Tuesday, May 8, 2012

Targeted failure


The whole article from wikipedia:

Dalcetrapib or JTT-705 is a CETP inhibitor in development by Hoffmann–La Roche.[1] A 24 week clinical trial showed increased HDL levels.[2]

As of 2010[update] five phase II trials had started and there was no evidence of the raised blood pressure seen with torcetrapib.[2]

dal-PLAQUE phase IIb trial found an evidence of plaque reduction. [3]

dal-VESSEL phase IIb trial found no evidence of flow-mediated dilatation improvement. A 17% increase of Lp-PLA2 mass level was noted.[4] Lp-PLA2 is associated with coronary heart disease and stroke.

dal-OUTCOMES phase III trial passed its first interim review in July on 2011 and will continue as planned. [5]

Development was halted on May 7, 2012 “due to a lack of clinically meaningful efficacy.” [6]

End of the wiki quote

Is it clear? Some further explanations:

More than six years after Pfizer famously abandoned a drug that was designed to raise HDL, or good, cholesterol, Roche is now making the same move. The drugmaker this morning released a brief statement saying that an independent Data and Safety Monitoring Board recommended stopping a Phase III study of some 15,000 patients for its dalcetrapib medication due to a lack of clinically meaningful efficacy.


“Lowering cardiovascular risk beyond that which is achieved with intensive statin treatment is a very challenging goal and while we have always stated that dalcetrapib is a high-risk project, we are disappointed by the fact that this drug didn’t provide benefit to the patients in our study,” Hal Barron, the Roche chief medical officer and head of global product development, says in the statement (see here).
 
The move is a big blow to Roche, which previously cited the drug as one of nine forthcoming medicines with potential blockbuster sales potential. Dalcetrapib “was potentially one of the largest new assets they had in the late-stage pipeline,” Karl Heinz Koch, an analyst at Helvea, tells Bloomberg News. “In that sense it does leave a large gap.” Roche stock plummeted on the news.

Dalcetrapib or JTT-705 is a CETP inhibitor. Well, I have written a lot about the inefficiency of targeted medicines. For me this story is very ordinary, the failure was not directly expected but very probable as with other “targeted” drugs. Do we see the message here: “new paradigm has to be developed”?

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