TapImmune, Inc. (TPIV), 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.”
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