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Replies to #891 on Biotech Values
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DewDiligence

01/20/04 3:29 PM

#897 RE: isolution #891

Re: Therapeutic window:

>> I don't expect wondrous things coming from that compound [Oxi4503] except a wider therapeutic window than the actual CA4P which is quite narrow (but sufficient) <<

isolution: When you say that CA4P’s therapeutic window is “narrow,” what are you comparing it to? Can you give examples of drugs which have what you consider a medium therapeutic window, and examples which have a wide therapeutic window? T.i.a.

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DewDiligence

01/20/04 6:33 PM

#900 RE: isolution #891

isolution: Do you have any comment on this?

http://clincancerres.aacrjournals.org/cgi/content/abstract/10/1/96?etoc

The FDA is extremely finicky about QTc-prolongation, and high QTc readings have killed some otherwise promising drug candidates.

Fortunately, the CA4P dose needed for efficacy in AMD and other eye diseases should be comfortably below the level which can induce QTc-prolongation, and hence the patient pool receiving CA4P in these indications will probably not need to be restricted. The situation in cancer, where the CA4P dose will likely be higher than in ophthalmology, may be more problematic due to potential labeling restrictions.

BTW: I am still waiting for your reply to my previous post, which asked for examples of drugs with a “narrow,” “moderate,” and “wide” therapeutic window. T.i.a.