Microdosing approach, where harmlessly small quantities of a new medicine are studied directly in humans to circumvent years of animal testing, moves forward with publication of AZT study results
Vitalea Science, a bioanalytical company that provides measurement and consultation services to the biopharmaceutical industry, has announced major results of a microdose study using its Accelerator Technology.
The clinical study was performed with azidothymidine, better known as AZT, the first approved antiretroviral for combating HIV.
Vitalea's core technology, accelerator mass spectrometry (AMS), based upon particle accelerators, was enlisted to evaluate the human metabolism of AZT at a dosage far less than ever possible using conventional technologies.
The approach, dubbed microdosing, is more than just a technological exercise - this study demonstrates a new mode for drug development where harmlessly small quantities of a new medicine, or microdoses, are studied directly in people, circumventing years of animal testing.
The results of the microdose AZT study showed strong concordance between older data using much larger doses.
Similar results with regards to rates of absorption, retention, and elimination were revealed.
These data serve to validate the microdose platform in a new class of compound, says Vitalea.
The study, moreover, opens up entirely new avenues of investigation that should excite pharmaceutical chemists and clinicians.
"We were able to quantify the uptake and retention of the orally administered AZT in white blood cells", explained Stephen Dueker, president and chief scientist for Vitalea Science.
"For example, we can say with confidence that between 30 and 45 minutes after dosing, 0.09% of the oral dose resided within the white blood cells in the blood.
"We were also able to show uptake of AZT into the genetic material of these cells, which is ultimately how antivirals like AZT inhibit viral replication.
"Such data could not have been obtained by any other method".
These capabilities offer new tools for clinical pharmacologist in identifying the appropriate drug for a patient.
Personalised medicine promises to maximise efficacy while minimising toxicity.
"The individual response to drugs can vary tremendously", adds Dueker.
"Some of this behaviour can be explained through metabolic signatures in the individual.
"Accelerator Technology enables such profiling".
The study was conducted in collaboration with Radiant Research's Hawaii clinical facility.
"This study is an important demonstration of the unique dimension Accelerator Technology brings to human drug testing," stated Jon Ruckle, medical director, Radiant Research Honolulu and the principal investigator.
"It shows that Accelerator Technology allows tracing a drug through complex body compartments using a nanogram level dose, so small as to be essentially harmless.
"This margin of safety enables early human testing in place of many animal studies.
"Accordingly, we have the potential to more accurately assess a drug's potential value much earlier than with our traditional methods".
To date, only a handful of microdose studies have been carried out, principally only in Europe under the Consortium for Resourcing and Evaluating AMS Microdosing, better known as the Cream investigations.
Antivirals are a huge and necessary area for drug development given the global threats from bird flu, Aids, and chronic hepatitis, to name a few.
Vitalea says these results, together with a prior antiretrovial study, reveal Accelerator Technology as a powerful tool for investigating potent drugs in healthy, normal subjects.
Results of the AZT study should provide confidence to pharmaceutical companies in the USA looking for better ways to bring drugs to the market, it says.
The company expects to release full study results in a peer-reviewed journal later this year.
Vitalea Science is the first US-based company to offer commercial accelerator mass spectrometry (AMS) and supporting services to the pharmaceutical industry.
Vitalea's founding team brings years of research experience in application of particle accelerators to microdose studies.
This body of experience catapults Vitalea into a de facto industry leader in this field, kit says.
Radiant Research is a comprehensive clinical research company that provides phase 0-IV clinical drug development services to the biopharmaceutical and medical device industry.
Radiant comprises more than 40 wholly-owned premier clinical research sites in the USA, including seven clinical pharmacology units offering Phase I/IIa services.
Radiant employs over 1000 research professionals exclusively focused on providing professional, high quality comprehensive clinical research services.
In the past four years, Radiant has conducted more than 8400 clinical trials across 18 therapeutic specialties.
Radiant's says its client list includes every major pharmaceutical company and contract research organisation as well as many biotechnology and medical device companies.
