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I received news PR this morning about Galena Biopharma and wanted to share... $6.00 BUY rating set by MLV Capital for Galena Biopharma (GALE) Key Points • Validated Target NeuVax targets the same antigen as Herceptin® (trastuzumab), Genentech's (a wholly owned subsidiary of Roche OCT:RHHBY) $5.6 billion blockbuster monoclonal antibody. However, NeuVax has the potential to reach more patients, as it is being developed for patients with low to intermediate HER2/neu oncogene over-expression (classified as HER2/neu negative) with early stage breast cancer. • Strong Phase II Data Support Ongoing Registrational Phase III Phase II data has shown that the Phase III target population of node-positive, HER2/neu negative patients have increased disease free survival rates at both 24 and 36 month timepoints. 100% of NeuVax treated patients in this population were alive without disease after 36 months, a statistically significant improvement over 77.8% in control patients (p=0.035). The FDA has accepted disease-free survival at 36 months as a primary endpoint for this trial according to an SPA. Full enrollment of 700 patients is expected by mid-2013. • Unmet Clinical Need Despite effective initial surgery, chemotherapy and radiation, patients with no evidence of disease still face the possibility of disease recurrence. Nearly 25% of breast cancer patients with node-positive disease will have recurrent breast cancer. NeuVax is given intradermally and elicits an active immune response that can be visually monitored by clinicians by virtue of patients displaying a delayed-type hypersensitivity response (DTH) at the injection site. The ease of administration, we believe, will assist in adoption of the drug, when and if the vaccine is approved and marketed. • Potential Partnerships We believe that Galena will be able to maximize value for investors by forming a partnership agreement after having top-line Phase III data. If these data are similar to the Phase II data then NeuVax will present a new therapeutic option for treating breast cancer, and the only one for patients with early-stage HER2/neu negative disease. We think this makes NeuVax a potential game changer in the field, and a potentially valuable asset, and we would be accumulating at current levels of Galena's stock. | ||||||||||||||
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