Study marks launch of First-In-Human drug development platform, and ushers a new area of human drug testing that stands to accelerate the pace of new drug candidates from the lab bench to the bedside
Vitalea Science has received approval for reevaluating the HIV drug AZT (Glaxo Zidovudine) at sub-therapeutic 'microdose' concentrations.
The study will take advantage of Vitalea's core technology, accelerator mass spectrometry (AMS), which it argues is the most powerful analytical tool to enter the drug development market place in several decades.
Execution of the study marks not only the launch of Vitalea's First-In-Human (FIMs) drug development platform, but also serves to usher in a new area of human drug testing that stands to accelerate the pace of new drug candidates from the lab bench to the bedside, it says.
The study is to be conducted with only 450 nanograms of AZT (a quantity in mass equal to about 1/1000th the mass of a short hair).
This dose is about one millionth of the approved FDA doses and would be impossible to detect by any traditional analytic methods, it says.
Vitalea expects to reveal new insights into the dynamics of this drug's metabolism.
To date, only a handful of microdose studies been carried out, principally in Europe.
Although the advantages of human microdosing are clear, industry has been in a wait-and-see position, pending firm guidance on the technology from the US Food and Drug Administration (FDA).
In March of this year FDA released Draft Guidance for Exploratory Investigation New Drug (IND) Studies; while full adoption of the guidance is pending, it is seen as the de facto green light to implement microdosing as well as other innovative techniques to advance drug discovery.
Guidance similar to that issued by the FDA has been in place in Europe since January 2003.
Vitalea says the study is designed to expand the database on microdosing while opening up several new avenues of investigation.
Data from this microdose AZT study will be correlated with published pharmacokinetic data derived from conventional dose administration.
Vitalea believes it is the first US-based group to offer commercial accelerator mass spectrometry.
