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XMFHelical (< 20)

But it worked in animals



April 04, 2008 – Comments (0)

This is worth archiving and saving (yup another blog that just links someone else's blog).

Again from Derek Lowe

He goes through the major disease categories and gives you some idea of whether you should pay any attention at all to results in animal models.  In general - don't get excited about efficacy in animals.

As an outline:

Preclinical animal efficacy - generally not much value, except in some indications, don't invest based on it (unless you are a VC - in which case call me, we should chat).

Phase I:  Is just safety nothing more.  Again, it is there to kill a program but often not advance it.  So little attention to 'passed phase I' - it shouldn't be there if it wasn't going to pass, and too often it doesn't.  But.......a phase I program that peeked at efficacy, generally via some associated biomarker can be encouraging .  Biomarkers aren't necessarily endpoints, but can help design phase II trials, and if you get significant changes from a low population phase I trial, all the better.

Phase II:  The first real look at efficacy, hopefully with significance (but sometimes that requires too many patients for a practical phase II.  Biotech 'traders' seem to like to trade around the release of phase II data (I'm not a biotech trader and don't feel I ever know enough to do this).

Toxicity is another topic - here animal testing is mandated before you go into people.  The public play here is Charles River Laboratories (CRL).  This is a tough one that I've never gone bullish on in CAPS.  While they benefit from the increase in outsourcing and of clinical drugs, and don't care at all whether the drugs end up approved or not, they also are in an 'unappealing industry'.  The push in the technology is toward more cell based and 'non-animal' toxicity testing; in other words if the industry could do without a CRL - it would.  Right now, and probably for a long long time, it can't do without animal toxicity testing, but it can and is limiting how much it needs to do.  Hard to go bullish on a company facing those headwinds, despite the other trends in its favor (and solid past performance).


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