Diskusjon Triggere Porteføljer

PCI Biotech Fundamentale Forhold (PCIB)

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#166

FimaVacc første data

Pluss alle fra extension i live per desember


#167

Meeeh. Trist.


#168

Men dette var veldig bra, fra 33% respons til 83% med VACC!

The translation of the vaccination technology, fimaVACC, into humans by demonstrating
improvement of immunogenicity of vaccines in a Phase 1 study in healthy volunteers is
a main priority for PCI Biotech to establish the company in the immunotherapy field.
The dose-finding part of the Phase I study identified a well-tolerated dosing regimen
and the interim data suggest enhancement of several parameters of importance for
vaccination. PCI Biotech is collaborating with international experts to finalise and
publish the in-depth analysis and characterisation of the immune responses from Phase I.


#169

Wow. Alle 7 fra extension studien er fortsatt i live! Dvs at en har levd i 15mnd.

Bare 1 som lever fra fase 1. To døde siden sist.


#170

Var vel flere nyheter her.

Data from the first two fimaVACC cohorts analysed suggest that
the vaccination regimen provides a higher number of responders
(5 of 6) compared to control (2 of 6)

Så 2.5 bedre enn kontroll armen som brukte en annen adjuvant. Dette er jo veldig lovende for Firmavacc.


#171

“PCI Biotech is collaborating with international experts to finalise and publish the in-depth analysis and characterisation of the immune responses from Phase I.”


#172

Hvis alle extension studien er i live er det utrolig lovende! Det er et fantastisk signal på «what to come». Hvor står det?? GOT to SEE that one😃


#173

Link? Dette var MEGET positivt!


#174

Leste bare overskriftene…men takk til deg og andre som kommenterer detaljer.

Snart klar for presentasjonen nå

Lothian


#175

Står i interim rapporten


#176

De rekruterer fortsatt i extension studien. Bra


#177

Extension study to enable repeated fimaCHEM treatment
The promising early signs of efficacy in the Phase I study described above were based on a single
fimaCHEM treatment when added to the current standard of care (SoC) as background treatment. A Phase I extension study was initiated with the objective to determine safety and tolerability of repeated treatments with fimaCHEM, as this may well increase the encouraging signs of efficacy. In this study, the second fimaCHEM treatment is administered approximately three to four months after the initial treatment. Preliminary confirmation of achieved safety endpoint (at least five out of six patients without schedule limiting toxicity) in the Phase I extension study was reported in Q4 2018, supporting the proposed plan of including up to two fimaCHEM treatments in the pivotal study. The final confirmation of successful safety read-out is pending completion of site monitoring and a formal review by the appointed Cohort Review Committee (CRC) in first half of 2019.

The efficacy data from the Phase I extension study will be compiled in the same process. A total of 7 patients have been included and the first patient was treated in August 2017. All patients receiving two fimaCHEM treatments were still alive at last censoring (December 2018), but the overall survival data is not yet mature enough for reporting. Recruitment of patients is not expected to formally close until the CRC has completed their review and confirmed that the safety endpoint has been reached.
Based on this positive safety data, the plan is now to initiate the pivotal RELEASE study with up to two fimaCHEM treatments and include a seamless safety review by an Independent Data Monitoring Committee (IDMC) when eight patients have completed two treatments in the pivotal RELEASE study


#178

enig, men det kan meget vel være PCI som har avsluttet samarbeidet.


#179

Helt rått! For noen data!
Gratulerer og vel blåst!


#180

Ja, det kan hende. Det er derfor jeg finner det så trist at man pumper hjula ved å si at vacc muligens skal brukes i ultinovacs sin registreringsstudie. Det skaper bare fallhøyde, og fallhøyde er kanskje det siste et biotek trenger.


#181

Du får spenne fast sikkerhetsbelte da Glein😜


#182

Det kan mye vel hende at de med stategiske hensyn mener akkurat det du har vært inne på Glein. At det er for omkostningsfyllt og tidskrevende og teste safety for komboen på dette tidspunkt.


#183

Overlevelsen i dose-eskaleringsstudiet er allerede fantastisk!
Gjentar vi noe bare i nærheten så har vi en blockbuster på hånda, bankers.

Så med 2 behandlinger, på riktig dose er mitt kvalifiserte gjett at det klarer vi.

Det som er veldig interessant i denne sammenhengen er at det i RELEASE-studien er planlagt, med pasientens samtykke 6 blodprøver a 20 ml. Det tipper jeg er fordi man ser immunologiske effekter av første behandling, som blir forsterket av behandling nummer 2.
Med veldig spennende resultater fra fimaVACC i bakhodet er dette superinteressant😄


#184

Husker jeg riktig hvis det var 4 pasienter inkludert 01.01.18? Altså 4 som lever etter 12mnd eller lenger allerede?


#185

Hvorfor kan man rapportere på endepunktet overlevelse, men ikke legge frem tumorrespons?