Viralytics (ASX: VLA) provided an update of its lead product, CAVATAK in the 3 clinical trials the Company is currently running.  

1) Phase II CALM study: U.S. based 54 patient intratumoural late stage melanoma trial. This is the first CAVATAK  trial to be reviewed and allowed by the U.S. FDA.  Treatment of patients with CAVATAK has commenced at 2 U.S. sites. Additional patients from further sites have consented to join the trial and are expected to commence CAVATAK treatment shortly. Treatment consists of 10 visits where up to 8 individual tumours are injected with CAVATAK at each visit. 

The company currently has institutional board approval from 4 U.S. based sites to treat patients with CAVATAK with approval from a further 2 sites expected shortly. For further information about this trial, please visit the Clinical Trial website using the following link:  http://clinicaltrials.gov/ct2/show/NCT01227551

The U.S. based Phase II trial was commenced following the completion of 2 Australian-based Phase I trials of intratumoural administration of CAVATAK in late stage melanoma patients. 

2) Phase I intravenous late stage Melanoma, Prostate, Breast and Corectal cancer trial: Australian based, 9 patient trial.Intravenous delivery of CAVATAK is an important strategic aim of the Company. The ability to deliver CAVATAK intravenously will potentially allow the treatment of a greater range of cancers. In this Phase I study, 8 of 9 patients have been infused with CAVATAK and have completed the trial. The 9th and last patient is expected to enter the trial in early February. The primary objective of this study is patient safety. This trial is a crucial precursor to commencing a Phase II intravenous trial of CAVATAK.  Strategic planning for the intravenous Phase II trial protocol andprimary endpoint has commenced. To date, intravenous infusion of CAVATAK has been well tolerated.  

3) Phase I intratumoral late stage Head and Neck cancer trial: Australian based, 9 patient trial. This Phase I trial was designed to be a multi-dose, multi-injection safety study. Currently, 3 patients have been treated with CAVATAK in this study. 

The clinical objectives this trial was going to generate have now been superseded by those contained within the U.S. based Phase II melanoma trial discussed above.  As a result, a decision has been made to close this trial and direct the Company’s resources to its CAVATAK Phase II clinical development program. Viralytics’ clinical development program  is now clearly focused on its Phase II evaluation of CAVATAK in both intratumoral and intravenous settings, allowing investigation of both direct cancer cell oncolysis and development of anti-tumour immune responses.  

Source: VLA