Sirtex looks to Europe following FDA success

By Daniella Goldberg
Tuesday, 12 March, 2002

Small particle technology company Sirtex Medical is seeking European approval for its liver cancer treatment, following last week's announcement it had been approved by the US Food and Drug Administration.

Sirtex CEO Dr Colin Sutton said the company was working with the British Standards Institute to get a Community European Mark for the therapy, so it could be registered and sold in Europe.

"We've received a classification as an active implantable medical device," he said.

BSI recently visited Sirtex's North Ryde plant, and the Lucas Heights nuclear facility where the radioactive therapeutic is made.

Dr Colin Sutton, CEO SIRTeX Medical said Two and half years of working hard at it and we got it (US approval).

Sutton said Sirtex planned to emulate biotech giants ResMed and Cochlear, and directly distribute its SIR-Spheres therapy worldwide.

The company has established a Chicago HQ to precondition the market for the new therapeutic.

"There is a great deal of enthusiasm from doctors to use this therapy in conjunction with different chemotherapies and to collaborate in clinical trials," Sutton said.

The company already has a base in Bangkok, where it supplies products into Asia, particularly into Hong Kong, Singapore and Thailand market.

In Australia, the therapy costs $6,800 and is not yet approved for cover by the public health system.

In the pipeline are two more anti-cancer products, Dox-spheres and Thermo-Spheres, developed by Prof Bruce Gray, who invented the small particle technology.

The system works by loading cytotoxic agents onto microspheres work and delivering them into the blood stream using a catheter.

"Our trick is to access tumors by less invasive means, and we can put anything into the tumours via the blood supply" Sutton said.

The first commercialised microsphere, SIR-Spheres, is loaded with radioactive.

The second product, Dox-Spheres, incorporates Doxorubicin, a well known anti-cancer drug, and is in phase II clinical trials.

Thermo-Spheres, the latest product, contains nano-magnets that can carry heat directly to the tumour and heat is well known to potentiate chemotherapy and radiotherapy.

"Thermo-Spheres are more of a platform technology than a product," he says.

"Anything that can be triggered by heat, and there are lots of things, we would be able to turn on and off using our implanted nano-magnets. It's like a biological switch," he said.

"This is our blue sky project, we've only trialled in large animals, so its some time away," he said.

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