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Myrexis, Inc. Message Board

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  • jacosa jacosa May 26, 2011 5:49 PM Flag

    Temozolomide(Temodar and Temodal)

    You don't really want to wait for clinically significant brain involvement before enrolling patients. Patients are often too sick to interest at that point (toxic tumors, multiple sets of treatment side effects). A more natural point would be after exhaustion of conventional chemotherapy options (You'd REALLY like to try adding Azixa to an established second-line drug regimen, but that would take even longer). Patients at that point have 3-5 times the life expectancy of GBM salvage patients. I'm told that you can identify colon cancer patients at very high risk of brain metastases, but in general the patients in any study will be a lot more diverse than GBM patients--that means a bigger sample size. So a longer study with a bigger population (and harder analysis at the end). I think I remember something about $40 MM for the present 2b (which is anticipated to be usable as part of the registration filing). So let's say $100 MM to go after the primary GBM indication, which is doable, but $400 MM to go after a big 4 indication directly, which isn't doable for Myrexis. And because it would delay licensing even more than the quest for a primary GBM label, the cost of foregone revenue is higher.

    Anyway, the priorities look to me like 1) Get the drug licensed for something; THEN 2) Identify the situations where it gives the most benefit.

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