A survey of currently available immunoassays, coupled with excellent results from our Phase I studies and Interim Data, prompted us to plan a series of solid phase FLIA(TM) kits for opioid peptides. Due to its unusual stability and broader dynamic range, the functioning immunoassay for leu-enkephalin will be optimized in a FLIA(TM) format for commercialization. Using this assay as a model, the detection of other opioid peptides will be developed in a similar fashion. The EIA format will be upgraded to commercial status due to user familiarity with the assay. The molecular design approach for the generation of highly specific antibodies using the 2-lys analog, which was initiated in our Phase I study, will be further improved by focusing on the different means of binding the hapten peptide to the carrier protein. Extending from our encouraging Phase I results, various adjustments will also be made to our proprietary coating method to minimize the cross-reactivity of leu- enkephalin and met-enkephalin. The assay procedure, which was developed in our Phase I studies and improved during the Interim Period, will be further optimized to improve its accuracy, simplicity and sensitivity. From these studies, complete immunoasssay kits will be constructed, and their reliability will be tested during the Phase II period. The commercial assays will be expanded to include, at least, two other opioids. The ultimate goal is to provide a panel of specific, sensitive and reliable non-radioactive immunoassays for opioid peptides in a distinctly simple and economical format.
