Biotech Values

[steveporsche]

CLDX - Clark and Mcbio, for the future CDX-011 triple negative Phase III, Dr. Vahdat said in the Q&A at the January Analyst Day at around the 2 hour 20 minute mark the Phase III trial endpoint is still up in the air. And at the the 2 hour 43 minute mark she says that as long as the IIb shows data as good or better than MD choice the drug is still in the ballgame and it is all about designing the appropriate Phase III and getting the FDA to agree to design - pts should have multiple options and any result at or better than MD choice is good for triple negative given the poor prognosis. see webcast:

http://edge.media-server.com/m/p/639b475g/lan/en

Clark or Mcbio: With respect to the Phase III Rindopepimut (CDX-110) in Glioblastoma EGFRvIII+, 8 out of the 33 trial locations are in India - any worries that the FDA might wet their diapers about any potential trial protocol violations? I would guess that India might be worse than Eastern Europe in this respect.

http://clinicaltrials.gov/ct2/show/study/NCT01480479?term=Rindopepimut+%28CDX-110%29&rank=2&show_locs=Y#locn

Also, this recent journal article:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3257186/#SD1

"Major results were as follows: 1) the presence of EGFRvIII in GBM tumors correlates with longer OS. The association of EGFRvIII/Ki67 of 20% or less, of EGFRvIII/normal PTEN, and of EGFRvIII/methylated MGMT identified subgroups of GBM patients with better prognosis; 2) EGFRvIII expression is reduced in GBM recurring after adjuvant radiotherapy and TMZ; and 3) EGFRvIII-positive GBM neurosphere cells are less resistant to TMZ than their EGFRvIII-negative counterparts. Our findings on the prognostic significance of EGFRvIII in GBM diverge from previous studies, where this variant was found either to be unrelated to the patients' outcome [6,11,12,16–20] or to be associated with shorter survival (Table W5) [10,14]."

So if I am reading this correctly they are saying that EGFRvIII positive status leads to longer survival which is completely the opposite of what CLDX/Dr. Sampson have claimed that being EGFRvIII positive is a highly poor prognostic factor for survival. I do not know enough about the science to judge who is right or if this was just an oddball journal article.