Anti Cancer Virotherapy - natural virus used

Anti cancer virotherapy well tolerated in first human administration, research finds

(Banff, Canada March 14, 2005) An international medical conference here heard that an Australian developed anti-cancer therapy based on the use of a common cold virus to control cancer cell growth has begun safety testing in human subjects.

The research was presented to the third International Meeting on Replicating Oncolytic Virus Therapeutics, on Friday 11 March by Newcastle University associate professor, Darren Shafren.

The technology is licensed to Australian Stock Exchange listed biotechnology company, Psiron Limited (ASX:PSX).

Professor Shafren has previously tested this virotherapy on cancer tumours in mice and this is the first testing in humans. Two patients only were approved to receive this virotherapy.

Professor Shafren reported to the conference that this research team had injected a single dose of Coxsackie A21 (CVA21) virus directly into the advanced melanoma tumours of these patients with end stage disease.

Both patients had many sites of spread melanoma tumours and injected and non-injected tumours were subsequently removed from the patients.

Professor Shafren's group observed no "systemic toxic effects or localised inflammation" as a result of the injections of the viral material and basic blood chemistry and liver enzyme levels remain unchanged in the these two patients.

Professor Shafren told conference delegates that these findings suggested that administration of a single dose of CVA21 directly into a cancerous tumour was well tolerated.

"Administration of CVA21 may be of potential therapeutic benefit in controlling the spread of melanoma," Professor Shafren said.

CVA21 is one of a small group of naturally occurring rather than genetically modified viruses the Shafren team has been investigating as potential therapies for different hard to treat malignancies including melanoma and ovarian cancer.

These viruses occur naturally and routinely in the community causing mild infections in adult humans.

Previously the Shafren group has published research on CVA21 that showed success in specifically targeting and killing melanoma cells in mice .

The virotherapy technique involves the specific targeting and killing of cancer cells through the introduction into the body of the appropriate viral material which then reproduces at a rapid rate over a short period of time, devouring the cancer cells in the process by attaching to the cells' ICAM-1 (intercellular adhesion molecule-1) and DAF (decay accelerating factor).

This CVA21 technology which has been identified by Professor Shafren and his team to be effective in killing cancer cells, is on-licensed to Psiron, as has Echovirus Type 1 (EV1), which has shown promise in animal studies in ovarian cancer.

Professor Shafren's research has shown EV1 to be successful in attacking aggressive ovarian cancer cells in the test tube and infected mice .

### Psiron is an anti-cancer biotechnology company focusing on virotherapy. Psiron is developing a suite of viruses for treatment of a range of cancers. Research and development is currently at preclinical stage, progressing to Phase I clinical trials in 2005. Initial clinical trials will be on melanoma and ovarian cancer. More information is available at

Press Release, 3/14/05

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