Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced that human leukocyte antigen (HLA) - A24+ or HLA-A26+ women are now eligible for enrollment into the ongoing Phase 2b clinical trial with NeuVax™ (nelipepimut-S) in combination with trastuzumab (Herceptin®; Genentech/Roche). The trial evaluates node positive and triple negative, node negative breast cancer patients with immunohistochemistry (IHC) HER2 1+/2+ expressing tumors who are disease-free after standard of care therapy.
"Adding patients with HLA-A24 and/or A26 broadens the utilization of NeuVax in the ongoing Phase 2b combination trial with trastuzumab," stated principal investigator COL (ret) George E. Peoples, MD, FACS, Professor, Surgery, Uniformed Services University and Professor (adjunct), Surgical Oncology, MD Anderson Cancer Center. "Women with HER2 1+/2+ breast cancer currently have no other HER2-directed treatment options available to prevent the recurrence of their disease. We are pleased to expand our patient eligibility to offer NeuVax to more women, particularly those of Asian descent where HLA-A24 and A26 are prevalent."
The nelipepimut-S peptide works by binding to specific HLA proteins, or molecules key to immunological activity and are involved in the induction of protective T-cell immune responses. To date, NeuVax has been tested in trials with patients who are HLA-A2+ or A3+, representing more than 60% of the North American, European and Chinese populations. NeuVax has also been shown to bind to HLA-A24 and A26, which represents an additional 10-15% of the population in the U.S., but more importantly, represents up to approximately 70% of the population in Japan.
- See more at: http://globenewswire.com/news-release/2015/03/26/719056/10126450/en/Galena-Biopharma-Expands-Patient-Population-in-NeuVax-TM-nelipepimut-S-and-trastuzumab-Phase-2b-Combination-Clinical-Trial-in-HER2-1-2-Patients.html#sthash.T29QD064.dpuf