Fw: Superior clinical research - another example
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From: - V I N - <vivisectionkills@...>
Date: Wed, 31 Aug 2005 19:59:52 +0000
Superior clinical research - another example
Radiant completes first (14) Carbon microdosing study
By Wai Lang Chu
29/08/2005 - The first (14) Carbon microdosing study to take place in
United States has been completed by Radiant Research, who believe this
approach to clinical trials will lead to more accurate and earlier
pharmacokinetic (PK) data on drug candidates than is currently possible
through conventional development strategies.
"Microdosing or 'Phase 0' studies can be done much earlier than
Phase I studies, thereby reducing attrition in clinical development.
will ensure that limited resources are focused on the best drug
potentially saving several years and millions of dollars," said Michael
Lester, chief executive officer of Radiant Research.
The study re-evaluated the drug azidothymidine (AZT), at
"nanodose" concentrations (520 nanograms) isotopically labelled with
(14)Carbon. This dose is approximately one million fold lower than the
recommended daily dose in patients and would be impossible to detect by
traditional analytic methods.
In partnership with Vitalea Science, Radiant Research utilised the
Accelerator Mass Spectrometry (AMS) technique - currently the most
analytical tool to enter the drug development market place.
With AMS technology, Vitalea scientists were able to quantify AZT
concentrations in blood, urine, saliva, white blood cells, and even DNA
white blood cells for more than 72 hours after administering the drug to
"The completion of this study is a remarkable milestone for drug
development," said Jon Ruckle, medical director of early phase clinical
research at Radiant Research.
"The study not only validates our ability to conduct microdosing trials,
also demonstrates the utility of this tool in gathering human PK
about drugs at sub-therapeutic, sub-toxic doses very early in the
development cycle," he added.
"We chose AZT for this joint project because it is a prime example of
dual nature of a drug," said Stephen Dueker, President of Vitalea
"AZT carries some risk at therapeutic doses despite its proven ability
reduce HIV viral loads. Indeed, there is no safe and ethical way to
this drug at therapeutic doses in healthy volunteers," he added.
The FDA has sent out a strong call asking for the pharmaceutical
modernise the clinical components of drug selection and development.
adoption of microdosing using AMS Technology has been one of many
to this ongoing problem.
As many as one in three drugs fail in Phase I (healthy volunteer)
testing despite extensive pre-clinical screening of potential clinical
candidates with a wide variety of in silico, in vitro, ex-vivo and
A high proportion of these failures can be attributed to sub-optimal
pharmacokinetics (PK) leading to potential efficacy or safety issues in
Another company heavily involved with microdosing is Xceleron, who in
September 2004, struck a deal with GlaxoSmithKline GSK) which has
in the drug giants commissioning the pharmaceutical industry's first
in-house Accelerator Mass Spectrometry (AMS) facility.
Animal experiments have:
a 63% failure rate when detecting human carcinogens
a 75-95% failure rate for detecting drug side effects
a 70% failure rate for detecting drugs which cause birth defects
Success rates lower than those achieved by uneducated guesswork.
This is not science!!
Recommended website: The Absurdity of vivisection