['lizbeth]

The Phase II for we Her2 3+ individuals will start this year. The current Phase III is for Her2 1+ and 2+, the PRESENT study.

Typically adjuvant vaccines require enrollment into the trial within 6 months of completing Herceptin.

Apr 28, 2014

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Galena Biopharma Announces Department of Defense Grant for NeuVax(TM) (nelipepimut-S) Clinical Trial

• Phase 2 study in neoadjuvant, HER2 3+ Breast Cancer Patients to commence in 2014
• New study supports ongoing Phase 3 PRESENT study and Phase 2b in HER2 1+ and 2+ patients

PORTLAND, Ore., April 28, 2014 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced 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. The grant, a Breast Cancer Research Program (BCRP) Breakthrough Award, was obtained by Elizabeth A. Mittendorf, M.D., Associate Professor, Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center 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.
"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," said Mark J. Ahn, Ph.D., President and Chief Executive Officer of Galena Biopharma. "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."
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.
"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," added Dr. Mittendorf.
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.