Home > News

R-Pharm Has Completed Enrollment for the Phase III Clinical Trial of Taigexyn in Community Acquired Pneumonia in Russia

TAIPEI, Taiwan, November 27, 2017– TaiGen Biotechnology Company, Limited ("TaiGen") today announced that its Russian partner, R-Pharm JSC, has completed the patient enrollment of the Phase 3 clinical trial (CJ01060044) of Taigexyn® (nemonoxacin) in Russia. The Phase 3 is a multicenter, randomized, active-controlled study to compare the efficacy and safety of intravenous and oral Taigexyn® versus Tavanic® (levofloxacin) in adult patients with community acquired pneumonia. After the study is complete (last patient last visit), the results will be unblinded, analyzed and compiled into a new drug application (NDA) for filing in 2018.  


“We would like to congratulate our partner, R-Pharm, on the successful completion of Phase 3 enrollment. This is an important milestone in the development of Taigexyn® as this is the first Phase 3 trial conducted outside of Greater China.” said Dr. Ming-Chu Hsu, Chairman and CEO of TaiGen.
 

About CJ0106004 Clinical Trial in Russia
This is a Phase III, multicenter, randomized, double-blind, double-dummy, two-way, parallel group, active-controlled study to compare the efficacy and safety of intravenous and oral Taigexyn® versus Tavanic® (levofloxacin) in adult patients with community acquired pneumonia. The trial recruited 342 patients (171 patients per group) in 26 sites in Russia. The oral and intravenous formulations of Taigexyn® were studied in a single trial where the patients were given intravenous formulation for the initial three days and switch over to oral formulation for the rest of the treatment period. The study fulfils the clinical trial requirement and allows for the filing of the NDA of the oral and intravenous formulations of Taigexyn® in Russia and Commonwealth Independent States. The study is funded by R-Pharm.


Back