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Galena Biopharma, Inc. Message Board

  • techtrader79 techtrader79 Dec 6, 2012 8:20 AM Flag

    Is something wrong with the Phase 3 trial???

    I thought this was all about Phase 3, did something happen in that trial? I'm concerned given they are now talking about a "screen tool" from Leica Biosystems to help with patient selection in Phase 3. Were they not seeing results they wanted? And stepping back to running a Phase 2 trial comparing trastuzumab? What's with that? What am I missing???

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    • you my friend are an idiot full stop.

      do you even know what the PIII trial design is, its sixe timing, endpoints etc? apparenlty you do not, yet you invest, - plain stupidity.

    • You should not be concerned about the partnership with Leica. This is a very positive sign in my book. I work in the MDx space and what this means is that GALE is preparing to have a formal CLIA approved companion Dx as part of their label with the BLA submission to the FDA for approval.

      They are already "screening" for the low HER2(+) patients that don't meet the defintion for anti-HER2 therapy, which is IHC 3+ or HER2(+) by FISH (showig increased gene copy #/amplification).

      It's one thing for GALE to screen these patient for the phase 1 and phase2 trial with a RUO Dx sccreening tool, but when this vaccine is approved by the FDA for clinical use, GALE needs to have a clinical grade, CLIA-validated, commercial companion Dx.

    • this isn't acting right.........for good news tomorrow? cutting back to core position.JMHO

      Sentiment: Hold

    • thanks chainsaw.JMHO

      Sentiment: Hold

    • Denver & chainsaw, you both seem abreast (little pun).....do you both think there are enough subjects receiving neuvax, 30 in pII and ? in pI.....to actually make this poster friday ramp up gale? realize it's just a preclude to pIII....but a corralation that neuvax really works? are these samples enough to make conclusions? hence random sampling. JMHO

      Sentiment: Hold

      • 1 Reply to goodbrain005
      • Goodbrain, with regards to your question about the Phase II comparative trial with Herceptin, I just checked the latest information (updated on November 21) on the official clinical trials website, and this is set to commence in December, aiming to recruit 300 patients.

        As for the phase II SN33 trial that will be presented on Friday, I believe the number of patients on Neuvax was higher than 50. While sample sizes of phase II are rarely big enough to 'prove' efficacy of a drug (in the eyes of the FDA), I expect the results to be positive enough (ie large difference between arms and control even for the sample sizes involved) to cause sufficient excitement. The intermediate results certainly were.

    • the 300 subject pII is displayed under gale "pipeline"web ,beneath "present" is in progress.i wonder if they'll talk about friday also?JMHO

      Sentiment: Hold

    • the more accurate the screening of patients participating in any sort of scientific medical study, the more accurate are the Conclusions you may expect to generate as the study progresses. As i know the HER2 pathological diagnosis, part of the sub-sets of the patients is not only limited to the levels of "aggression" of the atypical cells (+1, +2 & +3), but there's also the deliniation of patients between those whose atypical cells are either pos or neg for indicated hormone "receptors" Estrogen and Progesterone. In that subset that is Negative for those hormone receptors, the traditional options of adjuvant treatments have been much fewer than for the subset of patients who are Pos for these two hormones. It is my perception that the scientists and experts at both GALE and at Leica Bio will further expand the ongoing Ph-3 trials to specifically INCLUDE the hormone neg population of women in the studies, thus offering yet another huge potential benefit in the adjuvant treatment of Breast Cancer. That Huge benefit is yet another chapter of what the NeuVax potential is all about. Finally, as to your question about Ph-3 trials - - - There is absolutely NOTHING wrong with these ongoing trials, in fact to the contrary. They must be proceeding very well for the likes of Teva and Leica to step up and become Partners with GALE. Also, please keep in mind that these trials take time to generate data. Please remember (to the best of my knowledge) that the Ph-3 trials only began (formally) as of Jan of THIS YEAR. We must all get a grip on what is simply called PATIENCE!!!!! In the mean time, take pride and be assured at least with the Facts that there are highly credible organizations willing to stand Side-by-Side with GALE as the necessary processes are continued and expanded (the clinical trials).

      Sentiment: Buy

    • You are misinterpreting this.

      These days, when a pharma company is set to launch (ie get FDA-approval) for a company that requires a companion diagnostic (such as HER2 testing), it is CRUCIAL for that company to enter into a partnership with a molecular diagnostics manufacturer as early in the process as possible.
      This allows sufficient time to seek approval by the FDA for the companion diagnostic (CDx) and drug (Rx) at the same time. Neuvax and the Leica test would both be FDA-approved.

      2 recent examples of this: Pfizer's Xalkori and Abbott Molecular's BreakApart FISH probe, and Roche/Genentech's Zelboraf and Roche's cobas BRAF test - both drugs had very successful launches due in part to the co-approval of their companion diagnostics.

      This is a great sign, and shows Galena know what they are doing and are aiming for FDA-approval in tandem with a CDx.

      In my opinion (as someone who works in the pharma industry with a focus on oncology), this is bigger news than the Teva announcement.

      Sentiment: Strong Buy

      • 3 Replies to flemishchainsaw
      • Agree it is more interesting news. And the companion diagnostic made me immediately think of Roche as well. I also wonder if its viewed as a prerequisite to further partnerships.

        Question to you since you seem knowledgeable in the area. Do you know if Her2 +1 and +2 patients could include some patients that are described as triple negative BrCa? I'm not familiar with the cutoff on Her2 staining for triple negative? Thanks in advance.

        Sentiment: Strong Buy

      • ez1954@rocketmail.com ez1954 Dec 6, 2012 8:52 AM Flag

        Thanks for the explanation.

        Much appreciated.

        Sentiment: Buy

      • reading through the prospectus of july in the sec statements......gale said they were going to do these tests. they also said they were going to start a 300 subject pII comparing the two different therapies/drugs combo............

        "Based on these results, in 2012 we plan to commence a randomized, multicenter Phase 2 trial in 300 patients that will compare NeuVax with trastuzumab versus trastuzumab with GM-CSF."

        what's going on with this TECH TRADER? same as you said above?

        Sentiment: Hold

    • they know low to interm node pos is good.(which is pIII.........trying to screen farther out with these other legs of trials.....is how i understand it.JMHO

      Sentiment: Hold

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