viralytics granted chinese patent

Viralytics Granted Chinese Patent for Lead Anti-Cancer Product CAVATAK

Viralytics Limited (ASX: VLA) has been granted a Chinese patent regarding the use of CAVATAK RNA as an anti-cancer agent in human melanoma. The company is researching the use of virotherapy technology with the naturally occurring coxsackieviruses and echoviruses to treat cancer.

Viralytics Limited is a leading anti-cancer biotechnology company that focuses on a range of cancers including melanoma, breast and prostate cancer. Virotherapy involves the use of viruses to treat cancer, with specific use of oncolytic viruses that grow in cancer cells and kills them. Their technology has shown efficiency and safety in pre-clinical studies.

Bryan Dulhunty, the Managing Director of Viralytics Limited, told the Australian Investor that the research the company was completing was very unique.

Were the only Australian company researching the use of live replicating viruses to treat and kill cancer cells, Mr. Dulhunty said.

CAVATAK is the lead product of Viralytics, and is the trade name for the coxsackievirus A21. It is a naturally occurring human virus similar to the common cold. CAVATAK attaches to the outside of cells with certain receptors that occur in higher numbers in melanoma cells than normal cells.

It naturally seeks out cancer cells to attach to and invade, Mr. Dulhunty said.

The destruction of the cell and the presence of the virus brings on an immune response.

Laboratory and animal studies have shown that human melanoma cells have high receptor levels and are highly susceptible to destruction by CAVATAK whilst blood lymphocytes are unaffected. Phase 1 clinical studies of CAVATAK began in 2005.

The new Chinese patent involves the delivery of viral RNA extracted directly from CAVATAK or synthetically manufactured RNA to human melanoma cells to initiate on oncolytic viral infection and cell death.

This patent in China differs from our other patents and really extends its possible uses, Mr. Dulhunty said.

Existing patents that have been awarded to Viralytics involve the use of a live whole virus whilst this application involves the use of only the viral RNA genetic blueprints extracted from within the CAVATAK particle.

The treatment regime offers a potential alternative in producing oncolytic infection in human melanoma cells compared to the delivery of purified CAVATAK particles, which is currently under Phase 1 clinical evaluation in patients with late stage melanoma, breast, prostate and head/ neck cancer.

Last month Viralytics had pre-clinical research published on the anti-cancer activity of three additional coxsackieviruses A13, A15 and A18 in human melanoma. The article states that the three coxsackieviruses exhibited similar oncolytic activity against malignant melanoma and grew quickly in human melanoma cells. The use of the three viruses is covered by existing US and European patents.

The two major advantages of the CAVATAK technology are the safety of the virus and the speed with which it replicates.

We are using the common cold virus whereas some of our competitors are working with a herpes virus or a measles virus, Mr. Dulhunty said.

Our virus replicates every six hours but our competitors viruses replicate every 2-3 days.

This means that in 48 hours we can deliver 256 times the dose.

A recent $1 billion acquisition of BioVex, the most clinically advanced company in this field, by Amgen has helped the market to see virotherapy as a viable anti-cancer treatment.

It really commercially validated the field, Mr. Dulhunty said.

We see the success of another virotherapy company as bringing commercial attention to our work.
Viralytics is now concluding Phase 1 clinical evaluation in patients with late stage melanoma, breast, prostate and head/neck cancer and is in discussions with the FDA to conduct a Phase 2 melanoma trial in the US with CAVATAK.

Weve got our initial response and they have asked for further information, Mr. Dulhunty told the Australian Investor.

We hope later this year to commence with a Phase 2 trial.

The company also has numerous viruses at the pre-clinical stage, including viruses for lung, pancreatic and brain cancer.

We would like to choose one to take to Phase 1/II trials this year, Mr. Dulhunty said.

February 2011