By Vera Gruessner

Major changes are occurring for the one and only preventive breast cancer vaccine of the Cleveland Clinic. This vaccine was found to prevent breast cancer on 100 percent of animal models studied and the research was published in the May 2010 issue of Nature Medicine. Ever since, study author Dr. Vincent Tuohy and his team have worked on gathering the funds necessary to begin Phase I clinical trials to see if the vaccine is as safe and effective in women as in mice.


After years of effort, finally the funding came through in September 2013 when anonymous private investors provided the money needed to start the next step of research. A spin-off company called Shield Biotech has been working ever since on gaining FDA approval to start trials, recruit subjects, and gather the resources necessary to get the research off the ground.

The Pink Paper explains that clinical trials for the preventive breast cancer vaccine are expected to start in 2015. These initial trials will work on determining the right dosage and determine the safety of the vaccine. It is predicted that this therapy can prevent the most lethal form of breast cancer called triple negative breast cancer. Initially, the women who will be subjects in the study will have already had triple negative breast cancer and the therapy will be used to prevent recurrence. A second phase of the trial will include women who have a high genetic risk of developing breast cancer. These will be women who also wish to undergo a mastectomy to prevent cancer. After the mastectomy, the tissues will be studied to see if the vaccine caused any inflammation or tissue damage. This part of the study will help analyze the safety of the vaccine.

Pink Vaccine

Phase I will take several years to complete. If all goes well, further studies will determine the overall efficacy of the vaccine. It may be ten or more years until we see whether this vaccine can go from bench to bedside. Nonetheless, this is very exciting news. We may see the results of a Phase I study in only a few years!


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