EPIPHANY BIOSCIENCES, INC. — Department of Health and Human Services SBIR Phase II: R

Description

Project Summary Abstract Kaposiandapos s sarcoma herpes virusKSHVis an oncovirus that causes several cancers including Kaposiandapos s sarcomaKSIt is estimated thattoof U Sblood donors have been infected with KSHVyet in some high risk populations such as homosexual menprevalence is as high asIn spite of HAARTKS remains the second most common AIDSassociated malignancyA third of AIDS KS cases now arise in individuals with relatively high CDcell counts and low HIVviral loadA recent study has observed a continuing high prevalence and increased acquisition of KSHV in HIVinfected persons on HAARTThe data clearly indicate that KS is still occurring in HIV infected individualseven in the context of successful HAARTIn immunosuppressed populationsapproximatelyintransplant patients will develop KSThe prevalence of KSHV is responsible for the continuing incidence of KS and its associated reduction in life expectancy of HIVindividualsDespite its strong disease associationparticularly in the HIVand immunosuppressed populationsthere is no FDA approved clinical diagnostic test for KSHV and consequently a significant unmet need remains for a simplecost effective commercially viable KSHV diagnostic kit that would be an essential component of any effort to control virus transmission and monitor serostatus of those already infectedThe ability to gauge the KSHV serostatus of an HIVindividual would help clinicians make appropriate interventional choices to prevent KS onsetThe overall goal of this project is to develop a serological multi antigen assay for the detection of KSHV antibodies that can be used commercially to diagnose at risk patients and identify blood tissue donors with KSHV infectionIn prior SBIR Phase I and II workEpiphany developed a single wellmulti antigenic KSHV enzyme linked immunosorbent assayELISAcalledComboIn screening a sera panel containing both KSHV truepositives and normallow risk blood donorsCombo was the only assay out ofother independent ELISAs to detect all consensus KSHV samples with excellent specificity and sensitivityestimated andgtrespectivelyFor the next stage of the kit developmentit is critical to examineComboandapos s performance against large sera banks of epidemiologically validated KSHV positive and negative controls with relevant confirmatory assays to establish the true effectiveness of the assayA collaborative consortium that merges Epiphany with the biomedical and clinical research capabilities of the University of MiamiUofMMiller School of Medicinethe Miami Center for AIDS ResearchCFARand the labs of DrEnrique AMesriCFARhas been createdTogetherEpiphany and Miami CFAR are uniquely equipped to achieve the following AimsIn Aimsyntheticmanufacturingand analytical process development will be implemented followed by pilot production of a set ofCombo diagnostic ELISA kitsIn Aimthese kits will be assessed and optimized by screening retrospective clinical blood samples and serologically characterized plasmaPMBCs and validated by western blotIn Aimlarge scale kit production will commenceAssay stability and validation studies will be performedA larger panel of HIVsera and tissues available to UofM CFARits cores and transplant centersand national repositories will be massively screened to establish sensitivity and specificityAchieving the goals of this project will establish the clinical and commercial value ofCombo ultimately resulting in the first FDA approved clinical diagnostic assay for KSHV Project Narrative Kaposiandapos s sarcoma herpes virusKSHVis an oncovirus that causes several cancers including Kaposiandapos s sarcomaKSespecially in patients with weakened immune systems such as those infected with HIVEven in the age of HIV antiretroviral therapyKSHV co infection remains a serious health issue for the HIV positive population and is still the second most common cause of malignancies among AIDS patientsDespite its strong disease associationparticularly in the HIV positive and immunosuppressed populationsthere is no FDA approved clinical diagnostic test for KSHV and consequently this project seeks to develop a simplecost effective commercially viable KSHV diagnostic assay kit that would be an essential component of any effort to control virus transmission and monitor serostatus of those already infected in order to help clinicians make appropriate interventional choices to prevent KSHV related disease