On 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, reported 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 (Press release, TapImmune, FEB 15, 2017, View Source [SID1234517725]). Schedule your 30 min Free 1stOncology Demo! 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.
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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."