Search jobs
08-Apr-2021
Celcuity Reports Preliminary Data from Phase 1b Trial of Gedatolisib plus Ibrance® and Endocrine Therapy for Patients with ER+/HER2- Metastatic Breast Cancer and Provides Corporate Update
Preliminary Phase 1b Data
- Gedatolisib showed a potentially differentiated safety and tolerability profile -
Corporate Update
- Proceeds from first $15 million tranche increase cash-on-hand to $44 million -
- Drug development capabilities and team broadened and expanded -
- Conference call and webcast scheduled for today, April 8 at 5 p.m. Eastern Time -
MINNEAPOLIS--(BUSINESS WIRE)--Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company pursuing an integrated companion diagnostic and therapeutic strategy for treating patients with cancer, today reported preliminary data for the 103 patients enrolled in the expansion portion of an ongoing Phase 1b clinical trial evaluating gedatolisib, a first-in-class PI3K/mTOR inhibitor, plus Ibrance and endocrine therapy, in ER+/HER2- advanced or metastatic breast cancer patients. As of the January 11, 2021 data cut-off date, 53 of the 88 evaluable patients (60%) had an objective response. Gedatolisib was also generally well tolerated, with the majority of treatment-related adverse events (TRAE) being Grade 1 or 2. The most common Grade 3 or 4 TRAEs related to gedatolisib were stomatitis and rash.