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Apricoxib Prolongs Time-to-Progression and Overall Survival in Biomarker-Selected NSCLC Patients
Date:6/6/2011

e United States. In the APRiCOT-L study, Tragara utilized a functional biomarker known as PGEM (a urinary metabolite of PGE2, the pro-inflammatory product of COX-2 activity) to select patients for inclusion into the trial in order to identify the patient population with the best chance of benefitting from apricoxib therapy. The patient selection process included an open-label five-day apricoxib run-in period where baseline and day five urine samples were collected from patients.

Patients with a 50% or greater PGEM decrease from baseline were eligible for randomization if all other eligibility criteria were met.

Time-to-progression was not statistically significantly different than erlotinib alone for the overall population. Safety profiles of the two arms were similar. The most common adverse events reported were of the skin and gastrointestinal tract, similar to the reported toxicity profile of erlotinib alone. Most events were mild to moderate.

"We are very pleased with the efficacy and safety outcomes of APRiCOT-L and the operational ease of employing the patient selection strategy," said Sara Zaknoen, M.D., chief medical officer, Tragara Pharmaceuticals, Inc. "We believe that apricoxib represents an important new potential treatment for patients with NSCLC and look forward to moving into Phase III."

Capoxigem has been shown to potently inhibit COX-2-derived PGE2 production, reversing the PGE2-dependent epithelial-mesenchymal transition (EMT) process and the associated progression and metastasis of solid tumors. Reversal of EMT has important implications for the treatment of NSCLC using COX-2 inhibitors in combination with other agents.

Apricoxib is being studied in another Phase II clinical trial evaluating its use in combination with chemotherapy as second-line therapy for NSCLC. This trial utilizes a patient selection methodology similar to APRiCOT-L. Additionally, the company completed enrollment in late 2010 in a Phase
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SOURCE Tragara Pharmaceuticals, Inc.
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