Celcuity collaborates with Puma Biotech & Wilmot Cancer Center

Celcuity Inc., a biotechnology company focused on an integrated companion diagnostic and therapeutic strategy for treating cancer patients, has recently announced a clinical trial partnership with the Wilmot Cancer Center and Puma Biotechnology for conducting Phase 2 clinical trial.

The phase 2 trial basically involves examining the efficacy and safety of Puma's drug, NERLYNX (neratinib), and Xeloda (capecitabine), a Genentech/Roche drug, in earlier cured patients selected with Celcuity's CELsignia HER2 Activity Trial who suffer from metastatic HER2-negative breast cancer.

As per the agreement, Wilmot Cancer Center will assist as the sponsor, and Ajay Dhakal, M.D., a medical oncologist at the University of Rochester Medical Center, will serve as the key investigator of this study.

Meanwhile, Puma will supply its pan-HER inhibitor NERLYNX, which is approved by the U.S. FDA (Food and Drug Administration) for early and late-stage HER2-positive breast cancer.

As part of the deal, Celcuity will offer its CELsignia HER2 Activity Trial to select HER2-negative metastatic breast cancer patients with brain metastases who have hyper HER2-driven motioning paths for the fund and will eventually fund the cost related to the patient trial.

As per sources, Celcuity anticipates getting interim results based on its estimates of patient enrollment 12 to 15 months after the commencement of the trial, followed by the final results 12 to 15 months later.

Based on its estimates of patient enrollment rates, Celcuity assumes to obtain provisional results 12 to 15 months after commencement of the trial followed by the final results 12 to 15 months later. The enrollment is expected to begin in early to mid-2022.

The trial's goal is to show that HER2-negative metastatic breast cancer patients with brain metastases who have hyperactive HER2 signaling cancer tumor, as determined by the CELsignia test, respond quickly to treatment with NERLYNX in combination with XELODA, a normally used chemotherapy in metastatic breast cancer patients.

Source Credit - https://www.businesswire.com/news/home/20211018005920/en/Celcuity-Announces-Clinical-Trial-Collaboration-with-University-of-Rochester-Wilmot-Cancer-Center-and-Puma-to-Study-Patients-with-Breast-Cancer-Brain-Metastases