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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 IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 24, 2022
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 IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2021
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 IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 28, 2021
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 IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 30, 2021
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 IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2020
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 IIProduct 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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