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Fimaporfin/gemcitabine - PCI Biotech

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Drug Profile

Fimaporfin/gemcitabine - PCI Biotech

Alternative Names: Amphinex; Fimaporfin delivered gemcitabine - PCI Biotech; TPCS-2A

Latest Information Update: 30 Jan 2022

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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.

    Yes - Cholangiocarcinoma
  • 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
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