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Northwest Biotherapeutics, Inc. Message Board

  • roger_peter1983 roger_peter1983 May 7, 2012 4:34 PM Flag

    News Release Schedule Immunotherapies Trials

    RPT-FACTBOX-Drugmakers on the cusp of new immunotherapy era
    07.05.2012 13:00:01

    May 7 (Reuters) - Global drugmakers and tiny biotechs are developing promising cancer vaccines and other
    treatments that use the immune system to attack tumors. ID:nL2E8FKDCG
    Leading doctors in the field believe the next 18 months could finally prove the broader value of this
    approach, one that has been over 100 years in the making.
    Below are some companies expected to release key clinical trial data this year or next:


    Company Product Disease Data expected
    Amgen AMGN.O Tvec Melanoma Phase III in 2012
    Bavarian Nordic BAVA.CO Prostvac Prostate cancer Phase III in 2013
    Bavarian Nordic Panvac Breast cancer Phase II in 2012
    GlaxoSmithKline GSK.L MAGE-A3* Lung cancer Phase III in 2012
    Glaxo/Agenus MAGE-A3/QS-21 Melanoma Phase III in 2013
    Bristol-Myers Squibb BMY.N BMS-936558 Kidney cancer Phase II in 2013
    Oncothyreon ONTY.O /Merck KgaA MRCG.DE Stimuvax Lung cancer Phase III in 2013
    Newlink Genetics NLNK.O HyperAcute Pancreatic cancer Phase III late 2012/early 2013
    Vical Inc VICL.O Allovectin Melanoma Phase III in late 2012
    Transgene TRNG.PA TG4010 Lung cancer Phase III under way
    Celgene Corp CELG.O /GlobImmune Inc GI-4000 Pancreatic cancer Phase II in 2012
    Idera Pharmaceuticals IDRA.O IMO-2055 Head and neck cancer Phase II in 2012
    Generex Biotechnology GNBT.OB AE37 Breast cancer Phase II in 2012
    Jennerex Biotherapeutics JX-594 Liver cancer Phase II in 2012
    Northwest Biotherapeutics NWBO.OB DCVax Brain cancer Phase II in 2013

    *Used with Agenus Inc AGEN.O QS-21 adjuvant

    (Reporting by Bill Berkrot)
    ((bill.berkrot@thomsonreuters.com)(1 646 223 6030))

    Keywords: HEALTH IMMUNOTHERAPY/

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    • Another week, another press release. More great news, though. They've moved into phase 3 (as approved by FDA) for their brain cancer trial.

      Only good things to come. (I hope!)

      BETHESDA, MD, May 17, 2012 -- Northwest Biotherapeutics (OTC.BB: NWBO) (NW Bio)
      announced today that it now has 41 clinical trial sites open and recruiting across the United States
      in its ongoing clinical trial of DCVax
      ®
      -L immune therapy for Glioblastoma multiforme (GBM),
      the most lethal form of brain cancer. This is ahead of the Company’s previous projection of 40
      sites by the end of Q2, 2012. The Company plans to continue adding clinical trial sites in the US
      and Europe, and expects to have at least 60 sites open and enrolling by the end of Q3, 2012.
      The Company also announced that the FDA has accepted an amendment of the clinical trial, which
      does not make any change in the treatment regimen, which leaves all data collected to date intact
      for use in the trial’s overall results, and which includes the following:
       Designation as a Phase III trial
       Expanded and enhanced statistical endpoint analyses
       Addition of another cohort of patients which can potentially expand the application
      of DCVax
      ®
      -L, and which increases the trial to up to 300 patients
       Addition of interim analyses for efficacy

      More here:
      http://www.nwbio.com/pdf/press2012.05.17.pdf

    • Sit...excellent post and I totally agree with you. I heard the same thing about Kings College in England. I posted this on another board on how England, Germany with Fraunhofer with compassionate use and GBM trials there is no other US competitor in similar trial outside of US like NWBO. I also believe there is a quality financing deal that will be announced in near future or these prestigous organizations through their due diligence would not even be involved nor put capital to get all this going with NWBO.

    • When people say i dont know bout the EU.You do as announcements have been made.
      They can now treat people compassionatly
      without FDA approval.
      This is being understated i feel.300 million people in Europe.Also you will get people traveling to Europe from America, as rich people will not want to part of the trail as it is placebo.
      What we need is an update from Kings Collage.Just because they only announced recently, people are assuming they are a year behind the Germans .They are not . All the regulation and processes have been sorted so they have been working on this behind the scenes for at least a year too.Also to you Americans. Kings Collage London is probably the most respected Medical facility in the country. I am long here as you know , but i feel Europe is being very understated here.Lets see where this goes with revenue deals in the next few months.Also NWBO must be a massive favourite to get a trail upgrade reading that article posted above.Lots can happen here news flow wise to get the broader market interested.

    • Thanks for the info that clears some things up. I thought that the patient enrollment in germany would possibly give us a 110 patient count by sept with 24 of the centers over thier coming on line after the june filing gets accepted. I know it is always if, if, if, but if they reach the milestone will nwbo be able to report patient progress then. I think this will inprove the value of nwbo providing the news matches phase 1. I would think fraunhofer will finish the study regaurdless of the finiancing or is this wishful thinking

    • That is the plan. If they do not get accelerated approval then it's most likely curtains. Don't know the EU regs.

    • There remains a possibility that a shortened clinical trial could be run. They (possibly) could get conditional approval on a Phase II and run a confirmatory Phase III

      http://www.reuters.com/article/2012/05/09/drugs-breakthrough-idUSL1E8G8A8920120509?type=companyNews&feedType=RSS&feedName=companyNews&rpc=43

    • IMUC is not mentioned.

      NWBO will be worth double digits ($10 or more) or go BK by 2014

      IMO it'll be worth double digits

 
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