GALE Reports Clinical Biomarker Data Demonstrating the Role of NeuVax in Preventing Breast Cancer Recurrence
NeuVax Demonstrates Consistent Reduction of Circulating Tumor Cells (CTCs) in Vaccinated Patients, Corresponding With Its Previously Documented Increase in CD8+ Cytotoxic T-Lymphocytes and Enhanced Delayed Type Hypersensitivity (DTH) Reactions
LAKE OSWEGO, Ore., Oct. 26, 2012 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE), a biotechnology company focused on developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, presented data from the Phase 1/2 clinical trial of NeuVax™ (nelipepimut-S or E75) at the 27th Annual Meeting of the Society for Immunotherapy of Cancer. The event is being held October 26-28, 2012 at the Bethesda North Marriott Hotel & Conference Center in North Bethesda, Maryland.
The poster presentation entitled: "Trends in Circulating Tumor Cells (CTCs) in Multiple Adjuvant Trials of HER2-Directed Peptide Vaccines (PVs)" measured CTCs from blood samples from NeuVax (nelipepimut-S or E75) patients using the CellSearch® system (Veridex). CTCs are cells that have detached from the primary breast tumor and circulate in the bloodstream, and may then cause the growth of additional tumors (metastases) in different tissues. These recurrences may occur soon after the original cancer or many years after the initial treatment. Increased presence of CTCs predicts the likelihood of a recurrence of the cancer resulting in poor disease-free survival (DFS) and overall survival (OS), suggesting a dormancy of isolated micrometastases.
These results showed a total of 26 patients receiving NeuVax had at least two CTC measurements made during the vaccine treatment. In 16/26 NeuVax treated patients, the CTCs decreased during the time of treatment, corresponding with an increase in the patients' E75-specific CD8+ cytotoxic T-lymphocytes (killer T-cells) and an increase in their delayed type hypersensitivity (DTH) reactions. DTH is the measurable signal on the skin that the patient is immunologically responding to treatment. None of these patients had a recurrence of their cancer during the five year follow-up period.
Data presented indicate that vaccine treated patients were more likely to show a decrease in CTCs than control patients. Furthermore, the use of NeuVax boosters appears to provide long-term benefit from the return of CTC. As a result, investigators concluded that these results lend credence to the notion that breast cancer is a chronic disease and that monitoring CTC trends may be clinically useful in the adjuvant setting as a surrogate for response to vaccine treatment.
"Even with the major advances in earlier diagnoses and better treatment options,approximately 25% of resectable node-positive breast cancer patients will still relapse within three years, despite having no evidence of disease following surgery and chemotherapy/radiation treatment," stated Mark J. Ahn, Ph.D., Galena's President and Chief Executive Officer. "The data presented today shows that treatment with NeuVax reduces CTCs and therefore may prevent growth of future micrometastasis, lending support to the idea of using the woman's immune system to prevent relapse of her breast cancer."
Final NeuVax Phase 1/2 results will be reported at the San Antonio Breast Cancer Symposia in December 2012