NeuVax is a peptidevaccine aimed at preventing or delaying the recurrence of breast cancer in cancer survivors who achieveremission after standard of care treatment (e.g., surgery,radiation,chemotherapy).[1] The product's developer is the USbiotechnology companyGalena Biopharma.
NeuVax in Phase II showed effectiveness in early-stage, node-positivebreast cancer with low-to-intermediate HER-2 expression, where the five-year recurrence rate dropped from 26% to 6%. The vaccine is now in a Phase III study called PRESENT, short for (Prevention ofRecurrence inEarly-StageNode-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVaxTreatment (ClinicalTrials.gov identifier NCT01479244[4]). This study is taking place under an FDA Special Protocol Assessment.
NeuVax works by harnessing the patient's own immune system to seek out and attack any residual cancer cells that express HER2/neu, a protein associated with tumors inbreast,ovarian,pancreatic,colon,bladder andprostate cancers.[5]
NeuVax has been tested as adjuvant treatment in nearly 200 breast cancer patients over a total of 5 years, and has shown to be safe and effective in Phase 2 trials.[6] As a result, two additional NeuVax trials registered or underway are: (1) a 700 patient Phase 3 trial for FDA approval - not yet recruiting[2][needs update] and (2) a 300 patient Phase 2 trial studying the combination of NeuVax andHerceptin® (trastuzumab).[7]
^abClinical trial numberNCT01479244 for "Efficacy and Safety Study of NeuVax(TM) Vaccine to Prevent Breast Cancer Recurrence (PRESENT)" atClinicalTrials.gov
