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Roche Holding AG Message Board

  • dobie.davis dobie.davis Jan 6, 2012 1:18 PM Flag

    Roche collaboration

    I found this and think it's an interesting collaboration and wonder what kind of partnership might come out of these trials with GALE. I'll be watching this one closely.

    A Phase II Combination Trial is Planned in 1H12

    Based on the preliminary positive results, GALE plans to initiate a Phase II trial in the 1H2012. The FDA has approved the trial in January 2012.

    The planned Phase II trial is being funded by Galena Biopharma and Genentech/Roche through the Henry M. Jackson Foundation. Each company will provide their respective drugs for the 300 patient trial and approximately half of the funding necessary to complete the trial. The trial will be conducted at twenty sites worldwide and is expected to commence in the first half of 2012.

    This trial will enroll 300 breast cancer patients with HER2 low-expressing tumors in order to establish the benefit of the combination versus trastuzumab alone in the adjuvant setting.

    The study will be a multi-center, prospective, randomized, single-blinded Phase II trial evaluating NeuVax + trastuzumab (vaccine) vs. trastuzumab + GM-CSF (control) alone in the adjuvant setting in breast cancer patients. HLA-A2/A3+ node positive (or node negative if also negative for both ER and PR) breast cancer patients with HER2 1+ or 2+ expressing tumors who are disease-free after completing standard adjuvant therapies will be enrolled and randomized. Patients must have adequate cardiac function for enrollment (LVEF >50%), and randomization will be further stratified based on HER2 status (1+ or 2+) and nodal status (N0, N1, N2, or N3).

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