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news.Viralytics has completed its phase I late stage melanoma trial of Cavatak. The primary safety objective of this trial was to assess the safety and tolerability of two doses of Cavatak, when injected directly to a single tumour. The trial was well tolerated with no reports of serious adverse events.
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The secondary objective of the trial also monitored the injected tumour and other distant tumours for signs of Cavatak activity against actively progressing metastatic melanoma. Injected tumours of one-third of patients reduced in size, while the injected tumours of a further 22% of patients remained stable.
Dr Mark Smithers, principle investigator for the study, from the Princess Alexandra Hospital, Brisbane, said: “A successful completion to this study was very important. We have now established a safety profile that allows the product to advance to Phase II efficacy evaluation. Cavatak offers to be an exciting alternative in the attempt to establish successful immune therapy of Melanoma. Immune therapy, I believe, will play a significant role in the future treatment of this disease.”
The study conclusions also support the progress of development to phase II, where repeated dosing over a longer period of time would be used to establish the efficacy of Cavatak in effectively treating Melanoma.
Viralytics will use this report for FDA Investigational New Drug (IND) filing. The company will conduct its planned phase II melanoma trial under an IND filing.