Oxford Biomedica Says Trovax Cancer Drug To Enter Phase Ii Trial
AFX News Limited
March 3, 2003
Oxford Biomedica PLC said it received ethical approval from the UK Gene Therapy
Advisory Committee (GTAC) for its therapeutic cancer vaccine TroVax to enter a
Phase II clinical trial in patients receiving chemotherapy for colorectal
cancer.
The trial is planned to start within two months.
The drug has successfully completed a Phase I/II trial in metastatic colorectal
cancer patients and has been shown to be safe and well tolerated in these
patients, Oxford Biomedica said.
GTAC has approved an open label Phase II trial in up to 15 patients of 5 doses
of TroVax in patients receiving 5-fluorouracil, leukovorin and irinotecan.
The end-points of the trial will be the immune response to TroVax and safety in
conjunction with this chemotherapy. Therefore the trial is expected to last only
6 months after the recruitment of the last patientm.
Oxford Biomedica chief Executive Alan Kingsman said: "Making TroVax a potential
phase III product for 2004 should potentiate our ability to find the right
partner for this product. The Company is also seeking approval for trials to
study the use of TroVax for other cancers as part of the strategy to broaden the
market potential of the product."
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