Surgeon General’s Warning – “Smoking does not Kill”

Good news for smokers and non-smokers: the lung cancer vaccine is arriving from Cuba.

In the late 1700s, physician Edward Jenner injected a young boy with cowpox to test his hypothesis that those who were infected with that disease never contracted the vastly more serious smallpox. A few weeks later, Jenner gave the boy a dose of smallpox. Fortunately for the boy, it worked, and Jenner is known as a hero and a pioneer in vaccination.

These days 3 Cuban drugs have been prepared for Phase II clinical trials. The most promising vaccine, a compound called SAI-EGF, is set to start its trial late this year or early in 2006.

A biotech startup figured out how to cut federal red tape and so CancerVax became the first U.S. company to license cancer drugs from Castro’s island.

Maybe we are approaching the day when smoking will not imply health risks, but just some dust in the lungs, which could be removed by coughing.

CancerVax CEO David Hale, first learned about SAI-EGF at the 2001 meeting of the American Society of Oncology in San Francisco, where Hale saw the new research exhibited on a poster.

It struck him as a novel approach to targeting the EGF pathway, so he approached the poster’s authors and discovered that both scientists were from the Centro de Inmunologia Molecular (CIM) in Havana. “I was shocked,” Hale says.

Hale decided to try to license the vaccines for distribution in the U.S. But he faced the challenge of overcoming four decades of U.S. government animosity toward Cuba. Hale hired two high-powered D.C. lobbyists H.P. Goldfield and Richard A. Popkin to rally support on Capitol Hill.

David F. Hale

David F. Hale President and CEO CancerVax Corp

CancerVax’s strategy was to stress the importance of developing a treatment for non-small-cell lung cancer. “Politics shouldn’t get in the way of saving lives,” says Hale.

When Castro started speaking about the importance of the agreement to the Cuban scientific community and to cancer patients around the world, everybody finally knew the deal would happen.

And on July 13, 2004, CancerVax was granted permission to license three promising cancer vaccines from the communist nation. It was the first such deal in the 41-year history of the U.S. trade embargo against Cuba.

The Cuban Cure

It is the immune system’s job to eradicate foreign invaders, such as viruses, but to be effective, the immune system must be trained to recognize what is foreign.

This is why the first time a person’s body is infected with a pathogen it doesn’t recognize, the person gets sick, and it takes time for the immune system to fight back. But the next time the pathogen comes along, the immune system is ready and wipes it out quickly.

The vaccine works by stimulating the body’s immune system to attack the tumours more vigorously. A sugar-protein molecule that is found on the surface of many cells in the body is slightly altered in cancer cells, making it more visible to the immune system.

Pieces of tumor recovered from six patients showed that, in three of them, immune-system proteins penetrated into the tumors and killed many of their cells. That kind of result is heartening considering that prior surgery and chemotherapy had severely weakened the natural protection given by their own immune systems. No toxic side effects occurred in any of the patients.

Fidel Castro

Fidel Castro

The drug targets a protein known as epidermal growth factor, or EGF, which is the sustenance of many tumors. EGF exists benignly in blood until a cancer tumor is present. It then locks onto the tumor’s EGF receptor and stimulates its growth. SAI-EGF causes the immune system to create antibodies that prevent EGF from latching onto those receptors.

“Breakthrough is not a word I use, but this comes close,” said H’kan Mellstedt, from the Karolinska University Hospital in Stockholm, commenting on the vaccine. “I have been involved in cancer vaccines for 20 years, and scientists are always cautious. But these are very exciting results.”

The previous trial added to optimism that vaccines against cancer will work. Professor Mellstedt said that several cancer vaccines were showing signs of progress. We are seeing encouraging results in colorectal and kidney cancer and in malignant melanoma (skin cancer), he said.

The development of vaccines and therapeutic monoclonal antibodies to treat malignant diseases is one of the most significant achievements of Cuban science.

About CancerVax Corporation

CancerVax Corporation is a biotechnology company focused on the research, development and commercialization of novel biological products for the treatment and control of cancer.

CancerVax’s corporate headquarters and research and development facility is located in Carlsbad, Calif, and its biologics manufacturing facility is located in the Los Angeles area.

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