SAN JOSE, Calif., Sept. 5, 2018 /PRNewswire/ -- ITUS Corporation (NASDAQ : ITUS ) and its research partner, Moffitt Cancer Center, today announced that a pre-IND meeting with the US FDA has been scheduled on Tuesday, October 16, 2018. The meeting is to discuss numerous aspects of the planned clinical trial of their CAR-T therapy for ovarian cancer.
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".
ITUS, a cancer-focused biotechnology company, is harnessing the body's immune system in the fight against cancer. Its wholly owned subsidiary, Anixa Diagnostics Corporation, is developing the CchekTM platform, a series of inexpensive non-invasive blood tests for the early detection of solid tumors, which is based on the body's immune response to the presence of a malignancy. Its majority owned subsidiary, Certainty Therapeutics, Inc., is developing CAR-T based immuno-therapy drugs which genetically engineer a patient's own immune cells to fight cancer. ITUS also continually examines emerging technologies in complementary or related fields for further development and commercialization. Additional information is available at www.ITUScorp.com.
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SOURCE ITUS Corporation
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