Date: 2017-08-11
Type of
information: Treatment of the first patient
phase: 1
Announcement: treatment of the first patient
Company: PCI Biotech (Norway)
Product: fimaChem technology
Action
mechanism: fimaChem is an enhancement technology of chemotherapeutics for localised treatment of cancer.
Disease: inoperable extrahepatic bile duct cancer
Therapeutic
area: Cancer - Oncology
Country: Germany
Trial
details:
Latest
news:
- • On August 11, 2017, PCI Biotech announced that the first patient has been dosed in the fimaChem Phase I extension study with the objective to evaluate safety and tolerability of repeated treatments with fimaChem in patients with inoperable perihilar bile duct cancer. This first patient was dosed at the University Hospital Frankfurt, Germany.
- A Phase I study, including 16 patients, was completed in 2016 with early promising signs of tumour responses and encouraging emerging overall survival data, based on a single fimaChem treatment. In order to further optimise the treatment regimen in Phase II, a Phase I extension study is initiated with the objective to evaluate safety and tolerability of repeated treatments with fimaChem.
- The second fimaChem treatment will be done 3-4 months after the initial treatment. The Phase I extension study will include a minimum of 6 evaluable patients. The extension study will run in parallel with the ongoing regulatory interactions and other preparatory activities for a potential pivotal Phase II study.
- • On April 21, 2017, PCI Biotech announced that a poster of the fimaChem technology will be presented at the International Liver Congress 2017 - the annual meeting of the European Association for the Study of the Liver (EASL). The poster is named "Phase I study with Photochemical Internalisation (PCI) - A novel technology for treatment of perihilar cholangiocarcinoma" and includes a brief technology and method background and results from the recent fimaChem phase I study.
- The results include an update on interim average overall survival data of 14.5 months per end March 2017, with 25% of the patients still being alive. Patients are on PCI Biotech's phase I study in inoperable extrahepatic bile duct cancer for six months, and thereafter followed for survival only.
- The median overall survival (OS) in the studies that established gemcitabine and cisplatin as standard treatment in cholangiocarcinoma (CCA) was 11.7 and 11.2 months respectively (Valle et al. NEJM (2010) 362:1273-81 and Okusaka et al. BJC (2010) 103:469-74). These results may however not be directly comparable to the data in the fimaChem phase I study, as these studies include a wide range of different inoperable CCA patients, while the fimaChem phase I study focuses on inoperable perihilar CCA patients.
Is
general: Yes
