20 April 2009, Sydney: Viralytics Limited (ASX: VLA) has received ethics committee approval to increase the dosage levels of CAVATAK™ in its Phase I intravenous breast cancer, prostate cancer and melanoma trial.
Dosing will now commence at what was the highest dosing level of the original trial schedule and escalate to approximately 100 fold higher levels than planned for in the original design.
The intravenous trial will now comprise nine patients in total. For completion of the trial, a further six patients need to be recruited.
While Phase I studies are designed primarily to assess patient tolerance, increasing the CAVATAK™ dosing schedule may provide meaningful preliminary efficacy data in preparation for a Phase II study.
Overall, CAVATAK™ continues to be well tolerated by late stage cancer patients participating in all three Viralytics Phase I clinical trials.
About Viralytics Ltd
Viralytics is listed on the Australian Securities Exchange (ASX code: VLA). Viralytics’ ADR trades under VRACY on the OTC market in the USA. Viralytics’ principal asset is the intellectual property relating to CAVATAK™, an Oncolytic Virus technology. CAVATAK™ is the trade name for Viralytics’ proprietary formulation of the Coxsackievirus Type A21 (CVA21). CVA21 is a virus that occurs naturally in the community. CVA21 attaches to the outside of a cell, using a specific ‘receptor’ on the cell’s surface (like a key fitting a lock). CVA21 uses two receptors to infect cells, intercellular adhesion molecule-1 (ICAM-1) and/or decay accelerating factor (DAF). Both of these receptor proteins have been demonstrated to be highly expressed on multiple cancer types, including: melanoma, prostate cancer, breast cancer, multiple myeloma and others.