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Primary Endpoint Achieved in CAVATAK Phase 2 Melanoma Trial
Date:9/18/2013

SYDNEY, Sept. 18, 2013 /PRNewswire/ -- Viralytics Limited (ASX: VLA, OTCQX: VRACY) has achieved the primary endpoint in its Phase 2 clinical trial of CAVATAKTM in the treatment of late stage melanoma patients (the CALM study).

The Phase 2 trial is a single arm study being conducted at 10 US sites and is designed to investigate the safety and efficacy of intratumoral CAVATAKTM (Coxsackievirus A21) in 54 evaluable1 patients with late stage (IIIc and IV) malignant melanoma.

The primary endpoint measured is immune related Progression Free Survival (irPFS) at six months after first dose of CAVATAK™. Progression Free Survival is the length of time, during and after treatment, that the patient lives with the cancer without it worsening. It includes patients that achieve a complete tumour response2, partial tumour response3 or stable disease4.

The primary endpoint of the study was to have 10 patients from a total of 54 evaluable patients reporting irPFS at six months after the first dose of CAVATAK™.  This was achieved after only 30 evaluable patients, representing an irPFS rate so far of 33%. 

"Achieving the primary endpoint of the CALM study before patient recruitment has been completed is very encouraging. In addition to the positive irPFS data we have observed responses in both injected and non-injected lesions," said Dr Robert Andtbacka, Lead Study Investigator from the Huntsman Cancer Institute in the US.

Dr Malcolm McColl, Chief Executive Officer of Viralytics said: "We are delighted to achieve this major milestone in the development of CAVATAK™. Given the excellent progress achieved to date and the encouraging feedback from key opinion leaders in the melanoma field we also believe it is now timely to consider the design of a randomised study in
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SOURCE Viralytics Ltd.
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