SAN DIEGO, July 25, 2017 /PRNewswire/ -- Trovagene, Inc.
(NASDAQ: TROV), a precision medicine biotechnology company,
today announced the publication of clinical results from a Phase 1
dose escalation study of PCM-075 (formerly NMS-1286937) in patients
with advanced or metastatic solid tumors in the peer-reviewed
journal Investigational New Drugs. PCM-075 is an
investigational, orally available, highly-selective PLK1
inhibitor.
The publication, entitled "Phase 1 Dose-Escalation Study of
NMS-1286937, an Orally Available Polo-Like Kinase 1 Inhibitor, in
Patients with Advanced or Metastatic Solid Tumors," presents
results from a Phase 1, open-label, dose escalation trial performed
by Nerviano Medical Sciences in patients with solid tumors,
including colorectal (n=4), pancreatic (n=4), lung (n=2), sarcomas
(n=2) and single patients representing hepatocellular, ampullary,
prostate, ovarian and skin cancers.
PCM-075 was administered orally, once daily for five consecutive
days, every three weeks, to evaluate drug metabolism, 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 average age of
patients enrolled was 63 years and nearly eighty percent had
received between 3 to 7 previous anti-cancer therapies prior to
study enrollment.
This first-in-human phase 1 study established safety of PCM-075
and successfully identified a recommended Phase 2 dose (RP2D) of 24
mg/m2/day for treating solid tumors. Of the 21 patients
enrolled, 19 received a total of 44 cycles of treatment with a
median number of cycles per patient of 2 (range 1-6). Sixteen of
the 19 patients (84.2%) enrolled in the study were evaluable for
efficacy, with stable disease observed in 5 of the 16 (31.2%)
patients, including patients with colorectal (2), pancreatic (1),
head and neck (1), and basal cell carcinoma (1).
The study identified thrombocytopenia and neutropenia as the
primary on-target toxicities, which is consistent with the expected
mechanism of action of PCM-075 and results from preclinical
studies. These hematologic toxicities were reversible, with
recovery occurring within 3 weeks. One patient experienced grade 3
constipation adverse event, which authors conclude likely was due
to concomitant treatment with opiates. No other clinically relevant
safety findings emerged.
"The data from this first-in-human trial demonstrated that
PCM-075 is generally safe and well-tolerated in patients with
advanced cancers," said Dr. Glen
Weiss, principal investigator and first author. "Data from
preclinical work, coupled with the results of the Phase 1 trial,
suggest that PCM-075 could become a new therapeutic option for the
treatment of solid tumors and hematological malignancies, including
acute myeloid leukemia."
"We are pleased to see the publication of the Phase 1 data in
Investigational New Drugs," said Bill Welch, Chief Executive Officer of
Trovagene. "This peer-reviewed publication shows the potential for
PCM-075, including patients with hematological malignancies as a
possible target population for PLK1 inhibition. The safety data are
supportive of our planned Phase 1b/2 clinical trial in patients
with acute myeloid leukemia and we look forward to reporting our
clinical development progress with PCM-075."
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 several different
hematologic malignancies, as well as solid tumors such as 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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