Arno starts enrolling patients in Phase I/II trial of onapristone to treat prostate cancer

According to previous Phase II clinical trials, onapristone is shown to exhibit anti-tumour activity in patients with breast cancer.

The pre-clinical testing has demonstrated that onapristone had blocked the activation of the progesterone receptor (PR), which is believed to be a mechanism that inhibits the growth of APR-driven breast, endometrial and other tumours.

Patient enrollment in the Phase I/II trial follows approval of an Investigational Medicinal Product Dossier from the UK Health Authority, Medicines and Healthcare products Regulatory Agency (MHRA), ethics committee authorization and subsequent site authorization.

Arno Therapeutics president and chief executive officer Glenn Mattes said globally, prostate cancer is the second most common cancer in men, and the fifth leading cause of death from cancer in men, with an estimated 1.1 million new cases diagnosed and 307,000 deaths during 2012 alone, according to the International Agency for Research on Cancer.

"These numbers are staggering, and our ultimate goal is to evaluate onapristone in the subset of advanced CRPC patients who are more likely to respond to this personalized treatment, for which there is an immense unmet medical need," Mattes said.

"The trial marks Arno’s second Phase I study actively enrolling this year and we are excited by the momentum generated thus far."

The trial, designed to evaluate the safety and anti-cancer activity of onapristone in the select patient population, is being conducted at the Institute of Cancer Research, London, and the Royal Marsden NHS Foundation Trust in the UK.

About 60 patients are expected to be enrolled in the trial, for which additional sites are planned in the UK.

Biotrial, a drug evaluation and pharmacology research company, has been engaged by the company as its contract research organization (CRO) for the Phase I/II trial.