This week, the Roswell Park Cancer Institute of Buffalo, New York, signed a partnership with Havana’s Center for Molecular Immunology to import the Cuban lung cancer vaccine CimaVax.
The drug has already undergone rigorous testing in Cuba, where it has shown success in reducing antibody responses in lung cancer patients and reducing future tumor growth.
Dr. Candace Johnson, director of Roswell Park, announced the partnership upon returning from a two-day state foreign trade mission to Havana, which was led by New York Governor Andrew Cuomo.
"This agreement establishes a collaboration between our two institutions to develop a cancer vaccine in lung cancer," Johnson said."We're very excited to take this to the United States to treat patients."
Vaccines are exempt from the United States trade embargo with Cuba, which still stands and can only be lifted by Congress. But without approval from the Food and Drug Administration, CimaVax will not be rolled out in the United States.
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“There are exceptions when it relates to science and medicine,” Johnson told Medical Daily. “This is really between us and the FDA.”
For now, Scientists are awaiting authorization to perform clinical trials to demonstrate to the FDA the vaccine’s safety and effectiveness.
Johnson said the plan is to get testing underway within eight months to a year, provided they can put together the more than 1,000-page investigational new drug (IND) application for the FDA’s review.
“I don’t disagree this is unique, because it’s Cuba, and perhaps there may be more paperwork involved. But we don’t anticipate any difficulties,” Johnson told Medical Daily. “It’s just a matter of filing the right papers and doing the right things ahead of time before bringing it into the States.”
Johnson said federal health agencies from Europe and Asia have already vetted the research; America is simply next in line.
Lung cancer is the most common cause of cancer deaths, killing 163,000 Americans in 2014, according to the American Cancer Society. In Cuba, cancer is the second-leading cause of death, behind only cardiovascular disease, according to the World Health Organization.