Cancer drug passes clinical development milestones

An anti-cancer drug designed by researchers at Bath, which is being developed by the pharmaceutical company Ipsen, has made important clinical progress.

The drug BN83495, also known as STX64, was designed and chemically synthesised several years ago in the Medicinal Chemistry Group of the University’s Department of Pharmacy & Pharmacology.

This drug and its associated intellectual property formed part of the assets of the Bath-Imperial College London spin-out company Sterix Ltd that was acquired by Ipsen in 2004.

Ipsen has now tested the drug in post-menopausal women with advanced breast cancer to find the optimum dose.

Breast cancer is the most common form of cancer in the UK and is the second leading cause of cancer death among women. Approximately 75 per cent of women with newly diagnosed metastatic breast cancer have the hormone-dependent version of the disease, meaning that tumours are stimulated by steroid hormones.

The drug can be given orally and is termed a “first-in-class” irreversible steroid sulfatase inhibitor. It works by blocking an enzyme pathway that gives rise to precursors of the steroid hormones oestrogen and an androgen that can trigger the growth of hormone-dependent tumours.

Phase I trials are being conducted in five centres in France, Belgium and the UK – the preliminary results of which were presented at the San Antonio Breast Cancer Symposium in Texas, USA, in December.

Additionally, in November 2009 Ipsen started international, multi-centre, controlled, randomised Phase II trials for the drug in advanced endometrial cancer.

Endometrial cancer, which develops from the inner lining of the uterus, is the most common cancer found in the female reproductive system.

The trials will test the drug in post-menopausal women who have recurrent or advanced disease and who cannot be treated with surgery and radiotherapy, comparing it with another drug called megestrol acetate.

Professor Potter, of the Bath scientific team, said: “It is highly rewarding for the whole team to see the progression of this drug from the bench in a synthetic laboratory in Bath all the way into diverse major clinical trials in real patients.

“Although there is still plenty of work to be done in the coming years, we are very hopeful that this drug will indeed continue to prove its worth and become a new hormonal option for women with limited treatment options, targeting several types of cancer.

“This work emphasises the strength of Medicinal Chemistry at the University of Bath and demonstrates that academic scientists can play a key role in the drug discovery and development processes, particularly in the generation of new ideas and targets for therapeutic intervention.”

The drug has also entered trials in castrate-resistant prostate cancer and Ipsen plans to extend the clinical programme to include ovarian cancers in the near future.

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