Prima Biomed begins recruitment in Europe
Prima BioMed (ASX:PRR) has started recruiting patients into its CANcer VAccine Study (CANVAS) trials in Europe, with patients likely to be enrolled in Ukraine.
CANVAS is a multicentre, randomised Phase II trial of CVac, a cancer vaccine for the treatment of patients with epithelial ovarian cancer who have undergone surgery and are in remission after standard first‐line treatment.
The study objectives are to ascertain whether CVac, compared to a placebo, improves the time patients remain in remission before tumour progression (progression-free survival) and extend overall survival of patients. Results to date show the vaccine extends ovarian cancer patients’ lives by an average of 18 weeks.
Safety, quality of life, manufacturing quality and additional laboratory assessments will also be investigated.
One thousand patients will be recruited to CANVAS at over 100 sites throughout Australia, the USA, Europe and Asia, to have 800 evaluable study patients undergo dosing.
The first patient was recruited to the trial last year in the US. The company anticipates most patients will be enrolled in Europe. Prima has obtained regulatory approval in multiple European countries including Belarus, Belgium, Poland, Germany, Lithuania, Latvia and Ukraine.
The company received a manufacturing licence from the TGA in March 2012 to produce the vaccine in Australia.
Prima BioMed (ASX:PRR) shares remained flat $0.11 at around 2 pm Tuesday.
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