Oxford BioMedica received approval in July 2001 from the UK's Gene Therapy Advisory Committee (GTAC) for the further development of the MetXia clinical programme
The new trial, designated BC2, will evolve from the successful BC1 Phase I/II trial in breast cancer patients.
BC2 will use the MetXia product made from an enhanced manufacturing process.
In parallel with the current BC1 trial, BioMedica has been developing its manufacturing technologies for gene therapy products.
The primary goal of these developments has been the configuration of a robust process that could satisfy market demand should the product gain approval in the future.
This has now resulted in a process that can manufacture MetXia at a 100-fold higher efficiency than the prototype process used for BC1.
The resultant product delivered to the patients' tumour cells is the same, as is the mode of delivery.
This new high efficiency process would be the one to be used in commercial manufacture, therefore the Company has decided to accelerate the testing of the product from this new process by the initiation of a new clinical trial designated BC2 that is a development of the BC1 trial.
Patients that would have been recruited into the later stages of BC1 will now be recruited directly into BC2.
Commenting on this news, chief executive professor Alan Kingsman said: "The new production method will make a significant difference in terms of the commercial production of MetXia.
"However, because the product and the mode of delivery is the same, there is no need to change the fundamental aspects of the current protocol of the trial - BC1 will simply evolve into BC2.
"This is yet another successful application to GTAC and we are pleased to see the MetXia programme developing in this way."
