Benzinga | Nov 15, 2021 11:11AM EST

Celcuity Announces Clinical Trial Collaboration And Supply Agreement With Pfizer To Provide Ibrance(R) For Planned Phase 3 Clinical Trial

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(r) (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(r) (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."