YORK, U.K.—Looking to tap into the dramati­cally growing U.S. market for preclinical pharmacokinetics (PK) studies, microdos­ing specialist Xceleron recently announced its plans to establish its first pharmaceutical testing facilities in Maryland. The move fol­lows the company's initial foray when it set up a North American office in Gaithersburg, Md. in May 2005.

 

Xceleron uses accelerator mass spec­trometry to analyze the PK parameters of subtherapeutic or subpharmacological doses of drugs in humans. The method—also known as Phase 0—allows drug com­panies to get a sense of how their lead can­didates may behave when the tests move to full clinical trials.

 

"It is becoming increasingly clear that the ability to detect issues with pharmacoki­netics before the drug moves into clinical testing will ultimately save considerable resources in time and money for pharma­ceutical and biotechnology companies," says Dr. Amarpreet Dhiman, healthcare analyst for Frost & Sullivan, in a 2005 report on the ADME market.

 

Xceleron CEO Dr. Colin Garner points to a recent study his company commissioned, which suggested Xceleron's services could lead to an increase in future sales revenues for clients by as much as 10 percent.

 

"It's early days for the proof of this technology, but if it delivers that early ADME/PK informa­tion as advertised, this could be a bonanza for Xceleron and for phar­ma," says Jack Gardner, senior ana­lyst with Kalorama Information.

 

Topping the list of things to do is the acquisition of a new accel­erator mass spectrometer and lab space, and the hiring of additional personnel—a $7.5 million invest­ment by company estimates.

 

"This is a positive indication that the technology is working and some major pharmas are interest­ed," Gardner suggests. "Xceleron is counting on FDA support for this early investigation work."

 

But excitment for microdosing is not universal. In January, Dr. Punam Sandhu from Merck told Drug Discovery News: "While there may be situations in which a preemptive human PK screen­ing strategy via microdosing could prove valuable, we do not see this approach as having general util­ity considering the time/resource requirements and the limitations of a microdose to predict thera­peutic dose PK in certain situa­tions."

 

Gardner suggests that this atti­tude is typical. "The fact is that there are many occasions where several drug candidates come out of discovery, where there is con­flicting animal PK data and where it is impossible to rationally select the right drug candidate going for­ward," he says. "Microdosing will be used in such situations.

 

"Indeed, owing to potential safety concerns such as the recent incident in a London Phase I unit, microdosing will become rou­tinely used by the pharma indus­try within the next five years. Microdosing makes first-into-human studies safer, more ethi­cal, reduces the use of animals and gets drugs faster down the devel­opment track."