“CANVAS” Phase II/III registration study

Prima BioMed Ltd has been in discussion with regulatory authorities in Europe and the United States. To make CVac™ available for prescription, studies must be conducted to show that the medication is safe, well tolerated and effective at preventing recurrence of the tumour. The company plans to commence a study designed to support registration of CVac™ globally by the end of 2011. This study will be conducted in multiple countries world-wide, including Australasia, Europe and the United States. It is expected that over one hundred clinical sites will be involved and one thousand patients will be recruited. The study will be a randomised, double blind, placebo controlled in patients who have recently completed surgery for ovarian cancer and about to receive chemotherapy. The aim of the study is to compare how effective CVac™ will be to prevent recurrence of ovarian cancer after chemotherapy, and to examine the safety profile of the vaccine compared to placebo.

Further details of the study will be posted on this website when recruitment opens.

For additional informaiton on the study please email:  enquiries@primabiomed.com.au or go to the following website www.clinicaltrials.gov/ct2/show/NCT01521143