Oxford BioMedica received approval from the UK's Gene Therapy Advisory Committee (GTAC) for MetXia to enter a two-stage Phase I/II clinical trial in patients with pancreatic cancer
Two leading clinical centres in Liverpool and Leicester have supported this regulatory application and plan to commence recruitment before the end of the year.
The trial will be an open label study and will initially recruit six patients to assess the safety of MetXia and to identify the optimal dose for the second stage.
In the second part of the trial, the cyclophosphamide prodrug will be gradually escalated to identify a maximum tolerated dose.
Up to 21 patients will be recruited and endpoints include safety, clinical response and time to disease progression.
MetXia is also being investigated in breast cancer patients and a second Phase I/II trial in breast cancer is ongoing.
The broadening application of MetXia into pancreatic cancer is an important development for this novel anticancer agent.
The ongoing Phase I/II breast cancer trial continues to support our initial clinical findings that MetXia is safe, well tolerated and offers potential clinical benefit.
In the proposed pancreatic cancer study MetXia will be delivered directly to the pancreatic tumour via an intra-arterial catheter together with the cyclophosphamide prodrug.
Unlike oral administration of cyclophosphamide used in the breast cancer trials, this strategy avoids the initial metabolism of cyclophosphamide in the liver, thereby maximising its localised activation in the pancreatic tumour.
This clinical protocol, therefore, could enhance the potential efficacy of MetXia.
Pancreatic cancer is amongst the most aggressive with median survival time of only 6-12 months from diagnosis for inoperable cancers.
Current treatment options are primarily based on the chemotherapeutic agents 5-fluorouracil and, more recently, gemcitabine.
However, these have a minimal effect on median survival underlining the need for novel therapeutic strategies.
Given the short survival times and the lack of therapeutic options for this disease, positive data from this trial could lead to accelerated approval for MetXia in this indication.
Commenting on this news, chief executive professor Alan Kingsman said: "This is the first in a series of applications of MetXia following on from the successful Phase I/II trials in late-stage breast cancer patients".
"Success in pancreatic cancer should accelerate MetXia's commercial development."
