SYDNEY, AUSTRALIA--(Marketwired - January 17, 2014) - Prima BioMed Ltd (ASX: PRR) (NASDAQ: PBMD) ("Prima," the "Company") today announced that the amended CAN-004 protocol was approved by the Belgian Federal Agency for Medicines and Health Products. This is the first regulatory agency to approve the amended CVac™ clinical trial design. CAN-004 is a multicentre, randomized, phase 2 trial of CVac for the maintenance treatment of epithelial ovarian cancer in remission.
In November 2013, Prima announced significant updates to its CVacTM clinical development program based on progression-free survival results from its randomized CAN-003 trial. In the CAN-003 trial, CVac demonstrated a strong trend of increased progression-free survival in ovarian cancer patients in remission after second line treatment, as compared to those patients who did not receive CVac.
The CAN-004 trial will enroll a new cohort of 210 epithelial ovarian cancer patients in remission after second-line platinum-based chemotherapy. 76 patients in remission after first-line surgery and chemotherapy have previously been randomized onto the CAN-004 trial. Overall survival (OS) will be the primary endpoint with secondary endpoints including progression-free survival (PFS), adverse events, and immune monitoring.
Matthew Lehman, Prima's CEO: "We are very pleased to have received approval for the CAN-004 protocol amendment in Belgium, and we anticipate other regulators will soon follow. It is exciting that we will soon be able to re-start recruitment of the CVac clinical trial for ovarian cancer."
Prima maintains updated information about the CAN-004 trial on the U.S. National Institutes of Health clinical trial registry at www.clinicaltrials.gov and will provide regular updates in the Company's quarterly conference calls.
About Prima BioMed
Prima BioMed is a globally active leader in the development of personalized immunocellular therapeutic products for the treatment of cancer. Prima is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders. Prima's lead product is CVac™, an autologous dendritic cell-based product currently in clinical trials. www.primabiomed.com.au.