SAN DIEGO, Aug. 21, 2017 /PRNewswire/ -- Trovagene,
Inc. (NASDAQ: TROV), a precision medicine biotechnology
company, today announced compelling results of preclinical research
of PCM-075 with a Histone deacetylase (HDAC) inhibitor in
Non-Hodgkin Lymphoma (NHL) cell lines. This synergy
assessment study was conducted by Dr. Steven Grant, Associate Director for
Translational Research and co-Leader, Developmental Therapeutics
Program, Massey Cancer Center.
PCM-075, Trovagene's investigational Polo-like kinase 1 (PLK1)
inhibitor, showed significant synergy in combination with a HDAC
inhibitor of up to 80% in aggressive double-hit B-cell lymphoma
(DLBCL) and mantle-cell lymphoma cell lines. DLBCL and mantle
cell lymphomas within NHL represent challenging malignancies
without a standard-of-care treatment and confer a poor prognosis
for patients.
Additionally, PCM-075 synergy has been evaluated in combination
with more than ten different chemotherapeutics, including
cisplatin, cytarabine, doxorubicin, gemcitabine and paclitaxel, and
targeted therapies, such as HDAC inhibitors, FLT3 inhibitors, and
bortezomib. These therapeutics are used clinically for treatment of
many solid and hematologic cancers, including Acute Myeloid
Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Non-Hodgkin
Lymphoma (NHL), Multiple Myeloma, Adrenocortical Carcinoma (ACC),
Triple-Negative Breast Cancer (TNBC), Small-Cell Lung Cancer
(SCLC), and Ovarian Cancer.
"We are excited to see the synergistic benefits with PCM-075 in
combination with a HDAC inhibitor in the most difficult cell lines
in NHL," said Bill Welch, CEO of
Trovagene. "This data complements our recent announcement of an
in-vivo study demonstrating synergy of PCM-075 with a leading
investigational FLT3 inhibitor, as well as PCM-075 synergy with
many chemotherapeutics. We have an active Investigational New Drug
(IND) in place with the FDA for each of solid tumors and
hematologic malignancies, which could facilitate the development of
PCM-075 across a number of cancer types."
The consistent and significant synergistic effects observed in
preclinical research on tumor cell death indicates that PCM-075
could be effective in combination therapies to address a broad
range of tumor types, as well as the emergence of drug-resistant
tumors.
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 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.