Prima Biomed Commences "CANVAS" Clinical Trial in Europe
SYDNEY, AUSTRALIA -- (Marketwire) -- 02/27/13 -- 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(TM) 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 undergo dosing.
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.
About Prima BioMed
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(TM), an autologous
dendritic cell product currently in clinical trials for ovarian
cancer patients who are in remission.
For further information please contact:
Ms. Jessica Brown
Prima BioMed Ltd.
+1 (919) 710-9061
Mr. James Moses
+61 (0) 420 991 574
Mr. Axel Muhlhaus
+49 (0) 69 905505-52
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