Enig i at man skal se fremover men et ærlig svar på dette vil kunne styrke (eller svekke) tiltroen til nye guidinger fra Per vedr Vacc og Nac.
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Spørsmål man eventuelt sitter igjen med etter presentasjonen kl. 08.30 kan sendes til Elisabeth fram til kl. 14.00 slik at det blir tatt i podkasten.
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Har vi ikke allerde mottatt svar paa dette da? AZ styrte og bestemte hva og naar PCIB fikk lov til og melde noe om samarbeidet til markedet.
Veldig bra:muscle:. Back to the core value trigger:RELEASE 
The company continues to have full focus on enrolment of patients into the RELEASE study. The expected timeline for the planned interim analysis is retained as a range from 2H 2022 to 1H 2023
The consequences of the pandemic and the new recruitment initiatives for the RELEASE study cannot yet be fully established, but early indications after implementation of the new amended protocol are encouraging. The opening of sites in Asia has also shown promise as the first patient was enrolled in South Korea in October, less than three months after opening of the first Asian site and we experience good initial screening activity.
trial is open in South- Korea and Taiwan. Other commercially interesting countries in Asia are considered to be Japan, Hong Kong and China. The Asian market is known to be fragmented and PCI Biotech do not foresee to commercialise fimaCHEM for bile duct cancer in Asia without a partner.
All patients have been followed-up for survival post-study and the finally confirmed median overall
Enabling intracellular delivery
Regular communication milestones for the RELEASE study
The RELEASE study builds on the favourable safety results and encouraging early signs of efficacy in the Phase I study, with more than 80% of the patients being progression-free at 6 months.
The fimaCHEM treatment boosts the chemotherapy effect locally in the bile duct. Local tumour response in the bile duct is important to maintain biliary drainage, and the primary tumour response may therefore be more important for survival outcome than would be the case for many other cancers.
Enabling intracellular delivery
survival (mOS) for the full study ended on 16.1 months at final censoring, with two patients still being alive.
The group in the dose escalation study that received the RELEASE study dose (n=6, cohort IV) had a mOS of 22.8 months and half of these patients exceeded 30 months survival. The mOS in the extension group (n=7), where patients received up to two fimaCHEM treatments of the RELEASE dose was 16.6 months, with one patient still alive at final censoring. Five of the seven extension patients received two fimaCHEM treatment. Although these are small patient groups with considerable heterogeneity, positive signs of objective tumour response seem to translate into encouraging survival data.
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«Given the uncertainty surrounding long-term consequences of the unprecedented situation with the COVID-19 pandemic, the anticipated timeline for the planned interim analysis is retained as a range from 2H 2022 to 1H 2023, and the current cash-position may therefore not be sufficient to reach interim read of the RELEASE trial. The company will closely monitor progress in relation to timelines and costs in the coming months.»
Ikke noe nytt dette, men selskapet gjentar at det kan bli et finansieringsbehov. Det ligger i kortene at det kan «lukte» en aldri så liten emisjon, dersom covid-19 i løpet av vinteren fører til ytterligere forsinkelser.
Ellers virker samarbeidet med israelske DC Prime interessant. 
Jeg håper Walday kan gi oss litt mer «kjøtt på beinet» her, selv om det sikkert begrenser seg.
Publisering av fimaVacc-resultater derimot lar vente på seg. Her forventer jeg en forklaring på hva som skjer. Nå er man vel i alle fall ikke bundet av AstraZeneca på dette området, hvis man noensinne var det?
I våres var beskjeden «may slide into H2…».
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Det er da faktiske nytt. Her fryktet mange indikasjoner om forsinkelser. Lettelsens sukk fra meg når det kommer forklaring i tillegg på indikasjoner om hvorfor de ser positive muligheter. Retain timeline fra forrige Q er helt topp.
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For those who want to verbally ask questions, they need to call in via the teleconference # 5-10 minutes before starting time
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For å vurdere selskapet bedre hadde det vært flott om Pcib hadde inkludert to slides i rapporteringen knyttet til status managing partners and alliances og business development.
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Dc prime er vel Nederlandsk, Aposense er vel selskapet fra Israel med FimaNac samarbeid,
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Stemmer, DCprime er et nederlandsk selskap hvor vår mann Sjoerd van der Burg er medlem av scientific advisory board: https://dcprime.com/company/
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Significant efforts are being invested by the global health community to research and develop potential treatments against COVID-19. Most vaccine companies are currently focused on reaching or progressing clinical development of their own established technologies and may not be open for the inclusion of new technologies in the short term.
Er nok en forklaring til hvorfor enkelte av samarbeidene innen fimaNAc ble avsluttet. De er opptatt av å levere koronavaksine.
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Ja, du har selvsagt rett. Jeg blandet navnene, men jeg mente forskningssamarbeidet med vår nye israleske partner. Vil gjerne ha mer info om dette.
Du finner en beskrivelse av samarbeidet her https://dcprime.com/collaborations/
In September 2020, DCprime and PCI Biotechannounced an extensive research collaboration combining DCprime’s cancer vaccine expertise with PCI’s unique intracellular delivery technology via PhotoChemical Internalisation. The collaboration builds on preclinical proof-of-concept results on a novel cancer vaccination concept based on tumor-independent antigens (TIAs) previously presented by DCprime at the 34th SITC Annual Meeting in November 2019. Within the collaboration, DCprime and PCI Biotech will combine the TIA vaccination concept with PCI Biotech’s technology platforms.
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Er det riktig at RELEASE kun hadde 1 pasient innrullert i Q3? Var det kun 1 pasient forrige kvartal også?
hvor får du det tallet fra?
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Enig. Kvartalsrapporten var i den positive enden. Hadde tidligere ikke fått med meg at DC Prime både omfattet Vacc og Nac, så ble positivt overrasket
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Jeg er bare sporadisk inne på pci tråden. Jeg mener at det var slik, tar jeg feil?
Jeg har ikke sett noen tall for innrulleringen i Q3. Så hvis du ikke kan fremlegge det så tar du nok feil 
Det er minst en pasient innrullert. Mer enn det kan jeg ikke se at det er meldt. Men man kan håpe på flere selvfølgelig.
Siden de bare nevnte den første pasienten i Asia, antok jeg at den første pasienten også var den eneste i alle regioner for kvartalet. Vi får se på presentasjoenn.