Independent Review Board Confirms Interim Safety Profile of TPIV 200
JACKSONVILLE, FLORIDA – February 15, 2017 – TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics for the treatment of cancer and metastatic disease, today announced its lead cancer vaccine candidate, TPIV 200, received a positive recommendation from an independent Data Safety Monitoring Board (DSMB) to continue dosing triple-negative breast cancer (TNBC) patients in an ongoing Phase 2 clinical trial.
The planned safety review was performed when enrollment had reached 25 percent benchmark (20/80 patients). The four-arm trial is designed to test the safety, dosing level and optimal treatment regimen of TPIV 200, the company’s novel five-peptide vaccine designed to elicit a long-lasting adaptive immune response against TNBC cells, involving both “helper” and “killer” T-cells. The study tests two vaccine dose levels with and without cyclophosphamide priming of the immune system and will monitor for sustained immune response and relapse-free survival for three years. TapImmune will be enrolling the remaining patients at 12 clinical centers in the U.S. with enrollment completion targeted for the end of 2017.
“Successful completion of this safety review represents yet another clinical milestone achieved for TPIV 200,” said Dr. Glynn Wilson, chairman and CEO of TapImmune. “This is now our second TPIV 200 clinical study to complete a successful interim safety review allowing the continuation of recruitment according to the protocol. Our Phase 2 clinical trial in platinum-resistant ovarian cancer at Memorial Sloan Kettering Cancer Center, in combination with Astra-Zeneca’s durvalumab, had previously passed its initial safety review and this study has now recruited over 50 percent of total patients. We have two additional Phase 2 trials now enrolling or about to enroll ovarian and triple-negative breast cancer patients, and continue to believe TPIV 200 will have a significant impact in the cancer immunotherapy space. We look forward to bringing this product to these ovarian and breast cancer patients in need of advanced therapy in the most expeditious manner possible.”
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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