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Dendreon Corporation Message Board

  • llabtechtwo llabtechtwo Jan 13, 2012 8:10 PM Flag

    NEOACT

    I really want to see the data from pre-operation use of Provenge as this opens a whole new cadre of patients. Anyone know when this data is scheduled to be released?

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    • Abstract release date is Tues. Jan. 31 @ 6:00 p.m.

      Could be very interesting.

    • <Crescent, while generally the case (long confirmatory trials needed before earlier stage use) I believe the FDA left the door slightly adjar to DNDN's benefit. I believe if the findings are significant, that one or more peer reviews could force a label expansion. If not, at least we would get complete follow-through within the medical community that this first approved immunotheraphy does show clear medical benefit on the cellular level (not simply life extension). In addition, the trials underway to prove the added benefit of Frovenge to the placebo arm would be significant both in the U.S. and EU(very important for $'s for coverage).>
      ______________________________________

      Totally agree.

      Is that the Duke Frovenge study? I have forgotten when we are supposed to hear from them. Does anyone know?
      ____________________________________________________

      I seem to remember someone saying that we should hear the details at ASCO or GU ASCO? Anyone?

    • This is what most here should be focusing on.

    • <Crescent, while generally the case (long confirmatory trials needed before earlier stage use) I believe the FDA left the door slightly adjar to DNDN's benefit. I believe if the findings are significant, that one or more peer reviews could force a label expansion. If not, at least we would get complete follow-through within the medical community that this first approved immunotheraphy does show clear medical benefit on the cellular level (not simply life extension). In addition, the trials underway to prove the added benefit of Frovenge to the placebo arm would be significant both in the U.S. and EU(very important for $'s for coverage).>
      ______________________________________

      Totally agree.

      Is that the Duke Frovenge study? I have forgotten when we are supposed to hear from them. Does anyone know?

    • <"I believe if the findings are significant, that one or more peer reviews could force a label expansion."

      I agree that it is possible but in my opinion somewhat of a long shot.>
      _________________________________________________

      Since perception is everything, Positive findings from NeoAct will at the very least mean more patients seeking out Provenge, and a higher stock price because investors will see the future in the instant.

    • These results will be a huge catalyst for DNDN for sure unless it gets bought out soon.

    • Poster presentation on 2/2/12
      11:45-1:15 Abstract#42 Dr. N.Sheikh presenting.

      http://gucasym.org/MeetingProgram/GeneralPosterSessionA.aspx

    • "I really want to see the data from pre-operation use of Provenge as this opens a whole new cadre of patients."

      The problem is that no matter how good the data and increased patient interest, earlier use of Provenge would be considered off label and not covered by insurance so its impact on revenues would be insignificant. Any findings would have to be borne out in large future clinical trials.

      That said, the data is extremely important because it could give doctors additional comfort on Provenge's method of action. There has been a built in reluctance of physicians to use Provenge because it does not reduce PSA, tumor burden, nor any other traditional markers. Anything that helps show why Provenge works is a really big deal.

      Another really big deal is the ongoing initial sequencing studies to learn the optimal timing of administering all the treatments for prostate cancer that are becoming available. Right now, physicians are really not knowledgeable of the proper sequencing and are likely getting it wrong due to their bias in favor of chemo with its known affect on traditional markers, etc.

      • 3 Replies to crescentmotor_2000
      • Crescent, while generally the case (long confirmatory trials needed before earlier stage use) I believe the FDA left the door slightly adjar to DNDN's benefit. I believe if the findings are significant, that one or more peer reviews could force a label expansion. If not, at least we would get complete follow-through within the medical community that this first approved immunotheraphy does show clear medical benefit on the cellular level (not simply life extension). In addition, the trials underway to prove the added benefit of Frovenge to the placebo arm would be significant both in the U.S. and EU(very important for $'s for coverage).

      • I should have been more specific and more general at the same time. To clarify, what I meant was that moving forward with immunotherapy (not just DNDN) is when is the optimal time to administer. From past mistakes in the lab (my own) I personally believe that to maximize benefits all immunotherapies should be used at the earliest possible stage. This opens a whole new realm in cancer treatement... eventual prevention.

      • Very informative, good posts. Thanks and GL.

    • Dendreon's Management Presents at J.P. Morgan Healthcare Conference (Transcript), small part from the transcript regarding your question:

      .....So we began a study called the Neu-ACT study. It was a study that administered PROVENGE to patients prior to radical prostatectomy, prior to having their prostates removed. Then once we removed their prostate, we were able to look at the cell that infiltrates into the prostate to see if we were able to generate a mononuclear cell infiltrated in the process that was indicative of immune response against the prostate tissue, that’s what you’d want to see.

      Now, that data will be presented by Larry Fong at two meetings this year, both GU ASCO and the annual ASCO meeting later on this year. That will be an important data set, I think, to educate physicians on the potential mechanism of action of the product......

      http://seekingalpha.com/article/318441-dendreon-s-management-presents-at-j-p-morgan-healthcare-conference-transcript?source=email_rt_article&ifp=0

    • Gold referenced the data would be discussed soon. I take "interesting", as it actually changed the cancer tissue at a cellular level, thus limitted it's ability to metastasize. The ramifications of this study are not only huge for Provenge, but will pave the way for the next cancer platform Dendreon introduces.

      Dendreon plans immunotherapy treatment for many cancers, Provenge has paved the way for additional products:)

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