Viralytics reports positive data from Phase 2 Trial of CAVATAK
THE ROADHOUSE PHARMACY: Viralytics Limited (ASX: VLA) announced positive results from the company’s US Phase 2 CALM trial of CAVATAK™ in late-stage melanoma at the European Society of Medical Oncology (ESMO) 2014 Congress in Madrid.
Viralytics described CAVATAK as a novel cancer immunotherapy based on a proprietary cold virus that has been shown to preferentially infect and attack cancer cells.
To date, 22 of the 57 (38.6 per cent) patients have achieved the immune‐related Progression‐Free Surviva (irPFS) endpoint, exceeding the initial target of 18.5 per cent, or 10 of 54 evaluable patients reporting irPFS at six months after the first dose of CAVATAK.
Investigators also reported an overall response rate in 16 of 57 (28 per cent) patients, with an additional three patients remaining in the extension phase of the study and being monitored for the development of an overall response.
Viralytics claims CAVATAK continues to demonstrate activity in both injected tumours and non-injected tumours, including local and distant lymph nodes, lungs and other distant sites, suggesting an anti-tumour immune response.
The company said an interim one-year survival rate of 73 per cent (33 of 45) patients was achieved in what it descrtibed as being a challenging population with advanced, difficult-to-treat disease.
CAVATAK™ treatment continues to be well tolerated in patients, with no reports of drug related serious adverse events or grade 3 or 4 adverse events, and the majority of side effects being reported as grade 1.
“These latest results further demonstrate CAVATAK’s oncolytic immunotherapeutic activity,” Viralytics chief executive officer Dr Malcolm McColl said in the company’s announcement to the Australian Securities Exchange.
“Based on CAVATAK’s outstanding performance in this trial, and with strong support from leading oncologists, we plan to aggressively pursue our clinical development program.
“The commercial opportunity for CAVATAK, either as a monotherapy or in combination with other new agents, is reinforced by these very promising outcomes.”
Website: www.viralytics.com