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news.Galena Biopharma has announced the US Food and Drug Administration (FDA) approval of the investigational new drug (IND) application for the Phase 2 combination trial with NeuVax and Herceptin.
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The trial is being funded by Galena Biopharma and Genentech/Roche through the Henry M. Jackson Foundation.
Each company will provide their respective drugs for the 300 patient trial and approximately half of the funding necessary to complete the trial.
NeuVax consists of the E75 peptide derived from human epidermal growth factor receptor 2 (HER2) combined with the immune adjuvant granulocyte macrophage colony-stimulating factor (GM-CSF).
Galena Biopharma president and CEO Mark Ahn said the IND approval for the combination trial with trastuzumab is another major milestone for Galena’s product.
"We hope to expand and offer this additional therapy option for women who are not currently eligible to receive HER2-directed therapy as part of standard of care treatment," Ahn added.