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PCI Biotech
12.09.2017 08:59

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PCI Biotech: Initial clinical results from Phase I indicate that vaccination with fimaVACC enhances cellular immune responses

Oslo (Norway), 12 September 2017 - PCI Biotech (OSE: PCIB), a cancer focused clinical-stage company developing innovative therapeutics that address significant unmet medical needs today announced that the first immune response results from the fimaVacc Phase I study in healthy volunteers indicate enhanced overall T-cell responses at tolerable dose levels.

The clinical data cover more than 50% of the planned subjects in the ongoing dose finding part of the study and provide initial clinical support of fimaVacc's potential to enhance the cellular immune responses that are important for therapeutic effect of vaccines. The dose finding will continue to establish maximum tolerated dose and further explore the efficacy of fimaVacc. The study remains on track for completion by first half of 2018.

Per Walday, CEO of PCI Biotech, said: "Improving immunogenicity of vaccine candidates is a main priority in the immunotherapy industry. We believe that the fimaVacc technology may play an important part in solving this challenge and the initial immune response results in the Phase I study are encouraging. We look forward to the completion of this study, aiming for clinical translation of the promising preclinical results with the fimaVacc technology. "

The objectives of the Phase I study are to determine safety, tolerability and immune responses of fimaVacc in healthy volunteers. The study is designed as an open-label, antigen-adjuvant controlled study in up to 110 subjects.

Contact information:
Per Walday, CEO
12.09.2017 09:00

Innlegg av: Snøffelen (10.09.17 22:36 ), lest 501 ganger
Ticker: PCIB
RE^1: PCIB potential abscopal effects with fimaCHEM
Med immunoterapi er "abscopal effects" kommet mer i vinden. I følgende artikkel fra juli 2017 så fremlegges forslag for gradering.


"Generating and grading the abscopal effect: proposal for comprehensive evaluation of combination immunoradiotherapy in mouse models"

Det er også foreslått gradering for kliniske resultater (mouse models er pre-klinisk)

Forslag for kliniske resultater er gitt i tabell (Table 2A):


Abscopal effects, slik det tradisjonelt er oppfattet i litteraturen, er fra grading 2C, eller bedre.

"The progression of grades is based on preliminary data: in this case, a "true" experimental abscopal effect may be considered grade 2+."

Mao, det som er observert klinisk i fimaCHEM og gallegang er mer eller mindre senasjonelt, og det gir god grunn til å være svært optimistisk mtp fase 1 resultatene i fimaVACC.
04.10.2017 18:42

PCIB med ny fin melding:

PCI Biotech receives US Orphan Drug Designation for fimaporfin in the treatment of bile duct cancer (cholangiocarcinoma)

Oslo, 4 October 2017 - PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead product candidate, fimaporfin, for the treatment of patients suffering from cholangiocarcinoma (bile duct cancer). This patient population has no approved treatment alternatives today and fimaChem (fimaporfin) has the potential to play a role in this area of high unmet medical need.

"Receiving orphan status from the FDA is a crucial step in the development of this important new medicine for cancer patients in need of better local treatments. PCI Biotech's fimaChem treatment is well suited for treatment of bile duct cancer, with easy light access through routine endoscopic methods." said Dr. Per Walday, CEO of PCI Biotech.

"Orphan designation is a significant regulatory milestone and recognises the therapeutic benefits we seek to bring to the patients. It supports our further development of fimaChem in this indication and provides important development and commercialisation benefits."
13.11.2017 15:17

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