[Rich66]

http://www.defense.gov/news/newsarticle.aspx?id=66697

The researchers targeted the HER2/neu protein, which is expressed at varying levels in women with breast cancer, then honed in on the 60 percent of women who express the protein at low to intermediate levels. The vaccine is a mix of the E-75 peptide of the HER2 protein and an immune system stimulant.
They started with a 200-patient trial in 2001 and followed each woman for five years. Half of the women received the vaccine -- one injection a month for six months -- and the other half was the control group.
The outcome was very promising, Peoples noted. The recurrence rate among the women in the control group was 20 percent, and 10 percent among the women who received the vaccine. “We cut recurrence in half,” he said.
This success led to the next phase of testing, the colonel said, which will begin early this year and involve 700 to 1,000 patients.
Unlike the earlier phases, however, this step will be undertaken by a commercial company, Galena Biopharma, which has the resources and manpower to undertake such a large-scale test. The company will seek FDA approval and, if received, release the vaccine for public use.
This phase will take about five years to complete -- two years to enroll, then a three-year observation period, Peoples said.
“The end point is the recurrence rate after three years,” he explained.
Meanwhile, Peoples and his team will turn their attention to a multitude of other projects, many based on the same concept that made the E-75 vaccine so successful -- using the body’s own immune system to destroy cancer cells.
They’ve already taken the same vaccine and completed a trial with prostate cancer survivors. As with ovarian and lung cancer, prostate cancer also expresses the HER2 protein.
Peoples said he’s also intrigued by a successful trial they conducted on breast cancer survivors who express the HER2 protein at the highest levels, rather than the low to intermediate levels they focused on before. In this study, they combined their vaccine with the drug Herceptin.
They conducted a small trial with 60 women, Peoples said, and when they administered the vaccine and Herceptin together, the recurrence rate dropped to zero. “The preliminary data is very exciting,” he said. “But we need to wait and do larger trials.”