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Monday, October 26, 2009 9:17:56 PM
<< Small Australian company Viralytics was given prominent mention. No real discussion about the regulatory hurdles for an engineered virus but a very good article IMO. comments added >>
http://www.pharmaasia.com/article-7898-oncolyticvirotherapyofcancer-Asia.html
Oncolytic Virotherapy of Cancer
Erin Haley and Darren Shafren, University of Newcastle, and Viralytics
Modern day studies reveal that oncolytic viruses may be an effective therapy for dealing with cancer tumors.
Published Saturday, August 01, 2009
selected highlights...
Current Clinical Evaluation of Oncolytic Viruses
The genetic modifications and pre-clinical studies of oncolytic viruses outlined above have enabled the initiation of the clinical evaluation of an array of oncolytic viruses throughout the world. There are currently more than 10 different oncolytic viruses in various Phase I and II clinical evaluation studies. Comprising this panel of oncolytic viruses are both naturally occurring and genetically altered viruses, with routes of viral delivery including single/multiintravenous and intra-lesional injections.
In some clinical evaluation programs, oncolytic viruses are administered in combination with standard chemotherapeutic regimes and immune-suppressive agents. The tolerance profiles of cancer patients to oncolytic virotherapy are quite impressive when compared to those of cyto-toxic chemotherapeutics and some targeted monoclonal antibody therapies - with toxicity being limited to reports of "flu-like" symptoms following viral administration. The lack of statistical significant data from randomized clinical trials of oncolytic viruses against standard care agents, has historically cast a shadow as to the clinical future of this biologically targeted therapy.
In this environment however, two oncolytic virus companies, BioVex and Oncolytics Biotech have recently announced that they are undertaking pivotal randomized Phase III clinical trials with their lead candidates in late stage melanoma (OncoVexGM-CSF) and refractory head and neck cancers (Reolysin), respectively. Favorable outcomes from these trials should establish oncolytic virotherapy as an accepted targeted anti-cancer therapy, open the regulatory door for further pivotal oncolytic virus trials and finally, attract interest from pharmaceutical companies.
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More widespread independent exposure is going to pay dividends at some point IMO.
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