Information About the Breast Cancer Vaccine Research Program
Dr. Vincent Tuohy
In Spring 2017, Dr. Tuohy’s research program was awarded funding to launch a greatly anticipated clinical trial to begin testing the vaccine. The goals of this trial will be to determine proper dosage as well as safety parameters of the vaccine including risks and side effects; however, there are a few critical steps the team must accomplish to achieve regulatory compliance necessary for human testing. Prior to clinical trials, the Federal Drug Administration (FDA) requires that the investigational new drug (IND) must meet stringent criteria for use in humans. This is done to ensure that the components of the IND are properly made in a reproducible manner and is well defined, pure, and free from contaminants that could harm test subjects. From start to finish, this process is costly (~$1.5-2M) and requires specialized, offsite facilities dedicated to this effort. After this is complete, the team will submit an application to the FDA to obtain permission to use the IND in clinical trials. The first Phase I trial, slated to begin in early 2020, will focus exclusively on women who have recently recovered from treatment for triple-negative breast cancer, the most lethal form of this disease. If this trial indicates that the vaccine has an acceptable safety profile, it will be followed by a second Phase I trial, which will be open to women at high risk for triple-negative breast cancer who elect voluntary mastectomy to reduce their risk. Dr. Tuohy’s team plans to vaccinate them a few months prior to their planned mastectomy and then examine the removed breast tissues for any inflammation that the vaccine may induce. Once Dr. Tuohy and his team have determined the vaccine is safe in humans, they can begin to vaccinate cancer-free women.
Dr. Tuohy and his team are incredibly grateful for the passion and advocacy behind this important research initiative. Funding enables the team to expand and accelerate their research goals. We look forward to a world that provides pre-emptive immunity against breast cancer. We can make a difference together.
September 2017 IdeaStream Panel Discussion – A Must View! Click Here to Watch Dr. Tuohy and other distinguished Professionals from the Medical Industry
Recent Articles Regarding the Breast Cancer Vaccine:
2014 Article in Tire Review Magazine
2014 February Tuohy Currents Magazine Article