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Galena Biopharma, Inc. Message Board

e75present 9 posts  |  Last Activity: Sep 11, 2014 1:19 AM Member since: Feb 17, 2014
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  • Present trial was supposed to wrap up enrollment earlier this year and interim analysis was supposed to come out by mid 2014- so what happened ? Does it mean physicians and patients lost interest in the study because they figure out it was not an effective treatment?
    People like Dr George Peoples and Dr Mittendorf were busy advancing science- they did not stop with E75 vaccine- they were also studying AE 37 and GP-2 peptide – in phase II studies- in similar patient populations by the same lead investigator- so far it has been around 500 patients studied in AE 37 and GP-2 peptide studies- if it were not for these studies by the same investigator- PRESENT trail would have finished enrollment long time ago and we would have had interim result by now.
    The beauty of this science is that- potentially - these patient population can get multiple vaccines if these prove to be effective- like any other immunization such as MMR vaccine, etc.
    We just need to be patient - nothing has changed regarding basic fact about E75 efficacy.
    Dr Schwartz did say in the yesterday conference that he hope to update trial enrollment completion status to market in 1 to 2 months, although he also said that it will complete enrollment in coming 2 quarters.( maybe he is trying to be cautious)

  • e75present e75present Aug 24, 2014 5:10 PM Flag

    210 pts on placebo, 210 on Neuvax- total- 420 patients.
    Placebo recurrent- 210 x 22.5% = 47.25
    Neuvax recurrent 210 xx 11.25% = 23.62

    Sentiment: Buy

  • e75present e75present Aug 24, 2014 4:55 PM Flag

    Thank you- this is very useful.
    As you said - this is very conservative yet very optimistic guess ( i.e- no recurrence in Neuvax arm).
    If - let's say - Neuvax reduce recurrent rate by 50% in PIII study- then it will be about 22 months from 420th patient enrolled. Then- Interim result may come sooner-

  • Reply to

    A perfect storm

    by e75present Jul 21, 2014 3:15 PM
    e75present e75present Jul 21, 2014 11:55 PM Flag

    If we analyze Phase II data objectively- and study the design of the phase III PRESENT trial , one could derive a reasonable conclusion.
    Phase II final result.
    Over all vaccine group showed improvement is DFS although P value was 0.05 ( statistically not significant).
    When you look at the subset analysis- patient who get optimal dosage, node +, Her-2 1+ and 2+ and patient who get booster vaccine every 6 months- There is significant improvement in DFS- statistically significant in each group. Cancer. 2012 May 15;118(10):2594-602. doi: 10.1002/cncr.26574. Epub 2011 Oct 11.
    Current phase III study population is specifically selected for the group with above characteristics those associated with positive results. Patients are selected only if ALL OF THE above subset characteristics are met - and they are getting optimal dosing AND booster treatments.
    There are also several other important facts.
    In Phase II study- when patient and tumor characteristics/ demographics were compared - only statistically significant difference between vaccine group and control group is ER/PR ( hormonal status.)
    ER/PR status is one of the most significant risk factor for recurrent disease in breast cancer.
    ER/PR negative cancer are more aggressive cancer and recurrent risk is much higher than ER/PR positive patients.
    Let us look at the ER/PR status in phase II study.
    Vaccine group- ER/PR neg- 31%, Control group- ER/PR neg- 17% P value 0.04.
    ( Cancer Research: December 15, 2012; Volume 72, Issue 24, Supplement 3
    doi: 10.1158/0008-5472.SABCS12-P5-16-02 )
    That mean vaccine group had more aggressive cancer population- almost double than control group.
    Now imagine if ER/PR status were even - Phase II result could have been significantly better for Neuvax.

    Sentiment: Strong Buy

  • Reply to

    A perfect storm

    by e75present Jul 21, 2014 3:15 PM
    e75present e75present Jul 21, 2014 11:45 PM Flag

    It is all about expectation.
    People like Cramer think E75 will not work base on the wrong assumption that vaccine/ immunotherapy generally does not work.
    We can only look at E75 Phase II data objectively and study how phase III was designed to optimize the E75 effect. And make rational expectation of the phase III result base on these - not guaranteed - but much more likely to be a positive study than not.
    I will repost my previous post regarding this topic.

  • Reply to

    A perfect storm

    by e75present Jul 21, 2014 3:15 PM
    e75present e75present Jul 21, 2014 8:08 PM Flag


  • Reply to

    A perfect storm

    by e75present Jul 21, 2014 3:15 PM
    e75present e75present Jul 21, 2014 3:16 PM Flag

    But E75 is different- it is mass producible- cost will be very low- delivery is so simple that it can even be given at home by patient herself if needed be.
    Whe prople eventurally realize these misconception , and after positive interim result- who knows what will happen to the share price.
    It is a perfect storm.

  • e75present by e75present Jul 21, 2014 3:15 PM Flag

    Current Galena share price is unreasonably low due to multiple reasons.
    Manipulations by shorts does play significant role.
    More importantly- two key misunderstanding of the Galena's E75 vaccine probably contributing to this suprisingly low price.
    It is undisputed that market is very large for E75 vaccine - as it concern breast cancer adjuvant treatment. ( As oppose to some rare cancers) - breast cancer adjuvant treatment is the most common chemotherapy treatments given in oncology clinics day to day.
    But following two misunderstanding is creating a perfect storm for future exponential increase ins tock price.
    Number one misunderstanding:
    Lay people believe ( i.e- Cramer and alike) that generally vaccine/ immune therapy does not work in cancer treatment - Cramer specificalyy pointed out a study from U Penn where one stydy on immunotherpy prove to be ineffective during interview with Mark Ahn in Janurary, 2014.
    Little knowledge is dangerous- People in oncology field are fully aware that Tsunami of immunotherapy is changing cancer management landscape from melanoma, reanl cell carcinoma to other solid tumors - lung cancer, breast cancer ,etc.
    Number two misunderstanding:
    Again uninformed people will say that- even if E75 work- it may not generate revenue- a case in point- DNDN's Provenge- immunotherapy for such a large market - metastatic prostate cancer patients.
    The problem is the cost of delivering provenge and some techinical difficulty it comes with it. In a sense- they need to produce individual new medicine after getting patient blood- there is no mass production and cost is very high due to this. It can only be given in certain tertiary centers as oppose to in front line community oncology clinics - it never catch up with oncologist to the level it wass expected. Therefore DNDN is in current situation.
    But E75 is different- it is mass producible- cost will be very low- delivery is so simple that it can even be given at home

    Sentiment: Strong Buy

  • e75present e75present Jul 3, 2014 11:59 PM Flag

    Hi Dan,
    Not that I have ever doubt you- but now with this post you made it beyond any doubt that you were there at the meeting. I was there- I was late- but before Ahn open the floor for questions.

    Later- I personally had a brief talk with him- I come back with very similar impressions as yours.
    Thank you for your contribution to this board.

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