The new study for NeuVax, an immunodominant nonapeptide derived from the extracelular domain of the HER2 protein, will seek to establish if the therapy is effective in preventing breast cancer recurrence in high-risk HER2 3+ patients. The study will be supported by Galena and overseen by MD Anderson Cancer Center.
Mark J.Ahn, Chief Executive Officer of Galena, said that ” the receipt of this grant from the Department of Defense for a new clinical trial is a significant validation of the potential utility of NeuVax in a variety of cancer settings.”
Mittendorf added that, “based on other encouraging studies using NeuVax and Herceptin in other treatment settings, this study explores this promising combination approach of complimentary targeted agents in clinically high-risk HER2 3+, or positive, patients.”
The study will be conducted as a multi-center, prospective, randomized, single-blinded Phase 2 clinical trial, and it is expected to enroll approximately 100 patients with a diagnosis of HER2 3+ breast cancer with HLA A2+ or HLA A3+ and a high risk for recurrence. These high-risk patients have higher recurrence rates than other HER2 3+ breast cancer patients due to incomplete response at surgery, or to be found pathologically node-positive after intervention.
Eligible patients will be randomized to receive NeuVax, GM-CSF (granulocyte macrophage-colony stimulating factor), trastuzumab or GM-CSF alone.
For MD Anderson’s Dr. Mittendorf, this isn’t the first time that she has been at the head in critical drug development research that involved the military. As reported by BioNews Texas back in October of 2013, she also served as the principal investigator in a military-led international clinical trial for a new breast cancer vaccine that is currently under development.