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prr could be blockbuster from 1 october, page-11

  1. 236 Posts.
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    The abstract of the October 1st presentation has been published on the conference website. It doesn't give too much away that I can see apart from some additional data on serious adverse events. The last sentence is the key imo.

    http://eccamsterdam2013.ecco-org.eu/Scientific-Programme/Abstract-search.aspx

    "Clinical study of autologous dendritic cell therapy targeting mucin 1 for treatment of ovarian cancer patients in first remission
    J. Goh, C. CAN-003 Study Team, S.E. Gargosky, H. Gray

    Background: Cvac is an autologous cellular therapy targeted to elicit a T cell response to tumors that over-express mucin 1 such as epithelial ovarian cancer (EOC). CAN-003 is a phase 2b study evaluating the effect of Cvac on progression free and overall survival, as well as safety and immune responses, in patients in remission from EOC.

    Design: Patients were eligible if they had stage III or IV EOC and obtained a complete response to standard first or second line platinum/ taxane based chemotherapy. The first 7 patients received Cvac to allow evaluation of manufacturing in the US and for safety evaluation. Patients were then randomized either to Cvac therapy or standard of care (SOC). Patients in the active group were treated with up to 10 doses of Cvac, 4 weekly for 7 doses, and 8 weekly for three additional doses. The trial is closed to enrolment and will be completed in 2013.

    Results: 63 patients were enrolled into the trial; 36 Cvac and 27 SOC of which 42 were in first remission and 21 were in second remission. Patients were mostly Caucasian; 1 was African American and 2 were Asian.

    10 SAEs were reported in total. 7 SAEs in Cvac patients and 3 SAEs were reported in SOC; none were unexpected and only one (abdominal pain) was classified as possibly-related to Cvac.

    Interim analysis has shown positive trends in PFS; as of 17 August 2012, the median PFS for days on study as 365 days for Cvac, 421 day for non-randomized Cvac, and 321 days for OSC. Updated PFS data will be presented at the meeting. As expected, assessment of anti-mucin-1 responses have indicated no humoral response, however, interim immune results show a T cell response that was mucin 1-specific after 3 Cvac doses. T-cell responses throughout the course of Cvac treatment will be presented at the meeting.

    Conclusion: Study data show that immunotherapy with Cvac is well tolerated. Immunological outcomes are consistent with the mechanism of action and the interim trends are encouraging for PFS."
    ...........................................................

    Good luck all. Herro
 
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