Following a recent independent Data and Safety Monitoring Board ('DSMB') review of its phase III trial for Cerepro (Study 904), Ark Therapeutics said it would continue to follow patients in the study until the end of June. Cerepro is Ark's lead product for the treatment of high grade glioma (malignant brain tumour).
Study 904 is a standard care controlled study to assess the efficacy and safety of Cerepro in 250 patients with high grade glioma. Patients are randomised in a 1:1 ratio either to standard care alone or to standard care plus Cerepro treatment and patients are blinded to the point of treatment allocation. The multi-centre study is being conducted in Europe and Israel.
Trials completed to date have shown that Cerepro treatment produces an average extension of 7.5 months of life, giving around 15.5 months survival, whereas controls survived on average for around 9 months.
At this point the company will have a sufficiently full data set to provide reliable statistical evaluations of the clinical effects of Cerepro.
"This trial has the potential to provide us with key efficacy results. For this we need the full data set and, at present, we still have around 40 per cent of patients who have been in the trial less than a year. Thus we will need to be patient," said Dr Nigel Parker, CEO, Ark.
High grade glioma (malignant glioma) is a devastating and fatal form of 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. It is estimated that there are approximately 16,000 cases of malignant glioma in the EU which are operable.
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.
Cerepro is manufactured by Ark at its cGMP facility in Finland, which was granted the first ever European commercial gene therapy production licence in late 2005.
Ark Therapeutics Group plc is a specialist healthcare group addressing high value areas of unmet medical need within vascular disease, wound care and cancer.