Det var vel land og antall sites? Og deretter når x antall pasienter var behandlet…var det 8 pasienter?
Må finne ut av det til Q2.
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Snart Q2 presentasjon:
Half-yearly Report – Q2: 28.08.2019 (Presentation at Oslo Cancer Cluster Innovation Park)
Fra Q1 2019 rapport:
Highlights of the first quarter
fimaCHEM
First sites for the pivotal RELEASE study open for enrolment
Successful safety read-out in the Phase I extension study confirmed (subsequent event)
Completion of the full Phase I study and formal closure of recruitment (subsequent event)
Presented Phase I dose-escalation results at the annual conference of the US Cholangiocarcinoma Foundation and at the 3rd Asia-Pacific Cholangiocarcinoma conference in Taiwan
fimaVACC
Successful clinical translation (subsequent event)
Corporate
Further strengthened the Scientific Advisory Committee
Regular communication milestones
The planned communication milestones for the pivotal RELEASE study will be the initiation of the study, meaning first patient enrolled, and thereafter quarterly updates on the number of countries and clinical sites open for recruitment. Other milestones will be communicated as appropriate, including outcome of the IDMC reviews, as well as further details regarding timing and plan for interim analysis. In addition, the company will continue with quarterly updates on survival data from the Phase I study.
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Stemmer nok godt det.
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Det trenger du ikke. Les bl.a. svar fra Skuggedal til en av våre forumfeller.
Kortformen: Deltakende land + antall aktiverte klinikker, og dessuten ved sikkerhetsavlesning fra IDMC når åtte pasienter er ferdig behandla i den eksperimentelle armen.
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Takk. Da er husken fremdeles intakt.
Kursen til PCIB er alt annet enn intakt, den er utbombet det siste året.
Det kan eg snart ikkje lenger akseptere…
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Er spent på overall development strategy for fimavacc!!!
The overall clinical data covering more than 90 subjects provide clinical support of fimaVACC’s potential to enhance the cellular immune responses that are important for therapeutic effect of vaccines. This enhancement of cellular immune responses was seen at well tolerated fimaVACC dose levels, with the tolerability of fimaVACC also established across a wide range of doses. The analysis of overall T-cell responses has been done in collaboration with Oslo University Hospital, The Radium Hospital, while the analysis of CD8 T-cell responses has been done at the Department of Medical Oncology at Leiden University Medical Centre (LUMC) under the leadership of Professor Sjoerd van der Burg. After reviewing the overall results of the Phase I study, Professor van der Burg said ‘These encouraging results obtained by including fimaporfin during vaccination merit further exploration in a relevant clinical disease to assess if the enhanced immune responses translates into clinical benefit’.
Based on the successful clinical translation, PCI Biotech is now assessing the format and potential conferences for publication and presentation of the more detailed study results. The planned immune analysis of the Phase I study samples is now completed and recruitment is stopped. The overall development strategy for fimaVACC is under assessment.
Research and development supported by a grant
The fimaVACC programme is supported by a government grant from the Research Council of Norway (BIA-programme) of up to NOK 13.8 million distributed over the course of three and a half years, 2017- 2020.
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Limer inn denne som en reminder og ja @Lothian de har tatt betydlige grep når det gjelder å få en så rask rekruttering i PF2 som mulig.
fra Q3 2018
Feasibility work to provide a solid foundation for clinical site selection
In preparation for the pivotal study, PCI Biotech has performed an extensive feasibility study initiated this summer"2018", reaching out to hospitals across Europe and the U.S., to provide a solid foundation for selection of clinical sites for optimal patient recruitment. Based on this foundation, the clinical site selection and initiation work are ongoing in parallel with national regulatory approval processes.
i tillegg har vi engasjert PPD, Vår CRO* «Contract Research Organization» som tar seg av sitene og holder trykket oppe med å innrullerer pasienter på de forskjellige åpne sitene.
PCI Biotech er fokusert mot igangsetting av den sentrale studien RELEASE med fimaCHEM og har styrket organisasjonen ytterligere ved å utnevne Karin Staudacher, M.Sc. som klinisk prosjektdirektør, fra november 2018. Staudacher vil påta seg operativt ansvar for PCI Biotechs pivotale studieutgivelse
Så hva kan vi vente oss av nyheter ved Q2 den 28.08 ?
#1. FimaChem Update -
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The RELEASE study, a pivotal clinical study with the potential of accelerated/conditional marketing approval as a first-line treatment given the rare disease status and high unmet medical need.
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PCIB vil fortsette med kvartalsvise oppdateringer om overlevelsesdata fra fase I-studien.
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I fase I-forlengelsesdelen fikk totalt syv pasienter den pivotale dosen, og fem av de syv pasientene fikk to fimaCHEM-behandlinger. Tre av de syv pasientene i utvidelsesdelen av fase I var i live ved sist sensurering (mars - mai 2019
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kvartalsvise oppdateringer om antall land og kliniske siter som er åpne for rekruttering i RELEASE studiet.
Ongoing regulatory and ethics approvals and site contract negotiations are progressing well. Regulatory and ethics approvals have been received for 6 countries by April 2019 (Norway, Germany, France, Spain, Sweden and Denmark). The first site was opened in Norway in March 2019 and a total of 2 sites in 2 different countries are open for enrolment by date of this report. -
US sites åpne, allerde?
Abscopal Effekt - når blir disse dataene evnt. frigitt ?
- I extensionstudiet vil det bli tatt et større volum med blod (et tillegg på 162 ml over ca. 6 mnd) i den utvidede fase I delen for å se på mulige immune effekter av PCI behandlingen og farmakokinetikken ved andre gangs PCI, samt at det tas blodprøve for analyse av platinum før og etter andre gangs PCI behandling
Asia startegien på plass?
Hvor langt er vi kommet i jobben med å få inn en partner til å ta seg av Asia sites i RELEASE studiet?
Vår CRO «Contract Research Organization» PPD har tre forskjellige kontorer i Japan og ett i Korea blant annet. Og dermed erfaring med hvordan man utfører kliniske studier i Japan og Asia
https://www.ppdi.com/
The Phase I results and the pivotal study design and plans were in Q1 2019 presented at two key conferences to increase awareness about fimaCHEM among both clinicians and patients: the US Cholangiocarcinoma Foundation in Salt Lake City, USA and the 3rd Asia-Pacific Cholangiocarcinoma conference in Taipei, Taiwan.
PCI Biotech’s lead product candidate is the photosensitiser fimaporfin (Amphinex®). PCI Biotech has an extensive collaboration with Norwegian and international hospitals and companies, among others; The Norwegian Radium Hospital in Oslo, University Hospital Zürich and University College London Hospital.
#2.FimaVACC
The analysis of overall T-cell responses has been done in collaboration with Oslo University Hospital, The Radium Hospital, while the analysis of CD8 T-cell responses has been done at the Department of Medical Oncology at Leiden University Medical Centre (LUMC) under the leadership of Professor Sjoerd van der Burg. After reviewing the overall results of the Phase I study, Professor van der Burg said ‘These encouragingresults obtained by including fimaporfin during vaccination merit further exploration in a relevant clinicaldisease to assess if the enhanced immune responses translates into clinical benefit’.
Based on the successful clinical translation, PCI Biotech is now assessing the format and potential conferences for publication and presentation of the more detailed study results. The planned immune analysis of the Phase I study samples is now completed and recruitment is stopped.
The overall development strategy for fimaVACC is under assessment.
#3.FimaNAC
SIX preclinical research collaborations in the area of nucleic acid therapeutics .
All the collaborators have the same purpose of exploring synergies between the partner’s proprietary nucleic acid technologies and the fimaNAC technology. Thereafter, the intention is to explore the potential for further partnerships.
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Top10BP - skal de teste fimaVACC oxo før en partneravtale evnt. foreligger?
The aim of the extension is to further evaluate the synergistic effects of both parties’ technology platforms in an in vivo setting and to determine whether PCI Biotech’s fima NAc technology has the potential to enhance the therapeutic effect of the partner’s nucleic acid therapeutic compounds.
The research collaboration is extended with 6 months until the end of 2019 and the companies have agreed to thereafter use the following 6 months (until end June 2020) to evaluate the potential for a further partnership.
Lykke til på Q2 alle sammen 
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Ikke minst spennende å høre om fimanac!!
6 research collaborations with key players in the field!
Fra Q1 rapport.
fimaNAC
The fimaNAC programme provides a targeted intracellular delivery technology for nucleic acid therapeutics. It is a preclinical stage collaborative programme, with six research collaborations established with key players in the field.
Focus on preclinical research collaborations
PCI Biotech employs a collaborative strategy for fimaNAC. Currently, the delivery technology is used in six preclinical research collaborations in the area of nucleic acid therapeutics. All the collaborators have the same purpose of exploring synergies between the partner’s proprietary nucleic acid technologies and the fimaNAC technology. Thereafter, the intention is to explore the potential for further partnerships.
The current collaboration partners span from an undisclosed big pharma company to five mid-/small- size biotechnology companies: Bavarian Nordic, BioNTech, eTheRNA immunotherapies, IMV and Phio Pharmaceuticals.
The ongoing collaboration with an undisclosed big pharma company has been extended several times, most recently until the end of June 2019 with the possibility for further extension.
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Bare for at ikke det skal være noen misforståelser: Det blir litt upresist å si at melding kommer etter 8 pasienter behandlet, for de får behandling i kontrollarmen også.
Safety read-out er etter at 8 pasienter er behandlet i den eksperimentelle armen (med amphinex/pci), så antakelig vil rundt 16 personer være rekruttert inn i studien og ha vært i behandling tilstrekkelig tid til at safety kan avleses på dem - på tidspunktet melding om safety kommer…
Det tar også noe tid fram til safety kan avleses på en pasient, så antakelig er et betydelig høyere antall pasienter rullert inn i studien enn de 16 som har nådd tidspunkt for at safety kan avleses.
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Disse åtte må vel også være av de som «rekker» dobbel behandling.
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Jeg skrev ovenfor: " … og dessuten ved sikkerhetsavlesning fra IDMC når åtte pasienter er ferdig behandla i den eksperimentelle armen."
Man bedriver sjølsagt ikke nekroterapi.
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Jeg kjøpte i går og ligger på kjøp i dag.Det er under børs uro at man skal kjøpe.
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Ja, jeg påpeker bare at det er langt ifra sikkert at alle i den eksperimentelle armen mottar to behandlinger. Kun 5/7 pasienter i extensionstudiet mottok to behandlinger, av forskjellige årsaker vil jeg tro.
Sannsynligvis må man ha flere enn 16 pasienter innrullert før denne safetymeldingen foreligger. 
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Ja, svært sannsynlig - av to grunner: Den du nevner OG avhengig av randomiseringen (det er jo ikke “ellemelle, du skal stå”).
Ellers var min replikk ovenfor med et glimt i øyet 
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stemmer det og lønna kommer på tirsdag , da blir det 6k til på meg, blir tunfisk til morgen middag og kveld denne mnd.
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skal vi på hytten i dag ? fra fruen
ja, om du fyller disel , eg er blakk
dog ligger eg med 1391 aksjer å fisker på 22,2 
God Helg og snart Q !
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Mener å huske at PW i et radiumpodcast sa at man ville 8 pasienter til IMDC safety avlesning når mellom 14 og 22 pasienter var innrullert. Mao randomiseringsalgoritmen er slik at det ikke er mulig at 8 pasienter kan ha fått PCI når kun 13 pasienter et innrullert, og det er garantert at minst 8 pasienter har fått PCI når 22 pasienter er innrullert.
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Dette var outlook Q1 2019.
Spennende å få Q2 den 28 august!
Outlook
PCI Biotech believes that the proprietary PCI technology has the possibility to unlock the true potential of certain classes of innovative medicines. Supported also by external collaboration partners’ opinion, the PCI technology has the opportunity of playing a significant role in the realisation of several new therapeutic modalities, including immunotherapy (fimaVACC) and nucleic acid therapeutics (fimaNAc).
Although the company’s focus is three-pronged, divided over the three programmes, most resources are currently spent on progressing the lead project of fimaCHEM, which is the clinical development programme of fimaporfin with gemcitabine for the treatment of inoperable extrahepatic bile duct cancer; a rare disease with high unmet medical need. Based on the encouraging early signs of efficacy in Phase I, the company worked with the key regulators in Europe and the U.S. receiving important guidance which informs the design for a pivotal phase study. The final pivotal study design has thus been determined and funding expected to finance the study beyond interim read-out is in place. During this next step, the company will maintain its full commitment of advancing the programme with the ambition of helping the patients currently left without effective treatment options achieve a good quality of life.
In parallel, the two other programmes, fimaVACC and fimaNAc, are proceeding in accordance with the established development strategy. The clinical validation of the fimaVACC technology is essential for PCI Biotech’s role within the immunotherapy space. The Phase I study in healthy volunteers provided affirmative results on translation of the technology into humans and key data to support decisions of the programme’s further development strategy. The fimaNAc programme continues to follow a collaborative approach, by pursuing out-licensing opportunities.
In short, the main priorities of PCI Biotech at this time are to:
Effectively drive the fimaCHEM clinical development programme in inoperable extrahepatic bile
duct cancer towards the market
Define and execute the strategy for the next phase of development for fimaVACC
Manage alliance and partnering activities across all commercially interesting areas for the PCI
platform
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Det tar litt tid fra innrullering til at man kan si Safety = OK på en pasient. Ved radomisering skal 14-18 inn før man kan med sikkerhet si at 8 har fått Pci. Innruleringen derimot ruller i bakgrunn mens man venter på Safety på de 8 første. Dermed kan man kun gi et estimat på hvor mange som er innrullert når safetymelding kommer. Så 20-25 skulle nok være innenfor.
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