SAN DIEGO, Oct. 18, 2017 /PRNewswire/ -- Trovagene,
Inc. (NASDAQ: TROV), a precision medicine biotechnology
company, today announced positive data from preclinical research
demonstrating synergy of PCM-075, its oral, highly-selective
Polo-like Kinase 1 (PLK1) Inhibitor, in combination with
abiraterone (Zytiga® - Johnson & Johnson).
Abiraterone is a potent and irreversible inhibitor of CYP17, a critical enzyme in androgen biosynthesis
and is indicated for the treatment of mCRPC in combination with
prednisone. This research was performed in collaboration with a
major cancer research institution.
"The synergy observed when we combined PCM-075 with abiraterone
appears to work through a novel mechanism that may modulate a
signaling pathway previously unknown to be associated with this
combination," said Dr. Mark
Erlander, Chief Scientific Officer of Trovagene. "This
unique combination appears to enhance the PCM-075 mechanism of
action of arresting cells during mitosis with subsequent tumor cell
death."
Metastatic Prostate Cancer is the third leading cause of cancer
death in men. Approximately 25,000 men progress to metastatic
Castration-Resistant Prostate Cancer (mCRPC) annually and receive
anti-androgen therapy with a mean progression-free survival of less
than two years. Abiraterone is the leading global anti-androgen
therapy, marketed by Centocor Ortho Biotech, Inc., a member of the
Johnson & Johnson family of companies, with 2016 sales in
excess of $2.0 billion. Even with the
broad adoption of abiraterone there continues to be a large medical
need to extend the benefit of response to abiraterone in mCRPC.
"We are encouraged by the preclinical data of PCM-075 in mCRPC,"
said Bill Welch, Chief Executive
Officer of Trovagene. "We previously completed a Phase 1 trial in
metastatic solid tumor cancers, which provided a recommended Phase
2 dose and dosing schedule for PCM-075 in a combination regimen.
We are working closely with key investigators to develop a
Phase 2 clinical trial protocol with oral dosing of PCM-075 and
abiraterone utilizing our existing solid tumor IND."
About PCM-075
PCM-075 is a highly-selective adenosine triphosphate (ATP)
competitive inhibitor of the serine/threonine polo-like-kinase 1
(PLK 1) enzyme, which is over-expressed in multiple hematologic and
solid tumor cancers. Studies have shown that inhibition of
polo-like-kinases can lead to tumor cell death, including a Phase 2
study in Acute Myeloid Leukemia (AML) where response rates up to
31% were observed when used in conjunction with a standard therapy
for AML (low-dose cytarabine-LDAC) versus treatment with LDAC alone
with a 13.3% response rate. A Phase 1 open-label, dose escalation
safety study of PCM-075 has been completed in patients with
advanced metastatic solid tumor cancers, and published in
Investigational New Drugs. Trovagene is initiating a Phase
1b/2 clinical trial with PCM-075 in AML that was accepted by the
National Library of Medicine (NLM) and is now publicly viewable on
www.clinicaltrials.gov. The NCT number assigned by
clinicaltrials.gov for this study is NCT03303339. PCM-075 has been
granted Orphan Drug Designation by the FDA for the treatment of
patients with AML.
PCM-075 only targets PLK1 isoform (not PLK2 or PLK3), is oral,
has a 24-hour drug half-life with reversible on-target hematologic
toxicities. Trovagene believes that targeting only PLK1 with
reversible on-target activity and an improved dose/scheduling
protocol can significantly improve on the long-term outcome
observed in previous studies with a PLK inhibitor in AML.
PCM-075 has demonstrated synergy in preclinical studies with
over 10 chemotherapeutic and target agents used in hematologic and
solid tumor cancers, including FLT3 and HDAC inhibitors, taxanes,
and cytotoxins. Trovagene believes the combination of its targeted
PLK-1 inhibitor, PCM-075, with other compounds has the potential
for improved clinical efficacy in Acute Myeloid Leukemia (AML),
Castration-Resistant Prostate Cancer (CRPC), Non-Hodgkin Lymphoma
(NHL), Triple Negative Breast Cancer (TNBC) and Adrenocortical
Carcinoma (ACC).
About Castration-Resistant Prostate Cancer (CRPC)
Castration-Resistant Prostate Cancer (CRPC) is defined by
disease progression despite androgen-deprivation therapy (ADT) and
may present as one or any combination of a continuous rise in serum
levels of prostate-specific antigen (PSA), progression of
pre-existing disease, or appearance of new metastases. Prognosis is
associated with several factors, including performance status,
presence of bone pain, extent of disease on bone scan, and serum
levels of alkaline phosphatase. Bone metastases will occur in 90%
of men with CPRC and can produce significant morbidity, including
pain, pathologic fractures, spinal cord compression, and bone
marrow failure. Paraneoplastic effects are also common, including
anemia, weight loss, fatigue, hypercoagulability, and increased
susceptibility to infection. Institution of treatment and the
choice of systemic or local therapy depend on a number of
factors.
About Trovagene, Inc.
Trovagene is a precision medicine biotechnology company
developing oncology therapeutics for improved cancer care by
leveraging its proprietary Precision Cancer Monitoring®
(PCM) technology in tumor genomics. Trovagene has broad
intellectual property and proprietary technology to measure
circulating tumor DNA (ctDNA) in urine and blood to identify and
quantify clinically actionable markers for predicting response to
cancer therapies. Trovagene offers its PCM technology at its
CLIA/CAP – accredited laboratory and plans to continue to
vertically integrate its PCM technology with precision cancer
therapeutics. For more information, please visit
https://www.trovagene.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking
within the meaning of the Private Securities Litigation Reform Act
of 1995. These statements may be identified by the use of words
such as "anticipate," "believe," "forecast," "estimated" and
"intend" or other similar terms or expressions that concern
Trovagene's expectations, strategy, plans or intentions. These
forward-looking statements are based on Trovagene's current
expectations and actual results could differ materially.
There are a number of factors that could cause actual events
to differ materially from those indicated by such forward-looking
statements. These factors include, but are not limited to,
our need for additional financing; our ability to continue as a
going concern; clinical trials involve a lengthy and expensive
process with an uncertain outcome, and results of earlier studies
and trials may not be predictive of future trial results; our
clinical trials may be suspended or discontinued due to unexpected
side effects or other safety risks that could preclude approval of
our product candidates; uncertainties of government or third party
payer reimbursement; dependence on key personnel; limited
experience in marketing and sales; substantial competition;
uncertainties of patent protection and litigation; dependence upon
third parties; our ability to develop tests, kits and systems and
the success of those products; regulatory, financial and business
risks related to our international expansion and risks related to
failure to obtain FDA clearances or approvals and noncompliance
with FDA regulations. There are no guarantees that any of our
technology or products will be utilized or prove to be commercially
successful, or that Trovagene's strategy to design its liquid
biopsy tests to report on clinically actionable cancer genes will
ultimately be successful or result in better reimbursement
outcomes. Additionally, there are no guarantees that future
clinical trials will be completed or successful or that any
precision medicine therapeutics will receive regulatory approval
for any indication or prove to be commercially successful.
Investors should read the risk factors set forth in Trovagene's
Form 10-K for the year ended December 31, 2016, and other
periodic reports filed with the Securities and Exchange
Commission. While the list of factors presented here is
considered representative, no such list should be considered to be
a complete statement of all potential risks and uncertainties.
Unlisted factors may present significant additional obstacles
to the realization of forward-looking statements.
Forward-looking statements included herein are made as of the
date hereof, and Trovagene does not undertake any obligation to
update publicly such statements to reflect subsequent events or
circumstances.
Trovagene Contact:
Vicki
Kelemen
VP, Corporate Communications
858-952-7652
vkelemen@trovagene.com
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SOURCE Trovagene, Inc.