melcher of St James’s University Hospital, Leeds.

Cavatak is a naturally occurring coxsackievirus which binds to the ICAM-1 receptor overexpressed in a variety of cancer types.

Cavatak was found to be well tolerated during a phase I study in 10 late-stage melanoma, prostate, breast or colorectal cancer patients.

Viralytics is also involved in a separate phase II trial of the treatment candidate in late-stage melanoma alone. The company presented some encouraging preliminary results during a melanoma conference in March.

Viralytics (ASX:VLA) shares were trading 1.43% higher at $0.355 as of around 12.30 pm on Wednesday.

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