On Jan. 20, 2012, Galena Biopharma, Inc. (GALE) announced the initiation of its Phase III PRESENT trial for NeuVax (E75 peptide plus GM-CSF) vaccine in HER2 1+ and 2+ breast cancer patients in the adjuvant setting to prevent recurrence.
The PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study is a randomized, multicenter, multinational clinical trial that will enroll approximately 700 breast cancer patients. The trial design has been updated to include current National Comprehensive Cancer Network guidelines and recently received Special Protocol Assessment (NYSE:SPA) concurrence from the FDA. Based on a successful Phase 2 trial, which achieved its primary endpoint of disease-free survival (NYSE:DFS), the FDA has agreed that the design and planned analysis of the Phase III study adequately address the objectives necessary to support an acceptable regulatory submission for marketing approval.
The NeuVax Phase III trial will be conducted in adjuvant breast cancer patients who are node positive, have an HLA status of A2/A3+, and have low or intermediate HER2 expression (IHC 1+, 2+, sometimes referred to as HER2 negative). These patients are not eligible to receive Herceptin (trastuzumab, marketed by Roche-Genentech) therapy that is currently approved only for patients with high HER2, or 3+ expression.
According to the protocol, once qualified patients have achieved a complete response from current standard-of-care treatment (surgery, radiation and/or chemotherapy), they will be randomized and dosed with either NeuVax (E75 + GM-CSF) or control (placebo plus GM-CSF). Patients will receive one intradermal injection every month for six months, followed by a booster inoculation every six months thereafter. The primary endpoint is disease-free survival at three years or 139 events (recurrence of cancer). A data safety monitoring board will conduct an interim analysis for safety and futility after 70 events. Galena is currently on track for the initiation of approximately 100 investigator sites in the U.S. and abroad.
We think the initiation of the PRESENT Phase III trial of NeuVax is a major milestone for GALE. This trial brings NeuVax a step closer to the market and to the breast cancer patients who need new treatment options. The initiation also is ahead of our expectation.
The market for NueVax is huge in our view. According to US centers for disease control and prevention (NASDAQ:CDC), in the US alone, approximately 202,964 individuals are diagnosed with breast cancer each year. Among these patients, approximately 20,000 (around 10%) will be eligible for NeuVax treatment. This is a huge market for NeuVax, which can reach a blockbuster status easily.
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