TapImmune Begins Phase 2 Trial of T-cell Therapy for Platinum-sensitive Ovarian Cancer Patients

TapImmune Begins Phase 2 Trial of T-cell Therapy for Platinum-sensitive Ovarian Cancer Patients
TapImmune has initiated a Phase 2 clinical trial to evaluate the T-cell therapy TPIV 200 in platinum-sensitive ovarian cancer patients. Following regulatory and Investigational Review Board (IRB) approval, the first three clinical sites were allowed to begin enrolling patients. The multicenter, randomized Phase 2 clinical trial (NCT02978222) will evaluate the activity of TPIV 200, a T-cell therapy that targets the folate receptor alpha protein, as a consolidation treatment following completion of at least four cycles of a platinum-containing regimen. The study will enroll 80 patients with recurrent platinum-sensitive, non-mucinous ovarian, fallopian tube, or primary peritoneal cancer. The trial's primary endpoints include the assessment of progression-free survival following two years of treatment and time to disease progression or recurrence of ovarian cancer. Secondary endpoints include a two-year post-treatment assessment of overall survival (OS), best overall response, including complete responses and partial responses, disease control rate, response rate, and cancer antigen (CA)-125 response. The clinical trial has Fast Track designation from the U.S. Food and Drug Administration (FDA), which also granted TPIV 200 Orphan Drug status for ovarian cancer. "The opening of this study represents the fulfillment of a major 2016 milestone," Dr. John Bonfiglio, president and CEO of TapImmune, said in a press release. "We now have three clinical studies utilizing TPIV 200 with approvals to enroll patients." He said a fourth study in triple-negative breast cancer sponsored by the Mayo Clinic with a $13.3 million grant from the U.S. Department of Defense is scheduled to begin shortly. "We believe the depth of these clinical programs will give us
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