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Saturday, November 10, 2012

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?
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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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Pharmacy History

"The earliest known compilation of medicinal substances was ARIANA the Sushruta Samhita, an Indian Ayurvedic treatise attributed to Sushruta in the 6th century BC. However, the earliest text as preserved dates to the 3rd or 4th century AD.
Many Sumerian (late 6th millennium BC - early 2nd millennium BC) cuneiform clay tablets record prescriptions for medicine.[3]

Ancient Egyptian pharmacological knowledge was recorded in various papyri such as the Ebers Papyrus of 1550 BC, and the Edwin Smith Papyrus of the 16th century BC.

The earliest known Chinese manual on materia medica is the Shennong Bencao Jing (The Divine Farmer's Herb-Root Classic), dating back to the 1st century AD. It was compiled during the Han dynasty and was attributed to the mythical Shennong. Earlier literature included lists of prescriptions for specific ailments, exemplified by a manuscript "Recipes for 52 Ailments", found in the Mawangdui tomb, sealed in 168 BC. Further details on Chinese pharmacy can be found in the Pharmacy in China article."

From Wikipedia: http://en.wikipedia.org/wiki/Pharmacy#History_of_pharmacy

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