WASHINGTON - Federal regulators have given approval for U.S. clinical trials of a Cuban-developed lung cancer vaccine.
New York Governor Andrew Cuomo announced the Food and Drug Administration’s decision Wednesday at the Roswell Park Cancer Institute in Buffalo.
Lung cancer is the second most commonly diagnosed cancer in both men and women, according to the American Cancer Society, which estimates nearly 160,000 Americans will die from the disease this year, with non-small cell cancer the most frequently diagnosed type, by far.
The Cuban lung cancer vaccine, called CIMAvax, was developed by the Center of Molecular Immunology in Havana. It works as a form of immunotherapy.
CIMAvax does not target and kill cancer cells directly, as many forms of chemotherapy do. Instead it targets a protein found naturally in the body, epidermal growth factor, that signals cells to grow — and in the case of cancer cells, to grow uncontrollably.
The vaccine stimulates the immune system, leading the body to produce antibodies that stop epidermal growth factor from attaching to cancer cells. The Roswell Park institute’s chief executive, Candace Johnson, says the protein acts as food for the cells of non-small cell lung cancer, and they cannot survive without it.
With the Cuban vaccine stimulating the patient’s own immune system, cancer cells are blocked from receiving the protein they need, and they die.
“And it works, that's the beauty of it,” Johnson said.
Roswell Park is the first center to receive permission to sponsor the U.S. testing of any Cuban medical therapy and “bring Cuban science to the U.S.,” as Johnson said. She and Cuomo have been negotiating to win Cuban and U.S. approval for the landmark clinical trial for more than a year.
The trial is expected to start within a month for 60 to 90 patients.
CIMAvax will be tested in combination with an immunotherapy medication intended to strengthen the body’s built-in defenses against an array of disease-causing invaders, such as viruses and bacteria.
The idea of using the immune system to attack cancer is not new, and two similar vaccines are in the early stages of development in the U.S.