Business
Celcuity Inc. Reports Second Quarter 2023 Financial Results and Provides Corporate Updates
Phase 3 VIKTORIA-1 clinical trial is now recruiting patients at nearly 200 sites in 20 countriesPresented updated results from Phase 1b study of gedatolisib
About this update from Celcuity Inc.
[{"type":"text","content":"Phase 3 VIKTORIA-1 clinical trial is now recruiting patients at nearly 200 sites in 20 countriesPresented updated results from Phase 1b study of gedatolisib in treatment-naïve advanced breast cancer at the ESMO Breast Cancer Annual CongressMedian progression free survival (PFS) was 48.6 months in treatment-naïve patients with HR+/HER2- advanced breast cancer who were treated with gedatolisib in combination with palbociclib and letrozoleManagement to host webcast and conference call today, August 10, 2023, at 4:30 p.m. ET MINNEAPOLIS, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today reported financial results for the second quarter ended June 30, 2023 and provided other recent corporate updates. “Patient enrollment in the Phase 3 VIKTORIA-1 trial is progressing in-line with our planned timeline. Nearly 200 sites are now recruiting patients in 20 countries,” said Brian Sullivan, CEO and Co-Founder of Celcuity. “We are also very encouraged by the updated median PFS and DOR data we reported for gedatolisib in combination with letrozole and palbociclib in the first-line setting. These results continue to drive our confidence that gedatolisib can play an important role in improving outcomes for women with HR+/HER2- advanced breast cancer, regardless of PIK3CA-status.” Second Quarter 2023 Business Highlights and Other Recent Developments The VIKTORIA-1 Phase 3 trial remains on track to provide initial data and analysis of the PIK3CA wild type patient sub-group in the second half of 2024 and data for the PIK3CA mutated patient sub-group in the first half of 2025. The Phase 3 VIKTORIA-1 clinical trial is now recruiting patients at nearly 200 sites in 20 countries.VIKTORIA-1 is evaluating gedatolisib in combination with fulvestrant, an endocrine therapy, with and without palbociclib, a CDK4/6 inhibitor, in adults with HR+/HER2- advanced breast cancer. In May 2023, updated results from a Phase 1b trial evaluating gedatolisib, in combination with palbociclib and the aromatase inhibitor, letrozole, were presented at the 2023 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress, with data updated as of March 16, 2023. For treatment-naïve patients from Escalation Arm A and Expansion Arm A (n=41), mPFS was 4...