Prima Biotech has approval to manufacturing CVac cancer treatment on 3 continents
The Therapeutic Goods Administration (TGA) has granted manufacturing approval for Prima BioMed (ASX:PRR) to produce its CVac ovarian cancer vaccine in Australia, for use in a major clinical trial.
Prima BioMed (ASX:PRR) has received Therapeutic Goods Administration (TGA) approval to produce its CVac immunotherapy ovarian cancer vaccine in Australia. Prima BioMed is already producing CVac in the US, and has also received manufacturing approval in Europe.
CVac is a treatment candidate designed to extend the time in remission for patients diagnosed with ovarian cancer.
If successful, it will be the first maintenance-based therapy product for ovarian cancer to reach the market.
Sydney-based Prima BioMed has received a manufacturing license from the TGA to produce the vaccine for use in the Australian leg of its multinational CANVAS clinical trial.
CANVAS (CANcer VAccine Study) will be a multi-centre, randomised, double-blinded, placebo-controlled trial. It will involve 800 patients at 150 centres across 22 countries.
The company enrolled the first patient in the trial in the US in February, and expects to complete recruitment by the second half of 2013.
All patients will be in complete remission after completing surgical treatment and chemotherapy for ovarian cancer. The trial will help determine whether CVac can indeed extend the time in remission.
Certification from the TGA means that the Office of Manufacturing Quality is convinced that CVac will be produced in accordance with best-practice standards.