Seattle, Wash. - Radiant Research Inc., a comprehensive clinical research company that provides phase 0-IV clinical drug development services to the biopharmaceutical industry, today announced the completion of one of the first "microdosing" studies to be conducted in the United States.

"Microdosing or 'Phase 0' studies provide our biopharmaceutical sponsors with the ability to obtain early human pharmacokinetic (PK) data on drug candidates more accurately and expeditiously than possible through conventional development strategies," stated Michael Lester, Chief Executive Officer of Radiant Research. "Under the recently revised regulatory guidelines allowing the use of an exploratory investigational new drug application (IND), microdosing 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."

The study re-evaluated the drug azidothymidine (AZT), at sub-therapeutic "nanodose" concentrations (520 nanograms) isotopically labeled with 14Carbon. 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. Radiant Research partnered with Vitalea Science, utilizing Vitalea's core technology, Accelerator Mass Spectrometry (AMS) - to date the most sensitive analytical tool to enter the drug development market place - to analyze the samples. 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, M.D., Medical Director of Early Phase Clinical Research, Radiant Research | Honolulu. "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." Dr. Ruckle, board-certified in internal medicine, is a highly experienced clinical investigator who has conducted over 200 Phase I-IV clinical trials as well as acting as the principal investigator on this study.

"We chose AZT for this joint project because it is a prime example of the dual nature of a drug," stated Stephen R. 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. AMS Technology ushers in a new era for gaining early human data on virtually any investigational compound since the chemical exposure is well below levels that could elicit adverse effects."

"The data looks fantastic and we are very pleased to partner with Radiant Research in bringing our analytical platform to the U.S. market", notes Dueker. "The FDA sent out a strong call asking for the pharmaceutical industry to modernize the clinical components of drug selection and development. Radiant Research has answered this call through its early adoption of microdosing using AMS Technology."

In addition to its 45+ wholly-owned premier phase II-IV clinical research sites, Radiant Research now has eight clinical pharmacology units comprising 320 beds. Ultimately, Radiant Research intends to have 10 clinical pharmacology units by the end of 2005 with approximately 500 beds, each having access to special patient populations and the therapeutic expertise of experienced clinical investigators.

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About Radiant Research:

Based near Seattle, Washington, Radiant Research (radiantresearch.com) is a comprehensive clinical research company that provides Phase 0-IV clinical drug development services to the biopharmaceutical and medical device industry. Radiant is comprised of more than 45 wholly-owned premier clinical research sites nationwide, employing over 1,000 research professionals exclusively focused on providing professional, high quality comprehensive clinical research services. In the past four years, Radiant has conducted more than 8,400 clinical trials across 18 therapeutic specialties. Radiant's client list includes every major pharmaceutical company and contract research organization as well as many biotechnology and medical device companies.

About Vitalea Science:

Established in September 2003, Vitalea Science is the first U.S.-based group to offer commercial Accelerator Mass Spectrometry (AMS). Vitalea's founding team brings years of research experience in application of AMS to microdose studies. This body of experience catapults Vitalea into a de facto industry leader in AMS. For more information about Vitalea's AccelTM platforms and how they can be customized to solve specific problems, please contact Vitalea Science via their website: www.vitaleascience.com.

Contact
Michael K. Lester Chief Executive Officer RADIANT RESEARCH (425) 468-6200		Jon Ruckle, M.D. Medical Director of Early Phase Studies RADIANT RESEARCH Honolulu (808) 592-2632		Arlin Blood, Ph.D. Site Director RADIANT RESEARCH Honolulu (808) 592-2632