Viralytics: Phase 2 Melanoma Clinical Trial – CAVATAK™

Viralytics Limited (ASX: VLA, OTC: VRACY): is pleased to provide an update on progress with our Phase 2 CAVATAK™ clinical trial for late stage melanoma, currently being conducted under an IND in the US.

The highlights include:

• 13 subjects have now been dosed with CAVATAK™ out of an approximate target of 63 subjects;
• 3 of 13 subjects have demonstrated immune-related Progression-Free Survival (irPFS) at 6 months;
• 2 of 13 subjects have moved on to the extension study;
• 5 of 13 subjects currently being treated with CAVATAK™ have not been enrolled on the study long enough to either assess 6-month irPFS or eligibility for the extension study.

Since our last ASX release in July 2012, we advise that one more subject has moved into the extension study of the Phase 2 clinical trial making a total of two subjects now on the extension study.

A subject is eligible to join the extension study once they have completed the required dosing schedule and achieved at least stable disease status at six months.

The purpose of the extension study is to make continued treatment available for subjects who display a clinical benefit from CAVATAK™, even after their treatment is completed.  “A move onto the extension trial is considered a positive sign for CAVATAK™” said Viralytics’ Chief Medical Officer, Dr Jeffrey Weisberg.

Subjects who move on to the extension study give Viralytics the additional benefit of being able to continue studying the effectiveness of CAVATAK™ over a further six month period.

As part of a drive to accelerate subject recruitment for the Phase 2 study, we can announce that an additional four new prestigious US cancer centres have been engaged to recruit subjects for our trial:

• St Mary Medical Centre in San Francisco;
• Rush University Medical Centre in Chicago;
• Moores UCSD Cancer Centres in San Diego; and
• Atlantic Melanoma Centre in New Jersey.

“We are keen to increase subject recruitment for the study and expect to see an acceleration of recruitment as a result of these new trial sites coming on-board” said Viralytics’ Chief Scientific Officer, Associate Professor Darren Shafren.

The primary objective of the Phase 2 trial will be achieved when immune-related Progression-Free Survival at six months is observed in approximately 12-14 of 63 target subjects.

Enquiries 
Darren Shafren
Chief Scientific Officer
T: 02 9988 4000
M:0418469179
E: Darren.Shafren@viralytics.com
Website:www.viralytics.com