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news.Galena Biopharma has announced that the Department of Defense (DoD) will provide funding towards a new clinical trial with NeuVax to prevent breast cancer recurrence in high-risk HER2 3+ patients.
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The grant, a Breast Cancer Research Program (BCRP) Breakthrough Award, was obtained by The University of Texas MD Anderson Cancer Center department of Surgical Oncology associate professor Dr Elizabeth A Mittendorf, who will oversee the investigator-sponsored trial.
Galena will support the trial with study drug and funding and will have access to the research to support ongoing registrational studies.
Galena Biopharma president and CEO Dr Mark J Ahn noted that 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.
"This trial significantly expands the breast cancer patient population for NeuVax, adding women who are HER2 3+ to our ongoing trials in the HER2 1+ and 2+ patients. We are excited to work with Dr. Mittendorf and her team to advance this trial that is expected to initiate in the second half of 2014," Ahn added.
The protocol for the multi-center, prospective, randomized, single-blinded Phase 2 trial is being finalized and is expected to enroll approximately 100 patients with a diagnosis of HER2 3+ breast cancer who are HLA A2+ or HLA A3+ and are determined to be at high-risk for recurrence.
High-risk is defined as having received neoadjuvant therapy with an approved regimen that includes trastuzumab but not obtaining a pathological complete response at surgery, or those who undergo surgery as a first intervention and are found to be pathologically node-positive.
These high-risk patients are known to have higher recurrence rates than other HER2 3+ breast cancer patients. Eligible patients will be randomized to receive NeuVax + GM-CSF (granulocyte macrophage-colony stimulating factor) + trastuzumab or trastuzumab + GM-CSF alone. The primary endpoint of the study is disease-free survival.
Dr Mittendorf said 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 grant was awarded through the Congressionally Directed Medical Research Program (CDMRP), funded through the Department of Defense (DoD), via annual Congressional legislation known as the Defense Appropriations Act.