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Celcuity, Puma Bio Collaborate on Clinical Trial

NEW YORK (360Dx) – Celcuity said after the close of the markets on Tuesday that it will work with Puma Biotechnology in a Phase II clinical trial.

As part of the deal, West Cancer Center will be the sponsor and principal investigator on the trial, which will use Celcuity's CELx HER2 Signaling Function test to evaluate the efficacy and safety of Puma Bio's Nerlynx (neratinib) and chemotherapy on patients with early-stage triple-negative breast cancer. Up to 27 patients will be part of the trial, the partners said.

Celcuity will initially fund the patient-related trial costs. Patient enrollment is expected to begin in early 2019, and Celcuity expects interim results in 10 to 12 months after the enrollment of the first patient and final results within 18 to 24 months. 

The Minneapolis-based cellular analysis company, which develops companion diagnostics, submitted an investigation device exemption application to the US Food and Drug Administration to use its CELx HSF test for the clinical trial and received approval by the agency in mid-2018, it said.

"Establishing collaborations to evaluate the efficacy of a pharmaceutical company's therapy in patients selected with our CELx HSF test is an important objective for Celcuity," company Cofounder and CEO Brian Sullivan said in a statement. "It is the first step in what we hope can eventually lead to better treatment options for breast cancer patients."