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Sensitive Pediatric Pharmacology Assays for HIV Drugs Developed by Vitalea Science

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Vitalea Science announced that it had received a National Institute of Allergy and Infectious Disease (NIAID) grant to develop and test assays to quantify intracellular uptake of the active metabolite of a nucleoside reverse transcriptase inhibitor (NRTI) drug that can be applied to children and neonates.

"Until now most drugs, although used in children, do not have pharmacology information pertinent to this population. Children are not small adults and are obviously not large rats, yet drug information relating to children is extrapolated from adult or animal data," said Dr. Le Vuong.

Dr. Vuong is one of the recipients of the Small Business Innovation Research (SBIR) award and is Chief Operating Officer of Vitalea Science, Inc., a bio-analytical Contract Research Organization (CRO) focused on providing ultra-sensitive detection of drug metabolism using Accelerator Mass Spectrometry (AMS).

According to the FDA, only 25% of all drugs in use today have been studied and labeled for pediatric patients. The main reason is the prior lack of sensitive analytical tools which required administration of drug doses and collection of blood samples that are too large for children and neonates.

Without feasible and safe means for pediatric testing and labeling, children can be placed at risk for under- or overdosing. In addition, the lack of age-appropriate formulations, such as liquids or chewable tablets, can result in improper administration of drugs.

"There is very little known about the drug disposition of nucleoside/nucleotide analogs in pediatric populations. Given the magnitude and frequency at which the youngest of children globally are exposed to these drugs, better clinical pharmacology tools are of high priority," said Dr. Vuong.

"We now have the tools to study drug disposition in pediatrics using AMS," Dr. Stephen Dueker, President of Vitalea Science, confirmed.

Dr Dueker continued, "AMS achieves attomole (10-18) sensitivity for drugs labeled with safe and effective 14C isotopes. The level of sensitivity achieved with AMS is the highest for any known analytical instrument. Perinatal exposures and infant incorporation of a microdose of labeled NRTI drug may be quantified by AMS safely using permissible small blood samples."

For Phase 1 of the SBIR, Vitalea scientists will develop and validate a method to quantify intracellular concentrations and final DNA incorporation within lymphocytes.

"This work will demonstrate capability for quantification of pharmacodynamic parameters, intracellular concentration and DNA incorporation that may provide robust measures of target cell exposures from circulating doses." Dr. Vuong stated. "The ultimate aim of this work is to obtain a robust analytical platform for clinical pharmacology tailored to better serve pediatric populations."