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FOR IMMEDIATE RELEASE
Contact: Lesley Keays
Phone: (508) 597-5775
Email: inquiry@aptivsolutions.com
Aptiv Solutions Awarded Pivotal
International Cancer Vaccine Trial
Reston, Virginia, September 28, 2011 – 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™, 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™ 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

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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 (NASDAQ: RXII) 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™ (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™ Treatment) study. The Phase 3 trial is expected to
commence in the first half of 2012.
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