Cancer drug trials halted by regulator


solbecTRIALS of a potential new cancer treatment made from a noxious weed have been halted after concerns were raised by the drug regulator.

Australian manufacturer Solbec Pharmaceuticals has suspended testing of its developmental drug Coramsine, designed to work alongside chemotherapy to treat advanced cancers.

The company was about to enlist up to 120 skin cancer and kidney cancer patients for trials at 16 hospitals nationwide.

However, concerns raised by the Therapeutic Goods Administration (TGA) have put the studies on hold.
The problems are believed to be related to pre-clinical data and proposed trial protocols supplied by the company, which has received a $2.26 million commonwealth grant to develop the drug.

"Basically, we were enrolling until the TGA contacted us with an issue that they were concerned (about) and we've had to postpone everything," said Solbec general manager David Sparling.

"We don't even really know exactly why at this stage, so it's very frustrating.

"It's disappointing because we'd been going so well."

Coramsine uses an extract from the fruit of the Devil's Apple, an exotic shrub which grows as a noxious weed in Australia.

It is designed to work by adjusting the immune system.

An initial trial on eight patients with cancerous tumours found three responded to the drug without any serious side effects.

These phase two trials were to test effectiveness in treating advanced malignant melanoma and renal cell carcinoma.

The TGA said the company had agreed not to proceed until its concerns were resolved.