Updated on 18 September 2013
Viralytics' phase II clinical trial of Cavatak (CALM) achieves primary endpoint prior to patient recruitment
Singapore: Australia-based biotech company, Viralytics, achieved the primary endpoint in its phase II clinical trial of Cavatak in the treatment of late stage melanoma patients (the CALM study).
Phase II 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.
“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, CEO, Viralytics, said that, “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 melanoma patients.”