Xynomic Pharma Doses First Chinese Patient in Pivotal Phase 3 Kidney Cancer Trial and Hires Medical Monitor
09/26/2019 news admin
| Source: Xynomic Pharmaceuticals Holdings, Inc.

SHANGHAI, Sept. 13, 2019 (GLOBE NEWSWIRE) —  Xynomic Pharmaceuticals Holdings, Inc. (“Xynomic”, stock ticker: XYNO), a clinical stage US-China oncology drug development company, today announced the dosing of the first Chinese patient in its on-going global pivotal Phase 3 trial of Xynomic’s abexinostat combined with pazopanib as a first- or second-line therapy against renal cell carcinoma (RCC) at Peking University Cancer Hospital & Institute. Dr. Jun Guo, Professor and Medical Director at Peking University Cancer Hospital & Institute, is the leading principal investigator for this trial in China.

According to US International Trade Administration, China is the second largest pharmaceutical market in the world, forecasted to grow from $108 billion in 2015 to $167 billion by 2020, representing an annual growth rate of 9.1 percent. Total public and private healthcare expenditure reached $640 billion in 2015 and is expected to almost double to $1.1 trillion by 2020.

A global randomized pivotal Phase 3 trial is underway of abexinostat + pazopanib as a first- or second-line therapy in patients with locally advanced or metastatic RCC. Currently, this trial is being conducted in the United States, Europe and South Korea. The U.S. Food and Drug Administration has granted Fast Track designation to abexinostat, in combination with pazopanib, as a first- or second-line treatment of RCC in Q1’2019.

“There are approximately 46,900 new cases of kidney cancer patients in China per year, according to Chinese Society of Clinical Oncology. Majority of patients develop resistance to pazopanib or other current standard-of-care therapies. Combining abexinostat with pazopanib has shown to reverse drug resistance in a Phase 1b study conducted by University of California, San Francisco and could significantly prolong patients’ progression-free-survival time. We are excited to start the China arm of this on-going global trial and look forward to working with Dr. Jun Guo and other leading China kidney cancer specialists.” Mr. Y. Mark Xu, Chairman and CEO of Xynomic, commented.

In addition, Dr. Kapilan Rajagopalan has joined Xynomic as the Medical Monitor for clinical development. Prior to joining at Xynomic, he worked as a Safety Case Manager-Case Intake at Tata Consultancy Services from 2018 to 2019 and from 2016 to 2017 as Safety Operations Physician at Tata Consultancy Services, doing work for two large multinational pharmaceutical companies. From 2014 to 2015, Dr. Rajagopalan was a MD/MBA intern at Humana. From 2012 to 2013, Dr. Rajagopalan was a family medicine resident physician at St. Joseph Mercy Hospital. We believe that Dr. Rajagopalan’s experience in performing medical review for oncology pharmaceutical products and his MD education in the USA will enhance Xynomic’s medical monitoring function. Dr. Rajagopalan holds a Bachelor of Science in Biology from the University of Cincinnati, graduating with Summa Cum Laude honors, a MBA from the University of Louisville with distinction, and a MD degree from the University of Cincinnati.

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 other clinical stage drug candidate XP-105 (BI 860585) is a Phase 2 ready, ATP-competitive mTORC1/2 inhibitor against solid tumors. Xynomic’s pre-clinical oncology drug candidate XP-102 (BI 882370) is a pan-RAF inhibitor.

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