SAN DIEGO, April 16, 2018 /PRNewswire/ -- Trovagene,
Inc. (NASDAQ: TROV), a clinical-stage oncology therapeutics
company, developing targeted therapeutics for the treatment of
hematologic and solid tumor cancers, today announced the
presentation of data showing that PCM-075 exhibits synergistic
activity when combined with FLT3 inhibitors in a human xenograft
acute myeloid leukemia (AML) model, at the American Association for
Cancer Research (AACR) Annual Meeting in Chicago, IL.
The poster entitled Selective Polo-like Kinase 1 (PLK1)
Inhibitor PCM-075 is Highly Active Alone and Shows Synergy When
Combined with FLT3 Inhibitors in Models of Acute Myeloid Leukemia
(AML) presents data demonstrating that PCM-075 in combination
with quizartinib (Daiichi-Sankyo) resulted in 97.3% tumor growth
inhibition (TGI), compared to 77.9% with quizartinib and 80.2% with
PCM-075 as monotherapy.
Additionally, in other in vitro data presented, PCM-075 was
found to have synergistic effects when combined with therapies used
routinely in many hematologic and solid tumor cancers, including
paclitaxel, sorafenib, doxorubicin and cytarabine.
"We are encouraged by the synergy we are seeing when PCM-075 is
combined with targeted and standard-of-care chemotherapies in
preclinical studies," said Mark
Erlander, PhD, Chief Scientific Officer of Trovagene. "The
specificity of PCM-075 to PLK1 may complement the mechanism of
action of other oncology therapeutics when used in combination
which could improve and extend the duration of response."
About Trovagene, Inc.
Trovagene is a clinical-stage, oncology therapeutics company.
The Company's primary focus is to develop targeted cancer
therapeutics for improved patient care and to optimize drug
development by leveraging its proprietary technology in tumor
genomics. Trovagene has broad intellectual property and proprietary
technology to analyze circulating tumor DNA (ctDNA) and clinically
actionable biomarkers to identify patients most likely to respond
to specific cancer therapies. The Company plans to continue to
vertically integrate its tumor genomics technology with targeted
cancer therapeutics. For more information, please visit
https://www.trovagene.com.
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 has an ongoing 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
PLK1 inhibitor, PCM-075, with other compounds has the potential for
improved clinical efficacy in Acute Myeloid Leukemia (AML),
metastatic Castration-Resistant Prostate Cancer (mCRPC),
Non-Hodgkin Lymphoma (NHL), Triple Negative Breast Cancer (TNBC)
and Adrenocortical Carcinoma (ACC).
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, 2017, 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.