LAKE OSWEGO, Ore., Aug. 14, 2012 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE), a biotechnology company focused on developing innovative, targeted oncology treatments addressing major unmet medical needs to advance cancer care, today reported its financial results for the quarter ended June 30, 2012 and provided an update on recent business developments.
"We have made significant progress in advancing our development stage pipeline of leading cancer immunotherapies, as well as strengthening our team and resources. In the last quarter, we presented key Phase 2 data at ASCO and were issued an important patent to support our ongoing development of the NeuVax™ Phase 3 PRESENT trial," said Mark J. Ahn, Ph.D., President and Chief Executive Officer. "In addition, I am pleased to report that we have already opened 33 investigational sites for Phase 3 patient enrollment in the U.S., and are in the process of opening additional sites in Canada, Europe, and Asia. We remain focused on completing enrollment of our global registrational trial, as well as partnering activities."
Recent Business Highlights
- Positive data presented at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting shows NeuVax (nelipepimut-S or E75) improves Disease-Free Survival (DFS) at 60-month median follow-up:
- After establishing statistical significance at the 24-month Landmark Analysis (p=0.0358) and the 36-month Landmark Analysis (p=0.035), the 60-month median follow-up from the Phase 1/2 trial demonstrated a 5.6% recurrence rate with NeuVax vs 25.9% recurrence rate in the control arm, a recurrence reduction of 78.4% in the target patient population. The combined trials in the Intent-to-treat (ITT) population (n=187) continued to demonstrate an excellent safety and efficacy profile.
- Booster inoculations, which are included in the ongoing Phase 3 PRESENT ( Prevention of Recurrence in Early- Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study trial, were shown to be well-tolerated and appear to maintain long-term peptide-specific immunity and reduce disease recurrence rates. The data presented also showed that circulating E75-specific CD8+ T cells and local skin reactions can be re-induced with subsequent inoculations over a time period of up to five years. In the Phase 1/2 trial, boosted patients have better recurrence rates and improved disease-free survival compared to patients who did not receive the vaccine.
- Issued a key patent from the U.S. Patent and Trademark Office (USPTO) for NeuVax™ (nelipepimut-S or E75). The patent covers the use of NeuVax, a HER2/neu peptide vaccine, for inducing immunity to breast cancer recurrence in HER 2 negative patients (low-to-intermediate IHC levels of 1+ or 2+ and a FISH rating of less than 2.0). This is the patient population targeted for Galena's ongoing Phase 3 PRESENT trial. The patent provides NeuVax exclusivity for this indication until 2028, not including any patent term extensions.
- Appointed additional Oncology Experts to strengthen the Company's Scientific Advisory Board (SAB).
- Gabriel N. Hortobagyi, M.D., F.A.C.P., is a Professor of Medicine and Chairman of the Department of Breast Medical Oncology and holds the Nellie B. Connally Chair in Breast Cancer Research at the University of Texas MD Anderson Cancer Center.
- Robert Figlin, M.D., F.A.C.P., is the Associate Director of the Academic Development Program and Director of the Division of Hematology/Oncology at Cedars-Sinai's Samuel Oschin Comprehensive Cancer Institute. He is board-certified in both medical oncology and internal medicine.
- Completed Spin-Off of RXi Pharmaceuticals.
- One-for-one RXi Pharmaceuticals stock dividend was paid to Galena stockholders as of the payment date of April 27, 2012.
Q2 2012 Financial Highlights Net loss for the three months ended June 30, 2012 was $0.2 million or $0.003 per share on a basic and diluted basis, versus a net loss of $3.8 million, or $0.10 per share on a basic and diluted basis for the three months ended June 30, 2011.
- Galena retains minority equity interest in RXi (32.7 million shares of RXi common stock with a value of $4.3 million as of June 30), with potential to receive up to $45 million in milestones.