The Roswell Park Cancer Institute hopes to start clinical trials in the United States for CimaVax sometime in 2016.
HAVANA, Dec. 3 (UPI) — The Cuban government is expanding a clinical trial for the drug CimaVax to more of the country, officials from the Molecular Engineering Center announced this week.
The Roswell Park Cancer Institute struck a deal with the Cuban government in May to develop the drug in the United States for clinical tests, which have not started yet.
CimaVax targets non-small-cell carcinoma, the most common form of lung cancer, by targeting a growth factor cancer cells need to survive rather than the tumor itself. Although this does not prevent or cure the disease, it has been shown in trials to extend patient survival significantly beyond other treatments.
A phase 2 clinical trial in 2008 showed the drug prolonged life for all patients, but especially for patients younger than 60, who survived about 18 months longer than patients who did not receive the vaccine. Roughly two-thirds of patients who received the vaccine in the trial survived for a year.
Geidy Lorenzo, a researcher at Cuba’s Molecular Engineering Center, told the Cuban News Agency his institution would begin delivering CimaVax to policlinics throughout the country to expand its national ongoing trial. While it is starting with a slow roll-out, the drug is expected to be available across Cuba at some point in 2016.
More than 3000 patients in Cuba, where it has been available since 2011, have been treated with CimaVax — and about 5000 people worldwide have received it since the drug began clinical trials in other countries.
Roswell Park Cancer Institute is currently waiting for the Food and Drug Administration to review its filing to begin a phase 1 clinical trial on the drug in the United States. Researchers there are hopeful to begin the trial sometime in 2016.
“The bottom line is that this vaccine works,” Dr. Kelvin Lee, chairperson of the department of immunology at Roswell Park Cancer Institute, wrote in a blog post. “The ease of administration — a shot in the shoulder once per month — combined with the inexpensive cost could make it a very attractive option in the United States.”
By Stephen Feller