On September 5, 2018 ITUS Corporation (NASDAQ: ITUS) and its research partner, Moffitt Cancer Center, reported that a pre-IND meeting with the US FDA has been scheduled on Tuesday, October 16, 2018 (Press release, Anixa Biosciences, SEP 5, 2018, View Source [SID1234530493]). The meeting is to discuss numerous aspects of the planned clinical trial of their CAR-T therapy for ovarian cancer.
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Dr. Amit Kumar, CEO of ITUS stated, "We are pleased to be meeting with the FDA this fall, as anticipated. We have submitted pre-clinical data, as well as a series of questions, to the FDA. Coming out of this meeting, our goal is to have a good understanding of the design for the clinical trial in our Investigational New Drug (IND) application. Assuming the FDA does not require additional animal studies, we hope to file the IND application in early 2019, with human testing potentially beginning shortly thereafter."
Dr. Jose Conejo-Garcia, Co-head of Immunology at Moffitt Cancer Center, the inventor of the technology, and the Principal Investigator of the team developing the therapy, added, "We are heading towards the first in human trial of our hormone receptor based Chimeric Antigen Receptor T-cell technology, which internally we refer to as Chimeric Endocrine Receptor T-cell technology (CER-T). Our unique approach, could create a whole new platform for CAR-T that takes advantage of hormone-receptor combinations. To date CAR-T therapy has only shown efficacy in certain liquid tumors. We hope our approach will enable chimeric receptors expressed on T cells to work on the vastly larger numbers of solid tumors relative to hematological malignancies".