ALBANY – Roswell Park Cancer Institute has struck a deal with a Cuban research organization to commence what officials hope will be a clinical trial for a lung cancer vaccine to be made available in the United States.
The announcement was made Tuesday by Roswell Park’s chief executive officer, Dr. Candace Johnson, at the conclusion of a two-day state foreign trade mission to Havana with Gov. Andrew M. Cuomo and other officials and private-sector executives
“It’s very exciting,’’ Johnson said in an interview with The Buffalo News after arriving back in New York on Tuesday evening.
She said the Buffalo cancer facility has had informal exchanges with students and scientists in Cuba over the years, but that this is the first involving a study with Cuba’s Center for Molecular Immunology to research a vaccine already in use in the Caribbean nation. She said the vaccine, which is injected, will be subject to clinical trials, pending federal approval, and that there are hopes it could be used in both the prevention and treatment of lung cancer and possibly other cancers.
Roswell Park was among the participants, with companies such as JetBlue and Pfizer, on a trip Monday and Tuesday led by Cuomo. He is the first governor to try to get a foot in Cuba’s door since President Obama began pushing to relax the long freeze-out of Cuba by the United States.
“The isolation of the past has not been productive,” Cuomo said at the end of the trip during a session with reporters at the Havana airport.
The Havana-based Center for Molecular Immunology did not immediately respond to an email seeking comment Tuesday night.
It was not immediately clear what can, and can’t, occur with the Roswell announcement since it will still take an act of Congress to lift trade ties between the two nations. Obama has said the United States needs to restore diplomatic relations with the Caribbean nation, a move opposed by many federal lawmakers.
John Kavulich, president of the U.S.-Cuba Trade and Economic Council, said a clinical trial agreement would be permitted under existing laws allowing for educational exchanges between the two nations.
However, he said, it could be years before numerous federal agencies – including the Treasury Department, Food and Drug Administration and Commerce Department – would be able to approve licenses needed for the clinical trial.
Kavulich said the research collaboration between Roswell and the Center for Molecular Immunology can proceed, but federal approval is needed if Roswell Park wants to bring a product into the U.S. from Cuba. He said a clinical trial involving another U.S. health group was announced back in the 1990s, but did not proceed.
The presence of a Roswell executive on Cuomo’s Cuba trip came four months after the governor proposed a $15 million state funding cut to the Buffalo hospital, calling the amount of state taxpayer assistance to Roswell each year “absurd.” The funding cut was restored in the new state budget.
In an interview, Johnson, the Roswell Park head, said Roswell has had an academic relationship with Cuba in which students and scientists have been on exchange trips between the two nations. She said the Cubans have a worldwide reputation for a strong molecular immunotherapy research program. The vaccine that Roswell wants to bring from Cuba to the U.S. is in use in Cuba but has only undergone one research study and more clinical trial work is needed to determine if it could be used on patients here.
Johnson said she signed an agreement Tuesday with the deputy director of the Havana cancer research group after meetings on Monday. She said Roswell Park has been aware of the lung cancer vaccine for about six months, but that the trade mission with Cuomo to Cuba helped finalized a deal.
Johnson said the vaccine has been shown to have some potential in inhibiting the growth of cancer cells.
Roswell already has a federal license to bring vaccines into the United States for research purposes, though the vaccines cannot be used on patients.
“We don’t expect to have problems with the FDA,’’ she said of the new agreement for the lung cancer vaccine. “They’ve done similar things like this before, but this is Cuba. We’re hopeful it won’t take a long time.’’
The agreement includes the Havana organization agreeing to release about 1,000 pages of documents providing details about the vaccine, including how it is produced, components and other details that will then be used by Roswell to present its case before U.S. federal officials.
Johnson said that in addition to treating cancer, the vaccine could be used in prevention efforts, such as after a tumor is removed in an early-stage lung cancer patient to prevent recurrence of the disease. “We’re a long way from that because there are lots of phases of testing for the development of a drug,’’ she said.
Johnson said potential financial components, including any commercialization of the vaccine if it is ever approved for use in the U.S., were not discussed in Tuesday’s agreement.