Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

For me the big enchilada in the room is the Poziotinib abstract

Well, the poziotinib abstract wasn’t the one I was hoping for. The 1 presented was for the US Ph 2 trial that semi-recently started recruiting pts. I was hoping for an update of the Korean P2 in MBC that stopped recruiting pts in February. Oh well, but I did find some interesting info in that the US trial dosing was different than the Korean MBC study. For the US P2, for each cycle, eligible patients receive 24 mg of poziotinib orally (as three 8-mg tablets) once daily whereas in the Korean trial pts receive 12 mg PO once daily. So they are getting twice the dose in the US study. This explains to me why at one of the CCs earlier in the year, Raj indicated that in the Korean study they weren’t receiving anti-diarrhea medicine since it wasn’t needed but, I think, at the last CC, he indicated for the US study they were receiving anti-diarrhea medicine which was a little puzzling since that would be a marketing advantage for poziotinib against Puma Biotechnology’s Neratinib. If you remember, Puma Biotechnology got slammed last month because the diarrhea was so bad that they needed to add a 3rd med to the mix. In getting twice the dose, I could see them playing it safe by giving them anti-diarrhea medicine to prevent Adverse events. Regarding giving twice the dose several other things crossed my mind. Having had the luxury of running 4 or 5 Korean studies, they realized they could give a larger dose without any significant increase in AEs. However, on the other side of the coin, what if they noticed that the smaller dose wasn’t effective enough in the Korean MBC study and that’s why we didn’t see any abstract for it at SABCS. Am I worrying to much? After all Raj did say at RBC Healthcare CC in Feb that for the 68 pts already treated in the P2 MBC Korean study that the data looked ‘Impressive’. If the data has not matured yet that might be ‘Impressive’ but if they did not report the data because it wasn’t impressive, well, I wouldn’t be surprised since you don’t know what to believe when it comes out of Raj’s mouth. Here’s hoping that he is accurate for a change. Bottom line is if we don’t hear anything positive by spring or at ASCO I think we can put any immediate impact on share price from poziotinib on the back burner. Man, I started writing a short comment so I'll stop here.