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Viralytics’ (VLA) Phase II clinical trial of Cavatak or the CALM study has met its primary endpoint of progression-free survival (PFS) in tpatients suffering from late stage melanoma.

Being carried out at 10 US sites, the Phase II trial is aimed at investigating the safety and efficacy of intratumoral Cavatak (Coxsackievirus A21) in 54 evaluable patients with late stage (IIIc and IV) malignant melanoma.

Under the trial, the primary endpoint was to have 10 patients from a total of 54 reporting immune related PFS (irPFS) at six months after the first dose of Cavatak and it was achieved after only 30 evaluable patients, representing an irPFS rate of 33% so far.

PFS is the length of time, during and after treatment, which the patient lives with the cancer without it worsening, and it includes patients who achieve a complete tumour response, partial tumour response or stable disease.

Huntsman Cancer Institute’s lead study investigator Robert Andtbacka said: "In addition to the positive irPFS data we have observed responses in both injected and non-injected lesions.

Currently 44 patients are enrolled in the study, while full enrolment is expected to be completed by the end of 2013.

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According to Data Monitoring Committee, Cavatak also met required safety, tolerability and response criteria.

Viralytics CEO Malcolm McColl said, "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."

In addition, Viralytics plans to start STORM (Systemic Treatment Of ResistantMalignancies), a Phase I/II trial of intravenous Cavatak, in patients with melanoma, prostate, lung or metastatic bladder cancers.

The STORM trial, which has earlier received regulatory approval from the UK Medicines and Healthcare products Regulatory Agency, will begin at three UK sites later in 2013.

Cavatak is a proprietary formulation of the common cold Coxsackievirus Type A21 (CVA21), which binds to specific ‘receptor’ proteins expressed on several cancer types such as, melanoma, prostate, lung, breast, bladder cancer and multiple myeloma.

Image: Melanoma on a patient’s skin. Photo: courtesy of Jmh649.