August 07, 2019 16:00 ET | Source: Xynomic Pharmaceuticals Holdings, Inc.
RALEIGH, N.C. and SHANGHAI, Aug. 07, 2019 (GLOBE NEWSWIRE) — Xynomic Pharmaceuticals Holdings, Inc. (“Xynomic”, stock ticker: XYNO), a clinical stage US-China oncology drug development company, announced that the Independent Ethics Committees at three leading Chinese cancer hospitals (Fujian Provincial Hospital, Tongji Medical College in Huazhong University of Science and Technology, and Qilu Hospital of Shandong University) have approved Xynomic’s application to conduct pivotal Phase 3 trial using Xynomic’s abexinostat, in combination with pazopanib, in patients with renal cell carcinoma.
Dr. Jun Guo, a professor and the medical director at Peking University Cancer Hospital & Institute, will be the leading principal investigator for this trial in China. According to Fudan University’s Hospital Management Institute, Peking University Cancer Hospital & Institute is one of the top 3 cancer specialty hospitals in China.
“High performing investigator sites are essential to a successful clinical trial. One of the most important decisions Xynomic makes when embarking on a new clinical trial is the choice of the principal investigators. We are very pleased to work with these sites that have world-class infrastructure to fulfill all the activities specified in the protocol. In addition, these sites routinely treat a large number of lymphoma patients, critical to our patient recruitment effort.” Mr. Y. Mark Xu, Chairman and CEO of Xynomic commented.
In addition, the Independent Ethics Committees at the Cancer Hospital Chinese Academy of Medical Sciences in Beijing and West China Hospital of Sichuan University have approved Xynomic’s application to conduct two pivotal Phase 2 trials, one to test abexinostat as a third-line mono therapy against diffuse large B-cell lymphoma (“DLBCL”) and the other as a third-line mono therapy against follicular lymphoma (“FL”). According to Chinese Medical Association’s Chinese Society of Hematology, DLBCL and FL are the most prevalent and second most prevalent non-Hodgkin’s lymphoma subtype, respectively, in China.
About Xynomic Pharmaceuticals Holdings, Inc.
Xynomic Pharmaceuticals Holdings, Inc. is a clinical stage oncology-focused biopharmaceutical company. Its current pipeline mainly consists of 3 drug candidates; Xynomic owns global exclusive development, manufacturing and commercialization rights to each of these. Its lead drug candidate abexinostat is in global potentially pivotal clinical trials against renal cell carcinoma (in combination with pazopanib) and non-Hodgkin’s lymphoma (as a single agent). Xynomic’s XP-105 (BI 860585) is a Phase 2 ready, ATP-competitive mTORC1/2 inhibitor against solid tumors. Xynomic’s XP-102 (BI 882370) is a Phase 1 ready pan-RAF inhibitor.
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