Jacksonville FL, January 10, 2017 – (NASDAQ: ), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer and metastatic disease today announced the opening of its Phase 2 company-sponsored ovarian cancer study in platinum-sensitive ovarian cancer patients. The company’s first three clinical sites have received regulatory and Investigational Review Board (IRB) approval to begin enrollment. The study will utilize TPIV 200, a T-cell therapy targeting the folate receptor alpha protein.
This ovarian cancer study is an 80-patient double-blind placebo controlled study designed to examine the potential benefits of using the company’s lead product candidate TPIV 200 in combination with standard of care chemotherapy. The study has Fast Track designation from the FDA and the product (TPIV 200) has orphan drug status for ovarian cancer.
“The opening of this study represents the fulfillment of a major 2016 milestone,” said Dr. John Bonfiglio, President and COO of TapImmune. “We now have three clinical studies utilizing TPIV 200 with approvals to enroll patients. A fourth study in triple-negative breast cancer sponsored by the Mayo clinic with a $13.3M grant from the Department of Defense is scheduled to begin shortly. We believe the depth of these clinical programs will give us an excellent understanding of how this exciting T-cell therapy can potentially be used in the treatment of both triple-negative breast and ovarian cancers.”
TapImmune, Inc. is a leader in the immunotherapy of woman’s cancers advancing multiple Phase 2 and Phase 1b/2 clinical studies for the treatment of ovarian and breast cancer. The company’s peptide- or nucleic acid-based immunotherapeutic products comprise one or multiple naturally processed epitopes (NPEs) designed to comprehensively stimulate a patient’s killer T cells and helper T cells, and to restore or further augment antigen presentation by using proprietary nucleic acid-based expression systems. The company’s technologies may be used as stand-alone medications or in combination with current treatment modalities.
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This release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements”. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stored in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update the forward-looking statements.
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