Posts under tag: FDA
Cuba has for several years had a promising therapeutic vaccine against lung cancer. The 55-year trade embargo led by the US made sure that Cuba was mostly where it stayed. Until—maybe—now.
The Obama administration has, of course, been trying to normalize relations with the island nation. And last month, during New York Gov. Andrew Cuomo’s visit to Havana, Roswell Park Cancer Institute finalized an agreement with Cuba’s Center for Molecular Immunology to develop a lung cancer vaccine and begin clinical trials in the US. Essentially, US researchers will bring the Cimavax vaccine stateside and get on track for approval by the Food and Drug Administration.
“The chance to evaluate a vaccine like this is a very exciting prospect,” says Candace Johnson, CEO of Roswell Park. She’s excited, most likely, because research on the vaccine so far shows that it has low toxicity, and it’s relatively cheap to produce and store. The Center for Molecular Immunology will give Roswell Park all of the documentation (how it’s produced, toxicity data, results from past trials) for an FDA drug application; Johnson says she hopes to get approval for testing Cimavax within six to eight months, and to start clinical trials in a year.
To read the rest of this article, check out Wired.com