TMS Co., Ltd. announced that Corxel Pharmaceuticals announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration of the PRC (NMPA) has approved the Clinical Trial Application (CTA)
for ORION (Optimizing Reperfusion to Improve Outcomes and Neurologic Function), the global registrational study including China cohort, that will investigate the effects of JX10 (TMS-007) on functional recovery in acute ischemic
stroke (AIS) patients, who present within 4.5 to 24 hours from "last known well". The Company plans to participate in the global study as partner in Japan. About TMS-007(JX10) TMS-007 (JX10) is an investigational drug candidate for the treatment of acute cerebral infarction (AIS), and its mechanism of action is both thrombolytic and anti-inflammatory. The important thing in the treatment strategy for acute cerebral infarction is to restore blood flow as soon as possible after the onset of symptoms. TMS-007 (JX10) extends the short treatment period of administration within 4.5 hours after the onset of symptoms, which is the current standard of treatment, and may provide treatment opportunities to many patients. In a Phase II clinical trial conducted by our company in Japan, subjects administered TMS-007 (JX10) showed significantly improved clinical outcomes (no symptoms at all or symptoms but able to work without obvious impairment) after 90 days compared to placebo. This result was also confirmed by angiographic findings. TMS-007 (JX10) is currently undergoing a global study to further evaluate its efficacy and safety for the treatment of acute cerebral infarction by CORXEL.