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Galena Biopharma, Inc. Message Board

  • zahnd9898 zahnd9898 Mar 4, 2013 1:52 PM Flag

    NeuVax - Truth and Facts

    VERY NICE INFO.
    52
    Galena Biopharma Milestones
    NeuVax (
    nelipepimut
    or E75)
    #

    NeuVax demonstrates promising
    in vitro
    and
    in vivo
    efficacy in HER+ tumor
    models
    #

    US IND approved and Phase 1/2 solid tumor trials completed
    #

    SPA (Special Protocol Assessment) approved by FDA for 36 month DFS
    endpoint
    #

    NeuVax demonstrates statistically significant DFS (Disease Free Survival) in
    36 month landmark data analysis
    #

    Complete CMC process development to support registration trials in Q4 11
    #

    Initiate FPI in Ph 3 NeuVax v. Placebo in 1H 12
    G

    Initiate FPI in
    Ph
    2 NeuVax combination trial with Herceptin in 2012
    G

    Complete enrollment of n=700
    pts
    G

    Achieve positive interim analysis at n=70 events
    G

    Complete
    Ph
    3 clinical study at 36 months
    G

    File Biologic License Application (BLA) to the US FDA
    Folate
    Binding Protein-E39 (FBP)
    #

    US IND approved and IRBs approved
    #

    Initiate FPI in Ph 1/2 in ovarian, endometrial and breast cancers in 1H 12
    G

    Enroll 20-30 patients in
    Ph
    1/2

    Sentiment: Strong Buy

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • Take a look do the HOMEWORK IT IS UP TO YOU FACT IS FACT!

      YOUR DD WILL REWARD YOU!

      Sentiment: Strong Buy

    • Good information!

    • ASCO !
      TIC TOC!

      Sentiment: Strong Buy

      • 1 Reply to zahnd9898
      • This girl is going to run and it will be over $3.00.
        More fuel for the fire!
        Folate Binding Protein-E39 (FBP)

        Folate Binding Protein-E39 (FBP) is a targeted vaccine aimed at preventing the recurrence of ovarian, endometrial, and breast cancers. The FBP vaccine consists of the E39 peptide derived from the folate binding protein combined with the immune adjuvant granulocyte macrophage colony stimulatingfactor (GM-CSF). FBP is over-expressed (20-80 fold) in more than 90% of ovarian and endometrial cancers, as well as 20–50% of breast, lung, colorectal, and renal cell carcinomas. FBP has very limited tissue distribution and expression in non-malignant tissue making it an ideal immunotherapy target.

        Ovarian cancer occurs in over 22,000 patients per year in the U.S. and is the most lethal gynecologic cancer. Despite the incidence of ovarian cancer being only approximately 20% that of breast cancer, the number of patients that die from ovarian cancer is nearly 50% that of breast cancer. Due to the lack of specific symptoms, the majority of ovarian cancer patients are diagnosed at later stages of the disease. These patients are routinely surgically debulked to minimal residual disease, and then treated with platinum- and/or taxane-based chemotherapy. While most patients respond to this treatment regime and become clinically free of disease, the majority of these patients will relapse, and once the disease recurs, the treatment options and successes drop dramatically.

        Endometrial cancer is the most common gynecologic cancer and occurs in over 46,000 women, with over 8,000 deaths, in the US annually. There are two basic types of endometrial cancer: endometriod and papillary serous. The latter has a much more aggressive clinical course and the majority of these patients will die of this form of the disease.

        THIS GIRL IS ON FIRE!

        Sentiment: Strong Buy

    • GALE will be the noticed at ASCO as an add on to the next cancer drug.

      Sentiment: Strong Buy

      • 1 Reply to zahnd9898
      • Look at the who's who!

        Meeting:
        2013 ASCO Annual Meeting

        Abstract No:
        LBA509

        Citation:
        J Clin Oncol 31, 2013 (suppl; abstr LBA509)
        Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2013 Annual Meeting but not presented at the Meeting, can be found online only.

        Author(s): Gabriel N. Hortobagyi, Martine J. Piccart-Gebhart, Hope S. Rugo, Howard A. Burris, Mario Campone, Shinzaburo Noguchi, Alejandra T. Perez, Ines Deleu, Mikhail Shtivelband, Louise Provencher, Norikazu Masuda, Shaker R. Dakhil, Ian Anderson, David Chen, Amy Damask, Alan Huang, Robert McDonald, Tanya Taran, Tarek Sahmoud, José Baselga; Department of Breast Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX; Jules Bordet Cancer Institute, Brussels, Belgium; University of California, San Francisco, San Francisco, CA; Sarah Cannon Research Institute, Nashville, TN; CLCC René Gauducheau, Centre de Recherche en Cancerologie, Nantes Saint Herblain, France; Osaka University, Osaka, Japan; Memorial Cancer Institute, Breast Cancer Program, Hollywood, FL; AZ Nikolaas, Sint-Niklaas, Belgium; Ironwood Cancer and Research Centers, Chandler, AZ; Centre des Maladies du Sein Deschênes-Fabia, Hôpital du Saint-Sacrement, Quebec City, QC, Canada; Osaka National Hospital, Osaka, Japan; Cancer Center of Kansas, Wichita, KS; Redwood Regional Oncology Center, Santa Rosa, CA; Novartis Pharmaceuticals, Oncology, Florham Park, NJ; Novartis Institutes for BioMedical Research, Cambridge, MA; Oncology Translational Medicine, Novartis Institute for Biomedical Research, Cambridge, MA; Novartis Institutes for BioMedical Research, Inc., Cambridge, MA; Novartis Pharmaceuticals Corp, Florham Park, NJ; Novartis Pharmaceuticals Corp, East Hanover, NJ; Memorial Sloan-Kettering Cancer Center, New York, NY

        Abstract Disclosures

        Sentiment: Strong Buy

    • Up!

    • Well ! Those negative writers dare not give a verifiable rebuttal to these facts. So, they just gang up in giving thumbs down to this truthful message.

      What a bunch of cowards, hiding behind the truth and have no courage even to put forth LIES!

      That is why they deserve to be call Maggots=no backbone!

    • The truth

      Sentiment: Strong Buy

    • True!

    • Waiting for a HUGE MOVE!

      Sentiment: Strong Buy

    • Good and verifiable facts. Up!

    • View More Messages
 
GALE
2.895+0.105(+3.76%)Jul 22 4:00 PMEDT

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