On October 3, 2016 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age‐related macular degeneration and fibrotic diseases, reported the successful completion of an End-of-Phase 2 meeting with the United States Food and Drug Administration (FDA) and a Protocol Assistance Meeting with the European Medicines Agency (EMA) (Press release, Tracon Pharmaceuticals, OCT 3, 2016, View Source [SID:SID1234515559]). TRACON reached agreement with both regulatory agencies regarding key elements of the Phase 3 program for TRC105 in angiosarcoma and expects to initiate enrollment in the Phase 3 study by year-end. Schedule your 30 min Free 1stOncology Demo! "We appreciate the valuable discussions and guidance from our End-of-Phase 2 discussion with FDA and Protocol Assistance Meeting with EMA, and are confident that we have a robust design for TRC105’s first Phase 3 trial," said Charles Theuer, M.D., Ph.D., President and CEO. "With the successful completion of the regulatory meetings, we are focused on advancing TRC105 as the first potential therapeutic specifically for the treatment of angiosarcoma, an ultra-orphan indication with a high unmet need. We look forward to initiating our Phase 3 program before the end of the year."
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End-of-Phase 2 Meetings and Phase 3 Study Design
The U.S. and European regulators separately determined the acceptability of the following key aspects of the proposed Phase 3 randomized trial:
One-to-one randomized trial of TRC105 in combination with Votrient (pazopanib) versus Votrient alone.
A planned total enrollment of 124 patients with an adaptive design based on an interim analysis that allows for sample size re-estimation up to a maximum of 200 patients, as well as enrichment of more responsive patients based on the subtype of angiosarcoma, visceral or cutaneous.
Primary endpoint of progression-free survival (PFS) with overall survival (OS) as a secondary endpoint.
Open label format with independent blinded assessment of endpoint data.
Eligible patients will be stratified by treatment naive versus greater than one prior cancer therapy and will not have received a prior VEGF inhibitor.
The trial will provide at least 80% power to determine an improvement in median PFS from 4.0 to 7.3 months using a two-tailed alpha of 0.05.
TRACON intends to submit the proposed protocol for special protocol assessment to FDA later this year.
About TRC105 (carotuximab)
TRC105 (carotuximab) is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation, and also expressed on fibroblasts, a cell that causes fibrosis. TRC105 is currently being studied in multiple Phase 2 clinical trials sponsored by TRACON or the National Cancer Institute for the treatment of solid tumor types in combination with VEGF inhibitors. The ophthalmic formulation of TRC105, DE-122, is currently in a Phase 1/2 trial for patients with wet AMD. TRC205, a second generation antibody to endoglin, is undergoing preclinical testing in models of fibrosis. For more information about the clinical trials, please visit TRACON’s website at View Source