A novel diagnostic biomarker for Hepatocellular Carcinoma(HCC)

DESCRIPTIONprovided by applicantHepatocellular carcinomaHCCis usually undetected until its later stageswhere theyear survival rate for patients is less thanHoweverthe survival rate can be as high asif the cancer is detected earlyUnfortunatelyearly detection of HCC is not possible with any screening tests that are currently availablesuch as ultrasound or imaging technologiesAlpha FetoproteinAFPwhich is currently the diagnostic marker used for HCC screeningis limited by its low specificity and lack of sensitivity Thereforea method of detecting HCC accurately and or in its early stages would greatly improve our ability to manage and treat the diseaseBackground and ObjectiveWe aim to complete the development of HepatoDetect ran ELISA based diagnostic systemwhich strongly confirmed its ability to identify both early and late stage Hepatocellular CarcinomaHCCwith high sensitivity and specificity during our phase I studyThe HepatoDetect rdiagnostic kit is based on the use of a monoclonal antibody to quantitatively detect a protein specifically secreted by liver cancer cellsLiver Cancer Serine Protease Inhibitor KazalLC SPIKThe effectiveness of LC SPIK as a marker in distinguishing HCC from other liver diseasesnon liver diseases and healthy subjects was evaluated in phase I and showed that the mean level of LC SPIK in HCC patientsng mlwas significantly higherP andltthan in patients with hepatitisliver cirrhosispancreatitis and in healthy subjectsng mlng mlng ml andng mlrespectivelyUsing a cut off value ofng mlthe sensitivity and specificity of serum LC SPIK for HCC wereandrespectivelycompared to onlyandfor AFPMost encouragingLC SPIKandapos s accuracy in detecting very early stage HCCtumor size andltcmwascompared to onlyfor AFPThe data clearly supports that the technology is significantly better than AFPWe are also confident that HepatoDetect rhas significant advantages over other current screening and diagnostic methodologiesincluding many of those still in developmentImaging technologiesCTMRIUltrasoundare operator dependent and very expensivebiopsies are invasiveand developmental technologies such as MDKmidkineand Gpare less specific and are not yet validatedWe propose to further optimizevalidateand complete the development of our HepatoDetect rdiagnostic kit for clinical use in our phase II studyProcedureAimWe will standardize and optimize our technology and complete development for andquot HepatoDetect randquotto screen for HCCThis ELISA kit would be reliableeasy to operateand inexpensiveAimUsing this kitwe will continue to systematically evaluate the performance of LC SPIK in HCC using a largedouble blinded sample setwhich includesHCC specimens andcontrols from subjects with normal liverspancreatitishepatitis and cirrhosisThe ultimate goal is to receive FDA pre market approval for this product and to commercialize itMarketNearlymillion people in US andmillion people worldwide are affected by HBV or HCVandof them are at a high risk of developing HCCFor these peopleroutine examinations for cancer are necessaryThus there is a very large market for HCC detection and testingCompetitionCurrentlythe only diagnostic marker used for HCC detection is AFPwhich is significantly less effective than our solutionand there are no other similar products available PUBLIC HEALTH RELEVANCEImCare Biotech is developing an ELISA test kit for the diagnosis of HCCThe technology used involves quantitative detection of a protein named LC SPIKwhich is uniquely secreted by liver cancerUsing a monoclonal anti LC SPIK antibody IM CAa test kit HepatoDetect rhas been developed and large scale clinical examination will be pursuedImCare Biotech is looking to commercialize HepatoDetect rafter FDA approvalOur preliminary clinical studies suggest that this test kit may be more sensitivemore specificand more reliable than AFPan existing biomarker for HCCin diagnosing liver cancerespecially in its early stagesThe kit would offer many advantages over current alternatives including higher efficacylow costand ease of use