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Rich Steffens  

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  • Acadia Pharmaceuticals And Galena Biopharma: What A Difference A Trial Design Can Make [View article]
    They have yet to achieve their spin out, but this from next week's SABCS is for AE37,

    P5-16-05 The combination of trastuzumab and HER2-directed peptide vaccines is safe in HER2-expressing breast cancer patients Hale DF, Vreeland TJ, Perez SA, Berry JS, Ardavanis A, Trappey AF, Tzonis P, Sears AK, Clifton GT, Shumway NM, Papamichail M, Ponniah S, Peoples GE, Mittendorf EA. Brooke Army Medical Center, San Antonio, TX; Cancer Immunology and Immunotherapy Center, Athens, Greece; MD Anderson Cancer Center, Houston, TX; Uniformed Services University of the Health Sciences, Bethesda, MD.
    Nov 29, 2012. 08:02 PM | Likes Like |Link to Comment
  • Acadia Pharmaceuticals And Galena Biopharma: What A Difference A Trial Design Can Make [View article]
    He may have meant low her2 expressing subjects as compared to those with her2 3+. I wrote about this last week, and COL G Peoples explained the reasoning-

    I asked Col Peoples to explain why NeuVax, and other HER2 targeting peptide vaccines, appear to bring greater benefit patients with lower HER2 expression. Col Peoples explained that:

    "The basic biology between HER2 0-2+ vs 3+ has been well-documented, and we use this distinction clinically when we subtype breast cancers. 3+ tumors are more aggressive/dangerous. We have shown that vaccines work best in less aggressive tumors.

    The immune system can become tolerized against large quantities of antigen. More is not always better (contrary to the argument). We have shown an element of tolerance in the T cells from HER2 3+ patients relative to the T cells in lower expressors.

    HER2 is sufficiently immunogenic that even the lower levels of HER2 expression can be recognized by highly-specific, vaccine-induced T cells. These CTL can recognize and destroy tumor cells with low and intermediate expression levels (hundreds of papers demonstrating this concept because there are actually only a couple of HER2 over-expressing cell lines available for experimentation. The vast majority of all of the lab work has been done on low- and intermediate-expressors).

    Most importantly, one of the documented differences in the 3+ tumors, and probably related to their aggressiveness, is that these tumors down-regulate HLA expression, making themselves "invisible" to the immune system. Rolf Kiessling at the Karolinska Institute, Stockholm has written extensively about this phenomena (see attached paper by clicking HERE). We are currently trying to verify whether Herceptin treatment can restore the HLA expression, explaining our observation that the CTL-eliciting vaccines, such as NeuVax, may be useful in the 3+ patients in combination with Herceptin."

    http://bit.ly/SqfkDj
    Nov 28, 2012. 10:51 AM | 2 Likes Like |Link to Comment
  • Acadia Pharmaceuticals And Galena Biopharma: What A Difference A Trial Design Can Make [View article]
    What do you mean by inverse dosing response?
    Nov 28, 2012. 09:52 AM | Likes Like |Link to Comment
  • Acadia Pharmaceuticals And Galena Biopharma: What A Difference A Trial Design Can Make [View article]
    Nice work, Brian. Beyond the full 5 yr results in the NP and ND subjects, I think this poster that will be presented next week at SABCS may be quite interesting,

    "P5-18-07 Completed SN33 Trial: 60 month follow-up of Early Stage Node Positive HER2 Negative patients with NeuVax ™(E75) and sargramostim Mazanet R, Schwartz MW, Ramadan D, Lavin PT. Galena Biopharma, Lake Oswego, OR; Aptiv Solutions, Southborough, MA."

    Anyway, in case you'd like to look this over, here's the actual Phase III study protocol,

    http://bit.ly/TqA6QX

    I hope that link works, lol. Best wishes.
    Nov 28, 2012. 08:49 AM | 2 Likes Like |Link to Comment
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