OPKO Health, Inc. (NASDAQ:OPK) (“OPKO” or “the
Company”), announces that the Company has enrolled the first
patient in a Phase 2b dose ranging trial of OPK88004, its orally
administered selective androgen receptor modulator (SARM), to treat
men with benign prostatic hypertrophy (BPH) or enlarged
prostate. BPH is a non-cancerous condition in which an
overgrowth of prostate tissue pushes against the urethra and the
bladder, limiting the flow of urine. BPH affects
approximately 50 million men in the U.S.
This trial will enroll approximately 125 men with BPH at 30
sites in the U.S. to identify appropriate doses given over a four
month treatment period to reduce prostate size, the primary
efficacy endpoint of the study. The study will also assess
secondary endpoints, including blood prostate specific antigen
(PSA) levels and body composition parameters such as lean body mass
and fat mass.
Interest in evaluating OPK88004 as a treatment for BPH is based
on data from a 12 week study of 350 men who showed significantly
decreased fat mass, increased
lean body mass, and increased muscle strength
without significantly changing PSA levels in the overall
population, while reducing PSA levels in men with elevated PSA
levels. The selective and antagonistic properties of OPK88004
appear to be well suited to potentially reduce prostate hypertrophy
in BPH subjects, while providing anabolic benefits such as
increased lean body mass and muscle strength. In previously
conducted dog studies, treatment with OPK88004 for 6 months
decreased prostate weight by up to 75%, demonstrating the potent
antagonistic effects of OPK8004 on androgen receptor activity in
the prostate.
“We are enthusiastic to be initiating this study in men
suffering from BPH, as there are no adequate treatment options for
this common debilitating condition that affects men as they
age. We believe that OPK88004 has the potential of
establishing a new standard of care for a disease that affects
millions of men worldwide,” stated Phillip Frost, M.D., Chairman
and Chief Executive Officer of OPKO Health.
“Given the large number of patients with BPH, we expect to
complete the study and to have topline results before the end of
2018,” added Dr. Frost.
About Benign Prostatic HypertrophyBenign
prostatic hypertrophy is a non-cancerous condition in which an
overgrowth of prostate tissue pushes against the urethra and the
bladder, blocking the flow of urine. Prostate gland
enlargement is a common condition in men as they get older.
According to the Mayo Clinic, the severity of symptoms in men with
BPH varies, but tend to worsen over time. Common signs and symptoms
of BPH include frequent or urgent need to urinate, increased
frequency of urination at night (nocturia), difficulty starting
urination, weak urine stream or a stream that stops and starts,
dribbling at the end of urination, straining while urinating, and
an inability to completely empty the bladder.
Medications are the most common treatment for BPH and include
alpha blockers and 5-alpha reductase inhibitors, both of which have
adverse side effects such as sexual dysfunction, dizziness and
retrograde ejaculation. Surgical procedures to treat males
with BPH are often associated with complications and lengthy
recovery times.
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 BioReference 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 and IV
forms marketed by partner, TESARO; OPK88003, a once-weekly
oxyntomodulin for type 2 diabetes and obesity that is a clinically
advanced drug candidate among the new class of GLP-1 glucagon
receptor dual agonists, and OPK88004, a selective androgen receptor
modulator being developed for benign prostatic hypertrophy and
other urologic and metabolic conditions. Our biologics business
includes 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. We also have various production
and distribution assets abroad, multiple strategic investments and
an active business development strategy. More information is
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
expectations for the market for OPK88004, the expected benefits of
OPK88004 and whether it will effectively reduce prostate size and
positively impact PSA levels, lean body mass, and fat mass, whether
it will provide anabolic benefits while reducing or avoiding
prostate hypertrophy, whether the clinical trials for OPK88004 will
be successfully completed on a timely basis or at all and whether
the data from the trial will support submission or approval,
validation and/or reimbursement for OPK88004, the expected timing
of commencing and concluding our clinical trials and having top
line results, enrollment in clinical trials, and disclosure of
results for the trials, the timing of our regulatory submissions,
our ability to market and sell any of our products in development,
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, as well as integration
challenges for Bio-Reference, EirGen, Transition, and other
acquired businesses, the risks inherent in funding, developing and
obtaining regulatory approvals of new, commercially viable and
competitive products and treatments, that earlier clinical results
of effectiveness and safety may not be reproducible or indicative
of future results, that OPK88004 and/or any of our compounds or
diagnostic products under development may fail, may not achieve the
expected results or effectiveness and may not generate data that
would support the approval or marketing of products for the
indications being studied or for other indications, that currently
available over-the-counter and prescription products, as well as
products under development by others, may prove to be as or more
effective than our products for the indications being studied. In
addition, forward-looking statements may also be adversely affected
by general market factors, competitive product development, product
availability, federal and state regulations and legislation, the
regulatory process for new products and indications, manufacturing
issues that may arise, patent positions and litigation, among other
factors. 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.
Company OPKO Health, Inc. David Malina,
305-575-4100 Investor Relations or Investors LHA
Anne Marie Fields, 212-838-3777afields@lhai.com or Bruce
Voss, 310-691-7100 bvoss@lhai.com
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