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prr cancer vaccine - anzgog presentation, page-2

  1. 2,306 Posts.
    From the notes -

    "Most advanced ovarian cancer vaccine in
    development for maintenance: Cvac ™

    • CVac is an autologous, dendritic-cell based therapy or
    cancer vaccine targeting abnormal mucin-1
    • Proven technology with FDA approval of Provenge ®
    • Well tolerated in all studies to date
    • Granted orphan product status by the U.S. FDA & EMA
    – Additional several years of exclusivity and priority
    regulatory treatment
    • Phase I & Phase IIa trials are complete with promising
    results
    • Phase IIb is fully recruited and ongoing

    CANcer VAccine Study (CANVAS

    • 1000 patients, 800 evaluable
    • Epithelial Ovarian Cancer: first remission
    • Double Blind, Placebo Controlled
    • Powered to demonstrate clinically significant
    effect on PFS and OS (HR 0.77, p=0.049, 90%
    power
    • 22 countries, 120 investigative sites
    • Australia is a key country for recruitment
    • First patients already enrolled in the US

    Summary

    • Malignant tumours evolve to fool the immune
    system
    • Re-education of the immune system may be an
    effective modality
    • Vaccines are in clinical development for ovarian
    cancer
    • Vaccine therapy will complement existing
    approaches
    • Vaccines could mean better quality of life and
    longer survival for our patients "

    I like the bit included by no coincidence " • First patients already enrolled in the US "

    ... becuase we are now catering to a US audience
 
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