Dallas, Texas 05/16/2014 (FINANCIALSTRENDS) –Galena Biopharma Inc (NASDAQ:GALE), a bio pharmaceutical company that is developing as well as commercializing many innovative and targeted oncology treatments which address many major and unmet medical needs in the advancement of cancer care, announced that the Department of Defense will now provide it with funding towards its new clinical-trial with NeuVax in prevention of breast cancer recurrence in the high-risk HER2 3+ patients. This grant, which is a Breast Cancer Research Program Breakthrough Award, has been obtained by Elizabeth A. Mittendorf, M.D., the Associate Professor at the Department of Surgical Oncology, at The University of Texas’ MD Anderson Cancer Center.
She will be overseeing this investigator-sponsored trial. Galena Biopharma Inc (NASDAQ:GALE) will support this trial with the study drug and the funding and will also have access to research to now support the ongoing registrational studies. The GALE President & Chief Executive Officer, Mark J. Ahn, Ph.D said that the receipt of the grant from the DoD for their new clinical-trial is a very significant validation of potential utility of their NeuVax in different cancer settings. The trial very significantly expands the breast-cancer patient population for the drug NeuVax, and adds women who are HER2 3+ to the ongoing-trials in HER2 1+ & 2+ patients.
They are very excited to work with Dr. Mittendorf & her team to now advance the trial that is projected to commence in the 2H 2014. Protocol for this multi-center & prospective, randomized & single-blinded Phase II trial is now being finalized and is also expected to enroll around 100 patients with the diagnosis of the HER2 3+ breast cancer and who are HLA A2+/ HLA A3+ & are determined to be at the high-risk for recurrence. This high-risk is also defined as having received the neoadjuvant therapy with the approved regimen which includes trastuzumab but does not obtain a pathological complete response during surgery.