London, UK, 7 April, 2009 - Ark Therapeutics Group plc (AKT:LSE) (“Ark” or “the Company”) is pleased to announce that it has completed the first update of the results of its Cerepro® Phase III trial (Study 904) in accordance with reporting regulations. Cerepro®, Ark’s novel gene-based medicine, is being developed as an Orphan Drug for the treatment of operable malignant glioma. The update showed the main results strengthening in Cerepro’s® favour.
Study 904 was a multicentre, standard care controlled, pivotal trial in 236 patients. The study was designed to confirm the safety and efficacy of Cerepro® in patients with operable high grade glioma (brain cancer) against current standard care treatment options. Standard care was surgery and radiotherapy or surgery and radiotherapy followed approximately 40 days post-operatively by temozolomide, depending on the investigating centres’ standard practice and patient suitability. Patients were randomised to either standard care plus Cerepro® (one administration by multiple injection into the healthy brain at the end of the tumour resection procedure) or standard care alone. The primary endpoint was survival, defined as time to death or re-intervention(1). At randomisation, the treatment groups were well matched in terms of demographics and the standard prognostic features (age, Karnofsky Score etc).
Results of the Phase III trial were first reported on 30 July 2008 when 53 patients had yet to reach a primary endpoint. In the latest update analysis, median survival and adverse event profile results are consistent with those previously reported. On the primary endpoint of death or re-intervention, Kaplan Meier curves have improved to show a clear sustained separation from around 4 months post surgery in favour of Cerepro® treatment. Significance levels associated with the main data have improved in the update analyses. Twenty nine patients have still to reach a primary endpoint event (versus 53 previously), of which 18 have been treated with Cerepro® and 11 received standard care.
In relation to secondary endpoints, Magnetic Resonance Image (MRI) assessment of the progression free survival time, accounting for pseudo-progression, are supportive of the primary endpoint results. The effect of Cerepro® on overall survival (all cause mortality) is, as expected, complicated by the number of crossover therapies used after reintervention. Data do however show increasing support for improved overall survival in patients receiving Cerepro® after about 500 days with 56 patients in the trial still alive.
A marketing approval application (MAA) for Cerepro® was filed with EMEA in Q4 2008 and regulatory review commenced early this year. An opinion from the CHMP is expected in Q4 of this year.
(1) Re-intervention is defined as any kind of treatment (surgery, chemotherapy or radiotherapy) given to prolong survival after tumour recurrence.
Dr. Nigel Parker, Chief Executive of Ark commented: ‘We are pleased with the latest update of the study. The pattern we are seeing appears to be closely tracking our experiences with the previous Phase II studies where results strengthened in favour of Cerepro® treatment as the data on the longer surviving patients becomes available. The update will be provided to the regulators in accordance with standard process. Overall, our adenoviral platform and portfolio is making consistent progress and we look forward to providing the market with further updates on the portfolio in due course.’’
