Galena Biopharma Presents NeuVax Phase 1/2 Boosters Improve Disease-Free Survival at 60-Month Median Follow-Up
- Booster inoculations are well-tolerated and appear to maintain long-term peptide-specific immunity and reduce disease recurrence rates
- Booster inoculations are included in the ongoing Phase 3 PRESENT trial
LAKE OSWEGO, Ore., June 4, 2012 (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, presented data from the Phase 1/2 clinical trial of NeuVax™ (E75) at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting being held June 1-5, 2012 in Chicago, Illinois. The poster entitled, "Safety and Long-Term Maintenance of Anti-HER2 Immunity Following Booster Inoculations of the E75 Breast Cancer Vaccine" (Abstract #2529) was presented on Saturday, June 2, 2012 and was selected for the oral session, "Developmental Therapeutics — Clinical Pharmacology and Immunotherapy."
The Phase 1/2 clinical trials evaluated the NeuVax (E75) vaccine, an HLA A2/A3 restricted HER2/neu (HER2) peptide, mixed with GM-CSF. The trials (SN-33 (Node Positive) and SN-34 (Node Negative)) evaluated a combined 187 patients and have completed a median 60-months of follow-up, with the final patients expected to complete their booster treatments and final follow-up visits by September 2012. The final data analysis is expected to be reported in the fourth quarter of this year.
Initially, patients in the trials were given a series of up to six inoculations of NeuVax dosed once a month. As the trials progressed, the physicians noticed that E75-specific immunity waned after this initial monthly Primary Vaccine Series (PVS) and translated to late recurrences of cancer in some patients. This declining immunity was identified by monitoring the level of CD8 T-cells in each of the patients. Through this evaluation, it became clear that immunological boosters would keep the level of circulating E75-specific CD8+ T cells elevated during the conduct of the trial. As a result of this finding, a voluntary booster program was added to the trials to maintain long-term immunity following the initial monthly PVS.
The booster program offered patients an additional inoculation every six months with a maximum of six boosters. Because the booster program was voluntary, not all women chose to receive the full six additional doses. To date, 53 patients received at least one booster. The results show that, at a median of 60-months, the disease-free survival (DFS) for the booster group (n=53) was 96.2% vs 80.5% in the control group (n=79) (p=0.01); and, the recurrence rate for the booster group was 3.8% vs 18.9% in the control group. This data shows three essential outcomes from the trials:
- Booster inoculations are well-tolerated and appear to assist in the maintenance of long-term peptide-specific immunity.
- 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.
- Boosted patients have better recurrence rates and improved DFS compared to patients who did not receive vaccine.
"The data presented on Saturday reinforces our Phase 3 trial design and suggests that women will receive the most benefit from NeuVax when their monthly inoculations are followed by booster dosing. We believe this immunity will give these patients protection from their cancer returning," said Rosemary Mazanet, M.D., Ph.D., Executive Vice President and Chief Medical Officer.
As a result of these findings, booster inoculations have been incorporated into the design of 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. This Phase 3 trial design has been granted a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration. Galena's Phase 3 trial will enroll node-positive patients with low-to-intermediate HER2 (1+, 2+) expression.
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 that achieved its primary endpoint of disease-free survival, the Food and Drug Administration granted NeuVax a Special Protocol Assessment 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 ongoing and additional information on the study can be found at www.neuvax.com.
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% of them have breast cancer tissue that tests positive for some level of HER2 staining (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 50% of patients with tumors that stain low or intermediate for HER2 (HER2 1+ and 2+), who would not receive Herceptin after they successfully complete their surgery, adjuvant chemotherapy and radiation. This provides this large group of early-stage breast cancer patients an option for a HER2-targeted adjuvant treatment 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.
The Galena Biopharma, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=10647
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 and prospects of Galena's NeuVax product candidate. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including the risks that the anticipated benefits are not borne out in further clinical testing, as well as the risks, uncertainties and assumptions relating to the development of Galena's new product candidates 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 clinical benefits of NeuVax and results of further clinical testing 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.
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