Accium BioSciences Announces FDA Clears Path for Exploratory IND Studies.

SEATTLE -- Accium BioSciences today announced that the FDA has issued draft guidance that clarifies preclinical and clinical considerations in preparation of "Microdosing" or "Phase 0" clinical studies in the US. The guidance clears the path for drug developers in the US to obtain important pharmacokinetic information at a much earlier stage of clinical development using Exploratory IND studies. The new FDA guidance contains details about a new investigational drug application process, the "Exploratory IND" that will enhance post-discovery drug development.

"Exploratory IND studies can help identify, early in the process, promising candidates for continued development, and eliminate those lacking promise. As a result, exploratory IND studies may help reduce the number of human subjects and resources, including the amount of candidate product, needed to select promising drugs," said the FDA.

Through the Exploratory IND process, sponsors can combine preclinical data with first-in-human data to select the best drug candidates to advance to Phase I clinical trials. Obtaining human data prior to final candidate selection reduces the risk of failure in later clinical trials and decreases the overall cost of the drug development process. Despite extensive preclinical screening of potential candidates with a wide variety of in silico, in vitro, and animal models, many compounds continue to fail in Phase I clinical studies. Drug developers no longer have to depend solely on preclinical data for Phase I candidate selection.

As defined in this guidance, Exploratory IND studies are performed at microdose levels not to exceed 1/100th of the dose calculated to yield a pharmacological effect with a maximum dose of 100 ug. These microdose studies require highly sensitive instrumentation for reliable determination of drug concentration in plasma and other samples. Accelerator Mass Spectrometry (AMS) is the most sensitive tool developed for quantification of drug and metabolite concentrations in Exploratory IND studies performed at microdose levels.

"As the first US company to provide complete in-house AMS analytical services, Accium BioSciences is excited to make Exploratory IND studies available to US researchers. The FDA's Critical Path initiative and this Exploratory IND guidance make new sets of tools available that improve the predictability, efficiency and safety of the drug development process while reducing the time and resources required to select drug candidates most likely to succeed in later clinical trials," said Michael Chansler, Vice President of Business Development at Accium BioSciences.

"Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies" is available at the following link: http://www.fda.gov/cder/guidance/6384dft.doc

About Accium BioSciences, Inc.

Accium BioSciences, Inc., headquartered in Seattle, Washington, is the first commercial Accelerator Mass Spectrometer (AMS) facility in the US. Accium BioSciences offers a full range of ultra-sensitive PK/ADME services for preclinical studies, turnkey Phase 0 clinical study services and ultra-low radiation PK/ADME, mass balance and bioavailability studies for Phase I clinical studies.