The Breast Cancer Vaccine

Cleveland Clinic

Awaiting Phase I Clinical Awaiting Phase I Clinical TrialsTrials

In 2010, Dr. Vincent Tuohy of the Cleveland In 2010, Dr. Vincent Tuohy of the Cleveland Clinic published his results on a preventive Clinic published his results on a preventive breast cancer vaccine in breast cancer vaccine in Nature MedicineNature Medicine– The research showed that 100% of the mice in the The research showed that 100% of the mice in the

experimental group did not develop the disease experimental group did not develop the disease despite being bred to grow breast tumorsdespite being bred to grow breast tumors

In 2013, the Cleveland Clinic announced that In 2013, the Cleveland Clinic announced that it is awaiting FDA approval to start Phase I it is awaiting FDA approval to start Phase I clinical trials on the breast cancer vaccine clinical trials on the breast cancer vaccine through its spin-off company Shield Biotechthrough its spin-off company Shield Biotech

Phase I Divided into Two Phase I Divided into Two PartsParts• The first part of the The first part of the

Phase I trial will Phase I trial will consist of consist of understanding the understanding the correct dosage and correct dosage and frequencyfrequency– Triple-negative breast Triple-negative breast

cancer patients will be cancer patients will be followedfollowed

• The second part of the The second part of the study will consider the study will consider the safety of the vaccine safety of the vaccine for women who are at for women who are at risk of breast cancerrisk of breast cancer

The Creator of the Vaccine

“We have proposed that breast cancer may be effectively controlled by providing healthy cancer-free women with pre-emptive immunity against emerging breast tumors. We propose to provide women with an immune defense or shield that will protect them from developing breast cancer. Our data show that safe and effective immune

protection against this disease can be induced by vaccinating against proteins that are no longer

expressed in aging breast tissues but are significantly over expressed in triple-negative breast cancer, the most aggressive and lethal form of this disease. We hope to provide women with a safe, effective and

relatively benign alternative to invasive prophylactic mastectomy.”

- Dr. Vincent Tuohy

Supporting the Breast Cancer Supporting the Breast Cancer VaccineVaccine

““The Cleveland Clinic announced today that The Cleveland Clinic announced today that it has secured the necessary funds to move it has secured the necessary funds to move

the preventive breast cancer vaccine the preventive breast cancer vaccine developed by Professor Vincent Tuohy in developed by Professor Vincent Tuohy in

2010 forward into a Phase I clinical trial to 2010 forward into a Phase I clinical trial to see if it’s safe for use in women. As an early see if it’s safe for use in women. As an early

supporter of this, the world’s first supporter of this, the world’s first preventive breast cancer vaccine, I am preventive breast cancer vaccine, I am thrilled that the money that has been thrilled that the money that has been

denied by traditional funding sources to denied by traditional funding sources to Professor Tuohy for the last three years has Professor Tuohy for the last three years has finally materialized…. But we must not get finally materialized…. But we must not get ahead of ourselves in rejoicing, for the next ahead of ourselves in rejoicing, for the next

step is to test Tuohy’s vaccine in a small step is to test Tuohy’s vaccine in a small group of healthy volunteers to make sure it group of healthy volunteers to make sure it

is safe for use in women.  Such a clinical is safe for use in women.  Such a clinical trial is called a Phase I study, and it must – trial is called a Phase I study, and it must –

and will be – rigorously conducted and and will be – rigorously conducted and reviewed.  As happy as we are that the reviewed.  As happy as we are that the

funds required for such a study are now at funds required for such a study are now at hand, we must be sober about what lies hand, we must be sober about what lies

ahead. “ahead. “• Dr. Kathleen T. Ruddy of the Breast Dr. Kathleen T. Ruddy of the Breast

Health and Healing FoundationHealth and Healing Foundation