Oh, one more: Ariad also made it more difficult for patients with high blood pressure to be eligible for EPIC enrollment.
"All of these new exclusion criteria tell me that the
More evidence Iclusig is too toxic for use in front-line CML patients comes from M.D. Andersen Cancer Center, which lowered the Iclusig dose to 30 mg from 45 mg (the FDA approved dose) in the single-arm "Cortes" frontline CML study.
Ariad CEO Harvey Berger addressed the lowered dose in the Cortes study on the company's second-quarter earnings call:"... they started at 45 milligrams as in the EPIC trial and completely enrolled a cohort at 45, and then wanted to study an additional group of patients at 30, so that they have data at both of the -- starting at each of those dose levels. It -- what happened was the 45-milligram cohort where 45-milligram patients enrolled quickly and they got through the enrollment of those patients, and now we're enrolling 30-milligram patients so they can do some comparison of the 2 groups." Sounds like spin to Ariad shorts I spoke with this week. "Again, the reason to lower a drug's dose is usually because of unacceptable toxicity." An interim analysis of the EPIC study is expected about one year from now in the third quarter of 2014 -- unless independent data safety monitors stop the study early because Iclusig is too toxic. "The EPIC study is a ticking time bomb," one of the Ariad shorts told me. There's more to the Ariad short thesis, including the expected launch soon of a cheap, generic version of Gleevec in CML and the limited commercial potential of cancer drug AP26113, but I'll stop here. Next up, an update to a discussion in last week's Mailbag about Prosensa (RNA), GlaxoSmithKline (GSK) and the timing of the presentation of the drisapersen phase III study results: We have an exact date! On Oct. 8, Glaxo will present the drisapersen data at the Oligonucleotides Therapeutics Society (OTS) annual meeting in Naples, Italy. Here is a link to the agenda for the conference.