RESTON, Va., Sep 28, 2011 (BUSINESS WIRE) -- Aptiv Solutions, a leader in designing and executing adaptive clinical trials, announced it has been selected to manage a major breast cancer clinical vaccine program for Galena Biopharma, a biopharmaceutical company that develops innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. Galena's key product is NeuVax(TM), a cancer immunotherapy aimed at treating targeted breast cancer patient populations.
Aptiv Solutions will initiate and manage the Galena Phase 3 trial entitled "PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax(TM) Treatment)". This pivotal trial under an FDA-approved SPA (Special Protocol Assessment), with more than 100 planned trial sites involving over 700 patients worldwide, is expected to commence in the first half of 2012.
"Galena conducted a very professional, rigorous and thorough evaluation of clinical research service providers to conduct its trial. We are delighted to have been chosen to provide full-service clinical trial program support for Galena's NeuVax development," stated Gene Resnick, MD, Chief Medical Officer of Aptiv Solutions. "Our clinical trial experts will provide Galena with a dedicated and diverse team to manage the PRESENT trial start-up and all related clinical trial activities for global implementation, including consideration of adaptive trial design strategies. The award of this international trial highlights the deep oncology capabilities of Aptiv Solutions. We are extremely pleased to be involved in this vital project targeting a major breast cancer patient population."
"NeuVax has the potential to bring an important new therapy to the market for breast cancer patients, and our selection of a clinical research service provider was a critically important strategic decision for Galena," noted Galena President and CEO Mark J. Ahn, PhD. "We have utmost confidence that under the direction and guidance of oncology product development expert Dr. Gene Resnick and his colleagues, we have selected a team of professionals who will work closely with Galena to execute a high quality clinical trial. I look forward to building a long-standing and collaborative relationship with Aptiv Solutions."
About Aptiv Solutions
Aptiv Solutions is a global biopharmaceutical and medical device development services company focused on recognizing, understanding and enabling clients to capitalize on rapid and fundamental changes facing companies developing products in the pharmaceutical, biotech and medical device market. The company offers clients an extensive portfolio of innovative services including adaptive clinical trial design and execution, medical device consulting and trial execution, early phase product strategy, regulatory services, pharmacovigilance, clinical staffing and the operational support of a global clinical research organization. Aptiv Solutions has over 750 professionals in North America, Europe, the Middle East, Japan, and Australia. Visit the Aptiv Solutions website at www.aptivsolutions.com .
About Galena Pharmaceuticals Corporation
Galena Pharmaceuticals Corporation /quotes/zigman/109669/quotes/nls/rxii RXII +5.88% is a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics. For more information, visit www.galenabiopharma.com .
About NeuVax(TM) (E75)
NeuVax consists of the E75 peptide derived from HER2 combined with the immune adjuvant granulocyte macrophage colony stimulating factor (GM-CSF). Treatment with NeuVax stimulates cytotoxic (CD8+) T cells in a highly specific manner to target cells expressing any level of HER2. NeuVax is given as an intradermal injection once a month for six months, followed by a booster injection once every six months. Based on a successful Phase 2 trial, which achieved its primary endpoint of disease free survival (DFS), the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax(TM) Treatment) study. The Phase 3 trial is expected to commence in the first half of 2012.