Oxford BioMedica announced encouraging results from its ongoing Phase I/II trial with MetXia in breast cancer patients
The company also announced regulatory progress towards starting a Phase I/II trial with MetXia in pancreatic cancer.
The current Phase I/II trial in breast cancer is using an improved formulation of MetXia that effectively increases the dose level.
One of the goals of the trial is to show that this higher potency form is safe.
The trial is also designed to confirm the encouraging responses observed in an earlier clinical trial of the original formulation of MetXia in breast cancer and melanoma patients.
The ongoing trial seeks to confirm the immune stimulatory properties of MetXia as well as to determine whether the higher potency version of the product delivers the therapeutic gene to tumours more efficiently in humans, as it does in preclinical models.
So far, the data suggest that MetXia is meeting all expectations with respect to safety, gene transfer and immune stimulation.
The patient recruitment for the low dose is now complete and data from the first patients show that delivery of the therapeutic gene to tumour cells is more than ten-fold better than in the previous trial and also that patients are mounting an anti-tumour immune response.
If this high level of response to MetXia is maintained, there will be no need to recruit all 12 patients and the study can be terminated early.
Furthermore, if the systemic anti-tumour effect is a reproducible feature of MetXia as the trial continues, then the product could be considered for treatment of disseminated metastatic disease, which would greatly enhance its commercial potential.
In addition, the company has proceeded with its plans to take MetXia into a Phase I/II study in pancreatic cancer by seeking approval for the trial from the UK Gene Therapy Advisory Committee (GTAC).
GTAC is currently considering the application.
The proposed trial is expected to enrol 25 patients who have previously been diagnosed with metastatic pancreatic cancer.
The trial will be conducted at the Royal Liverpool University Hospital and Leicester Royal Infirmary.
Commenting on progress with MetXia, Oxford BioMedica's chief executive, prof Alan Kingsman said "The new data are most encouraging.
"If they are confirmed in a few additional patients then we can expand the potential market for MetXia based on its systemic anti-cancer effects.
"Notwithstanding these results, we are pleased to be making progress towards our first trial in pancreatic cancer, a disease where there is a clear unmet medical need and accelerated product approval is a possibility."
