Fimaporfin/gemcitabine - PCI Biotech
Alternative Names: Amphinex; Fimaporfin delivered gemcitabine - PCI Biotech; TPCS-2ALatest Information Update: 30 Jan 2022
At a glance
- Originator PCI Biotech
- Class Amines; Antineoplastics; Benzenesulfonates; Deoxyribonucleosides; Fluorinated hydrocarbons; Ketones; Porphyrins; Pyrimidine nucleosides; Pyrimidines; Small molecules
- Mechanism of Action Photosensitisers
-
Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
- Available For Licensing Yes - Cancer
Highest Development Phases
- Phase II Cholangiocarcinoma
Most Recent Events
- 24 Jan 2022 PCI Biotech decides to stop the phase II RELEASE trial in Cholangiocarcinoma (Combination therapy, Metastatic disease, Inoperable/Unresectable) in Belgium, Denmark, France, Finland, Germany, Italy, Norway, Poland, Sweden, Spain, South Korea, Taiwan, USA, and Ukraine (IV) due to results from the phase III TOPAZ-1 trial (NCT04099888),
- 13 Dec 2021 Independent Data Monitoring Committee (IDMC) recommends to continue the phase II RELEASE trial in Cholangiocarcinoma and permitted to continue with up to two fimaChem treatments as stated in the protocol
- 28 May 2021 Fimaporfin/gemcitabine receives Orphan Drug status for Cholangiocarcinoma (Inoperable/Unresectable, Late-stage disease, Metastatic disease, Combination therapy) in South Korea