Viralytics secures another cancer centre in the U.S. to host Phase II late stage Melanoma trial Friday, December 09, 2011 by Angela Kean
Viralytics (ASX: VLA) has begun recruiting patients at the Huntsman Cancer Institute for its U.S. Phase II CAVATAK Melanoma trial after receiving institutional review board approval.
The Phase II trial will comprise up to 63 patients (54 evaluable) and is a single arm intratumoral injection trial involving the injection of CAVATAK into multiple tumours on up to 10 separate occasions over an 18 week period.
The primary endpoint of the trial will measure immune-related progression-free survival at six months.
CAVATAK is an oncolytic (cancer killing) virus. Direct injection of the virus into tumors may kill cancer cells by the lytic action of the virus.
This action also releases tumor cell debris that may illicit a response by the patient’s own immune system against the tumour.
The Phase II study will assess the performance of CAVATAK in both of these actions in late stage melanoma.
Viralytics received approval from the U.S. Food and Drug Administration to run this trial in the U.S. in June 2011.
The first centre to grant the company approval to conduct its trial was the Mount Sinai Comprehensive Cancer Center in Miami, Florida in October.
Viralytics said at the time it expected a further three U.S.-based sites to approve the commencement of the trial in the next four to six weeks.
VLA Price at posting:
35.2¢ Sentiment: Buy Disclosure: Held
