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Galena Biopharma Provides Product Pipeline Update At The ASCO 2013 Annual Meeting

  • In completed Phase 1/2 trials of NeuVax™ (nelipepimut-S), patients who exhibit robust in vitro immunologic response have lower recurrence rates.
  • NeuVax companion diagnostic, the Leica Bond Oracle HER2 IHC assay, improves the accuracy of HER2 protein expression levels and patient targeting.
  • FBP (folate binding protein) peptide immunotherapy demonstrates excellent safety, robust immunologic responses, and preliminary efficacy in ovarian and endometrial patients in ongoing Phase 1/2a study.

LAKE OSWEGO, Ore., June 3, 2013 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced two publications at the American Society of Clinical Oncologists (ASCO) 2013 Annual Meeting taking place May 31-June 4 in Chicago, Illinois. The Company also provided an update on the ongoing Folate Binding Protein (FBP-E39) Phase 1/2 clinical trial.

NeuVax™ (nelipepimut-S) continues to demonstrate durable response rates

The NeuVax poster presentation entitled: "Biomarker Correlation to Clinical Response in Phase I/II Trials of the Adjuvant Breast Cancer Vaccine, NeuVax (nelipepimut-S or E75)" examined the relationship between in vitro immunologic response (IR) and clinical recurrence (CR) after five years of follow-up in patients with breast cancer. The study looked at the levels of E75 specific T-cells as measured by the dimer assay and correlated the IR with clinical benefit, or lack of recurrence. The dimer assay is a a way of counting E75-specific killer T cells that are induced by the NeuVax vaccine. The vaccine was administered in the adjuvant setting to prevent recurrence in breast cancer patients rendered disease-free following standard-of-care therapy.  Evaluable patients (n=187) combined both the SN-33 (node-positive) and SN-34 (node negative) patients from the Phase 1/2 NeuVax  trials.   In the study, the majority of the recurrences occur in women that had lower absolute levels of NeuVax-specific T cells or more modest increases in their NeuVax-specific T cells. 

The study concluded that in completed phase 1/2 trials of NeuVax, patients who exhibit robust in vitro IR have lower recurrence rates. This finding suggests that nelipepimut-specific CTL clonal expansion is a valid biomarker for CR in patients treated with NeuVax.  In the SN-33 trial, the 60-month Landmark Analysis demonstrated a 5.6% recurrence rate with NeuVax vs. a 25.9% recurrence rate in the control arm—a recurrence reduction of 78.4%.

"NeuVax works by stimulating the body's own immune system, via cytotoxic T lymphocytes (CTLs), to seek out and destroy micrometastatic cancer cells that may be circulating or deposited in a patient's body after they are deemed clinically disease-free. The data presented today demonstrates there is a correlation between the these NeuVax-specifc CTLs stimulated by the vaccine, and a reduction in recurrence of breast cancer in the women tested," said COL George E. Peoples, MD, FACS, Director, Cancer Vaccine Development Program; Deputy Director, United States Military Cancer Institute; Professor (adjunct), Surgical Oncology, M.D. Anderson Cancer Center; Professor, Surgery, Uniformed Services University; Chief, Surgical Oncology, Brooke Army Medical Center. 

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