SAN DIEGO, Aug. 16, 2017 /PRNewswire/ -- Trovagene,
Inc. (NASDAQ: TROV), a precision medicine biotechnology
company, today announced positive data from a preclinical in-vivo
study examining the combination of their PLK1 inhibitor, PCM-075,
with a leading investigational FLT3 Inhibitor. This FLT3
mutant xenograft model shows PCM-075 in combination with
Quizartinib resulted in 96% tumor growth inhibition versus
monotherapy with Quizartinib (81%) or PCM-075 (76%). This
research data is planned for future publication.
"Thirty percent of patients with AML harbor a FLT3 mutation.
This represents an opportunity for combination therapy with
PCM-075," said Bill Welch, CEO of
Trovagene. "We are encouraged by this initial preclinical data as
we continue to identify potential combination therapies using
PCM-075 within diverse AML patient populations."
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
malignancies, as well as solid tumors such as adrenocortical,
breast, prostate, ovarian, lung, gastric and colon cancers. PCM-075
is orally bioavailable and has been explored in an initial Phase 1,
open-label, dose-escalation safety study in patients with advanced
metastatic solid tumor cancers. Trovagene plans to initiate
clinical trials of PCM-075 in AML, since it has significant
advantages over prior PLK1 inhibitors evaluated in this indication,
including a higher selectivity, greater potency, oral
bioavailability and shorter half-life.
About Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is a hematologic malignancy in
which myeloid lineage cells of the bone marrow cease to
differentiate appropriately, resulting in a marked increase in the
number of circulating immature blast cells. As a consequence, the
counts of mature red blood cells, platelets, and normal white blood
cells decline, causing fatigue, shortness of breath, bleeding, and
increased susceptibility to infection. Patients harboring mutations
in the FLT3 receptor tyrosine kinase have a particularly poor
prognosis; however, significant progress has been made by the
emergence of a variety of targeted inhibitors capable of
suppressing FLT3 signaling. This has prompted the development of
second-generation FLT3 inhibitors, led by Quizartinib (Daiichi
Sankyo), which has demonstrated enhanced FLT3 specificity and have
been generally well tolerated in clinical trials. Molecular
insights provided by FLT3 inhibitors have shed light upon the
variety of mechanisms underlying the acquisition of resistance and
have provided a rationale supporting the use of combination
regimens with other emerging targeted therapies.
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.