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PCI Biotech - Fundamentale forhold (PCIB)

Denne bør ligge her:

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Takker, på småprat bare drukner infoen. Så denne tråden blir nok høyaktuelt fremover :wink:

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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. )

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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.

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PCI Biotech: First patient enrolled in Asia in the fimaCHEM pivotal RELEASE study

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7 posts were merged into an existing topic: PCI Biotech - Småprat 4 2020 (PCIB) - The day after

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)

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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.

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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.

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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

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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.

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Nei, det er ikke innvilget, bare publisert i US. I resten av verden er det publisert for en god stund siden. I EU har man fått et “letter of intention to grant” som jeg har skrevet før.

Poenget er at vi nok kan føle oss trygge på at det blir innvilget av alle kontorene. Men noe annet ville jo være helt krise også. I Japan var det bevegelse i dialogen med patentkontoret for kun et par uker siden. Patenter er TREG materie, men poenget er at beskyttelsen gjelder fra samme prioritetsdato i alle land, som for dette patentet er 14.10.2016.

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As per public request.

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Hver måned kårer jeg det jeg kaller Teksperter™ for noen av de mest populære investeringene våre :slight_smile:

Det er de 3 medlemmene som har fått flest likes på innleggene sine de siste 90 dagene. Teksperter™ får også en unikt merke på profilen sin og et trofé-ikon ved siden av navnet sitt. Du kan bli Tekspert™ i flere aksjer/investeringer, og troféet vil bare vises i tråder der du er Tekspert™.

Her er denne månedens Teksperter™ og det mest likte innlegget deres fra de siste 90 dagene:

  1. @Jubel (1628 likes)
  1. @polygon (1612 likes)
  1. @arve1954 (1277 likes)

Resten av topp 10:

  1. @Investor (1155 likes)

  2. @sjog (1037 likes)

  3. @StockDZ (1024 likes)

  4. @Snoeffelen (1017 likes)

  5. @Savepig (1002 likes)

  6. @ufo (863 likes)

  7. @rockpus (830 likes)

Gratulerer!

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@Logdec og @StockDZ lenket til denne stillingsutlysningen på småptattråden, men det virker som det bare forsvant i all småkranglingen. Jeg synes i alle fall dette er veldig spennede! Dette er altså en forskerstilling som skal fordype seg i PCI Biotech sin teknologi og chitosan-baserte carriers, som PCIB har et eget patent dedikert til. Og det skal gjøres i samarbeide med Universitetet i Padova, Italia, som også har lånt PCIB sin teknologi tidligere:

Folk kan grave seg ned i depresjon over mangel på kommersielle avtaler, men dette er i alle fall med på å legge grunnlaget for fremtidige muligheter og verdier!

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Fibrin glue (FG) has potential as a delivery vehicle for photosensitizer directly to the resection cavity, so it may bypass the blood-brain barrier (BBB) and increase the concentration of successfully delivered photosensitizer. A specialized form of photodynamic therapy (PDT), photochemical internalization (PCI), which involves both photosensitizer and chemotherapeutic agent internalization, can locally inhibit the growth of cells. This will allow the reduction of recurrence of malignant gliomas around surgical resection. This study will look at the efficacy of FG loaded with drugs in mediating both PDT and PCI in inhibiting 3-dimensional tumor spheroid growth in vitro. Experiments were conducted on spheroids comprised of F98 glioma cells using photosensitizer AlPcS2a and chemotherapeutic drug bleomycin (BLM). At 2-, 24-, 48-, and 72-h increments, supernatant covering an FG layer within a well was collected and replaced by fresh medium, then added to spheroid-containing wells, which contained the respective chemicals for PDT and PCI. The wells were then exposed to light treatment from a diode laser, and after, spheroid growth was monitored for a period of 14 days. Significant spheroid growth inhibition was observed in both PDT and PCI modalities, but was far greater in PCI. Additionally, complete growth suppression was achieved via PCI at the highest radiant exposure. Achieving a slow photosensitizer release, significant F98 spheroid inhibition was observed in FG-mediated PDT and PCI. The present study showed BLM-PCI was the most efficacious of the two modalities.
Published: 30 October 2020. Photosensitizer delivery by fibrin glue: potential for bypassing the blood-brain barrier. Lina Nguyen, Eric O. Potma, Jimmy N. Le, Julie Johnson, Gabrielle Romena, Qian Peng, Kristian Berg & Henry Hirschberg. Lasers in Medical Science (2020)

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Phthalocyanine chloride disulfonic acid ( AlPcS2a) er altså en photosensitizer som er til salgs over disk, og som er brukt i mange forsøk som ikke har noe med PCIB å gjøre. Den har kvaliteter som gjør at PCIB inkluderer den i metoden i FimaNAc patentet, men disulfonated tetraphenyl chlorin (TPCS2a), eller Amphinex er i følge PW bedre egnet i denne (og forhåpentligvis mange andre) applikasjoner.

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Vi har nå lenge spekulert i om PCIB vil/har lykkes i gallegangskreft (cholangiocarcinoma / bile duct cancer), og kanskje vil bukspyttkjertelkreft (pancreatic cancer) være det neste naturlige steget?

Tidligere i år søkte nemlig Oslo universitetssykehus HF - og mest sannsynlig PCIB sine forskere der - om midler fra Norges forskningsråd til et prosjekt kalt «PCI of novel diabodies; Attacking druggable and undruggable targets in pancreatic cancers»

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PCI Biotech: Invitation to third quarter 2020 results presentation

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Sylfersk presentasjon fra Berg, Selbo, Høgset. Sjekk slide 19 som viser CR i Hilar CCA. Utrolig!

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