BUENOS AIRES -- The idea of a vaccine for lung cancer sounds absurd at first. Lung cancer isn't the flu, after all. But, after a 19-year quest by researchers in Argentina and Cuba, such a medicine is now a reality.
The story of the vaccine begins in 1994, when a group of Argentine scientists who dreamed of creating a cancer vaccine met with a group of Cuban scientists who had an idea of how to make one. And it reaches its finale on July 1, when a drug called Vaxira (Racotumomab) goes on sale in Argentina.
Developed by ID+i, an Argentine consortium of universities, government ministries, and Grupo Insud, a local pharmaceutical conglomerate, along with Cuba's Molecular Immunology Center (CIM, in Spanish), the vaccine required $100 million of investment, Dr. Hugo Sigman, Grupo Insud's CEO and the founder of ID+i, says. Besides Argentina, the drug has also already been approved in Cuba and has been licensed to 25 countries in the Americas and Asia, from Brazil to Cambodia.
One of the more head-turning aspects of the drug is its classification as a vaccine. It is not a vaccine in the traditional sense of a preventative shot given to kids, but rather an anti-idiotypic vaccine. Instead of introducing a weakened version of a virus so that the body is ready to fight when the real version shows up, vaccines like Vaxira encourage the body to fight lung cancer tumor cells that are already present in the body. In this sense, a better label for the drug would be an "active immunotherapy treatment," Dr. Daniel Alonso, ID+i's scientific director, says.
"It is not a cure for cancer," he says. "But it is a treatment option for prolonging a patient's life."
In the case of Vaxira, the Cuban investigators identified a compound called an antigen present in the cell walls of non-small cell lung cancer tumors and, along with the Argentine group, developed a medicine that would convince the body to attack that antigen, thereby destroying the cells. After being tested on some 1,700 patients, including 1,200 included in an ongoing clinical trial, the drug was approved for use in late-stage lung cancer patients. Only about 8 percent of late stage cancer patients survive two years, Dr. Alonso says, while 24 percent of those who took the cancer vaccine in the clinical trials survived that long.
For Argentina, leading a medical breakthrough is a bit of a homecoming. Argentina was once one of the world's top centers of scientific inquiry, and Argentine scientists won Nobel Prizes in 1947, 1970 and 1984. But the country's glory has faded in recent decades, and Dr. Sigman says that the desire to show that Argentina could discover great drugs was part of the inspiration for the vaccine. "As a doctor, as an Argentine and as someone who has a commitment to our country and region, I've always had the perception that we haven't been capable of working in the innovation industry," he says. The second inspiration, according to Dr. Sigman, was meeting patients who couldn't physically handle chemotherapy or radiation therapy and needed a new treatment option.
The course of treatment for Vaxira, which consists of five buildup shots given every two weeks and then ten booster shots given every four weeks, costs $20,000. Dr. Sigman says that he expects that the drug will be approved in the majority of the 25 countries where it has been licensed by 2015, and that the Argentine/Cuban joint venture should earn back its $100 million investment five years after that.
As hopeful as the drug may be for some, it will be a while before cancer patients in the U.S. can use it. In addition to the usual FDA approval required of all drugs sold in the U.S., Vaxira has to clear another hurdle before it hits pharmacy shelves: the Treasury Department's Office of Foreign Assets Control (OFAC). The OFAC enforces trade sanctions against countries such as Cuba, where 40 percent of the joint venture is held, and it would have to give special permission before Vaxira could be sold in the U.S. In the meantime, Dr. Sigman notes, the U.S.-based pharmaceutical company Merck has a similar drug in clinical trials.
Photos from ID+i/Grupo Insud