Rochester, NY (PRWEB) October 20, 2013
The failure of Ariad Pharmaceutical’s leukemia drug, Iclusig is no surprise to the CBCD. If top management at Ariad, and/or their investors, had turned to the CBCD, the Center would have told them that the chance of completing a successful clinical trial was almost zero.
What’s the argument? The productivity crisis in pharmaceutical R&D.
Iclusig was designed to target one specific molecule. However, like every drug, it impacts more than the specific molecule it was designed to target. When a drug impacts the ‘other’ molecules, it causes adverse reactions, or side effects. This was clearly the case in the development of Iclusig because in this case, some of the ‘other’ molecules were actually known.
As the author of an article published in February, 2013 in the formulary management journal P & T wrote, “The primary target (of Iclusig) is Bcr-Abl, an abnormal tyrosine kinase that is expressed in CML and Ph+ ALL (2).” If one carefully notes, however, the drug also “selectively blocks other tyrosine kinases, including FLT3, RET, KIT, and the members of the fibroblast growth factor receptor (FGFR) and platelet-derived growth factor (PDGFR) families (2).”
What kind of adverse reactions resulted from Iclusig’s impact on the ‘other’ molecules?
The answer is frightening. “Serious and fatal cases of arterial thrombosis (the formulation of a blood clot) and liver injury have occurred during treatment… cardiovascular, cerebrovascular, and peripheral vascular thrombosis, including fatal myocardial infarction (MI) (heart attack) and stroke have occurred in treated patients (2).”
In fact, because of these dangerous adverse reactions, “Ariad Pharmaceuticals Inc. abruptly terminated a pivotal clinical trial of its leukemia drug … a move that raised new safety questions and sent the company’s shares plunging more than 40 percent (1).”
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