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TRACON Pharmaceuticals, Inc. Initiates Phase 2 Clinical Trial Of TRC105 In Patients With Soft Tissue Sarcoma


9/4/2014 10:15:57 AM

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SAN DIEGO, Sept. 4, 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 Phase 2 portion of a clinical trial evaluating TRC105 in combination with Votrient® (pazopanib), a vascular endothelial growth factor (VEGF) inhibitor, to treat patients with soft tissue sarcoma. TRC105, an anti-endoglin antibody, is being studied in multiple clinical trials in combination with agents that inhibit angiogenesis by targeting the VEGF pathway.

"Soft tissue sarcoma is an angiogenesis-driven tumor with limited treatment options available for patients," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Based on our experience in the Phase 1 portion of the clinical trial, where the combination of TRC105 and Votrient was well-tolerated, we are moving forward into the Phase 2 portion of the clinical trial and look forward to working closely with our investigators and collaborators."

Dose escalation in the Phase 1 portion of the clinical trial of TRC105 in combination with Votrient has been completed and the combination was well-tolerated at the approved dose of Votrient and the recommended Phase 2 dose of TRC105. The Phase 2 portion of the trial is a multicenter, open-label, nonrandomized clinical trial of TRC105 in combination with Votrient in patients with soft tissue sarcoma. Approximately 60 patients are expected to be enrolled at approximately eight sites in the United States, including the sites that conducted the Phase 1 portion of the clinical trial: Mayo Clinic-Rochester, Mayo Clinic-Jacksonville, Duke University, Mount Sinai Hospital, Sarcoma Oncology Center-Santa Monica, and the University of Alabama-Birmingham.

In the Phase 2 portion of the clinical trial, TRACON expects to correlate progression-free survival and overall response rate with endoglin expression on sarcoma tissue to assess whether direct endoglin expression on sarcoma cells may serve as a biomarker that identifies responsive sarcoma subtypes.

About TRC105

TRC105 is a novel, clinical stage antibody to endoglin, which is a protein that is overexpressed on 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

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