Replies to post #57114 on Ariad Pharmaceuticals Inc fka ARIA

[kiki27]

The SAE numbers are of no surprise to any one. This was a heavily pretreated population and were started on the 45mg dosing schedule. When mitigation procedures are implemented and dosing schedules are altered Ponatinib becomes a much safer drug. Simply put, doctors will learn how to use this drug and it's use will increase and expand to the other indications we are finding out about. Seems to me, company knows this, and are developing strategies to do just that.

[biotech_researcher]

Casablanca, you stated that very well.

"22% of CP patients experienced an arterial thrombotic serious adverse event (SAE), and 27 percent of CP-CML patients experienced any arterial thrombotic event, independent of severity or attribution of relationship to ponatinib." (As a Citi analyst put it, there was no clear evidence seen in reduction of ATEs.) This overshadowed the remarkably impressive data showing very strong anti-leukemic activity in the very sick patients being given Iclusig. Maybe others will differ, but I believe this removed the likelihood, however remote it might have been, that Iclusig would be even 2nd line therapy, certainly in the near term. As various analysts have noted today, there will be no change to the black box label. And the market responded predictably to this news.

This is what I tried to pass along, but everyone doesn't want to listen. This dismal news means it is "game over" for Ariad to stay independent. I'm all for a buyout, but due to the ASH data, and the prevalent AE's, it looks like $11-$12 is the new take-out price.

[STOCKSEEK]

Just in case some missed the update today...

Here are the facts that were disclosed:

Of those that went through a prospective dosage reduction (meaning a reduction after starting at the higher dosage) experienced 7% occurrence (ATE) as compared to a 10% occurrence (those with no dosage reduction). That's a 30% reduction despite starting at the higher dosage level.

Trails with new dosage levels from inception will begin in January, which I believe will lead to a further reduction.

All this with.... retained responsiveness to the drug - continued effectiveness - at this point of which is best in class (as competitor comparator studies released at ASH show).

This in my opinion is very good news.

Here is the direct excerpt from today's results update for those that may have missed it.

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From today's PR...

Safety Update Following Prospective Dose-Reduction Recommendations (Data from October 10, 2013 to October 6, 2014)

Of the patients who underwent prospective dose reduction, 5 of 70 patients (7%) without prior events had a new arterial thrombotic event during the twelve-month interval following prospective dose reduction.
Of the patients who did not undergo prospective dose reduction, 7 of 67 patients (10%) without prior events had a new arterial thrombotic event in the same time interval.
“These data show that the majority of patients in the PACE trial retained response, even when lowering the daily dose of Iclusig,” stated Frank G. Haluska, M.D., Ph.D., senior vice president of clinical research and development and chief medical officer at ARIAD. “The safety and efficacy of Iclusig at starting doses lower than 45 mg will be studied in a randomized trial set to begin next year.”