Early news from Solbec’s SBP002: no toxicity

Perth biotech Solbec Pharmaceuticals (ASX:SPB) is confident of taking its promising cancer drug SBP002 into Phase II clinical trials after a midstream review of data from its current phase 1 trial.

The company reported today that the drug, a combination of two glycoalkaloids from a thorny roadside weed called devil’s apple (Solanum linneaeanum) produced no unexpected toxic effects in volunteer patients.

The Phase I trial, at Perth’s Sir Charles Gairdner Hospital, is enrolling volunteer patients suffering from advanced mesothelioma and melanoma cancers, which are normally rapidly lethal.

Solbec MD and CEO Steve Carter says the principal investigator, Professor Michael Milward, is continuing to enrol cancer patients in the Phase I trial, which combines a dose-ranging study, with pharmacokinetic and tolerability studies.

Carter says patients with untreatable cancers who show benefit from the experimental therapy will be maintained on SBT002 therapy and will automatically be enrolled in the company’s planned Phase II clinical trial.

Solbec’s lead compound has been granted investigational new drug (IND) status by the US Food and Drug Administration.

It has been administered to patients in Melbourne, with late stage mesothelioma and melanoma cancer patients in Australia under the Therapeutic Goods Administration’s special access scheme, which allows promising new cancer drugs to be trialled, on a compassionate basis, in volunteer patients with inoperable, metastatic cancers.

Over the past three years, number of patients from Melbourne, Brisbane, Perth, and in New Zealand and the US, have been treated with SBP002 on compassionate grounds.

Carter said 10 of 12 palliative-care patients enrolled during the past year are still alive, despite being given only weeks to live with inoperable tumours, and one of the original patients treated three years ago had survived 2 1/2 years with metastatic melanoma.

In some patients, the growth of secondary tumours has either slowed markedly, stabilised or regressed to a point where surgery to remove tumours became possible. In several patients, the secondary tumours had actually disappeared without surgery.

Patients have also reported a feeling of wellbeing within a few days of commencing treatment, and have regained some of the weight lost to cachexia – the wasting condition associated with late-stage cancer – and have also experienced some relief from the pain of cancer.

Carter said the company had no immediate plans to sign up a commercial partner to take the drug into Phase III trials, but said eight companies – including five multinational pharmaceutical companies - had expressed an interest in commercializing the drug.

These companies were being kept informed of SBP002’S progress in the trial, as well as new research.