TransThera Biosciences Co. Ltd issued the following announcement on Nov. 7.
TransThera Biosciences Co. Ltd, announced today that company received Orphan Drug Designation from US Food and Drug Administration (FDA) for TT-00420, a clinical stage investigational drug, for the treatment of cholangiocarcinoma.
Dr. Frank Wu, Founder and CEO of TransThera, commented: "Cholangiocarcinoma lacks effective therapies and remains a huge unmet medical need around the world. TT-00420 has demonstrated great potential in multiple experiments. We believe that today's orphan drug designation will help accelerate the development of this potential product in the clinical trials and bring meaningful benefit to cholangiocarcinoma patients. We are very excited about this news, which expands the horizon of our lead product in development. In addition to triple negative breast cancer, cholangiocarcinoma is identified by our scientists to be second indication for TT-00420."
TT-00420 is in global Phase I trial both in the US and China. Dose expansion Phase Ib/II trials in cholangiocarcinoma and triple negative breast cancer are planned to start in 2020.
About TT-00420
TT-00420 is a novel, small molecule, spectrum-selective multiple kinase inhibitor, developed by TransThera Biosciences. A global, phase I, first-in-human trial is currently ongoing to evaluate the safety and tolerability of TT-00420 in patients with advanced solid tumors. More information about this study can be found on ClinicalTrials.gov, using identifier NCT03654547.
About Cholangiocarcinoma
Cholangiocarcinoma is a rare cancer that forms in the bile ducts with poor prognosis. Common treatment options for cholangiocarcinoma include surgery and chemotherapy, but recurrence is common and disease-free survival time is low. Thus, clinical trials are necessary to develop and evaluate effective therapies for treatment of this disease.
About TransThera Biosciences
TransThera Biosciences, specialized in developing novel NCE drugs, was founded in 2016 in Nanjing, China. It aims to identify novel therapies to target diseases with unmet medical needs via internal research platform and open innovation. TransThera's current portfolio covers therapeutic areas such as oncology, cardiovascular, and inflammatory diseases. For more information, please visit www.transtherabio.com.
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