PCIb - The RELEASE Trial
https://www.youtube.com/watch?v=O32YB5dOyLs
https://www.pcibiotech.no/
fimaCHEM IN THE TREATMENT OF BILE DUCT CANCER
Bile duct cancer has been chosen as the first indication for fimaCHEM, as there is a clear medical need for better local treatment, access with light is easy by using standard endoscopic treatment procedures and the most used cytotoxic agents, gemcitabine, is one of the drugs that is significantly enhanced by PCI in preclinical studies. Fimaporfin has been granted Orphan Designation for this indication in EU and in USA.
https://www.pcibiotech.no/
fimaCHEM IN THE TREATMENT OF BILE DUCT CANCER
Bile duct cancer has been chosen as the first indication for fimaCHEM, as there is a clear medical need for better local treatment, access with light is easy by using standard endoscopic treatment procedures and the most used cytotoxic agents, gemcitabine, is one of the drugs that is significantly enhanced by PCI in preclinical studies. Fimaporfin has been granted Orphan Designation for this indication in EU and in USA.
Redigert 20.01.2021 kl 15:21
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Høydepunkt Ggk i q2, nå venter vi spent på Q3 - fpd Asia - fpd USA - partner Asia - innrullering av pasienter - kursstigning fra 23.5 kr.
▪ The main priorities during the COVID-19 pandemic has been identification and implementation of potential mitigating actions for progressing the RELEASE study. Screening into the RELEASE study has been severely affected in the first half of 2020 with only one patient recruited during the pandemic, and the study has yet to enrol the first US patient. The situation is still unclear and the long-term consequences of the pandemic are uncertain
▪ Good progress in Asia, with the first 8 RELEASE study sites recently opened. A total of 44 sites are open by mid-August 2020 across EU, US and Asia and >50 sites are planned to be included into the study
▪ The Asian clinical sites are located in South Korea and Taiwan, providing access to hospitals and KOL’s in a commercially interesting region with higher prevalence of bile duct cancer than in the US and EU
▪ Several new initiatives to recoup long-term recruitment projections are being implemented, with the aim to accelerate patient inclusion when the current constraints on clinical trials inflicted by the COVID-19 pandemic are resolved. A complete picture of the consequences for the RELEASE study and the effect of the new initiatives are not yet available, but a delay of 6-12 months may be anticipated. The expected timeline for the planned interim analysis by 1H 2022 is therefore extended to range from 2H 2022 to 1H 2023, and the current cash-position may not be sufficient to reach interim read of the RELEASE study
▪ An article with a case report series from the Phase I study has been accepted for publication in Endoscopy International Open. The article provides a detailed description of treatment effects in three select patients at the dose chosen for RELEASE
▪ The main priorities during the COVID-19 pandemic has been identification and implementation of potential mitigating actions for progressing the RELEASE study. Screening into the RELEASE study has been severely affected in the first half of 2020 with only one patient recruited during the pandemic, and the study has yet to enrol the first US patient. The situation is still unclear and the long-term consequences of the pandemic are uncertain
▪ Good progress in Asia, with the first 8 RELEASE study sites recently opened. A total of 44 sites are open by mid-August 2020 across EU, US and Asia and >50 sites are planned to be included into the study
▪ The Asian clinical sites are located in South Korea and Taiwan, providing access to hospitals and KOL’s in a commercially interesting region with higher prevalence of bile duct cancer than in the US and EU
▪ Several new initiatives to recoup long-term recruitment projections are being implemented, with the aim to accelerate patient inclusion when the current constraints on clinical trials inflicted by the COVID-19 pandemic are resolved. A complete picture of the consequences for the RELEASE study and the effect of the new initiatives are not yet available, but a delay of 6-12 months may be anticipated. The expected timeline for the planned interim analysis by 1H 2022 is therefore extended to range from 2H 2022 to 1H 2023, and the current cash-position may not be sufficient to reach interim read of the RELEASE study
▪ An article with a case report series from the Phase I study has been accepted for publication in Endoscopy International Open. The article provides a detailed description of treatment effects in three select patients at the dose chosen for RELEASE
PCI Biotech:
First patient enrolled in Asia in the fimaCHEM pivotal RELEASE study
Oslo (Norway), 26 October 2020 - PCI Biotech (OSE: PCIB), a clinical-stage
biopharma company developing innovative therapeutics that address significant
unmet medical needs in cancer today announced that the first Asian patient in
the fimaChem pivotal RELEASE study with registration intent in inoperable bile
duct cancer patients has been enrolled in South Korea.
The RELEASE study spans
across Europe, USA and Asia, following the recent opening of several clinical
sites in both South Korea and Taiwan.
First patient enrolled in Asia in the fimaCHEM pivotal RELEASE study
Oslo (Norway), 26 October 2020 - PCI Biotech (OSE: PCIB), a clinical-stage
biopharma company developing innovative therapeutics that address significant
unmet medical needs in cancer today announced that the first Asian patient in
the fimaChem pivotal RELEASE study with registration intent in inoperable bile
duct cancer patients has been enrolled in South Korea.
The RELEASE study spans
across Europe, USA and Asia, following the recent opening of several clinical
sites in both South Korea and Taiwan.
Redigert 26.10.2020 kl 18:04
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About the RELEASE study
The pivotal RELEASE study design is based on the outcome of meetings with the
two leading regulatory authorities European Medicines Agency (EMA) and the U.S.
Food and Drug Administration (FDA). The study programme consists of a single
open randomised two-arm study with 186 patients (93 patients per arm), having a
control arm with the standard of care (SoC) treatment of up to eight cycles of
the chemotherapies gemcitabine and cisplatin, and an experimental arm with up to
two fimaChem treatments in addition to SoC. The study’s primary endpoint is
progression free survival (PFS), with overall survival (OS) as a key secondary
endpoint. The study includes an interim analysis of objective response rate
(ORR), with the potential of accelerated/conditional marketing approval. In
addition, the study contains several other secondary endpoints that provide the
opportunity to generate robust comparative data of importance for market
acceptance of fimaChem as a first-line treatment for inoperable bile duct
cancer. The study is done at clinical sites across Europe, USA and Asia.
The pivotal RELEASE study design is based on the outcome of meetings with the
two leading regulatory authorities European Medicines Agency (EMA) and the U.S.
Food and Drug Administration (FDA). The study programme consists of a single
open randomised two-arm study with 186 patients (93 patients per arm), having a
control arm with the standard of care (SoC) treatment of up to eight cycles of
the chemotherapies gemcitabine and cisplatin, and an experimental arm with up to
two fimaChem treatments in addition to SoC. The study’s primary endpoint is
progression free survival (PFS), with overall survival (OS) as a key secondary
endpoint. The study includes an interim analysis of objective response rate
(ORR), with the potential of accelerated/conditional marketing approval. In
addition, the study contains several other secondary endpoints that provide the
opportunity to generate robust comparative data of importance for market
acceptance of fimaChem as a first-line treatment for inoperable bile duct
cancer. The study is done at clinical sites across Europe, USA and Asia.