The Food and Drug Administration has approved the first clinical trial to test a Cuban drug in the United States — a lung-cancer vaccine developed in Havana.
The decision on the early-stage trial was announced Wednesday by New York Gov. Andrew Cuomo (D) and officials at the Roswell Park Cancer Institute, based in Buffalo. The trial could start as soon as next month and will enroll 60 to 90 patients. It is likely to take three years to complete.
The trial will test the CIMAvax-EGF vaccine, combined with an immunotherapy drug called Opdivo, which has already been approved in the United States. The goal is to see if the pairing improves effectiveness.
Cuomo touted the fact that the FDA's action stemmed from the boost in a research partnership between Roswell and Cuba's Center of Molecular Immunology (CIM) that occurred during a New York state trade mission last year. About two months later, the United States formally restored diplomatic relations with Cuba after a half-century breach.
Lung cancer is the leading cause of cancer deaths in the United States, with a five-year survival rate of only 17 percent. According to Grace Dy, the principal investigator in the Roswell Park trial, "We're at an early stage in the development of this vaccine, which has never before been given to U.S. patients, so we have a lot to learn through this study. But the evidence so far is encouraging."
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