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    [{"orgOrder":0,"company":"PCI Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"PCI Biotech: Publication of Case Report Series from the Phase I Study in Bile Duct Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"NORWAY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"PCI Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"PCI Biotech: European Patent for Treatment of Bile Duct Cancer with the FimaChem Technology","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"NORWAY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"PCI Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"PCI Biotech: First US Patient Enrolled in the Fima Chem Pivotal RELEASE Study","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"NORWAY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"PCI Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"PCI Biotech Receives Orphan Drug Designation in South Korea for Fimaporfin in the Treatment of Bile Duct Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"NORWAY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"PCI Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"PCI Biotech: Update on Regulatory Interactions for the RELEASE Trial","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"NORWAY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"PCI Biotech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"PCI Biotech: Update on the RELEASE trial","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"NORWAY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"}]

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              PCI Biotech

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              PCI Biotech: Update on the RELEASE trial

              Details:

              PCI of gemcitabine with Amphinex shows an innovative treatment that could potentially produce significant local tumour response in patients. The study is well designed to demonstrate the potential benefit of Amphinex induced PCI of gemcitabine in bile duct cancer patients.

              Lead Product(s): Fimaporfin,Gemcitabine,Cisplatin

              Therapeutic Area: Oncology Product Name: Amphinex

              Highest Development Status: Phase II Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable January 24, 2022

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              PCI Biotech

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              PCI Biotech: Update on Regulatory Interactions for the RELEASE Trial

              Details:

              The interaction with the FDA and EMA initiated to explore the opportunity for a modified study design to address the retention risk in the control arm of the RELEASE study of Amphinex (Fimaporfin).

              Lead Product(s): Fimaporfin,Gemcitabine,Cisplatin

              Therapeutic Area: Oncology Product Name: Amphinex

              Highest Development Status: Phase II Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 07, 2021

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              PCI Biotech

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              PCI Biotech Receives Orphan Drug Designation in South Korea for Fimaporfin in the Treatment of Bile Duct Cancer

              Details:

              The fimaChem treatment regimen consists of an intravenous injection of fimaporfin, a photosensitiser drug followed four days later by an intravenous infusion of gemcitabine and a laser light application in the bile duct.

              Lead Product(s): Fimaporfin,Gemcitabine,Cisplatin

              Therapeutic Area: Oncology Product Name: Amphinex

              Highest Development Status: Phase II Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 28, 2021

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              PCI Biotech

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              PCI Biotech: First US Patient Enrolled in the Fima Chem Pivotal RELEASE Study

              Details:

              First US patient has been enrolled into the fimaChem pivotal RELEASE study with registration intent in inoperable bile duct cancer patients.

              Lead Product(s): Fimaporfin,Gemcitabine,Cisplatin

              Therapeutic Area: Oncology Product Name: Amphinex

              Highest Development Status: Phase II Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 30, 2021

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              PCI Biotech

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              PCI Biotech: European Patent for Treatment of Bile Duct Cancer with the FimaChem Technology

              Details:

              The European patent covers the intended use of fimaChem in combination with gemcitabine for the treatment of cholangiocarcinoma (bile duct cancer).

              Lead Product(s): Fimaporfin,Gemcitabine,Cisplatin

              Therapeutic Area: Oncology Product Name: Amphinex

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 16, 2020

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              PCI Biotech

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              • Development Update
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              PCI Biotech: Publication of Case Report Series from the Phase I Study in Bile Duct Cancer

              Details:

              PCI Biotech has announced case report series from the Phase I study with PCI Biotech's proprietary drug fimaporfin (AmphinexTM), for the treatment of inoperable extrahepatic bile duct cancer (eCCA), is accepted for publishing in Endoscopy International Open.

              Lead Product(s): Fimaporfin,Gemcitabine

              Therapeutic Area: Oncology Product Name: Amphinex

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable August 19, 2020

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