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Fw: Superior clinical research - another example

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  • SinDee
    ... From: - V I N - Date: Wed, 31 Aug 2005 19:59:52 +0000 Superior clinical research - another example Radiant completes first
    Message 1 of 1 , Aug 31, 2005
      -----Original Message-----
      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
      the
      United States has been completed by Radiant Research, who believe this
      approach to clinical trials will lead to more accurate and earlier
      human
      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
      traditional
      Phase I studies, thereby reducing attrition in clinical development.
      This
      will ensure that limited resources are focused on the best drug
      candidate
      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
      sub-therapeutic
      "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
      sensitive

      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
      of
      white blood cells for more than 72 hours after administering the drug to
      a
      human subject.
      "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,
      but

      also demonstrates the utility of this tool in gathering human PK
      information

      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
      the
      dual nature of a drug," said Stephen Dueker, President of Vitalea
      Science.

      "AZT carries some risk at therapeutic doses despite its proven ability
      to
      reduce HIV viral loads. Indeed, there is no safe and ethical way to
      evaluate

      this drug at therapeutic doses in healthy volunteers," he added.

      The FDA has sent out a strong call asking for the pharmaceutical
      industry to

      modernise the clinical components of drug selection and development.
      The
      adoption of microdosing using AMS Technology has been one of many
      responses
      to this ongoing problem.

      As many as one in three drugs fail in Phase I (healthy volunteer)
      clinical
      testing despite extensive pre-clinical screening of potential clinical
      candidates with a wide variety of in silico, in vitro, ex-vivo and
      animal
      models.

      A high proportion of these failures can be attributed to sub-optimal
      pharmacokinetics (PK) leading to potential efficacy or safety issues in
      humans.

      Another company heavily involved with microdosing is Xceleron, who in
      September 2004, struck a deal with GlaxoSmithKline GSK) which has
      resulted
      in the drug giants commissioning the pharmaceutical industry's first
      in-house Accelerator Mass Spectrometry (AMS) facility.

      http://www.drugresearcher.com/news/news-ng.asp?n=62151-xceleron-radiant-micr
      odosing
      ---
      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
      http://vivisection-absurd.org.uk/
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