9 December 2008, Sydney Australia: Viralytics Limited (ASX: VLA) has received approval to undertake a new phase I intratumoural (direct injection of accessible solid tumours) trial in Head and Neck Cancer. a cancer previously unchallenged with CAVATAK™. Approximately 45,000 new cases of Head and Neck Cancer are diagnosed each year in the US (approximately six percent of all cancers).
The primary objective of the study is to determine the safety of CAVATAK™ given by intratumoural injection in the treatment of recurrent, inoperable tumours of the head and neck. Three groups of patients will receive single or multiple (3 or 6) intratumoural injections of CAVATAK™. There will be three patients in each group.
Secondary objectives include the evaluation of CAVATAK™ replication, immune response to CAVATAK™ and any evidence of anti-tumour activity. The trial will be conducted in an Australian hospital and details of the trial will be available shortly at www.clinicaltrials.gov.
Data obtained from this new trial, together with that already accumulated from existing clinical evaluations of CAVATAK™ in patients with late stage melanoma, breast and prostate cancer (solid tumours) will expand the product profile of tolerance, bio-availability and anti-cancer mode of action in solid tumours.
Direct injection of accessible solid tumours, like Head and Neck Cancer, achieves localized delivery of high concentrations of CAVATAKTM, maximizing the potential for rapid tumour cell death and activation of favourable host anti-tumour immune responses. Such a delivery strategy also permits more accurate tumour measurement and scientific evaluation of the potency of CAVATAKTM. Supporting data from the monitoring of virus levels in the blood and size of remote tumours provides additional clinical insight into the distribution and bio-activity of virus produced following CAVATAKTM replication in the treated tumour. The Company believes this data will facilitate the earliest route to commercialization.
Cancers of the head and neck, which include cancers of the buccal cavity (cavity between the jaw and the cheeks), head and neck subset, larynx, pharynx, thyroid, salivary glands and nose/nasal passages. If caught early, the prognosis is excellent. However, about half of all cases of head and neck cancer are not identified until the disease is at an advanced stage
Clinical update: CAVATAK™ testing in two additional clinical trials
Viralytics currently has two other clinical trials actively recruiting cancer patients in Queensland, Australia.
Viralytics’ first phase I direct tumour injection dose escalation trial of CAVATAK™ in late stage melanoma patients has commenced dosing in the final (and third) group. Patients receive 100 times the dose given to the first group of three patients. Interim results from this trial were presented at the HMRI Conference on Translational Cancer Research held in September 2008 in Newcastle. The preliminary data showed that some patients experienced reductions in the size of injected tumours, which coincided with the presence of serum bio-markers indicating possible anti-tumour immune responses
Viralytics’ second phase I trial is an intravenous dose escalation trial of CAVATAK™ in late stage prostate, breast, melanoma cancer patients. In this trial, thirteen groups two patients received either single or multiple intravenous infusions of CAVATAK™. Dosing of the second patient group has commenced. To date, the treatment has been well tolerated and there have been no serious adverse events attributable to CAVATAK™.