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1 ASX/Media Release (Code: PRR) 14 September 2011 CVac TM Phase III CANVAS Ovarian Cancer Clinical Update Highlights Upcoming CVac Phase III trial to be named CANVAS CANcer VAccine Study Successful progress meeting recently completed with United States FDA German manufacturing authorisation for CVac commenced TGA manufacturing inspection completed in Melbourne CANVAS patient enrolment expected to commence Q4 this year Australian health care company Prima BioMed Ltd (ASX: PRR) provides this update on the clinical development program of its CVac ovarian cancer vaccine. Prima continues to make strong progress in its late-stage clinical trials for CVac. It recently completed patient enrolment for its 60 patient Phase IIb trial and plans to commence patient enrolment for its major Phase III trial in Q4 this year. The Phase III clinical trial has been formally named CANVAS (CANcer VAccine Study) and the trial will be referred to as CANVAS going forward. The Company advises that it recently completed a successful progress meeting with the US Food and Drug Administration (FDA) regarding the upcoming CANVAS trial. The meeting with the FDA follows the granting of Scientific Advice for the CANVAS trial (for the European component of the trial) by the European regulator, the European Medicines Agency (EMA) see ASX announcement of 21 February The CANVAS trial has been finalised based on feedback received from these meetings with the regulators, as well as advice from Prima s scientific and clinical advisory boards. Also, CVac manufacturing facilities in Melbourne and Leipzig Germany have been inspected by the respective regulators. Manufacturing authorisation has been commenced in Germany and a decision from the Therapeutic Goods Administration (TGA) in Australia is due in the near future. About CANVAS CANVAS(CANcer VAccine Study) will be a multinational, multi-centre, randomised, double-blinded, placebo-controlled trial of CVac as a maintenance treatment for epithelial ovarian, primary peritoneal, or fallopian tube cancer in complete remission. The goals of CANVAS are to; definitively establish that CVac is able to extend the time in remission, extend overall life expectancy and improve quality of life for patients. The CANVAS study will enrol 800 women who are in complete remission after completing first-line treatment for ovarian cancer.
2 Indicative CANVAS timelines The Company expects first patients to be enrolled in the trial in Australia and parts of Europe in Q The first patients are expected in the US in February CANVAS will be conducted at about 150 centres in 22 countries throughout Australasia, the US and Europe. Contact details for interested parties and updated details of trial centres, as they open, will be available at Based on expected recruitment rates, full patient enrolment should be complete by about Q CANVAS is an event driven study and actual study timelines will be dependent on patient outcomes in the trial (i.e. how long patients stay in remission and stay alive). As such, these timelines are indicative only and are provided only as a guideline. Prima will provide regular updates regarding actual enrolment and progression events throughout the CANVAS trial. ENDS For further information please contact: Mr Martin Rogers Mr James Moses Chief Executive Officer Investor and Media Relations Prima BioMed Mandate Corporate Ph: Ph: +61 (0) E: martin.rogers@primabiomed.com.au E: james@mandatecorporate.com.au Website: About CVac TM Ovarian Cancer Treatment CVac is Prima BioMed s core product. It is a vaccine therapy treatment for ovarian cancer sufferers that is administered post-surgery and post-chemotherapy to delay the relapse and control the metastases of the cancer. There is a large un-met medical need for new treatments for ovarian cancer which has a very high morbidity rate, and there are currently no maintenance-based therapy products commercially available. The Company has recently completed its Phase IIb trial for CVac with the US FDA and plans to commence CANVAS(CANcer VAccine Study) a multinational, multi-centre, randomised, double-blinded, placebo-controlled trial of CVac in Europe and the US this year. The Phase IIb and CANVAS trials aim to further confirm the ability of CVac to reduce the instance of relapse in ovarian cancer patients, control the metastases of the cancer and increase the life expectancy of patients. Prima s ultimate goal is to commercialise CVac into the multi-billion dollar global pharmacy oncology market. The global market for ovarian cancer therapeutics was valued at US$2.1b in 2007 and was estimated to have grown to US$3.6b 1. Regulatory approval and commercialisation of CVac TM is the core focus for Prima. 1 Thomson Business Intelligence, Ovarian Cancer Therapeutics Industry Analysis 2007
3 About Prima BioMed Prima BioMed is an ASX listed Australian health care company. The Company is focused on technologies in the fields of cancer immunotherapy and immunology. Prima s lead product is CVac TM ovarian cancer therapy treatment. It has completed two successful clinical trials and is progressing toward eventual commercialization in the United States, Australia, Europe, and globally. The Company s broader, long term goal is to develop commercial cancer treatment technologies and programs for global markets.
4 Clinical Appendix STUDY TITLE: CANVAS: A Randomized, Double-Blinded, Placebo-Controlled Trial of Cvac (Autologous Dendritic Cells Pulsed with Recombinant Human Fusion Protein [Mucin 1-Glutathione S-Transferase] Coupled to Oxidized Polymannose) as Maintenance Treatment in Patients with Epithelial Ovarian Cancer (EOC) in Complete Remission Following First-Line Chemotherapy STUDY OBJECTIVES: Primary Objective To assess the efficacy, in terms of progression-free survival (PFS), of Cvac as compared with placebo for the maintenance treatment of patients with epithelial ovarian cancer (EOC) in complete remission (CR) following first-line chemotherapy Secondary Objectives To assess the efficacy, in terms of overall survival (OS), of Cvac as compared with placebo for the maintenance treatment of patients with EOC in CR following first-line chemotherapy To assess the safety and tolerability of Cvac as compared with placebo To assess health-related quality of life (QoL) related to Cvac treatment as compared with placebo Exploratory Objectives To investigate the utility of biomarkers as predictors of PFS and/or OS and as potential markers of predictive clinical efficacy of Cvac To investigate histopathology of tumor samples for potential markers of predictive clinical efficacy of Cvac To evaluate host immunologic response to Cvac administration To assess the effect of Cvac on changes in Eastern Cooperative Oncology Group (ECOG) performance status from baseline as compared with placebo STUDY DESIGN: CANVAS is a multinational, multicenter, randomized, double-blinded, placebo-controlled trial of Cvac (autologous dendritic cells [DCs] pulsed with recombinant human fusion protein [mucin 1-glutathione S-transferase] coupled to oxidized polymannose) as maintenance treatment in patients with EOC in CR following first-line chemotherapy. To be eligible for study participation, patients must have a diagnosis of stage III or IV EOC, have undergone an optimal debulking surgery ( 1 cm of residual disease), plan to undergo platinum and taxane chemotherapy, with or without bevacizumab, and have a tumor that overexpresses mucin 1, as well as meet all other study inclusion and exclusion criteria at screening. Patients who meet all study inclusion and exclusion criteria will be randomized in a 1:1
5 double-blinded fashion to either the Cvac (active) group or the placebo (control) group. After randomization, patients will undergo leukapheresis for production of the study agent and then begin first-line chemotherapy. After completion of chemotherapy and confirmation of complete clinical and radiological remission (baseline), patients will enter the treatment phase of the study. Up to 1000 patients may be recruited and randomized to ensure that at least 800 patients continue to baseline and the treatment phase of the study. Patients will be enrolled at approximately 150 centers in Europe, North America, and Australasia. Study agent dosing will be every 4 weeks for the first 3 doses, then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each dose will be divided and administered as 4 intradermal injections. Patients will be evaluated every 8 weeks after baseline until progressive disease (PD) or death (PFS event), or until the end of the study if a patient does not progress during the study. Final analysis of PFS is planned to be conducted after 620 PFS events (PD or death) have occurred, unless the study is stopped early at interim analysis or otherwise due to the study stopping rules. Throughout the study, the Data and Safety Monitoring Board (DSMB) will monitor blinded safety measures and demographics at regular intervals as specified in the DSMB charter. The DSMB will also conduct one planned interim efficacy analysis of grouped blinded data analysis, after 400 PFS events, as specified in the DSMB charter.
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