Cuban lung cancer gets FDA trial "vaccine"

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Cancer institute in Buffalo, N.Y. to conduct clinical trial of CIMAvax on lung cancer patients

The U.S. Food and Drug administration has authorized the clinical trial of the lung cancer drug CIMAvax, according to New York Gov. Andrew Cuomo. He made the announcement at a news conference in the state capital Albany on Wednesday.

The trial will be conducted by Roswell Park Cancer Institute in Buffalo in partnership with Cuba's Centro de Inmunologia Molecular (CIM), CIMAvax's namesake.

CIMAvax is part of the next generation of cancer treatment called immunotherapy, which is a way of triggering the body's natural defences to attack cancer cells.

pictures mirror  (www.cbc.ca)

New York Gov. Andrew Cuomo announces the FDA's permission for clinical trials of the Cuban lung cancer drug Cimavax to proceed. (New York Governor's Office)

Lung cancer is the leading cause of cancer deaths in the United States, with a five-year survival rate of only 17 percent.

The vaccine developed by CIM has been approved by a number of countries, including Paraguay and Peru. Even so, Len Lichtenfeld, deputy chief medical officer at the American Cancer Society, has taken a cautious stance on the vaccine.

In a post in March that society officials said was still relevant, he noted that “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 risk 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.”

He added that the history of vaccines in treating cancer has shown many more failures than successes.

CIMAvax is already used on patients in Cuba with non-small cell lung cancer — reportedly costing as little as $1 to manufacture by one of Cuba's state biotech firms. FDA approval could clear the way for use in the U.S. and other markets.

Cuomo led a trade mission to Cuba in 2015 — a year before U.S. President Barack Obama's historic visit — after learning of the drug's potential by Roswell Park.

News of the collaboration comes just as the Obama administration eliminates obstacles to medical research from Cuba. The embargo exemption announced earlier this month by the U.S. Treasury Department's Office of Foreign Assets Control (OFAC) also allows pharmaceuticals from Cuba to apply for FDA clinical trial permission.

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