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KAPS Biotech: A novel biomarker to improve prostate cancer diagnosis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R42MD013412-02
Agency Tracking Number: R42MD013412
Amount: $495,303.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: 102
Solicitation Number: PA17-303
Solicitation Year: 2017
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-06-01
Award End Date (Contract End Date): 2023-05-31
Small Business Information
Williamsville, NY 14221-5810
United States
DUNS: 080083852
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (716) 845-3389
Business Contact
Phone: (716) 465-1173
Research Institution
BUFFALO, NY 14263-0001
United States

 Domestic nonprofit research organization

Prostate cancer (CaP) is the most common non-skin cancer in men and third most common cause of cancer
deaths in men. Black men experience a higher burden of incidence and mortality from CaP compared to White
men. The Prostate-Specific Antigen (PSA) test, a commonly used biomarker for early diagnosis and
management of CaP, cannot alone accurately predict the presence of CaP, its aggressiveness, or the risk of
post-treatment recurrence. The 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 PSA. Consequently, a search for more effective prostate tumor biomarkers
is overdue. KAPS Biotech’s preliminary studies show that concurrent measurements of the levels of serum
cytokines such as IL-8, TNF-α, and sTNF-R1 (KAPS biomarker) provide a significant advantage as a CaP
biomarker over PSA measurements alone in differentiating men with CaP from men without CaP. However,
these preliminary studies were carried out on a small sample and essentially contained no Black men. The
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 CaP. Further, the 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-making. Due to the reported significant racial differences in the
diagnoses of and mortality from CaP, future CaP biomarker studies should include a racially diverse sample of
men, especially Black men. Therefore, newly 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 making. To test the central hypothesis, this Fast Track proposal proposes the following specific aims:
Phase I: A small, one-year prospective proof-of-principle study to determine whether KAPS biomarker
(concurrent measurements of IL-8, TNF-α, and sTNFR1) can distinguish those with CaP from those without
CaP among Black and White men.
Phase II: A large, prospective cohort study to address the following aims:1. Determine whether KAPS biomarker can prospectively distinguish those with CaP from those withoutCaP among a large sample of Black and White men.2. Determine 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 Antigen (PSA) test is currently the most commonly used prostate cancer biomarker. The
PSA test has a 70% false positive and 30% false negative rate, meaning that, each year in the United States,
approximately 700,000 men undergo unnecessary prostate biopsies and more than a million men are
overtreated for prostate cancer. KAPS biomarker (which measures three relevant biomarkers at the same time)
outperforms the PSA test both in detecting prostate cancer and in differentiating between high- and low-risk
prostate cancers.

* Information listed above is at the time of submission. *

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