Dr. Januario E. CastroJanuario E. Castro, M.D., has received a 3-year R01 grant from the Food and Drug Administration to investigate a new immunogene therapy for chronic lymphocytic leukemia (CLL).

Dr. Castro is Assistant Clinical Professor of Medicine in the Divisions of Hematology-Oncology and Blood & Bone Marrow Transplantation.

Dr. Castro’s project is “Gene therapy of chronic lymphocytic leukemia using intranodal injection of Ad-ISF35.”

Its goal is to evaluate the clinical and pre-clinical activity of Ad-ISF35, a replication-defective adenovirus vector that encodes a chimeric (human-mouse) CD154 molecule. The Ad-ISF35 is employed to transduce cancer cells and induce anti-tumor responses.

Dr. Castro and his coworkers have conducted a promising preliminary Phase 1 clinical study of Ad-ISF35 in six patients. Recently, they reported some of their findings in the Proceedings of the National Academy of Sciences (PNAS).   Read the PNAS article

The R01 funding comes from the FDA’s Office of Orphan Products Development and is expected to start in May or June of this year.

The grant will allow Dr. Castro and his team to continue the Phase 1 trial as well as to begin an extension protocol and continue correlative studies to develop this new therapeutic strategy.

The project’s co-principal investigator is Dr. Castro’s mentor, Thomas Kipps, M.D., Ph.D., Professor of Medicine in the Division of Hematology-Oncology.

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