Viralytics: Cavatak trial for late-stage melanoma reaches target enrollment

Viralytics Limited announced it has achieved target enrollment in a phase 2 US trial of its proprietary formulation of Coxsackievirus A21 in treating late-stage melanoma patients.

The 54th patient with late-stage melanoma was injected with Viralytics’ Cavatak, according to a press release. The study is being conducted at 11 cancer clinics and is investigating the safety and efficacy of Cavatak, which uses direct cytolysis and possible immune response acts to eradicate local and metastatic cancer cells.

“We are delighted to achieve this key enrollment milestone … toward commercialization of Cavatak,” Malcolm McColl, BVSc (Hons), MBA, chief executive officer, Viralytics, said in the release. “The rapid enrollment in 2013 reflects excellent support from oncologists at our high caliber trial sites across the US and points to the need for better therapies to treat late-stage melanoma.”

The study had an overall immune-related progression-free survival (irPFS) of 35% at 6 months in 14 of 40 evaluable patients and a 60% 1-year survival rate (12 of the first 20 patients alive at 1 year), the release said. Primary endpoint of 10 of 54 evaluable patients reporting irPFS at 6 months after the initial dose of Cavatak was met in September when 30 patients were enrolled.

“These interim results … are very encouraging with Cavatak continuing to demonstrate promising anti-cancer activity while being well tolerated by patients,” researcher Robert Andtbacka, MD, CM, of the Huntsman Cancer Institute, Salt Lake City, said in the release. “Investigational new drugs with this profile are excellent candidates for randomized studies.”

Viralytics also announced plans to begin a phase 1/2 trial in the United Kingdom of Cavatak being delivered intravenously in patients with melanoma, prostate, lung or metastatic bladder cancers. Combination treatments with existing chemotherapies will occur in the trial’s second stage.