TRACON Pharmaceuticals Announces Initiation of TRC102 Combination Phase 1b/2 Trial

TRACON Pharmaceuticals 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, today announced the initiation of a two cohort clinical trial sponsored by the National Cancer Institute (NCI), containing a Phase 2 portion evaluating the combination of TRC102 and Alimta® (pemetrexed) in patients with mesothelioma and a Phase 1b portion evaluating the combination of TRC102, Alimta and cisplatin in patients with solid tumors. TRC102, a novel small molecule inhibitor of the base excision repair (BER) pathway of chemotherapy resistance, is being studied in multiple ongoing clinical trials supported by the NCI in combination with multiple chemotherapeutics. "TRC102 has shown promising data in multiple Phase 1 trials, and we are pleased that the NCI has chosen to move forward into Phase 2 testing," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Previously completed clinical trials sponsored by TRACON, Case Cancer Center and the NCI have demonstrated that TRC102 can be safely combined with three separate chemotherapeutics - Alimta, Temodar® (temozolomide) and Fludara® (fludarabine). This Phase 1b/2 study is part of a broad development program for TRC102 that includes a number of additional planned studies including a Phase 2 trial in glioblastoma patients combining TRC102 with Temodar." The clinical trial is an open-label, nonrandomized trial with a Phase 2 portion that will assess the activity of Alimta and TRC102 in patients with mesothelioma who have progressed on prior chemotherapy. In addition, the trial includes a Phase 1b dose-finding portion that will assess TRC102 in combination with Alimta and cisplatin in patients with refractory solid tumors. The two cohort clinical trial is expected to enroll a total of 58 patients. For additional information on this clinical trial, please visit https://clinicaltrials.gov/, trial identifier NCT02535312. About TRC102 TRC102 (methoxyamine) is a novel, clinical-stage small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in clinical trials sponsored by both the National Cancer Institute and Case Comprehensive Cancer Center. For more information about the clinical trials, please visit TRACON's website at http://www.traconpharma.com/clinical_trials.php.