KAPS BIOTECHNOLOGY LLC — Department of Health and Human Services STTR Phase I: 102

Description

Abstract Prostate cancerCaPis the most common non skin cancer in men and third most common cause of cancer deaths in menBlack men experience a higher burden of incidence and mortality from CaP compared to White menThe Prostate Specific AntigenPSAtesta commonly used biomarker for early diagnosis and management of CaPcannot alone accurately predict the presence of CaPits aggressivenessor the risk of post treatment recurrenceThe widespread use of PSA testing in CaP screening is controversial partially because patients with benign enlargement of the prostate often have elevated levels of PSA and many men with diagnosed CaP have a normal PSAConsequentlya search for more effective prostate tumor biomarkers is overdueKAPS Biotech s preliminary studies show that concurrent measurements of the levels of serum cytokines such as ILTNFand sTNF RKAPS biomarkerprovide a significant advantage as a CaP biomarker over PSA measurements alone in differentiating men with CaP from men without CaPHoweverthese preliminary studies were carried out on a small sample and essentially contained no Black menThe central hypothesis of this proposal is that both Black and White men with CaP have altered circulating levels of KAPS biomarker compared to men without CaPFurtherthe extent to which these levels are altered will vary according to CaP risk factors and can be used as a tool to improve the early detection of CaP and CaP treatment decision makingDue to the reported significant racial differences in the diagnoses of and mortality from CaPfuture CaP biomarker studies should include a racially diverse sample of menespecially Black menThereforenewly developed biomarkers must be validated in a robust and racially diverse population of men to improve the specificity of CaP diagnosis and to better inform CaP treatment decision makingTo test the central hypothesisthis Fast Track proposal proposes the following specific aimsPhase IA smallone year prospective proof of principle study to determine whether KAPS biomarkerconcurrent measurements of ILTNFand sTNFRcan distinguish those with CaP from those without CaP among Black and White menPhase IIA largeprospective cohort study to address the following aimsDetermine whether KAPS biomarker can prospectively distinguish those with CaP from those withoutCaP among a large sample of Black and White menDetermine whether KAPS biomarker can prospectively distinguish men with high risk CaP from thosewith indolent CaP among a large sample of Black and White men with CaP Narrative The Prostate Specific AntigenPSAtest is currently the most commonly used prostate cancer biomarkerThe PSA test has afalse positive andfalse negative ratemeaning thateach year in the United Statesapproximatelymen undergo unnecessary prostate biopsies and more than a million men are overtreated for prostate cancerKAPS biomarkerwhich measures three relevant biomarkers at the same timeoutperforms the PSA test both in detecting prostate cancer and in differentiating between highand low risk prostate cancers