PCI Biotech - Småprat 2019 (PCIB)

[idioten]

Mener kineserne har vært aktive med å presentere dette det siste året. Tror dette er positivt for Pcib. Pcib har vist at de leverer Crisp. Kansje noen får ut fingeren, og ser de kan bli akterutseilt om de ikke inngår partnerskap med Pcib? Om det ikke motsatte skjer, at de gjør det med kineserne.

[StockDZ]

Not sure if this has been discussed but seems there will be another partenering conference for the company I take this as a good sign

[Savepig]

Noen som kjenner seg igjen i dette? (Sjekk hele tråden)

Michael Gilman (michael_gilman)

[Jubel]

SPECIAL FEATURE - Platform Technologies: Not Just for Big Pharma

[Chrkni]

Hva tenker du med denne linken @Jubel, for oss som ikke har lest igjennom, kan du gi en kort oppsummering og dine tanker rundt denne artikkelen?

[Jubel]

Solid platform that serves as a foundation to produce clinical assets that is my first thought.

In the case of PCI Biotech; chem, Nac and Vacc.

The Vacc plattform seems to be translated to a clinical asset:

https://blog.medisin.ntnu.no/can-light-help-to-develop-effective-anti-cancer-vaccination/

PCI Biotech Fundamentale Forhold (PCIB)

17th International Photodynamic Association World Congress
Friday - Thursday 28 June - 4 July 2019

[Chrkni]

Ja, flott

[Columna]

«…the effect of PCI can potentially be of value also for therapeutic vaccination against infections by viruses and intracellular bacteria, and also for prophylactic vaccination for diseases where an improved CTL immune response would be of value…»

[TekBot]

08/04-2019 10:32:13: (PCIB) PCI Biotech: Final confirmation of successful safety read-out in the Phase I Extension study

…

Vis børsmeldingen

Oslo (Norway), 8 April 2019 . PCI Biotech (OSE: PCIB), a cancer focused clinical-stage company developing innovative therapeutics that address significant unmet medical needs today announced final confirmation of successful safety read-out for the Phase I Extension study in inoperable bile duct cancer patients which currently are left without effective local treatment options. The appointed Cohort Review Committee (CRC) completed a formal review confirming the Company.s preliminary report that no adverse reactions have been reported that would limit the delivery of up to two fima_Chem_ treatments in the pivotal RELEASE study with registration intent. The Phase I Extension study is now completed and recruitment will be formally closed.

The clinical data from the Phase I Extension study include a total of seven patients receiving fima_Chem_ treatment and five of these received two treatments. Three of the five patients that received two fima_Chem_ treatments had measurable disease at baseline and one of these had an overall partial tumour response according to RECIST at 6 months, one had stable disease and one had progressive disease due to the appearance of new lesions.

A post-study follow-up of the patients is ongoing. Five patients were alive at last censoring (December 2018 . mid-February 2019), which all had been treated with two fima_Chem_ procedures. Patient numbers are limited and it is too early to put any significance to the emerging survival data with 5 of 7 patients still being alive, but currently this translates to an interim median Overall Survival of approximately 12 months including all 7 patients, i.e. similar to best comparable published data on gemcitabine/cisplatin treatment alone.

Per Walday, CEO of PCI Biotech, said_: “With this positive safety clearance for repeated treatments, PCI Biotech is now fully focused on execution of the pivotal phase and we are eager to see the benefits fimaChem hopefully can provide to the patients in need of better local treatment options.”_

The pivotal RELEASE study has the potential of accelerated/conditional marketing approval as a first-line treatment given the rare disease status and high unmet medical need. Based on today.s positive safety data the RELEASE study will be initiated with up to two fima_Chem_ treatments and include a seamless safety review by an Independent Data Monitoring Committee (IDMC) when eights patients have completed two treatments.

About the RELEASE study
The pivotal RELEASE study design is based on the outcome of meetings with the two leading regulatory authorities European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). The study programme consists of a single open randomised two-arm study with 186 patients (93 patients per arm), having a control arm with the standard of care (SoC) treatment of up to eight cycles of the chemotherapies gemcitabine and cisplatin, and an experimental arm with up to two fima_Chem_ treatments in addition to SoC. The study.s primary endpoint is progression free survival (PFS), with overall survival (OS) as a key secondary endpoint. The study includes an interim analysis of PFS followed by analysis of objective response rate (ORR), with the potential of accelerated/conditional marketing approval. In addition, the study contains several other secondary endpoints that provide the opportunity to generate robust comparative data of importance for market acceptance of fima_Chem_ as a first-line treatment for inoperable bile duct cancer.

The RELEASE study is expected to start during the first half of 2019; the interim analysis of PFS and objective response rate (ORR) for potential accelerated/conditional marketing approval is expected to be available approximately 36 months after study initiation, while the final analysis is expected approximately 50 months from initiation. The pivotal study will be executed in clinical sites that first will open in Europe, followed by a roll-out in the U.S.

Contact information:                  
Per Walday, CEO
[email protected]
Mobile: +47 917 93 429

About PCI Biotech         
PCI Biotech is a biopharmaceutical company focusing on development and commercialisation of novel therapies for the treatment of cancer through its innovative photochemical internalisation (PCI) technology platform.  PCI is applied to three distinct anticancer paradigms: fima_Chem_ (enhancement of chemotherapeutics for localised treatment of cancer), fima_Vacc_ (T-cell induction technology for therapeutic vaccination), and fima_NAc_ (nucleic acid therapeutics delivery).

Photochemical internalisation induces triggered endosomal release that is used to unlock the true potential of a wide array of therapeutic modalities. The company.s lead fima_Chem_ programme consists of a clinical Phase I/II clinical study in bile duct cancer, an orphan indication with a high unmet need and without approved products.  fima_Vacc_ applies a unique mode of action to enhance the essential cytotoxic effect of therapeutic cancer vaccines, which works in synergy with several other state-of-the-art vaccination technologies.  fima_NAc_ utilises the endosomal release to provide intracellular delivery of nucleic acids, such as mRNA and RNAi therapeutics, thereby addressing one of the major bottlenecks facing this emerging and promising field.

For further information, please visit: www.pcibiotech.com   

Forward-looking statements  
This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements. PCI Biotech disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

http://www.netfonds.no/quotes/release.php?id=20190408.GlobeNewswire.GNW1000176798-en

[Chrkni]

En bekymring borte

Ser også at MOS er på 12 måneder, som er det samme som SoC, samtidig er 5 fortsatt i live

[Intendanten]

Nu kør vi​:sparkler: Herlig​:grinning:

[anon21766851]

Three of the five patients that received two fima_Chem_ treatments had measurable disease at baseline and one of these had an overall partial tumour response according to RECIST at 6 months, one had stable disease and one had progressive disease due to the appearance of new lesions.

Flere enn meg som forventet mer effekt av dobbel behandling? 33% ORR om jeg forstår det rett.

[Flottesen]

Det er vanskelig å tolke dette, det står at 5 pasienter har fått to behandlinger og at 5 pasienter er i live, alle har fått to behandlinger.
3 av disse 5 har “measurable disease”, betyr det at det to siste har hatt en komplett respons?
Hvis det er tilfelle, hvorfor ikke skrive det i klartekst?

[busk1]

Three of the five patients that received two fima_Chem_ treatments had measurable disease at baseline

Hva betyr dette? Hadde to av dem ikke tumor ved start av studien? Hvorfor var de inkludert? Når tas baseline-målingen? Eller er det pga at de radiologiske bildene ikke lot seg tolke?

[anon21766851]

Tolker det som at ikke tumor er målbar ihht kriteriene de bruker, ikke som at 2/5 har CR.

[coyw]

Enig der, tipper 2 av 5 ikke er målbar enda eller?

[busk1]

Kan ikke være “enda”. Var jo baseline de ikke hadde. Den dukker jo ikke opp etterhvert

[coyw]

Stemmer, leste for rask igjennom her.

[Chrkni]

Hva tenker du om MOS på 12 mnd, med 5 fortsatt i live?

Den biten er det kanskje ikke noe å legge vekt på pga lav N ?

[Flottesen]

Det er jo positivt at alle 5 pasientene som har fått dobbel behandling er i live, da vil vel MOS fortsette å øke.