Phase II results with Metxia in pancreatic cancer

The presentation was made by Paula Ghaneh, a consultant surgeon at the Royal Liverpool University Hospital, specialising in upper gastrointestinal and liver surgery, at the 13th United European Gastroenterology Week in Copenhagen, Denmark, on Tuesday, 18 October 2005.

Dr Ghaneh is one of the principal clinicians for the ongoing trial with Metxia.

The presentation assessed and compared clinical data from trials with several gene-based therapies in pancreatic and gastrointestinal cancers.

Ghaneh concluded that in contrast with these studies, Metxia therapy successfully demonstrated gene transfer in the tumour by regional delivery.

The two-stage Phase II trial is designed to evaluate Metxia and the chemotherapy prodrug cyclosphosphamide (CPA) in patients undergoing palliative surgery for pancreatic cancer.

In the first stage of the trial, two dose levels of Metxia were assessed in six patients in combination with a low dose of CPA.

These patients all had late stage localised or metastatic disease.

Each patient had two administrations of Metxia, prior and subsequent to surgery, followed by CPA.

In August, the Company reported that the first stage of the trial had been successfully completed.

Both dose levels of Metxia were safe and well tolerated.

Metxia comprises a highly engineered retrovirus that delivers the P450 gene to tumour cells.

The enzyme encoded by the P450 gene activates CPA to a form that destroys cells.

With conventional oral and intravenous administration of CPA, the drug is activated in the liver by the P450 enzyme.

This trial utilises catheter-enabled local delivery of both Metxia and CPA to the pancreas, thereby focusing gene delivery and activation of CPA in the target tissue.

This minimises the side effects of liver toxicity and systemic dispersal of activated CPA that are associated with oral administration of CPA.

The route of administration represents a novel and potentially highly potent strategy for optimising chemotherapy at the tumour site.

Following the encouraging results in stage one of the trial, patient recruitment is ongoing for the second stage with a fixed dose of Metxia and increasing doses of CPA.

Stage two will accrue up to 25 patients and will determine the optimal dose of CPA.

The trial is being conducted at the Royal Liverpool University Hospital and also at the Hammersmith Hospital, UK.

The second stage of the trial is designed to evaluate clinical benefit as well as safety.

Preliminary efficacy data from the second stage is expected in early 2006.

The 13th United European Gastroenterology Week in Copenhagen, Denmark, on 15-19 October 2005 brings together the 15 professional Societies either as Founding or Associate members.

The scope of these Societies ranges from general gastroenterological medicine and/or surgery to focused organ-oriented and special interest associations.

The presentation of the MetXia data by Dr Ghaneh was given during a session titled 'Pancreatic cancer from gene to therapy' on Tuesday, 18 October 2005.

The title of the presentation is 'Phase II trials in gene and antibody therapy'.

Dr Ghaneh of the Royal Liverpool University Hospital said: "We are very encouraged that MetXia has been well tolerated by patients to date and that we find expression of the transgene in the tumour.

"We look forward to recruiting more patients and evaluating the results from the second stage of the trial.

Commenting on the presentation by Dr Ghaneh, Oxford BioMedica's chief executive, professor Alan Kingsman said: "Dr Ghaneh's comparison of MetXia with other gene based therapies addresses the essence of Oxford BioMedica's core capabilities.

"We established the company because we believed that we had gene delivery technology, the efficiency and safety of which would solve many of the problems of gene therapy.

"Her conclusions vindicate that belief.

"We look forward to the analysis of the next stage of the trial and hope that we can provide benefit to patients with this devastating disease.