PVG.L Regulatory News (PVG)

7 Apr 2009 07:00



Cerepro®  Phase III trial update

-Analyses strengthen as more patients reach endpoint-

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.''

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Notes to Editors

Malignant glioma

Malignant glioma is a devastating and fatal form of brain tumour that is usually confined to the brain. The current standard therapy involves surgically removing the solid tumour mass (when possible) and initiating radiotherapy and/or chemotherapy. Even with the latest approved treatments, most patients die within one year of diagnosis, with average survival being about eight months. Little therapeutic progress has been made in recent years and the prognosis for malignant glioma patients is poor. A high unmet clinical need exists for new treatments that prolong life in this devastating disease. There are approximately 16,000 cases of malignant glioma in the EU which are operable.

Cerepro® 

Cerepro® is an adenoviral mediated gene-based medicine (ad.HSV tk) given by multiple injections into the healthy brain tissue of patients following surgical removal of the solid tumour mass. In the following days, ganciclovir, is given intravenously. Once treated, healthy brain cells surrounding the site where the tumour was removed express the enzyme thymidine kinase. This converts the ganciclovir to a substance which specifically kills dividing cells. The healthy neurones surrounding the tumour in the brain are non-dividing and are therefore not susceptible to this substance. In this way Cerepro® harnesses healthy brain cells to help prevent a new tumour from growing.

Ark Therapeutics Group plc

Ark Therapeutics Group plc is a specialist healthcare group (the "Group") addressing high value areas of unmet medical need within vascular disease, wound care and cancer. These are large and growing markets, where opportunities exist for effective new products to generate significant revenues. With five marketed devices, Kerraboot®, Kerraped®, KerraMax®, Flaminal® and Neuropad®, and three further lead pharmaceutical products in late stage clinical development: Cerepro®, Vitor™, and Trinam®, the Group is transitioning from an R&D company to a commercial, revenue generating business.

Ark's own products are sourced from related but largely non-dependent technologies within the Group and have been selected to enable them to be taken through development within the Group's own means and to benefit from Orphan Drug Status and/or Fast Track Designation, as appropriate. This strategy has allowed the Group to retain greater value and greater control of clinical development timelines, and to mitigate the risks of dependency on any one particular programme or development partner. Ark has secured patents or has patent applications pending for all its lead products in principal pharmaceutical markets. 

Ark has its origins in businesses established in the mid-1990s by Professor John Martin and Mr Stephen Barker of University College London and Professor Seppo Yla-Herttuala of the AI Virtanen Institute at the University of Kuopio, Finland, all of whom play leading roles in the Company's research and development programmes. 

Ark's shares were first listed on the London Stock Exchange in March 2004 (AKT.L). 

This announcement includes "forward-looking statements" which include all statements other than statements of historical facts, including, without limitation, those regarding the Group's financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to the Group's products and services), and any statements preceded by, followed by or that include forward-looking terminology such as the words "targets", "believes", "estimates", "expects", "aims", "intends", "will", "can", "may", "anticipates", "would", "should", "could" or similar expressions or the negative thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Group's control that could cause the actual results, performance or achievements of the Group to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Group's present and future business strategies and the environment in which the Group will operate in the future. Among the important factors that could cause the Group's actual results, performance or achievements to differ materially from those in forward-looking statements include those relating to Ark's funding requirements, regulatory approvals, clinical trials, reliance on third parties, intellectual property, key personnel and other factors. These forward-looking statements speak only as at the date of this announcement. The Group expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained in this announcement to reflect any change in the Group's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, readers are cautioned not to rely on any forward-looking statement.