6 Indest-2008-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A lung cancer vaccine that was developed in Havana, Cuba, will be the first such clinical trial to be approved by The Food and Drug Administration (FDA) for testing in the United States.  October 26, 2016, the approval was announced by New York’s Governor Andrew Cuomo alongside officials at the Roswell Park Cancer Institute in Buffalo.  The trial could start as soon as November 2016 and will enroll 60 to 90 patients. They are estimating that it will take around three years to complete.

A Research Partnership.

Governor Cuomo praised the fact that the FDA’s action followed the promotion of a research partnership between Roswell and Cuba’s Center of Molecular Immunology (CIM) that occurred during a New York state trade mission in 2015.

This lung cancer trial will test the CIMAvax-EGF vaccine, combined with an immunotherpay drug called Opdivo. Opdivo has already been approved in the U.S. Click here to visit the Roswell Park Cancer Institute website and learn more about the CIMAvax-EGF vaccine.

 The Leading Cause of Cancer Deaths Is Lung Cancer.

Lung cancer is the leading cause of cancer deaths in the U.S. There is a five year survival rate of only 17 percent of those who fall ill with lung cancer.  According to Grace Dy, the principal investigator in the Roswell Park trail, “We’re at an early stage in the development of this vaccine, which has never before been given to U.S. patients, so we have a lot to learn through this study, But the evidence so far is encouraging.”

The vaccine developed by CIM has been approved by a number of countries such as Paraguay and Peru.  Even though the vaccine has been approved by several countries already, Len Lichtenfeld, deputy chief medical officer as the American Cancer Society, has taken a cautious stance on the matter.

Litchenfeld stated, “currently we do not have the information we need to have to know whether or not this vaccine could be useful in treating lung cancer or possibly be used to prevent cancer in patients at high risks of developing lung cancer. The studies that have been reported from Cuba are small and have limitations that prevent us from knowing how the treatment could be applied to the typical patient with lung cancer.”

Currently, the United States and Cuba are working collaboratively to make certain that this vaccine will be as effectively as possible and help those suffering from lung cancer.

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“CHIPSA Looks Into Cuban Lung Cancer Vaccine United States Is Studying.” CHIPSA Hospital. (2016). Web.

Lee, Kelvin. “Where Does CIMAvax Currently Stand?” Roswell Park Cancer Institute. (March 28, 2016). Web.

McGinely, Laurie. “In A First, U.S. Trial To Test Cuban Lung Cancer Vaccine.” The Washington Post. (October 27, 2016). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

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