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Cerepro Phase III Trial Progress Update


Posted on: 01/05/2007

Cerepro Phase III Trial Progress Update


 

Patient Recruitment on Track and Positive Outcome from Latest Independent Data and Safety Monitoring Board Review

 

 

LONDON, Jan. 5, 2007 - Ark Therapeutics Group plc (LSE: AKT) ("Ark" or the "Company) today provides an update on the Phase III trial (Study 904) being undertaken on its lead product, CereproTM, for the treatment of high grade glioma (malignant brain tumour).

 

The independent Data and Safety Monitoring Board (DSMB) met on December 13th 2006 to review the data from the first 130 patients entered into the trial. Ark has now been notified by the DSMB that the side effect profile observed to date in Study 904 is in line with that previously reported, giving the DSMB no cause for concern nor requiring any alteration in the design and architecture of the trial. The DSMB has unanimously recommended that the Company continue the study without modification.

 

Recruitment into Study 904 has now passed 160 patients, in line with the Company's previous guidance.

 

Study 904 is a standard care controlled study to assess the efficacy and safety of CereproTM in up to 250 patients with high grade glioma. Patients are randomised in a 1:1 ratio either to standard care alone, or to standard care plus CereproTM 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 CereproTM treatment produces an average extension of 7.5 months of life, giving around 15.5 months survival in a disease where most patients will only live for around 8 months.

 

CereproTM is currently undergoing regulatory review for marketing approval with the European regulatory authority, the EMEA, and the Company expects the review to be completed around the end of March 2007. CereproTM is the first gene-based medicine1 to undergo full regulatory review.

 

The product is manufactured by Ark at its cGMP facility in Finland, which was granted the first ever commercial gene therapy production licence1 in late 2005.

 

Dr David Eckland, Head of Research and Development at Ark, said: "This is very solid progress, both in terms of patient recruitment into the trial and with the positive outcome of this latest data review by the DSMB. The fact that CereproTM is showing a consistent safety profile is further confirmation that the commercial production and quality standards we have established in Finland are delivering a reliable and predictable product."

 

1 Outside China

 

 

For further information please contact:

 

Ark Therapeutics Group plc: +44 (0)20 7388 7722

Dr Nigel Parker, CEO

Martyn Williams, CFO

 

Financial Dynamics: +44 (0)20 7831 3113

David Yates

Anna Keeble

 

 

Notes to Editors

 

High grade glioma

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.

 

CereproTM

CereproTM 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 CereproTM 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 two marketed devices, Kerraboot(R), and Flaminal(R), and three further lead pharmaceutical products in late stage clinical development: CereproTM, VitorTM, and Trinam(R), the Group is transitioning from an R&D company to a commercial, revenue generating business.

 

Ark's existing 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.


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