Monday, June 4, 2012

Galena Bio (Nasdaq: GALE) NeuVax Phase 1/2 boosters improve disease-free survival at 60 month

Galena Bio (Nasdaq: GALE) NeuVax Phase 1/2 boosters improve disease-free survival at 60 monthNorthern, WI 6/4/12 (StreetBeat) -- 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(TM) (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.

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