Roswell Park Cancer Institute secured FDA approval for an early phase I clinical study of a possible lung cancer vaccine developed in Cuba, Roswell CEO Dr. Candace Johnson announced today.
This is a first for an institution in this country, Johnson said.
The clinical trial of CIMAvax involving 60 to 90 patients with advanced lung cancer will start in about 30 days.
Johnson called CIMAvax "an incredibly innovative immunotherapy for lung cancer that was developed in Cuba" and a "significant first." "This is historic, the first time in the modern era that a Cuban and an American institution have been allowed to come together to create this joint company and venture," she said.
She added: "This would not have happened without Gov. Cuomo and his vision and his historic trade mission in 2015" to Cuba.
.@RoswellPark has approval for FDA to do early phase I clinical study of possible lung cancer vaccine, says Dr. Candace Johnson, Roswell CEO
— Aaron Besecker (@AaronBesecker) October 26, 2016
Speaking of that trade mission, Gov. Andrew Cuomo told the packed auditorium at Roswell: "The idea is 'let’s be the first state to Cuba. Let’s get our institutions to Cuba before anyone else, let’s seize the day, let’s carpe diem."
Roswell Park also has authorization from the Treasury Department to establish a joint business venture with Cuban researchers, Johnson said.
Lung cancer accounts for about 27 percent of all cancer deaths in the U.S. and is by far the leading cause of cancer death among both men and women, according to the American Cancer Society. It’s estimated that 158,040 Americans will die this year from the disease. That’s more than all the deaths from colon, breast, and prostate cancers combined.
The deal between Roswell Park and Cuba's Center for Molecular Immunology announced in April 2015 was the first formal step towards trying to bring clinical trials of the vaccine to the United States.
Roswell Park officials found out about the FDA approval in August and about the Treasury Department's approval last week.
Roswell Park posted information about eligibility for the clinical trial at roswellpark.org/cancer-vaccine.