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FDA Clears First Clinical Trial for Breast Cancer Vaccine
The FDA has cleared an Investigational New Drug Application for an experimental breast cancer vaccine to begin clinical trials.
According to a release from the manufacturer, the technology used to develop the vaccine was invented by Vincent Tuohy, PhD, and his team from the Cleveland Clinic.
The release noted that the vaccine technology focuses on a protein called alpha-lactalbumin, which is found in a woman’s mammary gland during the latter part of gestation and lactation.
After lactation ends, the protein does not express until breast cancer develops.
The researchers believe the vaccine will help a woman’s immune system destroy cancer cells before they can fully mature.
According to the release, animal studies have shown the vaccine can prevent breast cancer.
“We are pleased that the FDA has authorized us to commence human clinical trials of our potentially paradigm-shifting vaccine for the prevention of breast cancer. This approval triggers a cascade of events and activities that will eventually lead to recruitment of patients and initiation of the trial,” Amit Kumar, PhD, President and CEO of Anixa, said in the release.
Initial clinical trials are expected to focus on triple-negative breast cancer, but the release noted that the technology could be used for other forms of cancer as well.
The US Department of Defense is funding preclinical trials and two clinical trials.
By Adam Hochron
According to a release from the manufacturer, the technology used to develop the vaccine was invented by Vincent Tuohy, PhD, and his team from the Cleveland Clinic.
The release noted that the vaccine technology focuses on a protein called alpha-lactalbumin, which is found in a woman’s mammary gland during the latter part of gestation and lactation.
After lactation ends, the protein does not express until breast cancer develops.
The researchers believe the vaccine will help a woman’s immune system destroy cancer cells before they can fully mature.
According to the release, animal studies have shown the vaccine can prevent breast cancer.
“We are pleased that the FDA has authorized us to commence human clinical trials of our potentially paradigm-shifting vaccine for the prevention of breast cancer. This approval triggers a cascade of events and activities that will eventually lead to recruitment of patients and initiation of the trial,” Amit Kumar, PhD, President and CEO of Anixa, said in the release.
Initial clinical trials are expected to focus on triple-negative breast cancer, but the release noted that the technology could be used for other forms of cancer as well.
The US Department of Defense is funding preclinical trials and two clinical trials.
By Adam Hochron