Solbec expands devil's apple clinical trial

Perth biotech Solbec Pharmaceuticals (ASX:SPB) has expanded the Phase IIb clinical trial for its devil’s apple extract SBP002 – which is already showing promise as a treatment for mesothelioma -- and is commencing clinical trial identification studies against other forms of cancer.

Preliminary screening of SBP002 against 68 tumours has already been carried out by US oncologist Dr Robert Nagourney of Rational Therapeutics, and was presented recently to both the American Society of Clinical Oncologists and the American Association of Cancer Researchers.

The screening study – which used an ex vivo assay called EVA to tests cancerous tissue directly from patients rather than cultured cell lines -- showed that SBP002 provided a positive response in 57 per cent of the tumours treated.

In the preliminary study, Dr Nagourney identified four target tumour types -- melanoma, non small cell lung cancer (NSCLC), renal and colon cancer, against which SBP002 is likely to be most effective.

“We’ve got a happy problem – we haven’t found any cancers against which the compound isn’t active,” said Solbec business development manager Greg Barrington. “So we’re trying to find the cancers against which it is most effective.”

The new Phase IIb study will determine what cancer types, apart from mesothelioma, are most sensitive to SBP002, and whether using SBP002 in combination with currently available cancer drugs will improve the outcome for patients.

The new study follows the success of Solbec's Phase I/II clinical trials – conducted at Perth’s Charles Gairdner Hospital -- in which SBP002 produced no unexpected toxic side effects in patients with advanced mesothelioma and melanoma.

“The focus clearly has to remain on [SBP002’s] application against mesothelioma which provides access to the [US Food and Drug Administration] orphan drug status,” said Barrington.

“[These are] interesting results, which will open up new directions for research. But we might well be seeking development partners for those indications. The secret is to keep your eye on the main game,” he said.

SBP002 is a combination of two glycoalkaloids extracted from a thorny roadside weed called devil’s apple (Solanum linneaeanum). Solbec has a plantation of the devil's apple in Western Australia.