Solbec gets nod on cancer drug trial

Perth biotech Solbec Pharmaceuticals (ASX:SBP) has received approval to commence a Phase I clinical trial on its lead cancer therapeutic SBP002.

The trial, which will be carried out at Sir Charles Gairdner Hospital in Western Australia under the direction of Prof Michael Millward, will involve a maximum of 25 patients with advanced solid tumours and will take around six months to complete, said managing director Stephen Carter.

Primarily it will be used to evaluate safety, dosage and pharmacokinetic properties of the drug, with efficacy as a secondary endpoint.

Data from the trial will be used to support an IND application to the US Food and Drug Administration for a Phase II study expected to begin in the latter part of 2004, Carter said. The company plans to focus these trials on mesothelioma and malignant melanoma, which are both difficult to treat.

Animal studies of Solbec's drug, which is based on a mixture of two glycoalkaloids isolated from the fruit of Solanum linnaeanum, or devil's apple, have shown reduced tumour growth rates and eradication in models of mesothelioma and malignant melanoma in animal models.

The drug has been shown in pre-clinical studies to reduce the production of IL-6 -- a protein involved in proliferation of some cancer cells. More studies are being performed by the company to investigate the use of the drug to boost immune system function and as a therapeutic for a number of other diseases.

And a number of human patients have received the drug under the federal government's Special Access Scheme, with encouraging results including increased well-being, tumour size reduction, and reduced tumour growth rates.