Mayo høres bra ut - de har bra renomme. Pluss alt det andre seff.
Står fortsatt PFS som primary outcome, skulle det inte ändras till ORR (Overall Response Rate)?
Godt å se litt outreach
Jeg tipset Allison for en tid siden, har du også hatt kontakt med henne?
Dett er interessant. PW sier her at PCIB synes resultatene i onkologi er “very promising”, samsvarer det med at AZ også synes dette:
“Astra Zeneca has said that the results from their tests of fimaNAc look very promising in the oncology area. Now, they wish to see if the same technology can work in other disease areas”.
Videre
"it is a very good research collaboration , where we work together to get the best out of this research eksperiments. "
I Radium episode 140 fra 23:40 sier også PW at PCIB har god interaksjon med AZ.
Jeg ser frem til en avklaring her og tenker fortsatt at jo lenger tid dette tar jo “bedre”. Husk at det skal meldes markedet umiddelbart hvis AZ ikke har noe interesse av samarbeid videre jf Radium podcast.
PCI Biotech: Preclinical research collaboration with big pharma ended
Nice
skal vel godt ned på 20-tallet nå da som samarbeidet endte uten avtale? var jo der kursen kom fra.
Denne bør ligge her:
Takker, på småprat bare drukner infoen. Så denne tråden blir nok høyaktuelt fremover 
Ja, etter frustrasjonen er det nok ( bør det være) det fundamentale i Pcib sin forskning og resultater som har betydning. ( Som ikke har forandret seg i negativ retning. )
Fikk hørt Webinaret i helga.
Syns det var interessant at det ble nevnt at de nå åpner opp for pasienter som har hatt max 2 cycler med gem-cis.
Før var det krav om ingen behandling overhodet.
Forhåpentligvis er sånne tiltak som dette webinaret det som skal til for å trigge pasientinklusjon i Usa.
PCI Biotech: First patient enrolled in Asia in the fimaCHEM pivotal RELEASE study
About the Release study, the webinar was great,
however:
1 - There has been an emphasis on how the hospital needs to be an established hospital with VERY experienced personnel to handle the procedure not just endoscopy personnel but VERY experienced.
2 - Also, proximity of the centers is key to allow patients not to interrupt their treatment and finish it all the way (very frequent trips). Those were not communicated by PW. regarding ERCP, he just (often) said that it is standard procedure.
(could the first 2 points be a challenge for the commercialization phase to make the treatment accessible (fragmented market), or gives a higher pricing premium being a niche treatment when discussing with authorities ? ) I am not qualified to draw conclusion on this
3- The positive thing however, all side effects discussions were centered around photosensitivity with sunburn like symptoms with a risk exposure for 2 weeks post fimaporfin injection, which I believe it is manageable especially that people are now used to quarantine practices. I believe this was an encouraging information
4- Abscopal effect, Dr Trojan believes in it without affirming it. but the way I understand this is an “evidence” of this has been observed in phase-1 (own conclusion)
5- The other positive thing was to see our CMO intervening with good and cautious explanations (the context is different, the audience are patients, families and care givers, there is a speech difference between offering an investor hope to be rich vs offering a patient and his family hope to live longer)
Good points StockDZ
#2 very frequent trips and commercialization phase
As I understood this, “very frequent trips” are follow-ups during the time they (each patient) participate in the study, not based on the treatment itself (standard procedure).
I believe follow-ups are necessary to be sure that the treatment itself does not cause other complications and that they monitor the development of the individual patient.
Challenge for the Release study, may well be. Challenge for the commercialization phase, don’t think so. These patients will most probably be visiting hospitals several times with or without the Pcib treatment.
This is my understanding, but I am no expert at all in the field.
Flott beskrevet @StockDZ.
Jeg har også sett webcasten, og det som opmuntrer meg meget, er at Trojan åpenlys sier at de ser abskobal effekt.
Dette er ett usedvanlig utsagn fra en KOL. Når han sier det så står han fuldt inne for det og det eksisterer hos en viss andel av patienterne.
Det minder meg om det foredrag fra Boston, hvor lægen som stor for det nu nedlagte ØNH studiet var helt chokkeret over hvor gode resultater de hadde på pasienter.
Han havde praktisk talt aldrig sett noe lignende.
Patent History
Publication number: 20200338044
Type: Application
Filed: Oct 13, 2017
Publication Date: Oct 29, 2020
Applicant: PCI Biotech AS (Oslo)
Inventors: Anders HØGSET (Oslo), Per Edvard WALDAY (Oslo), Pål Kristian SELBO (Oslo), Kristin EIVINDVIK (Fornebu), Lena FINNESAND (Oslo)
Application Number: 16/341,186
Takker
The present inventors have surprisingly found that, advantageously, a method involving the use of a photosensitizing agent, TPCS2a, and gemcitabine at the doses defined herein, and irradiation with light of a wavelength effective to activate the photosensitizing agent results in significant improvements relative to standard treatments. As will be described in more detail in the Examples below, it has been demonstrated that after 6 months of treatment more than 80% of lesions had shrunk and more than 50% of lesions were no longer detectable. This is a remarkable and important result which offers new hope for the treatment of CCAs. The result is particularly surprising as the PCI method relies on release of molecules in the endosome into the cytosol and there was nothing to suggest that gemcitabine was taken up in cells into the endosome and hence could benefit from PCI treatment.