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HemOnc spoke with Candace S. Johnson, PhD, president and CEO of Roswell Park Cancer Institute, about the collaboration with Centro de Inmunologia Molecular in Havana; the effort to conduct a trial to test the lung cancer vaccine; and how this initiative may lay the groundwork for future U.S.-based investigations and improve access to those therapies.
Q: Can you describe the process you had to go through to obtain approval for this trial?
A: First, we had to seek special permission from the U.S. government — specifically, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) — to bring CIMAvax into the United States. We received such a license from OFAC in 2014, and that is when we started our preclinical research with CIMAvax. Then we had to reach out to the FDA to get permission for our clinical trial. That part really was very straightforward, and it was not all that different from the process we go through with any investigational new drug application for a new therapy. In between all of this, we made a number of visits to Cuba with our own teams to get our questions answered and start thinking about how to design the best trial.
Q: Cuba has developed other medical treatments that are not yet available in the United States. Might this initiative lay the groundwork for future U.S.-based investigations or improved access to those therapies?
A: Yes. Centro de Inmunologia Molecular scientists have created a number of innovative therapies, not just for cancer but for many other serious and common diseases and medical conditions, including Heberprot-P, a therapy they developed for diabetic foot ulcers. They have developed a number of vaccines and monoclonal antibodies. We are interested in how some other therapies might improve outcomes for patients in the U.S. and elsewhere, and we are now starting to look at a few of them in the lab. – by Jennifer Southall
For more information: Candace S. Johnson, PhD, can be reached at Roswell Park Cancer Institute, Elm and Carlton streets, Buffalo, NY 14263; email: firstname.lastname@example.org. Disclosure: Johnson reports no relevant financial disclosures.