SAN DIEGO, April 10, 2017 (GLOBE NEWSWIRE) -- 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 (AMD) and fibrotic diseases, announced today that the Company’s Phase 3 TAPPAS clinical trial of TRC105 in angiosarcoma was awarded Most Innovative Clinical Trial Design at the 2017 Clinical and Research Excellence (CARE) Awards, which are presented by Informa’s Pharma Intelligence, a leading provider of drug, device, company, clinical trial, and market intelligence.
The winners of the CARE awards were decided by a panel of distinguished industry experts. The panel recognized the innovative design of the TAPPAS trial, which has received a Special Protocol Assessment from the U.S. Food and Drug Administration (FDA), and analyzes TRC105 safety and efficacy data in real-time to determine the final study sample size and treatment population.
“This award is an important acknowledgement of the efforts of TRACON and our partner, Cytel, to design the TAPPAS trial with greater flexibility and efficiency to identify potential signs of clinical benefit in angiosarcoma, a rare and aggressive tumor with limited treatment options,” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON.
Cyrus Mehta, Ph.D., President of Cytel, said, "This study utilizes an innovative adaptive enrichment design that adjusts the sample size and the patient population based on an interim analysis of the accruing data. It is ideal for rare diseases like angiosarcoma where prior data are scarce and patient enrollment is difficult. The design was approved by both the FDA and EMA for adoption in a confirmatory Phase 3 setting."
The awards were announced at a ceremony in Boston, MA, on April 5, 2017.
About the Phase 3 TAPPAS Study
TRACON is enrolling patients in the Phase 3 TAPPAS trial (a randomized Phase 3 trial of TRC105 And Pazopanib versus Pazopanib alone in patients with advanced AngioSarcoma) under Special Protocol Assessment (SPA) with the FDA at sites in the U.S. and Europe. This one-to-one randomized trial of TRC105 in combination with Votrient (pazopanib) versus single agent Votrient features an adaptive enrichment design. The trial has an initial enrollment target of 124 patients and, based on an interim analysis, allows for sample size re-estimation up to a maximum of 200 patients, as well as enrichment of potentially more responsive patients with cutaneous angiosarcoma. The primary endpoint is progression-free survival, with overall survival as a secondary endpoint.
Further details of the study are available on www.clinicaltrials.gov under NCT02979899.
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 one Phase 3 and multiple Phase 2 clinical trials sponsored by TRACON or the National Cancer Institute for the treatment of solid tumors in combination with VEGF inhibitors. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. 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 http://www.traconpharma.com/clinical_trials.php.
TRACON develops targeted therapies for cancer, ophthalmic and fibrotic diseases. The Company’s clinical-stage pipeline includes: TRC105, an endoglin antibody that is being developed for the treatment of multiple cancers; DE-122, the ophthalmic formulation of TRC105 that is being developed in wet AMD through a collaboration with Santen Pharmaceutical Company Ltd.; TRC102, a small molecule that is being developed for the treatment of lung cancer and glioblastoma; and TRC253, a small molecule that is being developed for the treatment of prostate cancer. To learn more about TRACON and its product candidates, visit TRACON's website at www.traconpharma.com.
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