Archive for the ‘pharmaceutical’ Category

Animal models

April 27, 2007

Derek Lowe’s, “In the Pipeline“, had an interesting discussion on animal models and their ability to predict the efficacy of drugs in people…

Interestingly from what I have observed, being in the area, is that the success rate in the clinic of antiviral drugs against HIV, at least in the context of efficacy, is very high despite the fact that there are no animal models.

That’s right…what most people outside of the field might not realize is that the only pre-clinical “efficacy” model used for HIV drugs is cell culture antiviral activity. In almost every case bona fide activity in cell culture translates into clinical efficacy. The only thing standing in the way of a cell culture active compound and a clinical candidate is the usual ADME-Tox studies, but cell culture activity is usually (but not always) good enough to provide drug-like compounds. The caveat is that the anti-viral activity must be validated in order to weed out the “promiscuous” false-positive compounds.

This might be the reason that a lot of start-up companies are pursuing anti-HIV agents even thought the market is becoming very crowded (>20 drugs and counting)



March 27, 2007

Being a synthetic chemist, I have developed a cetain amount of superstition and am always concerned about angering the ‘gods’ of sucess. One thing that I have learned is that nothing puts a jinx on a program more than winning an award. And so it would appear with Pfizer’s Zyvox (linezolid), originally developed by Upjohn prior to the subsequent mergers with Pharmacia and Pfizer.

It seems that in a recent phase III trial where it was tested for its ability to prevent catheter-related infections it actually increased the risk of death and as such the trial has been halted.

The funny thing is, that the team which discovered Zyvox was recently honored by the ACS for this achievement while at the same time the Pharmaceutical Researchers and Manufacturers of America PhRMA) handed out a Clinical Trial Exceptional Servic Award to two researchers involved in the clinical development of the compound….coincidence???