Lifting the embargo on Cuban cigars and rum got everyone's attention. But the Obama administration also opened the door to more collaboration in medical research when it relaxed economic restrictions on Cuba earlier this month.
The significance of that became clear Wednesday when Gov. Andrew M. Cuomo visited Roswell Park Cancer Institute to announce the federal Food and Drug Administration has authorized the institute to conduct the first U.S. study of a drug developed by Cuban researchers.
The promising vaccine to treat lung cancer, called CIMAvax-EGF, will be offered to as many as 90 patients with advanced lung cancer to determine the optimal dosage and its effectiveness compared to standard therapy for those who have failed previous treatments.
The results so far for CIMAvax-EGF – in tests elsewhere in the world involving about 5,000 patients with non-small cell cancer – are modest, with patients living a few more months.
Nonetheless, success in the Roswell Park study would show progress against a disease with few good options. In the future, researchers hope to study CIMAvax-EGF to slow the growth of early lung cancers and apply it to other cancers, such as breast, prostate and colon.
“With this landmark clinical trial, Roswell Park, America’s first cancer center, becomes the first American institution to give CIMAvax to patients," said Candace Johnson, president and chief executive officer of the cancer center. "We’re the first center to get permission to sponsor the U.S. testing of any Cuban medical therapy to bring Cuban science to the United States.”
Roswell Park struck a deal with the Center for Molecular Immunology in Cuba to bring CIMAvax to the U.S. for study. A 2015 foreign trade mission to Havana included Cuomo and Johnson.
The Buffalo cancer center has had informal exchanges with students and scientists in Cuba since 2011. But this is the first formal scientific relationship with the country.
“This groundbreaking trial at Roswell Park is the result of our historic partnership with Cuba, and is a testament to New York’s storied legacy as a national leader in progress and innovation,” Cuomo said in a statement.
Cuomo told the packed Roswell Park auditorium that, "The idea is 'let’s be the first state to Cuba. Let’s get our institutions to Cuba before anyone else, let’s seize the day, let’s carpe diem."
Roswell Park also has authorization from the Treasury Department to establish a joint business venture with Cuban researchers, Johnson said.
Rather than attempting to kill cancer cells like a chemotherapy, CIMAvax targets epidermal growth factor, a protein found naturally in the body that signals cells to grow. The vaccine stimulates the immune system, leading the body to produce antibodies that stop epidermal growth factor from attaching to cancer cells and signaling them to grow out of control.
A Cuban study published this year of late-stage lung cancer patients found that those using the vaccine lived about three months longer than those who received standard care.
“You might call the results modest, but patients’ quality of life is better because the treatment is not as toxic, and we see the potential for using the vaccine earlier in cancer, as well as with other cancers. So, there is real hope here,” Johnson said.
Lung cancer is the second-most commonly diagnosed cancer in both men and women, with non-small cell cancer the most frequently diagnosed type, by far. An estimated 224,390 new cases of lung cancer projected in 2016 accounts for about 14 percent of all cancer diagnoses, according to the American Cancer Society. An estimated 158,080 Americans will die from the disease this year.
The overall five-year survival rate for all types of lung cancer is 17 percent, and even lower once it has spread to surrounding tissue and other parts of the body. The disease is often diagnosed at a late stage.
CIMAvax will be tested in combination with the immunotherapy nivolumab – brand name Opdivo. The immune system is the body’s built-in defense against an array of disease-causing invaders, such as viruses and bacteria. Vaccines teach the immune system to fight disease by acting like a real infection. The idea of using the immune system to attack cancer is not new, and a number of different approaches have been tried but without much success.
"This is a day we have been working toward for many years,” Agustín Lage, director of the Center for Molecular Immunology, said in a statement. “Our partnership with Roswell Park will allow us to learn things about our vaccine faster than what we could achieve working on our own, and we believe it is the best and quickest path for helping a great number of people both in Cuba and the U.S.”
The Roswell Park Alliance Foundation committed $2.4 million in donor funds to cover the cost of the initial study. Roswell Park posted information about eligibility for the clinical trial at roswellpark.org/cancer-vaccine.