Breast cancer vaccine set for large-scale testing

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A breast cancer vaccine spearheaded by the military is due to begin large-scale clinical trials early this year in preparation for FDA submission, according to a recent report by the American Forces Press Service.

Galena Biopharma ($GALE) has picked up rights to the therapeutic vaccine, which combines the E-75 peptide with the HER2/neu protein and an immune system stimulant, and was developed by the Cancer Vaccine Development Program at the San Antonio Military Medical Center. The vaccine is designed to spur immune attacks on HER2-driven cancers, and Galena's upcoming trials for the treatment aim to combat recurrence of breast cancer, according to the the AFPS article.

Outcomes from earlier phase testing in disease-free cancer survivors at risk of recurrence were promising: "We cut recurrence in half," center director and principal investigator, Army Col. Dr. George Peoples, told the AFPS. The new studies in 700 to 1,000 patients are expected to take about 5 years to complete, with the endpoint being recurrence after three years.

Galena (formerly RXi) acquired additional patent rights to the E-75 vaccine, which it has dubbed NeuVax, from the military in July 2011. The company, which is based in Portland, OR, announced in November it is working with Genentech on a mid-size trial studying NeuVax in combination with Genentech's blockbuster breast cancer drug Herceptin in 300 breast cancer patients currently not eligible for Herceptin therapy.

Dr. Peoples told the AFPS the center also has conducted a successful small trial of the vaccine and Herceptin together in which the recurrence rate was zero. In addition, the center has completed a trial with the vaccine in prostate cancer survivors. Prostate cancer cells also express the HER2 protein. - Janet Aker

- here's the AFPS article

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