08 January 2014, Sydney, Australia:Viralytics Limited (ASX:VLA, OTCQX:VRACY) can report that the 54thlate stage melanoma patient has been injected with CAVATAKTM, thus achieving the major milestone of target enrolment in the US Phase 2 CALM trial.
The Phase 2 trial is a single arm study being conducted at 11 US cancer clinics to investigate the safety and efficacy of intratumoral CAVATAKTM(Coxsackievirus A21) in patients with late stage malignant melanoma.
Dr Malcolm McColl, Chief Executive Officer of Viralytics said: "We are delighted to achieve this key enrolment milestone for the Company in our pathway towards commercialisation of CAVATAK™. The rapid enrolment in 2013 reflects excellent support from oncologists at our high calibre trial sites across the US and points to the need for better therapies to treat late stage melanoma."
It is also pleasing to report a highly encouraging overall irPFS (immune related Progression Free Survival) rate of 35% at 6 months (14 of 40 evaluable patients) and one year survival rate of 60% (12 of first 20 patients alive at one year).
The primary endpoint of the study required 10 patients from a total of 54 evaluable patients reporting irPFS at six months after the first dose of CAVATAK™. This was achieved in September after only 30 evaluable patients.
Dr Robert Andtbacka, Lead Study Investigator from the Huntsman Cancer Institute in the US said: "These interim results from the CALM trial are very encouraging with CAVATAK™ continuing to demonstrate promising anti-cancer activity while being well tolerated by patients. Investigational new drugs with this profile are excellent candidates for randomised studies."
Enquiries
Dr Malcolm McColl
02 9988 4000
Website: www.viralytics.com
Based in Sydney Australia, the company is listed on the Australian Securities Exchange (ASX: VLA) while Viralytics' ADRs also trade under VRACY on the US OTCQX International market.
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