Roswell Park Cancer Institute Launches Trial to Test Cuban Lung Cancer Vaccine

Excerpt:

“Roswell Park Cancer Institute launched a clinical trial that will assess CIMAvax-EGF, a novel Cuban-developed immunotherapy for lung cancer.

“This is the first time an American center received FDA authorization to sponsor a clinical trial offering a Cuban-made therapy to U.S. patients. Researchers are working to accelerate the process of this and other innovative therapies to patients worldwide through a historic new business venture with the Cuban research institute.”

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A Souvenir Smuggled Home From Cuba: A Cancer Vaccine

Excerpt:

“Zuby Malik is an unlikely candidate to violate international law. A 78-year-old mother of four with a crown of silver hair, she is a retired obstetrician-gynecologist with a penchant for order.

“But Ms. Malik is fighting for her life. After receiving a Stage 4 non-small-cell lung cancer diagnosis a year ago, she exhausted many of the treatments available to her and grappled with torturous side effects that left her itching and gasping for breath. During the summer, she decided to go to Cuba and bring back a cancer vaccine that is not approved in the United States. That she comes from a family steeped in medical training made the decision all the more difficult.”

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in a First, U.S. Trial to Test Cuban Lung-Cancer Vaccine

Excerpt:

“The Food and Drug Administration has approved the first clinical trial to test a Cuban drug in the United States — a lung-cancer vaccine developed in Havana.

“The decision on the early-stage trial was announced Wednesday by New York Gov. Andrew Cuomo (D) and officials at the Roswell Park Cancer Institute, based in Buffalo. The trial could start as soon as next month and will enroll 60 to 90 patients. It is likely to take three years to complete.

“The trial will test the CIMAvax-EGF vaccine, combined with an immunotherapy drug called Opdivo, which has already been approved in the United States. The goal is to see if the pairing improves effectiveness.”

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Cuba's Lung Cancer Vaccine: Hype or Hope?

Excerpt:

“Now that relations between the United States and Cuba are thawing, there has been a growing interest in forming medical partnerships.

“Of particular interest is a lung cancer vaccine called CimaVax, which was developed for non-small cell lung carcinoma. Available in Cuba since 2011, the vaccine has caught the attention of researchers and physicians not only in the United States but in other countries as well.

“But while intriguing, the question remains: Is it really a breakthrough in lung cancer treatment?”

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Cuba Has a Lung Cancer Vaccine—And America Wants It

“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.”