Moffitt Cancer Center and ITUS Corporation Announce Scheduling of Pre-IND Meeting with the FDA for their CAR-T Therapy
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 Corporation
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.
Forward-Looking Statements: Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect ITUS Corporation's current expectations concerning future events and results. We generally use the words "believes," "expects," "intends," "plans," "anticipates," "likely," "will" and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in "Item 1A - Risk Factors" and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.
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