Product category:
Antibodies
News Release from: Oxford BioMedica
Edited by the Laboratorytalk Editorial
Team on 21 May 2003
TroVax passes key regulatory hurdle in
the USA
Oxford BioMedica's TroVax Receives Clearance from the United States Recombinant DNA Advisory Committee to Enter a Clinical Trial for Renal Cancer
A review by the United States Recombinant DNA Advisory Committee (RAC) provided clearance to start a clinical trial with TroVax for the treatment of renal cancer The trial will be conducted at the Columbian Presbyterian Medical Center in New York
This article was originally published on Laboratorytalk on 25 Jun 2003 at 8.00am (UK)
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TroVax is Oxford BioMedica's leading cancer immunotherapy product.
It is designed specifically to stimulate an anti-cancer immune response and has potential application in most solid tumour types.
TroVax targets the tumour antigen 5T4, which is broadly distributed throughout a wide range of solid tumours.
The presence of 5T4 is correlated with poor prognosis.
The product consists of a pox virus (MVA) gene transfer system, which delivers the gene for 5T4 and stimulates a patient's body to produce an anti-5T4 immune response.
This immune response destroys tumour cells carrying the 5T4 protein.
Following successful Phase I/II clinical trial results in late stage colorectal cancer patients in the UK, TroVax is proceeding into Phase II trials in colorectal cancer and into further trials in renal and breast cancer respectively.
Both the renal and breast cancer trials are to be conducted in the United States under an Investigative New Drug (IND) application.
A prerequisite for the IND is approval by RAC.
Renal cancer represents a significant market opportunity with about 30,000 cases per year in the United States.
It is generally treated with Interleukin 2 (IL2).
However, the success rate is mixed and median survival is only about 13 months.
There is therefore a significant unmet medical need for an improved therapy for this type of cancer.
TroVax is to be tested with IL2 in a study of 25 patients.
Safety, immunogenicity and clinical benefit will be the primary objectives of the trial.
Commenting on the news the company's senior vice president for research and development, Susan Kingsman said: "Survival rates for renal cancer are poor and there are few novel therapies in development for this disease.
"We are delighted that TroVax is proceeding towards its first clinical trial in the United States for this unmet medical need.
"This is an important step in broadening the market potential of the product and thereby increasing its value".
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