Full Press Release Details
ASX/Media Release (Code: ASX: PRR; NASDAQ: PBMD; ISIN: US74154B2034)
PRIMA BIOMED COMMENCES CANVAS CLINICAL TRIAL IN EUROPE
Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD; ISIN: US74154B2034) ( Prima, the Company ) is pleased to announce
that it has commenced recruitment of patients into the CANVAS (CANcer VAccine Study) trial in Europe. Prima has authorized several centers in Ukraine to start enrolling patients. CANVAS is a phase 2/3 study of CVac for the maintenance treatment of newly diagnosed, late-stage epithelial ovarian cancer patients who achieve
remission after optimal debulking surgery and standard first line chemotherapy.
Prima has obtained the requisite ethics and regulatory
approvals in multiple European countries, including Belarus, Belgium, Bulgaria, Germany, Lithuania, Latvia, Poland and Ukraine. The Company anticipates that the majority of CANVAS patients will be enrolled in Europe. The trial is currently open for
recruitment at a number of centers in the United States and Australia.
Prima BioMed CEO Matthew Lehman said: We are pleased to open
enrollment for the CANVAS trial in Europe; we plan to progressively open sites across several European countries in the coming months. I would like to congratulate our clinical team and our manufacturing colleagues at the Fraunhofer Institute of
Cell Therapy and Immunology for bringing us to this milestone.
Prima maintains updated information about the CANVAS trial and enrolling
clinical centers on the U.S. National Institutes of Health clinical trial registry at www.clinicaltrials.gov.
The CANcer VAccine Study
(CANVAS) is a multi-centre, randomized, and placebo-controlled study of CVac in mucin 1 positive, epithelial ovarian cancer patients who have undergone optimal surgery and achieve complete remission after first-line chemotherapy.
1000 patients will be recruited to CANVAS at over 100 hospitals throughout Australia, the USA, Europe, and Asia to have 800 evaluable study patients
The study objectives are to ascertain if CVac, as compared to a placebo, is able to improve the time patients remain in
remission before tumor progression (progression-free survival) and extend overall survival of patients. Safety parameters, quality of life impact, manufacturing quality, and additional laboratory assessments will also be investigated.
Prima BioMed Ltd, Level 7, 151 Macquarie Street, Sydney NSW 2000
Phone: +61 2 9276 1224 Fax: +61 2 9276 1284
Prima BioMed is a globally active biotechnology company. As a leader in personalized biotherapeutic products for cancer, Prima is dedicated to leveraging its current technology and expertise to develop
innovative treatment options for patients and maximize value to shareholders. Prima s lead product is
CVac , an autologous dendritic cell product currently in clinical trials for ovarian cancer patients who are in
For further information please contact:
Ms. Jessica Brown, Prima BioMed Ltd.
+1 (919) 710-9061; jessica.brown@primabiomed.com.au
Australia Investor/Media:
Mr. James Moses, Mandate Corporate
+61 (0) 420 991 574; james@mandatecorporate.com.au
Europe Investor/Media:
Mr. Axel M hlhaus, edicto GmbH
+49 (0) 69 905505-52; amuehlhaus@edicto.de
Prima BioMed Ltd, Level 7, 151 Macquarie Street, Sydney NSW 2000
Phone: +61 2 9276 1224 Fax: +61 2 9276 1284