TRACON's TRC105 Receives FDA Fast Track Designation
"We are pleased to receive fast track designation for TRC105 for the treatment of patients with advanced renal cell carcinoma," said
The FDA created the Fast Track designation process to facilitate the development and expedite the review of drugs to treat serious diseases and address unmet medical needs. Fast Track designation confers important benefits, including the potential eligibility for Priority Review of a New Drug Application, if relevant criteria are met.
TRACON is sponsoring a multicenter, open-label, randomized clinical trial of TRC105 in combination with AXitinib in patients with Advanced or metastatic RCC (TRAXAR). The primary endpoint of the Phase 2b study is progression-free survival. Approximately 150 patients with clear cell RCC who have failed one prior VEGF inhibitor are expected to enroll in the study. Patients may have also failed one prior mTOR inhibitor and one prior immunotherapy. For additional information on this clinical trial, please visit www.clinicaltrials.gov, identifier NCT01806064.
About Advanced Renal Cell Carcinoma
About TRC105
TRC105 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. TRC105 is currently being studied in clinical trials sponsored by both TRACON and the
About TRACON
TRACON develops targeted therapies for cancer, age-related macular degeneration and fibrotic diseases. TRACON's current pipeline includes two clinical stage product candidates: TRC105, an anti-endoglin antibody that is being developed for the treatment of renal cell carcinoma, soft tissue sarcoma, hepatocellular carcinoma, glioblastoma and choriocarcinoma, and TRC102, a small molecule that is being developed for the treatment of lung cancer and glioblastoma. To learn more about TRACON and its product candidates, visit TRACON's website at www.traconpharma.com.
1 Cancer Facts & Figures 2015. American Cancer Society. Available at http://www.cancer.org/acs/groups/content/@editorial/documents/document/acspc-044552.pdf
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3 http://www.cancer.org/cancer/kidneycancer/detailedguide/kidney-cancer-adult-survival-rates
CONTACT:Casey Logan Chief Business Officer (858) 550-0780 ext. 236 clogan@traconpharma.com