ARTICLE | Company News

Galena Biopharma, MD Anderson Cancer Center, U.S. Department of Defense cancer news

May 5, 2014 7:00 AM UTC

The Department of Defense awarded the cancer center an undisclosed grant to fund a Phase II trial with Galena's NeuVax nelipepimut-S to prevent recurrence in breast cancer patients overexpressing epidermal growth factor receptor 2 ( EGFR2; HER2; ErbB2; neu). MD Anderson will sponsor the single-blind trial, which will enroll about 100 patients at high risk for recurrence to receive NeuVax plus Herceptin trastuzumab and granulocyte macrophage colony-stimulating factor (GM-CSF; CSF2) or Herceptin plus GM-CSF alone. The trial is slated to begin next half.

NeuVax is in the Phase III PRESENT trial to prevent recurrence of early stage, node-positive breast cancer with low to intermediate HER2 expression. The trial has a SPA from FDA. Galena (formerly RXi Pharmaceuticals Corp.) gained NeuVax - a vaccine consisting of an immunogenic peptide derived from HER2 and sargramostim - through its 2011 acquisition of Apthera Inc. (see BioCentury, April 18, 2011). ...