LAKE OSWEGO, Ore., Dec. 7, 2011 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biotechnology company focused on developing innovative, targeted oncology treatments addressing major unmet medical needs to advance cancer care, today announced five year efficacy data from the ongoing NeuVax™ Phase 2 trial at the 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium. The event is being held December 6-10, 2011 at the Henry B. Gonzalez Convention Center in San Antonio, Texas.
A presentation entitled, "Long-term clinical benefit of adjuvant breast cancer vaccine: 5 year efficacy of E75 with multiple booster inoculations," was given today during Poster Session 1. The results of the current long-term median follow-up at sixty months showed that the NeuVax (E75 plus GM-CSF) breast cancer vaccine is safe and well–tolerated, and demonstrates efficacy in preventing breast cancer recurrence in optimally-dosed and boosted patients. A total of 187 patients were enrolled in the study, with 108 in the Vaccine Group and 79 in the Control Group. Of the 53 patients who received at least one booster inoculation, a statistically significant disease-free survival rate of 95.9% was seen versus 79.7% in the control group (hazard ratio of 0.20; p=0.016). Several patients remain on study, and Galena estimates reporting final results of the five-year follow-up in the second half of 2012. For the combined intention-to-treat population, including those patients not getting boosters as well as those patients sub-optimally dosed, a strong trend to prevention of recurrence was still observed with the vaccine treated patients demonstrating a disease-free survival rate of 89.4% versus the 79.7% in the control group (hazard ratio of 0.52; p=0.098).
"Five years of data is a significant milestone, and NeuVax continues to show a decrease in recurrences for these women with breast cancer who would otherwise have no treatment options to maintain their disease-free state," said Rosemary Mazanet, M.D., Ph.D., Chief Medical Officer of Galena. "Our Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) trial dosing regimen will include the booster inoculations and is expected to commence in the first half of 2012 under an FDA-approved Special Protocol Assessment."
The ongoing Phase 2 clinical trial is vaccinating breast cancer patients with NeuVax in the adjuvant setting to prevent recurrences in clinically disease-free patients after completion of standard therapy. The phase 1/2 trials were performed as dose escalation/schedule optimization trials enrolling node positive and high-risk, node-negative patients with tumors expressing any level of HER2. Optimally dosed vaccinated patients were given 6 monthly injections with NeuVax. Due to observed waning immunity, a voluntary booster program was initiated four years ago, with inoculations starting at six months after completion of the initial treatment and continuing once every six months until study completion at 5 years from enrollment. Vaccinations and boosters were well tolerated with primarily grade 1 and grade 2 toxicities resolving primarily within 48 - 72 hours.
About NeuVax™ (E75)
NeuVax consists of the E75 peptide derived from human epidermal growth factor receptor 2 (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.
According to the National Cancer Institute, over 200,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, about 75% test positive for HER2 (IHC 1+, 2+ or 3+). Only 25% of all breast cancer patients, those with HER2 3+ disease, are eligible for Herceptin® (trastuzumab; Roche-Genentech), which had revenues of over $5 billion in 2010. NeuVax targets the remaining 50% of HER2-positive patients (HER2 1+ and 2+) who achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based biopharmaceutical company that develops innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information please visit us at www.galenabiopharma.com.
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Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the possible clinical benefits, expectations, plans and prospects of the development of NeuVax and Galena's other new product candidates. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including the risks that the anticipated benefits of the announced transactions are not achieved and that the proposed spin-off is delayed or is never completed, as well as the risks, uncertainties and assumptions relating to the development of Galena's new product candidates, including those identified under "Risk Factors" in Galena's most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q and in other filings Galena periodically makes with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this presentation.