BEHAVIORAL DIAGNOSTICS, INC. — Department of Health and Human Services SBIR Phase II: NCI

Description

Smoking is the most common preventable cause of morbidity and mortality in the United States Each year smoking causes the premature death of over Americans and $ billion of economic damage Effective treatment is possible but barriers to its implementation limits the success rate of smoking cessation in the general population to about Notably reward based incentive smoking cessation methods could triple or quadruple that abysmal response rate But their implementation is hindered by a number of factors most importantly the lack of a good biomarker for quantifying the decrease of cigarette consumption or reduction in harm RIH In a very successful prior R project we demonstrated that methylation at cg as quantified by our Smoke Signature assay increases as a function of successful smoking cessation and that DNA methylation at cg reliably distinguishes non smokers from smokers with an AUC of and methylation at cg regresses to mean as a function of the success of smoking cessation However our data are incomplete since the cohorts used in this Phase I study were limited in size and ethnic diversity In this Phase II project we will confirm and extend those findings into a more generally representative population and develop CLIA compliant processes that can be used to translate this Phase I finding into FDA approved digital droplet PCR ddPCR test a k a Smoke Signature for monitoring of smoking cessation In this Phase II project we will collect and characterize an ethnically diverse group of subjects as they undergo smoking cessation therapy We will then determine their DNA methylation as a function of smoking cessation success From this we will produce a refined reversion curve that can be used in biomarker guided therapy and create other data for the FDA submission of our assay Our project will have high commercial and clinical impact because the Smoke Signature assay could create the basis for an improved clinical paradigm for the treatment of smoking and be an unambiguous indicator of smoking for civil e g insurance companies etc assessments of smoking status Our plan is highly feasible because of Behavioral Diagnosticandapos s control of relevant intellectual property expertise in clinical epigenetics an operational ddPCR methylation assay access to subjects and staff of experienced clinicians It is innovative because epigenetic techniques have not yet been incorporated into behavioral medicine The project will led by our Chief Executive Officer Dr Rob Philibert who is an internationally known expert in clinical epigenetics He will be assisted by a team of co investigators who are leaders in their fields We are aided by Bio Rad a company that stands to gain from our success As a direct result we will create the data to support the submission of the assay to the FDA and a knowledge base for clinicians to assess the success of smoking cessation Narrative This project will demonstrate the clinical reliability of a new epigenetic test for smoking cessation treatment and advance it to FDA approval