Good news for the Pharmaceutical industry in a climate of spiralling costs for developing new drugs. By delivering sub-pharmacological (microdose) quantities of new drug candidates to human subjects, vital information can be gained at an early stage as to the potential for that candidate to become a drug. Pharmaceutical Profiles (Nottingham, UK) and Xceleron (York, UK), have announced a strategic business partnership to offer a commercial human microdosing service, where early testing is carried out using minute quantities of the new drug in the human body enabled by the use of the ultra-sensitive analytical technique of Accelerator Mass Spectrometry (AMS).

AMS is the most sensitive measuring device ever invented – it can count individual atoms – so providing the sensitivity needed to analyse samples from microdose studies. Only 20g of candidate drug are needed to perform a microdose study and microlitre samples required for valid measurement. Human microdosing essentially enables “First in Man” studies to be performed within 6 months of the new drug candidate being produced in the laboratory.

In a joint statement, Professor Colin Garner, CEO of Xceleron and Professor Ian Wilding, Executive Chairman of Pharmaceutical Profiles explained, "With so many drug candidates exiting discovery and entering development, the task of choosing and then advancing the right molecules into the clinic has become more and more difficult and the current system of producing potential new drugs is simply not working.

“Around 30% of drugs actually fail during healthy volunteer studies, and it will have cost the pharma company literally millions of dollars to get it to that stage in the first place. Microdosing offers a genuine way to highlight those new medicines most likely to be successful for the pharma company at a much earlier stage.”

For more information visit www.xceleron.co.uk or www.pharmprofiles.com.

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For further information, please contact:

Richard Gee +44 115 950 8399 This email address is being protected from spambots. You need JavaScript enabled to view it.
Paul Clewlow +44 115 974 9000 This email address is being protected from spambots. You need JavaScript enabled to view it.

Or www.pharmprofiles.co.uk

Editors Notes:

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 subsequent product failures can also be attributed to unsuitable pharmacokinetic (PK) or inappropriate absorption, distribution, metabolism and excretion (ADME) properties, manifesting themselves as equivocal efficacy or safety issues in man.

Researchers and regulators are continually searching for faster and more cost-effective ways of obtaining early human bioavailability data, both safely and ethically. The recent advance of ultra-sensitive AMS has made it possible to undertake clinical studies in man using extremely low drug doses to obtain early PK and ADME data. These doses may be 100 times below the level calculated to yield a pharmacological effect.

Pharmaceutical Profiles is an acknowledged leader in the areas of clinical drug development in which it specialises - principally inhalation, gastrointestinal and regional absorption studies. Its technology and expertise helps speed up the process of drug development and can help pharmaceutical and biotechnology companies make more informed decisions in early product development.

Xceleron is the world leader in biomedical applications of the ultra sensitive analytical technique of AMS. The company has worked for over 60 companies and organisations including 15 of the world’s top 20 pharmaceutical companies. Xceleron is GLP accredited and has the capacity to analyse 70,000 biological samples per annum.


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