Our Clinical Program

Global Phase 2 Developments of EC-18

Development Status

Development Status

Status

Global P2 trials (MRCT: Multi-Regional Clinical Trial)

Indications

Chemotherapy-Induced Neutropenia (CIN): Global Phase II Chemoradiation-Induced Oral Mucositis (CRIOM): Global Phase II Acute Radiation Syndrome (ARS): Awarded US FDA Orphan Drug Designation

IND

CIN: US FDA (’16. 8), Korea MFDS (’16. 12) CRIOM: US FDA (’17. 7)

Government grants updates

1st Korea Drug Development Fund on February 2015 2nd Korea Drug Development Fund on October 2015 3rd Korea Drug Development Fund on November 2016
Rank Status Study
1 Completed A Safety and PK Study of EC-18 in Healthy Subjects Condition: Chemotherapy-induced Neutropenia Interventions: Drug:EC-18, Drug:Placebo
2 Completed Study to Evaluate the Safety, Tolerability and PK of EC-18 After Oral Administration in Healthy Volunteers Condition: Chemotherapy-induced Neutropenia Interventions: Drug:EC-18, Drug:Placebo
3 Completed Evaluation of the Food Effect on the Safety, Tolerability, PK of EC-18 After Oral Administration in Healthy Volunteers Condition: Chemotherapy-induced Neutropenia Interventions: Dietary Supplement: high-fat diet, Drug:EC-18
4 On going Management of Severe Chemotherapy-induced Neutropenia in Advanced Breast Cancer Condition: Febrile Neutropenia Interventions: Drug:EC-18, Drug:Placebo
5 On going Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-escalating Study to Evaluate the Safety andEfficacy of EC-18 in Altering the Severity and Course of Oral Mucositis in Patients Being Treated with Concomitant Chemoradiation for Cancers of the Mouse, Oropharynx, Hypopharynx and Nasopharynx Condition: Chemoradiation-induced Oral Mucositis Interventions: Drug:Ec-18, Drug:Placebo