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TRACON Pharmaceuticals Initiates Randomized Phase 2 Clinical Trial of TRC105 in Patients With Renal Cell Carcinoma

SAN DIEGO, Dec. 1, 2014 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals, a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and age-related macular degeneration, today announced the initiation of dosing in the randomized Phase 2 portion of a clinical trial evaluating TRC105 in combination with Inlyta® (axitinib), a vascular endothelial growth factor (VEGF) inhibitor, to treat patients with renal cell carcinoma. TRC105, an anti-endoglin antibody, is being studied in multiple clinical trials in combination with agents that inhibit angiogenesis by targeting the VEGF pathway.

"Based on our experience in the Phase 1 portion of the clinical trial, where the combination of TRC105 and Inlyta was well-tolerated with encouraging signs of efficacy, we are moving forward into the Phase 2 portion of the clinical trial," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We look forward to working closely with our investigators over the coming months to enroll this important study."

Dose escalation in the Phase 1 portion of the clinical trial of TRC105 in combination with Inlyta has been completed and the combination was well-tolerated at the approved dose of Inlyta and the recommended Phase 2 dose of TRC105. The Phase 2 portion of the trial is a multicenter, open-label, randomized clinical trial of TRC105 in combination with Inlyta in patients with renal cell carcinoma. The primary endpoint of the Phase 2 portion of the study is progression-free survival. Approximately 150 patients are expected to be enrolled at approximately twenty sites in the United States, including sites that conducted the Phase 1 portion of the clinical trial: Dana Farber Cancer Institute, Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Cedars-Sinai Medical Center and the University of Alabama-Birmingham.

About TRC105

TRC105 is a novel, clinical stage antibody to endoglin, which is a protein that is overexpressed on proliferating endothelial cells and 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 National Cancer Institute for the treatment of multiple solid tumor types in combination with VEGF inhibitors. TRC105 is also expected to be studied in combination with VEGF inhibitor treatments in age‐related macular degeneration. For more information about the clinical trials, please visit TRACON's website at http://www.traconpharma.com/clinical_trials.php.

About TRACON

TRACON develops targeted therapies for cancer and age-related macular degeneration. TRACON's current pipeline includes two clinical stage product candidates: TRC105, an anti-endoglin antibody that is being developed for the treatment of multiple solid tumor types, and TRC102, a small molecule that is being developed for the treatment of lung cancer and glioblastoma. Both TRC105 and TRC102 are being developed for treatment in combination with currently available therapies. To learn more about TRACON and its product candidates, visit TRACON's website at www.traconpharma.com.

CONTACT: Casey Logan Chief Business Officer (858) 550-0780 ext. 236 clogan@traconpharma.com

Source:TRACON Pharmaceuticals, Inc.