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Viralytics Ltd Announces Achievement Of Primary Endpoint in CAVATAK Phase 2 Melanoma Trial

Tuesday, 17 Sep 2013 07:40pm EDT 

Viralytics Ltd announced that it has achieved the primary endpoint in its Phase 2 clinical trial of CAVATAK 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 CAVATAK (Coxsackievirus A21) in 54 evaluable patients with late stage (IIIc and IV) malignant melanoma. The primary endpoint measured is immune related Progression Free Survival (irPFS ) at six months aft er first dose of CA VATAK. 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 response, partial tumour response or stable disease. 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%. Other study endpoints include durable response rate, one overall survival. These will be reported on as sufficient data analysed. 

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