Viralytics Limited (ASX:VLA) is reaching milestones at a Phase 2 clinical trial of its CAVATAK anti-cancer drug in the treatment of late stage melanoma patients.
The Phase 2 trial at 11 U.S. sites is to investigate safety and efficacy of intra-tumoral CAVATAK injection in 54 patients with late stage malignant melanoma.
The primary endpoint of the study was to have 10 from 54 evaluable patients reporting immune-related Progression Free Survival at 6 months, which was achieved in September after only 30 evaluable patients, representing an irPFS rate of 33%.
Another key performance measure is the one-year survival following initiation of treatment with CAVATAK. Currently, 16 patients were evaluable by this measure with 9 alive at the 1 year endpoint, a success rate of 56%.
To put that into perspective, the mean one-year overall survival rate based on a review of 42 Phase 2 melanoma trials in patients treated with a variety of agents is 25.5%.
Viralytic's aim is to commence a randomised Phase 2 trial in melanoma patients in the late 2014. Strong recent recruitment rates indicate final patient enrolment by the end of this year.
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