CimaVax is both a treatment and vaccine for lung cancer and it has been researched in Cuba for about 25 years. Moreover, it has been offered to the Cuban public since 2011, free of charge. New York Governor Andrew Cuomo’s trade mission to Cuba that took place in April 2015 resulted in a signed agreement to bring CimaVax to the U.S. However, things are not that simple as researchers need to conduct clinical trials and replicate international scientists’ results before making it available to the American public.
President Barack Obama will be the first to visit Cuba in almost 90 years. The President and first lady Michelle Obama are going to travel to the island nation on March 21. The most exiting thing about this trip is the possibility of bringing this new drug to prevent lung cancer and even other types of cancers to the U.S.
“We’re still at the very early stages of assessing the promise of this vaccine, but the evidence so far from clinical trials in Cuba and Europe has been striking.” said Dr. Kelvin Lee, Jacobs Family Chair in Immunology and co-leader of the Tumor Immunology and Immunotherapy Program at Roswell Park Cancer Institute in Buffalo, New York
This highly hoped-for success of CimaVax availability in the U.S. is just one example of the possibilities that come with open trade between two nations.
“You never know how long these things would take .We would have loved to have had this already started because we’ve been working on this for quite a while, but we’re persistent and we’ll get it done.” said Candace Johnson, CEO of Roswell Park
Cuba has been known for its high-quality cigars and lung cancer is a major public health problem, as well as the fourth leading cause of death in the country. A 2007 study of patients with stages 3B and 4 lung cancer that has been published in the Journal of Clinical Oncology, confirmed the safety of the CimaVax. Furthermore, it showed an increase in tumor-reducing antibody production in more than half of the cases. In addition, it proved particularly effective for increased survival if the participants were younger than 60.
So far, 5.000 patients worldwide have been treated with CimaVax, 1.000 out of which in Cuba. Lee said that the latest study of 405 patients, which has not yet been published, confirms earlier findings about the safety and efficacy of the vaccine. Moreover, the shot is cheap (each costs the Cuban government just $1). Not to mention the fact that there were no significant side effects reported.
“We think it may be an effective way to prevent cancer from developing or recurring, so that’s where a lot of our team’s excitement comes in. There’s good reason to believe that this vaccine may be effective in both treating and preventing several types of cancer, including not only lung but breast, colorectal, head-and-neck, prostate and ovarian cancers, so the potential positive impact of this approach could be enormous.” Lee said
How it Works
CimaVax induces people to build antibodies against a certain growth factor that cancer cells make. For those who already suffer from lung cancer, this response results in the body actually getting rid of the cancer cells. In addition, for those who are currently healthy but at risk for developing lung cancer (for example, a patient in remission), the treatment acts as a vaccine to prevent future relapse. Johnson envisions that it could one day become a preventive vaccine that a person gets in childhood, pretty much like the way we get vaccinated against polio, measles, mubls and rubella.
Besides CimaVax, Roswell Park scientists are also reviewing other vaccine approaches from researchers at Cuba’s Center of Molecular Immunology (where CimaVax was created) that could one day help patients overcome brain and pancreas cancer, as well as leukemia and lymphoma.
“They are a very innovative group of scientists, and they have vaccines and drugs that we think could play a very significant role in our fight against cancer. We’re delighted to be working with them and we hope very soon that we can start our trial on CimaVax — hopefully the first of many clinical trials to be done with some of these Cuban vaccine approaches.” Johnson said
Just to be clear, CimaVax doesn’t cure cancer. It is a therapeutic vaccine that works by targeting the tumor, specifically going after the proteins that allow a tumor to keep growing.
“We hope to determine in the next few years whether giving CimaVax to patients who’ve had a lung cancer removed, or maybe even to people at high risk of developing lung or head-and-neck cancers because of a history of heavy smoking, may be beneficial and may spare those people from having a cancer diagnosis or recurrence.” Lee said
What Needs to Happen First
Roswell park faces plenty of bureaucratic hurdles before clinical trials for CimaVax actually begin.
They had to apply for a license from the Office of Foreign Assets Control at the Treasury Department to bring CimaVax into the U.S. The license allows them to use it for lab research, but it does not allow them to give it out to patients.
In order to start testing it on Americans, they need to get approval for trial from the U.S. Food and Drug Administration. For now, they are communicating about the design of the trial, Johnson stated.
Once the FDA signs off, Johnson has to submit the project to Roswell Park’s Scientific Review Committee to evaluate its merit, as well as their Institutional Review Board, a body that evaluates the ethical aspects of any medical research involving human subjects. These two processes alone can take months to complete. The entire process, from start to finish, can take years to complete, even though the experimental drug was invented in the U.S.
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