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Galena receives DOD grant for trial of NeuVax breast-cancer drug

  • Galena Biopharma (GALE) is receiving a grant from the U.S. Department of Defense for a Phase II trial of the company's NeuVax treatment. The study will look at whether the therapy can prevent breast cancer from returning in high-risk HER2 3+ patients.
  • The study is due to start this year and will support Phase III and Phase IIb trials in 1+ and 2+ patients.
  • Galena's shares are +14%. (PR)
Comments (16)
  • LDmeixler
    , contributor
    Comments (4) | Send Message
     
    The DOD doesn't generally fund studies that are not likely to work.
    28 Apr, 11:51 AM Reply Like
  • jammerculture
    , contributor
    Comments (393) | Send Message
     
    The DOD probably read those Dreamteam pieces.............

     

    yeah, just as stupid when I read it back
    28 Apr, 02:32 PM Reply Like
  • jackryanjr
    , contributor
    Comments (84) | Send Message
     
    This article, the title, and the quote from Mark Ahn, as usual, have a terrible record with facts lining up to the truth.

     

    This is 100% not a grant to Galena. No money has been awarded Galena in this grant. No money offered Galena in this grant. On economic terms, this study will cost Galena what small amount it takes to manufacture dosing for the 100 patients involved.

     

    Galena is simply involved because a scientist wrote a grant proposal in an non-sponsor initiated trial that brought her the funds to create her own study, while at the same time, for at least the purpose of funding, required Elizabeth A. Mittendorf, M.D. the need to obtain drug from the 2 actual sponsors of Neuvax (in trial) and Herceptin (in use).

     

    Here is a link to the ACTUAL Galena Press Release. In the Press Release, Galena makes every attempt to sound as though they are the driving force behind the study. In fact, they have almost nothing to do with it. More than anything, it is a furtherance of research in Texas at MD Anderson, one of the original Oncology & Research Hospitals involved in Neuvax PH1/2.

     

    http://reut.rs/1jaLOOU

     

    An excerpt from an actual Press Release states this:
    "The grant, a Breast Cancer Research Program (BCRP) Breakthrough Award, was obtained by Elizabeth A. Mittendorf, M.D., Associate Professor, Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center who will oversee the investigator-sponsored trial. Galena will support the trial with study drug and funding and will have access to the research to support ongoing registrational studies."

     

    The money happens to come via:
    "The grant was awarded through the Congressionally Directed Medical Research Program (CDMRP), funded through the Department of Defense (DoD), via annual Congressional legislation known as the Defense Appropriations Act."
    Most of the general public would comment this is Government Pork, were it not being granted for Cancer Research.

     

    This is a study that should actually do damage to NeuVax if the results continue as they did in the Ph1/2 trials that failed the highly expressive HER 2+ targeted population this study appears designed to go after. Some results will be obtained. As a single-blinded study, the results might never do more than aid an Oncology Department with a post-1st line standard of care patient treatment protocol against recurrence.

     

    The data supporting the HER2+ failure in the highly expressed population is concrete. It led Galena to completely re-direct patient population in their slow to enroll Ph3 NeuVax trial. At no point since the Ph1/2 was dissected has there been talk of using NeuVax in clinical trial for the patient population listed for this "Investigator" trial.

     

    Investigator Sponsored Trials have nothing to do with a NDA as Galena hopes for in their PRESENT trial. Highly negative safety issues that might arise may be presented to FDA at any time, although doubtful to occur.

     

    My colleagues and I believe the only reason a study like this would happen is for PhD Opportunity only, and only possible through pre-determined government spending in the space, and lastly by either writing a great Grant Proposal or knowing the correct person to have it delivered.

     

    There are many many questions. However, the only one I find troubling is this: Why do Galena and Mark Ahn ALWAYS distort the truth, so as to leave all statements to interpretation? This press release informs the public of this Investigator Initiated Trial, yet obliquely seems to steal the thunder from the actual Actors, those responsible for writing the grant, and certainly leads to SA articles claiming the DoD granted Galena money - which is patently FALSE.
    28 Apr, 08:37 PM Reply Like
  • NWCats404
    , contributor
    Comments (224) | Send Message
     
    @jackryanjr: You clearly know a great deal about GALE, admittedly more than I do, and spend a lot of time writing about it. However, at this point you sound more like a zealot than an objective critic. The press release has two statements from Dr. Ahn, both of which seem very vanilla to me. Essentially he says "We're excited" and "This is good news." Am I missing something? What, exactly, should he have said?
    29 Apr, 11:12 AM Reply Like
  • jackryanjr
    , contributor
    Comments (84) | Send Message
     
    I don't think Galena has any reason to submit a Press Release about this at the moment the Investigator Initiating does. Ahn is using Dr Mittendorf for the appearance of "doing good."

     

    It's a matter of Pride and Acumen for the rarely cheered researcher - with Ahn "Stealing her Thunder" at the absolute first moment of opportunity.

     

    It's like calling your bosses boss to explain that the report your boss is about to hand him/her has a page that you wrote, and really think it should be noted before anything else - including receiving the report.
    30 Apr, 02:06 PM Reply Like
  • MichaelJ8
    , contributor
    Comments (601) | Send Message
     
    this is really good news:

     

    I quote from the reuters press release:

     

    "Galena will support the trial with study drug and funding and will have access to the research to support ongoing registrational studies."

     

    no matter how you look at this, its good!

     

    I'm All in GALE!!
    28 Apr, 11:26 PM Reply Like
  • Abraxix
    , contributor
    Comments (340) | Send Message
     
    "The grant, a Breast Cancer Research Program (BCRP) Breakthrough Award, was obtained by Elizabeth A. Mittendorf, M.D., Associate Professor, Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center who will oversee the investigator-sponsored trial. "

     

    There is no other researcher more qualified to lead this study, she is preeminent, the best of the best!
    29 Apr, 12:17 AM Reply Like
  • lota33
    , contributor
    Comments (7) | Send Message
     
    WOW. let’s see how the short sellers will twist this one. They are at twisting reality to accommodate their own interests. see “jackryanjr”.
    29 Apr, 09:33 AM Reply Like
  • jackryanjr
    , contributor
    Comments (84) | Send Message
     
    No Position in GALE. I don't trade options and am never a short or writing for some other. In fact, my efforts related to Galena are in hopes of getting rid of rotten management, who to this date are only hurting NeuVax through terrible decisions and misleading propaganda.

     

    I love science. I dislike greatly what some small people in management do in pursuit of wealth at the expense of science. Especially over decades, and when it is their actual philosophy.

     

    Sounds like y'all might know Dr. Mittendorf? MD Anderson at UofT is an excellent center. Great volumes of good come from their work.

     

    Like hundreds of ideas, great research, great pre-clinical, great effort, and years of work don't always mean ideas pan out. I will always remember more than a decade of hoping, waiting, watching data and work on heart valves in a fish species at UCSF - which provided 2 PhD's - but never approached the end result of a breakthrough in valve science.

     

    NeuVax has already failed this trial group in clinical. Exactly why the ph3 does not approach this group. Combined with Herceptin as a "throw the kitchen sink" at recurrence for piece of mind - I'm fine with that. Breast Cancer sucks, and has affected me greatly. In this hard-core recurrence group, "the kitchen sink" is probably apropos. I am doubtful NeuVax will breakout from Herceptin in the results based on this Investigator Sponsored trial. Any choice outside radical mastectomy is better than none.

     

    What I wrote above, and will continue to state, is that Galena is a bad business, with leadership divorced from oncology results vs. enrichment schemes. Simply, they want money, cancer is their current vehicle.
    30 Apr, 02:00 PM Reply Like
  • HAEMAN
    , contributor
    Comments (44) | Send Message
     
    Man, For someone who has no position in GALE, you sure do take a lot of time to BASH the company.. Must have lost some $$$$$ on this one. No other reason to constantly over and over again bash it.
    20 May, 07:17 PM Reply Like
  • lota33
    , contributor
    Comments (7) | Send Message
     
    ah, OK. sure thing jackryanjr. Are you by any chance “Mrtipers”, the infamous flamer from the yahoo message boards. haha, I wouldn’t be surprised. Go to the Yahoo message boards and see what kind of filth and lies are being spread about GALE—by one person with dozens of IDs! Forgive me for being skeptical about anyone NOT having an agenda concerning GALE, especially when they have "no positions" or have NO ulterior motives. Having management sell their positions is no clear indication of fraud. However, being hell-bent on manipulating a stock with pseudo-science IS. check yourself mate, it’s not that difficult to see through the lies of manipulators.

     

    No matter what anyone says, the chances for NeuVax to be approved are decent and there is NO, LISTEN CAREFULLY, NO proof whatsoever that management did anything wrong—other than what any sensible person would do: buy low, sell high.

     

    Beware of manipulators. Long GALE. Multibillion market potential.
    4 May, 05:40 AM Reply Like
  • jackryanjr
    , contributor
    Comments (84) | Send Message
     
    Sorry - There is plenty of proof. I explained here months ago that SEC would start going through IP logs at associated companies, easily find the people disseminating insider information, posting it to various places, and that Galena was suing to silence critics. All true and all coming (more) to light this week as more companies report compliance with subpoenas stating exactly the above. Galena also reported on "black out's" within it's Q and annual guidance as filed with SEC, one of which is about the dates for the PRESENT trial - which are now blacked out. (SEC MAY 12, 2014 File No. 001-33958 - CF#30863) There are TWO derivative suits seeking to dismantle the board. Although GALE should have rescinded that ability to the public via use of Delaware Law- by stating such in their By-Laws. Since they did not, GALE therefore have no protection against the suits - although they just added those provisions to their by-laws for future suits.

     

    In an effort to distance myself from those who state the facts I quote are made up, I offer more links to SEC filings that state everything I have said.

     

    I personally do no see a P value coming out of the current investigator studies related to NeuVax and Herceptin. Meaning NeuVax will not significantly enhance the Herceptin Profile - and I hope that increased gm-csf does not cause the side effects it is known too by sometimes supporting tumor growth (as stated in it's drug profile at any FDA.gov site of your choosing).

     

    I laugh off any suggestion I am another person. I have no position in GALE. I feel bad for those who do... Not because I think holders are dim-witted, but moreso that such an emotional cancer was abused by a small group of profiteers at the expense of retail investors. I call this "Reverse Robin Hood" - whereby retail transfers its wealth to the rich by manipulation, politicking, and fraud.

     

    As I have stated - I am interested in removing insider anonymous leakers and the PR companies hiding more at sites like SA. I do not like the decision making at GALE, and feel Steve Kriegsman is at best complicit in all actions.

     

    I fully and completely understand the science- Sadly most who HATE on me do not know that this vaccine needs to meet totally different standards at FDA than an chemo-oncology compound, and therefore has a far more difficult route to approval.

     

    I believe ALL of the above is fully written in GALEs actual annual and quarterly reports, plus recent obligatory "freedom of information" requests to keep private certain dates and expenses. (SEC MAY 12, 2014 File No. 001-33958 - CF#30863) You must read the full filing, not the bullet point Press Release that summarizes.

     

    In 2011, RXII reported to SEC that NeuVax therapy would cost approx. $35K per patient in a forward looking quarterly statement long before data, protocol, and label for Ph3 was in place. (http://bit.ly/1gvDKZj) That number, and moreso the number of patients applicable has shrunk over the last 4 years (since the RXII quarterly filing), where it states total Breast and Colon population potential is 24K/year, meaning reimbursement potential is far less, as is patient population. Further, competition in this exact space has increased, and there are now multiple late phase trials, with more to come, looking at the same tumor type. (see ASCO 2014 BC abstracts NOT posters)

     

    Drop Mic. Exit stage left.
    16 May, 01:53 PM Reply Like
  • lota33
    , contributor
    Comments (7) | Send Message
     
    I’m sorry but all I hear is sophistry, i.e., half-truths which hide behind badly written pseudo-facts. Your long-winded “exposé” which effusively attacks GALE, betrays your so called altruistic (—and for the love of the science) motives. Instead, they project a desperate attempt to confuse and scare would-be investors for personal gain. I—for one—FULLY TRUST GALE's management. But alas, my vitriol is wasted here. Time will tell who is right and who is wrong. If I am wrong I will gladly apologize....I doubt THAT will happen tho.

     

    "Drop Mic. Exit stage left.” who are you Eminem? More like a Jim Cramer acolyte.
    24 May, 12:58 PM Reply Like
  • HAEMAN
    , contributor
    Comments (44) | Send Message
     
    JackryanJr, If you have no position in Gale, then just leave everything alone and quit posting stuff all over the Internet about GALE ! You have no position, so let the company FAIL on it's own and you can go Beat your chest with I WAS RIGHT, I WAS RIGHT if it happens. I think your personally obsessed with GALE and your writings. Man just let it go.... I for one am done reading anything I see posted from you about GALE. Why Why, would one with no position constantly write stuff about a company, unless of course one lost $$$ on their investment and has it out for the company, I see no other reason one would keep rambling on and on without a position in the stock. To make sure I see no future ramblings I will now use the wonderful BLOCK feature. Just nuts why one would continue to RAMBLE on and on about a stock he has no position in...
    24 May, 05:14 PM Reply Like
  • jackryanjr
    , contributor
    Comments (84) | Send Message
     
    Hyman - I don't hate the compunds I KNOW Ahn, Kriegers, and several BOD's have no interest in saving lives.

     

    As far as trading I made 50% trading GALE the last month. I want everyone to make money. I hate that the scum running the company hurt so many.

     

    I also believe SA is a joke with ZERO market effect excepting shorts. I do not play that game. I actually think SA should be forced to follow FA rules as a group-think concept with no anonymity.

     

    You find me other places too - where I do not attack GALE, but rather a psycho who has mailed me threatening letters to my HOME.
    11 Jun, 07:26 AM Reply Like
  • HAEMAN
    , contributor
    Comments (44) | Send Message
     
    Well, I think letters to home is terrible. Hope you got in at the bottom. She's going back up. Something is up with the last 2 days of trading and volume.
    11 Jun, 05:41 PM Reply Like
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