Vaccine Fights Breast Cancer Recurrence -- Research Summary

BACKGROUND: According to U.S. cancer statistics, 1 in 8 women will develop invasive breast cancer over the course of her lifetime. In 2011, an estimated 230,480 new cases of invasive breast cancer were expected to be diagnosed in women in the U.S., along with 57,650 new cases of non-invasive breast cancer. Breast cancer is the second most common diagnosed cancer among American women. (Source: www.breastcancer.org).

RISK FACTORS: A woman’s risk of breast cancer increases by nearly half if she has an immediate family member who has been diagnosed with breast cancer. About 15% of women who get breast cancer have a family member diagnosed with it. About 5-10% of breast cancers can be linked to gene mutations inherited from one’s mother or father. Mutations of the BRCA1 and BRCA2 genes are the most common. Women with these mutations have up to an 80% risk of developing breast cancer during their lifetime, and they are more likely to be diagnosed at a younger age (pre-menopause). (Source: www.breastcancer.org).

TREATMENT AND RECURRENCE: Breast cancer treatments can be local or systemic. Treatments include; surgery, radiation therapy, chemotherapy, hormone therapy, and biological therapy such as Herceptin. Herceptin works by using the body's own immune system to destroy cancer cells. Herceptin targets breast cancer cells that have high levels of a protein called HER2. Amplification or over-expression of the ERBB2 gene occurs in approximately 30% of breast cancers. It is strongly associated with increased disease recurrence and a worse prognosis. HER2 proteins have been shown to form clusters in cell membranes that may play a role in tumorigenesis. Recurrent breast cancer is breast cancer that comes back after initial treatment. Although treatment is aimed at eliminating all cancer cells, a few may survive. These undetected cancer cells multiply, becoming recurrent breast cancer. It may occur months or years after your initial treatment. (Source: webmd.com, mayoclinic).

NEW TREATMENT: NeuVax E-75 is a vaccine given as supplementary therapy to prevent disease recurrence. NeuVax consists of the E-75 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 definitive approach 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, which achieved its primary endpoint of disease-free survival (DFS), the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) 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. A Phase 3 trial is expected to begin in the first half of 2012. (Source: www.globenewswire.com). MORE
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