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Prima BioMed Receives Regulatory Scientific Advice on CVac Phase III Trial
Date:2/18/2011

nce as there is a large un-met medical need for new treatments for ovarian cancer which has a very high morbidity rate. CVac™ is a maintenance therapy administered post-surgery and post-chemotherapy to delay relapse and control metastases.

There are currently no products available as maintenance based therapies for ovarian cancer and the global market for ovarian cancer therapeutics was valued at US$2.1b in 2007 and is expected to total US$3.6b by 2010.

Regulatory approval and commercialisation of CVac™ is the core focus for Prima.

About Prima BioMedPrima 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 the CVac™ ovarian cancer therapy treatment. It has completed two successful clinical trials and is progressing toward eventual commercialisation 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.

Clinical AppendixStudy Title CAN-004: A Randomized, Double-Blinded, Placebo-Controlled Phase 2/3 Trial of CVac™ (Autologous Dendritic Cells Pulsed with Recombinant Human Fusion Protein [Mucin1-Glutathione S Transferase] Coupled to Oxidized Polymannose) as Maintenance Treatment in Patients With Epithelial Ovarian Cancer (EOC) Following Optimal Debulking Surgery and First-line Chemotherapy

Study DesignThis is a randomized, double-blinded, placebo-controlled Phase 2/3 trial of CVac as maintenance treatment in patients with EOC following optimal debulking surgery and first-line chemotherapy. The initial planned enrollment is 750 patients. The primary analysis of irPFS is planned to be conducted after 350 irPFS events (confirmed immune-related progressive disease [irPD] or death) have occurred. The primary analysis for OS is planned to be
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SOURCE Prima BioMed Ltd
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