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19 Sep 13 12:54

Preventive breast cancer vaccine development takes a step forward.

Researchers at Cleveland Clinic’s Lerner Research Institute found that a single vaccination could prevent breast tumors from occurring in mice genetically bred to develop breast cancer, while also inhibiting the growth of already existing breast tumors. If it is effective in humans it will provide women with an immune defense or shield that will protect them from developing breast cancer and provide women with a safe, effective and relatively benign alternative to invasive prophylactic mastectomy. The research was originally published in Nature Medicine in 2010.

Shield Biotech, the company that will develop this preventive breast cancer vaccine based on research from Cleveland Clinic’s Lerner Research Institute recently announced that it will complete preclinical development and seek permission from the FDA to test the vaccine as an investigational new drug in proof-of-concept, first-in-human clinical trials. The trials are expected to start within two years and will take about three years to complete. The first (Phase Ia) trial will involve women with triple-negative breast cancer who have recovered from current standard of care involving chemotherapy, radiation therapy, and/or surgery. This trial will determine the dose and frequency of vaccination needed to provide an optimum immune response. The second (Phase Ib) trial will involve healthy cancer-free women at high risk for developing breast cancer who have decided to undergo voluntary bilateral mastectomy to lower their risk. This trial will focus on the safety of the vaccine by examining the removed breast tissue for any potential changes.

These clinical trials are expected to lead to more advanced trials designed to determine the effectiveness of the vaccine in treating triple-negative breast cancer, as well as its potential for immunoprevention.


Category: Funding longer lives: Health/medicine


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