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 [heart-safety] risk with Iclusig is real," one of the investors shorting Ariad told me.
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.
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