CellProtect can start CP-201 phase 1 clinical trials in oncology in 6-8 months
- Completed active pharmaceutical ingredient (API) synthesis, scale-up, and manufacture to enable phase 1
- Completed formulation development to support phase 1 and phase 2
- Scientific advice from the German regulatory agency on chemistry and quality aspects complete in 2017
- Completed GLP toxicology study in accord with ICH S9 to enable start of full development
- Investigators identified and established clinical sites in Australia ready to begin phase 1
- Ongoing support for the existing patent portfolio and generation of new data for new patents
Following phase 1, CellProtect intends to rapidly advance CP-201 into phase 2 proof of concept studies in one or more indications.