SAN DIEGO, May 25, 2017 /PRNewswire/ -- Trovagene, Inc.
(NASDAQ: TROV), a precision medicine biotechnology company,
today announced summary data from a phase 1 safety study conducted
by Nerviano Medical Sciences with PCM-075, a polo-like kinase 1
(PLK1) inhibitor. This data is supportive of a planned phase
1/2 clinical trial in patients with acute myeloid leukemia (AML)
and is now being submitted for peer review publication by study
investigators.
The phase 1 safety study was an open-label, dose-escalation
trial in patients with advanced or metastatic solid tumors.
PCM-075 was administered orally, once daily for five consecutive
days, every day for three weeks, to evaluate drug metabolism and
first cycle dose-limiting toxicities (DLTs) and related maximum
tolerated dose (MTD). The study also evaluated PCM-075's
pharmacokinetic profile in plasma, its anti-tumor activity, and its
ability to modulate intracellular targets in biopsied tissue.
The phase 1 study enrolled 21 patients with confirmed metastatic
disease and a mean age of 62.7 years. These patients received
study medication at doses up to 48 mg/m2/day. The most common
cancer types for enrolled patients included colon, pancreatic,
lung, and head and neck cancer.
Thrombocytopenia and neutropenia were identified as the primary
DLTs, which are consistent with the expected mechanism of action
and results from preclinical studies. These hematologic
toxicities were reversible. One patient experienced grade 3
constipation, which may have been due to concomitant treatment with
opiates. No other clinically relevant safety findings
emerged.
"Hematologic side effects are expected with PLK inhibitors,
which induce mitotic cell cycle arrest preferentially in rapidly
proliferating blood cells, leading to cell death. This
suggests anti-tumor activity in hematologic malignancies and
supports our plans to develop PCM-075 for the treatment of AML,"
said Dr. Mark Erlander, Chief
Scientific Officer of Trovagene. "We believe the phase 1 data
indicates broad applications for PCM-075 in hematologic
malignancies and solid tumors and we plan to continue to assess,
and explore, additional precision cancer therapeutic opportunities
going forward."
The complete phase 1 data, study details and conclusions are
part of the manuscript that will be submitted by study
investigators for peer review publication.
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 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
Sr. Director, Corporate Communications
858-952-7652
vkelemen@trovagene.com
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SOURCE Trovagene, Inc.