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Celcuity Announces Clinical Trial Collaboration with University of Rochester Wilmot Cancer Center and Puma to Study Patients with Breast Cancer Brain Metastases
Study will evaluate the efficacy and safety of NERLYNX® plus XELODA® in patients selected by the CELsignia® Test who have metastatic HER2-negative breast
About this update from Celcuity Inc.
[{"type":"text","content":"\n\nStudy will evaluate the efficacy and safety of NERLYNX® plus XELODA® in patients selected by the CELsignia® Test who have metastatic HER2-negative breast cancer with brain metastases\n\n\nThe unique tumor insights CELsignia generates enable identification of new potential applications for targeted therapies and development of potential first-in-class drugs\n\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 announced a clinical trial collaboration with the University of Rochester Wilmot Cancer Center and Puma Biotechnology (Nasdaq: PBYI), a biopharmaceutical company, to conduct a Phase 2 clinical trial.\n\nThis open-label Phase 2 trial will evaluate the efficacy and safety of Puma's drug, NERLYNX (neratinib), and Xeloda (capecitabine), a Genentech/Roche drug, in previously treated patients selected with Celcuity's CELsignia HER2 Activity Test who have metastatic HER2-negative breast cancer. Under the agreement, The University of Rochester Wilmot Cancer Center will serve as the sponsor and Ajay Dhakal, M.D., a medical oncologist at the University of Rochester Medical Center, will serve as the principal investigator of this study. The University of Rochester Wilmot Cancer Center is one of the 51 NCI-Designated Comprehensive Cancer Centers in the U.S. tasked with developing new approaches to diagnosing and treating cancer.\n\n“This clinical trial could play a key role in creating a new treatment paradigm for metastatic HER2-negative breast cancer patients with brain metastases,” said Dr. Dhakal. “We are eager to begin working with Celcuity’s cutting-edge CELsignia technology to identify a new subset of patients who may respond to NERLYNX.”\n\nPuma will supply NERLYNX, its pan-HER inhibitor currently approved by the U.S. Food and Drug Administration (FDA) for early and late-stage HER2-positive breast cancer. Celcuity will provide its CELsignia HER2 Activity Test to select HER2-negative metastatic breast cancer patients with brain metastases who have hyperactive HER2-driven signaling pathways for the trial and will fund the patient-related trial costs. Based on its estimates of patient enrollment rates, Celcuity expects to obtain interim results 12 to 15 months after ...