SynCore’s global phase III clinical trial on pancreatic cancer second-line therapy, SB05PC (EndoTAG®-1) has reached its target number of patients to conduct interim analysis (IA). Detailed results will be released once completed. Currently, patient enrollment has been on track and study completion is expected by the end of this year.
SB05PC (EndoTAG®-1) is a cationic liposome embedded with paclitaxel, with orphan drug designation from EMA and US FDA. Since the beginning of August 2019, the global phase III clinical trial has reached the targeted 101 patient enrollment for IA, but mortality events will be needed for complete data analysis. SynCore Bio announces that conditions for IA have been met, its CRO will be responsible for collating and passing all data to the Data Monitoring Committee (DMC) for analysis.
Pancreatic cancer still has a market for unmet medical need, as current therapies are limited in improving overall survival (OS). EndoTAG®-1 Phase II results have shown that patients have increased OS by 22% and progression-free survival by 40%, thereby hopefully giving patients a better option clinically. As FOLFIRINOX is the standard of care in USA and most countries in Europe/ Asia, SynCore implemented the strategy of designing the clinical trial for a second-line therapy, after the failure of FOLFIRINOX. Pancreatic cancer incidence is the highest in China, EndoTAG®-1 has received NMPA’s approval for PIII pancreatic cancer first-line therapy, patient enrollment is anticipated to start this year. As of now, SynCore is in discussion with several pharmaceutical companies for regional/global commercialization rights.
| No. | Country | Status |
| 1 | USA | Phase III (pancreatic cancer second-line therapy) ongoing |
| 2 | Taiwan | |
| 3 | France | |
| 4 | Hungary | |
| 5 | South Korea | |
| 6 | Russia | |
| 7 | Israel | |
| * | Mainland China | Phase III (pancreatic cancer first-line therapy) ongoing |
About SynCore Biotechnology
SynCore Biotechnology Co., Ltd. (4192:TT) is a biopharmaceutical company with a comprehensive pipeline portfolio of new drugs in the areas of oncology, ophthalmology, dermatology and infectious diseases. The EndoTAG® technology platform is wholly owned by SynCore Bio. Please visit the Company’s website at http://www.syncorebio.com/
Contact
Charles Liang, Investor Relations Sarah Liu, Public Relations
Phone: (02) 2764-0826 Phone: (02) 2536-1237/ 0932-949928
Email: finance@syncorebio.com Email: sarahliu@time-ir.com.tw
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