“In your lifetime or my lifetime, we may be able to have a vaccine capable of stopping this terrible disease,” says Vincent Tuohy, PhD, at the Cleveland Clinic. After 11 years, his dream to develop a breast cancer vaccine is coming to fruition.
“We came up with this idea in 2002 when we realized we have this enormous deficiency in our healthcare system. We have a wonderful childhood vaccine program that protects us,”. “Yet we reach our adult years and face all these adult-onset cancers like breast cancer, ovarian cancer and prostate cancer.”
This led him to his groundbreaking finding: a single vaccine could prevent breast cancer tumors from occurring in mice genetically bred to develop the disease as well as stop the growth of already present breast cancer tumors. The research was published in 2010 in the journal Nature Medicine.
For the past three years, Dr. Tuohy and his colleagues have built upon that breakthrough. “I refer to it as my retired protein hypothesis,” he says. “With age, we retire proteins. They are no longer being made and almost every tissue goes through this process.” Think of it as grey hair: hair turns white because the pigment units in the follicle retire. This is what happens in the breast; certain proteins retire except that they can be rejuvenated by tumor tissue. “We identified a protein—more than one protein actually—that is overexpressed in the most aggressive form of breast cancer called triple negative breast cancer,” Dr. Tuohy says. The vaccine would be made up of these proteins, which would provide the immune system the ability to be pre-emptive against emerging breast tumors.
More from Prevention: 12 Myths To Ignore About Breast Cancer
Triple negative breast cancer is the most lethal form; it kills women at a three-fold greater rate than all other forms of breast cancer. It is highly aggressive and it recurs very rapidly with a very poor five-year overall survival rate compared to other breast cancers. What’s more: it is the most predominant form of breast cancer that occurs in high-risk patients with BRCA-1 mutations, who also have an 80% chance of getting breast cancer in their lifetime, Dr. Tuohy says. This perfect storm of breast cancer provides the team with the clinical trial population to determine safety and efficacy.
There will be two Phase I trial groups. “The first trial is the treatment arm where we will be testing the vaccine on women who already have triple negative breast cancer and have recovered. It is designed mostly, primarily, for safety and dosage. We need to determine the dosage in this population; the right dose that gives us the right immune response,” Dr. Tuohy explains. “We can see in that population, hopefully, whether or not our vaccine prevents or significantly delays the development of breast cancer in this high risk population.”
More from Prevention: Medical Tests That Can Save Your Life
For the second trial, Dr. Tuohy and colleagues hope to recruit some of the women who voluntarily undergo prophylactic mastectomies to reduce their risk of developing breast cancer. They will ask these women a few months prior to their procedure if they will be willing to be vaccinated. Then upon their mastectomy, Dr. Tuohy and his team will examine the tissue to see if the vaccine did any damage to the normal healthy tissues and ducts. “It is more of a safety trial after we have determine the right dose.”
Recruitment for Phase I testing will be done at the Cleveland Clinic in Cleveland. But for Phase 2 and, definitely Phase 3, there will be multicenter trials involving several sites where people can be recruited. “We don't want to go into what will and won't go into the inclusion or exclusion of subjects right now because that won't happen for another five years,” he says.
Yes, it will be five years before a breast cancer vaccine will see rounds of clinical trials that determine effectiveness. All in all, a breast cancer vaccine will not be publicly available for at least 10 years.
“It takes at least 10 years to develop a drug,” Dr. Tuohy says. “That is the reality. I didn't make the rules.”
No comments:
Post a Comment