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Replies to #13340 on Biotech Values
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DewDiligence

07/17/05 9:48 PM

#13341 RE: aslan2772 #13340

Re: ATryn, sepsis, and burns

>>one of the possiblilties eluded to by the results of the KyberSept trial is the possibility of loss of efficacy when AT III and Heparin are co-administered.<<

That’s not how I interpreted the sepsis results. Here’s what the sepsis study you cited actually said (#msg-7007573):

“There was some evidence to suggest a treatment benefit of antithrombin III in the subgroup of patients not receiving concomitant heparin.”

My interpretation is that this slight “evidence” of efficacy when AT was used without heparin was probably an artifact and that AT does not work in sepsis, period.

>>If this is the case, could it not be a potential stumbling block towards the use of ATryn in CABG, another indication GTCB is pursuing (assuming that AT alpha interacts similarily with Heparin)?<<

As described above, I do not agree with the premise here. Co-administration of heparin and AT does increase bleeding risk (as was reported in the sepsis trial), and this is what one would expect given the way these two proteins bind to one another in the normal anticoagulation process.

However, I do not see why co-administration of heparin and AT would cause a loss of efficacy in CABG or any other setting. If there were a problem with co-administration, it would be with safety, not efficacy; the safety problem—if there were one—would be no different with ATryn than with plasma-derived AT.

CABG is pretty far down on the list of likely ATryn indications, in my opinion, unless a deep-pocketed partner were willing to fund the trials.

>>Do you know if Heparin is used in burn victims?<<

I’m not aware that heparin is used routinely in burns, but I’m no expert on burn treatment. (If anyone knows or wishes to find out, please post.)

>>I'm only testing the soundness of MGMT's claim that they see a potential 500-700M$ market for ATryn.<<

The $500-700M figure cited by management should not be taken too seriously. Actual ATryn sales will be nowhere near that level for many years, if ever.

>>…I like the platform.<<

This is the main point. If approved, ATryn will be a nice little drug for GTCB, but its greater significance will be in proving the robustness of GTCB’s production platform. Regards, Dew