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Celcuity Announces Clinical Trial Collaboration and Supply Agreement with Pfizer to Provide Ibrance(R) (palbociclib) for Planned Phase 3 Clinical Trial
MINNEAPOLIS, MN / ACCESSWIRE / November 15, 2021 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing an integrated therapeutic and
About this update from Celcuity Inc.
[{"type":"text","content":"MINNEAPOLIS, MN / ACCESSWIRE / November 15, 2021 / Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company pursuing an integrated therapeutic and companion diagnostic strategy for treating patients with cancer, today announced that it has entered into a clinical trial collaboration and supply agreement with Pfizer to provide Ibrance® (palbociclib) for use in Celcuity's Phase 3 clinical trial at no cost to Celcuity.As previously disclosed, Celcuity expects to initiate a Phase 3 clinical trial in the first half of 2022 to evaluate gedatolisib, the company's pan-PI3K/mTOR inhibitor, in combination with palbociclib, a CDK4/6 inhibitor, and Faslodex® (fulvestrant), a selective endocrine receptor degrader, in patients with ER+/HER2- advanced breast cancer. Further details about the design of the clinical trial will be provided once feedback is obtained from the U.S. Food and Drug Administration (FDA).\"We are excited that Pfizer is providing palbociclib for this important Phase 3 clinical trial,\" said Brian Sullivan, Chief Executive Officer and co-founder of Celcuity. \"Our goal is to address the significant unmet need for new therapeutic options for patients who progressed on their first line of treatment for ER+/HER2- advanced breast cancer.\"About GedatolisibGedatolisib is a potent, reversible dual inhibitor that selectively targets all Class I isoforms of PI3K and mTOR. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Inhibiting all four PI3K isoforms, as gedatolisib does, limits the potential confounding effect of isoform interaction that may occur with isoform-specific PI3K inhibitors. Inhibiting mTOR also addresses potential resistance mechanisms that can result when PI3K isoforms are targeted in the absence of mTOR inhibition. A robust response rate and a favorable safety profile were observed in an on-going Phase 1b clinical trial that evaluated gedatolisib in combination with palbociclib and endocrine therapy in patients with ER+/HER2- advanced breast cancer. Based on these results, a Phase 3 clinical trial is planned.About CelcuityCelcuity is a clinical-stage biotechnology company seeking to extend the lives of cancer patients by pursuing an integrated therapeutic and companion...