Business
Celcuity Inc. Reports Fourth Quarter and Full Year 2021 Financial Results, Pivotal Phase 3 Trial Design for Gedatolisib in the Treatment of Advanced Breast Cancer, and Business Updates
Finalized pivotal Phase 3 trial design following formal meetings with FDAReceived FDA Fast Track designation for gedatolisib in HR+/HER2- metastatic breast
About this update from Celcuity Inc.
[{"type":"text","content":"Finalized pivotal Phase 3 trial design following formal meetings with FDAReceived FDA Fast Track designation for gedatolisib in HR+/HER2- metastatic breast cancerPresented updated Phase 1b data during a Spotlight Poster-Discussion Session at the 2021 San Antonio Breast Cancer Symposium in December 2021Entered into a clinical collaboration and supply agreement with Pfizer for planned Phase 3 clinical trial evaluating gedatolisib in combination with Ibrance® and Faslodex® in advanced breast cancer (ABC)Management to host webcast and conference call today, March 23, 2022, at 4:30 p.m. ETMINNEAPOLIS, MN / ACCESSWIRE / March 23, 2022 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing an integrated therapeutic and companion diagnostic strategy for treating patients with cancer, today announced financial results for the fourth quarter and full year ended December 31, 2021, the design for its pivotal Phase 3 trial for gedatolisib, an investigational pan-PI3K/mTOR inhibitor, and other recent business progress.The pivotal Phase 3 clinical trial, which is named VIKTORIA-1, will be an open-label, randomized study to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant with or without palbociclib in adults with HR+/HER2- advanced breast cancer whose disease has progressed after prior CDK4/6 therapy in combination with an aromatase inhibitor. Prior to finalizing the Phase 3 trial design, Celcuity conducted two formal meetings with the U.S. Food and Drug Administration (FDA) to obtain their feedback.The clinical trial will enroll subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Subjects who meet eligibility criteria and do not have confirmed PI3KCA mutations (WT) will be randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm A), gedatolisib and fulvestrant (Arm B), or fulvestrant (Arm C). Up to 351 subjects who are PIK3CA WT will be enrolled. Subjects who meet eligibility criteria and have confirmed PI3KCA mutations (MT) will be randomly assigned (1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm D) or alpelisib and fulvestrant (Arm E). Up to 300 subjects who are PIK3CA MT will be enrolled.The primary endpoints for this pivotal study are pro...