For several years Cuban doctors have been experimenting with a cancer treatment that holds great promise for the U.S. and the rest of the world. It’s called CIMAvax, and it’s a therapeutic vaccine shown to be effective in preventing the onset or progression of lung cancer in high-risk adults such as smokers or people who’ve already had lung cancers removed surgically.
The idea of a cancer vaccine is tantalizing to U.S. doctors, but until recently they couldn’t get their hands on it, even though research in Cuba has shown it can prolong life. But that’s about to change. The lifting of the longtime trade embargo won’t just mean the U.S. gets access to Cuban cigars and rum; it also means collaboration with the vaunted Cuban medical system, which manages to achieve life-extending outcomes at a fraction of the cost.
The latest sanction amendments from the Department of Treasury, issued Oct. 14, made it legal for the U.S. to import Cuban pharmaceuticals without violating the embargo. That means U.S. entities will not need government permission to collaborate with Cuban researchers or drugmakers, a change that will speed up the process for getting Cuban drugs in front of the Food and Drug Administration for review.
“We’re very excited about this because it’s going to make it much easier in the future to collaborate on a basic science level,” said Dr. Thomas Schwaab, an immunology expert and chief of strategy at Roswell Park Cancer Institute, in Buffalo, New York. The center spearheaded efforts in 2011 to obtain Treasury Department permission for a partnership with Havana’s Center for Molecular Immunology, the institution behind CIMAvax.
CIMAvax was developed in the 1990s and approved by Cuban regulators in 2008. Today, 4,000 patients around the world have used it, including 1,000 in Cuba.
“CIMAvax was given all over the world to thousands of patients… Really, patients in the U.S. have lost out on it,” Schwaab said. “It’s not going to be the magic drug, but it’s going to make a significant impact on how we treat lung cancer patients.”
Under the embargo, American entities interested in working with Cuban institutions or drugmakers needed a special license from the Treasury Department before moving forward. That process sometimes could take more than a year, and approval was not guaranteed. If the collaboration involved importing a Cuban drug, after the license was granted by Treasury, the product would still have to go through the FDA’s review process for international drugs, which includes clinical trials.
Importing the drugs from Cuba either during or after trials presented another challenge because of embargo restrictions. “How do you get the drug from Cuba to the U.S.? It’s an embargoed country; you can’t just fly in,” Schwaab said.
When Schwaab and his colleagues decided in 2011 that they wanted to work with the Center for Molecular Immunology, they had to go through the Treasury Department licensing process before they could collaborate with the Cuban team. After a trade mission to Cuba in 2015, Roswell Park signed an agreement with the Havana-based institution to try to bring CIMAvax to market.
Earlier this year, the teams finally got to the point of starting the FDA review and are hoping to start clinical trials by year-end. Thanks to the relaxing of the embargo, they can no import the drugs needed for the trials to move forward.
The changes announced by the Treasury earlier this month also eliminate the need to obtain a license before partnering with researchers in Cuba, significantly reducing the amount of time required to get a drug like CIMAvax into clinical settings in the U.S. Now, the most exciting opportunity for American institutes like Roswell Park lies in other promising cancer-fighting vaccines and innovative medicine under investigation in Cuba.
“We have been in very close discussions on a number [of other drugs] to obviously optimize this relationship as much as possible,” Schwaab said.
CIMAvax isn’t the only Cuban cancer vaccine showing promise. Others include Nimotuzumab, which could become an effective tool for fighting brain tumors, and Racotumomab, which is being tested on patients with lung cancer, breast cancer, and melanoma. The country also has a promising dengue vaccine and a drug for treating foot ulcers in diabetic patients that could also elicit interest from American doctors.
“[Cubans] don’t have the passive healthcare system like we do in the U.S., where we wait for someone to become sick and access the healthcare system that way,” said Dr. Paul K. Drain, an associate professor in global health at the University of Washington. “They really try and catch the disease early before it escalates into something that needs very expensive therapeutic and diagnostic [services] to address.”
With the new embargo rules, American researchers can now freely work with researchers in Cuba, which will make it easier for both countries to get involved in each other’s work at earlier stages. “It seems like with the embargo the walls are just being slowly broken, a little bit at a time,” Drain said. “I think this just moves us one step closer to having those potentials becoming a reality.”