Companies make strides to market in gene therapy

Picture courtesy Ark Therapeutics

Ark Therapeutics plc was given the go ahead to complete its Phase III trial in brain cancer without modification after an independent medical review said there was no safety concerns in the first 130 patients in the study.

Meanwhile, Oxford BioMedica plc announced that the Phase III trial of its cancer gene therapy product TroVax, has won the backing of the UK National Cancer Research Network (NCRN).

The news from London-based Ark shows the company’s commercially-approved manufacturing facility is delivering a reliable and predictable product, according to Nigel Parker, CEO. He said the approval to complete the trial means the company has cleared the last of the obstacles on the route to the first approved gene therapy product in a regulated market.

The Phase III trial of Cerepro, which delivers a gene that activates a non-toxic drug to a toxic state in situ, has a target of 250 patients and now has recruited 160. Cerepro became the first gene therapy product to move into a full review in 2005 when the European regulator EMEA accepted it for the exceptional approval route on the basis of two previous Phase II trials. This review is due to complete in March 2007.  

Parker said that following the approval to complete the trial Ark will now consult with the US Food and Drugs Administration to find out what it needs to do to get the product registered in the US. Cerepro has US orphan drug status.

The backing that Oxford-based Oxford BioMedica has received is a significant endorsement, as the NCRN  is responsible for providing the infrastructure to support cancer clinical trials in the UK. The adoption of the trial means that various National Health Service centres are able to participate in the study in renal cancer, ensuring rapid recruitment of patients.

In reaching its decision to adopt the trial, the Renal Cancer Clinical Studies Group of the NCRN evaluated TroVax and the trial design, concluding the product offers a potential improvement in patient care. There are no financial obligations or loss of commercial rights through NCRN’s involvement.

TRIST (TroVax Renal Immunotherapy Survival Trial) is a multi-centre Phase III trial of TroVax in patients with advanced or metastatic renal cell carcinoma. The first patient was treated in the TRIST study in November 2006, and sites are currently open in the European Union and Eastern Europe. Oxford BioMedica anticipates US sites will start recruiting patients shortly. The target is to recruit 700 patients in total and the trial is expected to reach a conclusion in 2008-09, with registration expected in.

Barry Hancock, Chairman of the Renal Clinical Studies Group said TroVax appears particularly well tolerated and is effective at inducing a significant immune response against a protein which marks out tumour cells. “There is a real need for novel, safe and effective treatments for this aggressive form of cancer. We aim to facilitate rapid patient recruitment through the participation of our network of centres in the UK.”

Mike McDonald, Oxford BioMedica’s Chief Medical Officer said NCRN’s involvement is a strong endorsement of the product and the trial design.

TroVax targets the tumour antigen 5T4, which is broadly distributed throughout a wide range of solid tumours. The product consists of a poxvirus gene delivery system, which delivers the gene for 5T4 and stimulates a patient’s body to produce an anti-5T4 immune response, destroying tumour cells carrying 5T4.