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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 - 53 of the 88 evaluable patients (60%) had an objective response - - Gedatolisib showed a potentially differentiated safety and
About this update from Celcuity Inc.
[{"type":"text","content":"\nPreliminary Phase 1b Data\n\n- 53 of the 88 evaluable patients (60%) had an objective response -\n\n- Gedatolisib showed a potentially differentiated safety and tolerability profile -\n\nCorporate Update\n\n- Entered $25 million debt financing agreement with Innovatus Capital Partners -\n\n- Proceeds from first $15 million tranche increase cash-on-hand to $44 million -\n\n- Drug development capabilities and team broadened and expanded -\n\n- Conference call and webcast scheduled for today, April 8 at 5 p.m. Eastern Time -\n\n MINNEAPOLIS--(BUSINESS WIRE)--\nCelcuity 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.\n\n“We are very encouraged by this preliminary data for gedatolisib from our ongoing Phase 1b trial in patients with breast cancer,” said Brian Sullivan, CEO and Co-Founder of Celcuity. “The robust response rate and the observed tolerability profile are particularly compelling given the need for a therapeutic regimen that can address endocrine therapy resistance. We look forward to sharing additional data from the study at a future medical conference in 2021. Developing a therapeutic such as gedatolisib allows us to more fully leverage our CELsignia cellular analysis platform.“\n\nPreliminary Phase 1b Data for Gedatolisib:\n\nThe preliminary Phase 1b data set for the 103 patients enrolled utilized a January 11, 2021 data cut-off. Patients were enrolled in one of four expansion arms (A, B, C, D), according to their prior treatment history for metastatic breast cancer. All patients received gedatolisib in combination with standard doses of palbociclib and endocrine therapy (either letrozole or fulvestrant). In Ar...