OPKO Health, Inc. (NASDAQ:OPK), announces that
data from a prospective study conducted at Veteran Affairs (VA)
hospitals confirming the 4Kscore test’s ability to accurately
predict aggressive prostate cancer were presented in a podium
presentation on May 16, 2017 at the 112th American Urological
Association (AUA) Annual Meeting in Boston.
The study entitled, “An Independent,
Multi-Institutional, Prospective study in the Veterans Affairs
Health System confirms the 4Kscore accurately predicts aggressive
prostate cancer,” was presented by Sanoj Punnen, M.D.,
Assistant Professor of Urologic Oncology at the Miller School of
Medicine, Department of Urology at the University of Miami in
Miami, Florida. The study is the second U.S. prospective clinical
study to establish the clinical validity of the 4Kscore test to
predict the presence of aggressive prostate cancer prior to
performing a prostate biopsy.
The VA study was conducted at eight VA hospitals across the
United States. A total of 366 men were enrolled in the study, and
208 (56%) of the participants were African American. Of all cancers
diagnosed among African American men, prostate cancer is the most
common (31% of all cancers), and African American men have a
twofold greater risk of prostate cancer mortality compared to
non-Hispanic whites.1
Overall, the 4Kscore demonstrated a high degree of accuracy for
predicting the presence of aggressive (Gleason score 7 and higher)
prostate cancer with an area under the receiver operator curve
(AUC) of 0.81, significantly better than PSA alone or a clinical
model based on PSA. Importantly, there was an equally high ability
of the 4Kscore to discern aggressive disease in the African
American men compared with the non-African American men (AUC = 0.80
v. 0.84, p = 0.32). The calibration and decision curve analysis
were also consistent with the performance shown in the first U.S.
validation study.
“The VA study confirms the 4Kscore’s accuracy in predicting a
man’s risk of having aggressive prostate cancer and showed that it
is an equally effective and vital clinical test for African
American men, who have the highest rates of prostate cancer
mortality,” said Phillip Frost, M.D., Chairman and CEO of OPKO
Health. “These positive results add to our growing body of clinical
evidence that demonstrate 4Kscore’s utility to accurately identify
the risk of aggressive prostate cancer. Moreover, these data
validate the clinical value of the 4Kscore test in a VA setting and
show it to be identical to the performance previously shown in
community and academic sites across the U.S. and Europe.”
About Prostate Cancer
According to the Prostate Cancer Foundation,2 “every 3.3
minutes a man is diagnosed with prostate cancer, and millions of
men and their families are fighting the disease globally. In the
United States, prostate cancer affects 1 in 8 men, making it the
most common non-skin cancer in America. This means that a
non-smoking man is more likely to develop prostate cancer than he
is to develop colon, bladder, melanoma, lymphoma, and kidney
cancers combined. In 2017 alone, it is estimated that more than
161,000 men will be diagnosed with prostate cancer, and more than
27,000 will die from the disease. A man of African descent is 73%
more likely to develop prostate cancer than a Caucasian man, and
more than twice as likely to die from the disease.”
About the 4Kscore™ Test
The 4Kscore is the only blood test that accurately identifies
risk for aggressive prostate cancer. The 4Kscore measures the blood
plasma levels of four different prostate-derived kallikrein
proteins: Total PSA, Free PSA, Intact PSA and human
kallikrein-related peptidase 2 (hK2). These biomarkers are combined
with a patient's age, digital rectal exam (DRE) status (nodule / no
nodule), and prior negative biopsy status (yes / no) using a
proprietary algorithm that calculates the risk (probability) of
finding a Gleason Score 7 or higher prostate cancer. The four
kallikrein panel of biomarkers utilized in the 4Kscore test is
based on over a decade of research conducted by scientists at
Memorial Sloan-Kettering Cancer Center and leading European
institutions. The 4Kscore test provides individualized risk for the
presence of aggressive prostate cancer and adds new information to
the patient-physician shared decision making discussion. The
4Kscore test is included in the 2016 National Comprehensive Cancer
Network and 2016 European Association of Urology Prostate Cancer
Guidelines.
About OPKO Health, Inc.
OPKO Health is a diversified healthcare company that seeks to
establish industry leading positions in large, rapidly growing
markets. Our diagnostics business includes Bio-Reference
Laboratories, the nation's third-largest clinical laboratory with a
core genetic testing business and a 400-person sales and marketing
team to drive growth and leverage new products, including the
4Kscore® prostate cancer test and the Claros® 1 in-office
immunoassay platform. Our pharmaceutical business features
RAYALDEE, an FDA-approved treatment for SHPT in stage 3-4 CKD
patients with vitamin D insufficiency (launched in November 2016),
VARUBI™ for chemotherapy-induced nausea and vomiting (oral
formulation launched by partner TESARO and IV formulation pending
FDA approval), OPK88003, a once or twice weekly oxyntomodulin for
type 2 diabetes and obesity which is a clinically advanced drug
candidate among the new class of GLP-1 glucagon receptor dual
agonists, OPK88004, a SARM (Selective Androgen Receptor Modulator)
for treating BPH (Benign Prostatic Hypertrophy) , OPK88002, a NK-1
antagonist to treat pruritus ( itching) in dialysis patients, and
OPK88001, a proprietary oligonucleotide to treat Dravet Syndrome.
In addition, the Company is advancing its CTP technology, which
includes a long acting hGH-CTP, a once weekly human growth hormone
injection (in phase 3 and partnered with Pfizer), and a long acting
Factor VIIa drug for hemophilia in phase 2a. OPKO also has
production and distribution assets worldwide, multiple strategic
investments and an active business development strategy. More
information available at www.opko.com.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains "forward-looking statements," as
that term is defined under the Private Securities Litigation Reform
Act of 1995 (PSLRA), which statements may be identified by words
such as "expects," "plans," "projects," "will," "may,"
"anticipates," "believes," "should," "intends," "estimates," and
other words of similar meaning, including statements regarding the
clinical utility for the 4Kscore test, its ability to accurately
predict aggressive prostate cancer in men generally and in the
African American population, the expected benefits of our 4Kscore
test, whether clinical trial results are indicative of the 4Kscore
test's ability to predict aggressive prostate cancer, as well as
other non-historical statements about our expectations, beliefs or
intentions regarding our business, technologies and products,
financial condition, strategies or prospects. Many factors could
cause our actual activities or results to differ materially from
the activities and results anticipated in forward-looking
statements. These factors include those described in our Annual
Reports on Form 10-K filed and to be filed with the Securities and
Exchange Commission and in our other filings with the Securities
and Exchange Commission. The forward-looking statements contained
in this press release speak only as of the date the statements were
made, and we do not undertake any obligation to update
forward-looking statements. We intend that all forward-looking
statements be subject to the safe-harbor provisions of the
PSLRA.
_________________
1 https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/cancer-facts-and-figures-for-african-americans/cancer-facts-and-figures-for-african-americans-2016-2018.pdf
2 https://www.pcf.org/c/about-the-prostate-cancer-foundation/
Company
OPKO Health, Inc.Tara Mackay,
305-575-4100tmackay@opko.com Investor RelationsorDavid Malina,
305-575-4137dmalina@opko.com Director of Investor
Relations
Media
Rooney PartnersTerry Rooney,
212-223-0689trooney@rooneyco.com orMarion Janic,
212-223-4017mjanic@rooneyco.com
or
Investors
LHAAnne Marie Fields, 212-838-3777afields@lhai.com orBruce
Voss, 310-691-7100bvoss@lhai.com
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