ISIS on thin ICE
Much as I am smitten with the ISIS story, this PR today makes me glad I've not fallen in love.
The ALT elevations with the 400 mg weekly dose drastically limit the drug's chances, IMO. That would be a very narrow therapeutic window for safety, if the 200 and 300 mg doses are chosen.
This sentence has me wondering about its validity:
The mild increases in ALT at the 400 mg/week dose likely reflect extreme lipid-lowering activity, not toxicity, and are consistent with perturbations in liver chemistries seen with statins.
Does anyone know of the scientific basis for this claim? The implication that the liver enzyme elevations occasionally seen with statins are related to the drugs working so well on lipid lowering seems far fetched to me.
Also, it's worth pointing out that ISIS 301012 is being developed so far as a once weekly SUBCUTANEOUS INJECTION. This snip made me smirk because I can't imagine that weekly injections (for life) to treat a lipid disorder has much chance of commercial success:
The drug's pronounced activity, its predictability, its reduction of all atherogenic lipids and triglycerides, as well as the opportunity for assured patient compliance with infrequent subcutaneous dosing are all attractive attributes.
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