BiovaxID: An Interview with Dr. Eduardo M. Sotomayor (Part 4 of a series)
BiovaxID: An Interview with Dr. Eduardo M. Sotomayor (Part 4 of a series):
By Ross Bonander, November 09, 2012
Excerpts:
"In this next installment in my ongoing series,"BiovaxID: On the Trail of the Lymphoma Vaccine", I interviewed one of the world's leading authorities on lymphoma, Dr. Eduardo M. Sotomayor.
Dr. Sotomayor serves as Chair of the Department of Malignant Hematology and holds the Susan and John Sykes Endowed Chair in Hematologic Malignancies at H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida."
"Dr. Sotomayor served as one of the principal investigators in the Phase III clinical trial evaluating BiovaxID in the consolidation setting against follicular lymphoma and co-authored the ensuing paper in the Journal of Clinical Oncology 1.
We discussed BiovaxID, the response to the vaccine by regulatory agencies in Europe and the US, as well as a similar lymphoma vaccine under development at Moffitt, and the mystery that is mantle cell lymphoma, among other things.
The Interview
Ross Bonander: Were you surprised when the FDA requested a second Phase III trial for BiovaxID?
Sotomayor: Yes. But you have to look at the history of this vaccine. The trial began in 2000. That was really before the widespread use of rituximab. Most of the patients in the trial received PACE chemotherapy. After ritiximab became common practice we had to modify the trial to allow patients to be treated with chemotherapy that included rituximab.
So one of the questions the FDA had was, 'This trial began before rituximab, how can you apply trial results to the current practice?'"
To read the full article and to view the other 3 parts of this series, click here.
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