With Obama's visit to Cuba, doctors hope lung cancer vaccine will get major boost

BALTIMORE - AUGUST 15: Chemotherapy treatments for lung cancer patients are mixed in the pharmacy at the Kimmel Comprehensive Cancer Center at Johns Hopkins August 15, 2005 in Baltimore, Maryland. Since its inception in 1973, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins has been dedicated to better understanding human cancers and finding more effective treatments. (Photo by Win McNamee/Getty Images) (2005 Getty Images)

While the historic thaw in relations between Cuba and U.S. was both applauded and condemned when it was announced in December 2014, in antiseptic hospital hallways it signaled a path to a medical collaboration that had remained untouched for more than six decades.

And, for now, it would appear the U.S. may have the most to gain from that collaboration.

Cuba may be submerged in poverty and isolation, but medical researchers there claim to have developed the first vaccine to treat lung cancer, the most lethal form of the disease in the U.S. with an average of 432 Americans killed every day.

The vaccine, which also may prove to be effective preventing the disease, is called CimaVax. A 2007 study of lung cancer patients published in the Journal of Clinical Oncology showed CimaVax is safe and effective.

It didn’t take long after the historic April 2015 handshake between President Barack Obama and Cuban president Raúl Castro that signaled the beginning of normalization of relations between the countreis for a high-profile U.S. medical delegation to set foot on Cuba and start the lengthy process that involves introducing a drug into the U.S. market.

“We’re still working on FDA approval, but we’re hopeful that this year we’ll start trials,” said Dr. Candace Johnson, CEO of Roswell Park Cancer Institute, a research center based in New York City that is evaluating CimaVax for U.S. use.

Although getting approval for a drug manufactured in Cuba is possible, it is not a simple process. It first must get approval from the Food and Drug Administration, which hasn’t dealt with Cuba in decades so it must figure out how the country deals with medical inventions.

CimaVax has been researched in Cuba for 25 years and has been free to the Cuban public since 2011. More than 3,000 patients have received treatment with the vaccine, and in December of 2015 clinical trials were expanded to treat Stages 2 and 3 of the disease.

“It’s been 50 years since the U.S. has been there, and a lot has changed,” said Dr. Kelvin Lee, chair of the Department of Immunology at Roswell Park. “The Cubans may be in phase 2 or phase 3, but that doesn’t mean the U.S. FDA will fast-track us.”

He said Cuba has become more advanced recently, particularly since many U.S. restrictions were lifted.

“We’re very encouraged, and it all looks very promising. We're cautiously optimistic following conversations with the FDA," he said.

Dr. Lee also believes the thaw could open the flood gates to other medical advances, including drugs and treatments, being introduced in the United States. Among other things, the medical industry in Cuba can develop drugs more quickly and at a lower cost than in the U.S. because it doesn’t have to go through layers of government bureaucracies or deal with a politically influential pharmaceutical industry.

CimaVax is no fluke, Lee believes. His team learned about vaccines being developed in Cuba that target only cancer cells to lessen the drug's toxicity, vaccines for cholesterol which would allow addressing heart disease and even a nose spray that may reverse traumatic brain injury.

"I was there, and there's a lot of exciting biotechnology happening in Cuba," Lee said. "The life expectancy in Cuba is the same as in the U.S. The infant mortality rate is the same as in the U.S."

He added, "They're very innovative and thoughtful, doing a lot as economically as possible."

And the costs in Cuba are a lot lower.

Each dose of CimaVax costs $1 to produce and has low levels of toxicity. For example, Johnson said, since the vaccine is essentially training your immune system to fight cancer, it won’t cause hair loss.

Johnson said they’re most excited about the preventative uses of CimaVax. “We’d like to use it in patients with Stage I – people with high-levels of recurrence. It could also be used to prevent cancer from growing.”

Johnson said there are many other drug vaccine approaches in Cuba that could be useful in cancer-related diseases.

“We’re hoping for new avenues [to] open to promising therapies for patients,” she said. “We want to be the gateway with the Cubans. As this progresses, this will be available to everyone.”

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