SAN DIEGO, Feb. 13, 2018 /PRNewswire/ -- Trovagene, Inc.
(NASDAQ: TROV), a precision medicine biotechnology company,
developing targeted oncology therapeutics, today announced the
addition of two leading institutions, Yale Cancer Center and
principal investigator Amer M.
Zeidan, MBBS, MHS, and Kansas
University Cancer Center and principal investigator
Tara Lin, MD, to conduct its Phase
1b/2 open-label, multicenter trial of
PCM-075 in patients with Acute Myeloid Leukemia (AML).
"We are excited to be part of this important clinical trial in
AML, an aggressive, and often difficult-to-treat cancer for which
there are limited treatment options for patients who have relapsed
or refractory disease," said Tara
Lin, MD, Associate Professor of Medicine, Kansas University Cancer Center.
The open-label, multicenter Phase 1b/2 trial is designed to evaluate the safety of
PCM-075 in combination with either low-dose cytarabine or
decitabine in patients with Acute Myeloid Leukemia (AML) and to
identify the maximum tolerated dose (MTD) in Phase 1b to administer to further evaluate the safety
and preliminary efficacy in Phase 2. The trial, which is being led
by hematologist Jorge Cortes, M.D.,
Deputy Department Chair, Department of Leukemia, Division of Cancer
Medicine, The University of Texas MD
Anderson Cancer Center, will be conducted at 10 sites throughout
the U.S. and is expected to enroll approximately 74 patients.
"We are pleased to be evaluating PCM-075 in this Phase
1b/2 trial for our AML patients,"
said Amer M. Zeidan, MBBS, MHS,
Assistant Professor of Medicine (Hematology), Yale Cancer Center.
"Through this trial, we look to gain insight into the safety,
tolerability and preliminary efficacy of PCM-075 when combined with
standard-of-care chemotherapy."
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). 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. In December, 2017, Trovagene
initiated a 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
PLK-1 inhibitor, PCM-075, with other compounds has the potential
for improved clinical efficacy in Acute Myeloid Leukemia (AML),
Castration-Resistant Prostate Cancer (CRPC), Non-Hodgkin Lymphoma
(NHL), Triple Negative Breast Cancer (TNBC) and Adrenocortical
Carcinoma (ACC).
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. The Surveillance,
Epidemiology and End Results (SEER) program estimates the annual
incidence rate of AML in the United
States (US) to be approximately 21,000 cases in 2017. Rates
of new AML cases have been rising an average of 3.1% each year over
the last 10 years. The median age of AML diagnosis is 68 years of
age, and approximately 45% of new diagnoses are among patients age
70 years or older.
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.
About Kansas University Cancer
Center
As one of the nation's top cancer programs, Kansas University Cancer Center is focused on
providing the highest quality comprehensive care. It is committed
to reducing the burden of cancer in Kansas by transforming cancer research and
clinical care. We've proven that commitment with our
population-focused research, cutting-edge clinical trials and
innovative cancer treatment. As a result of these efforts,
Kansas University Cancer Center has
been recognized as a National Cancer Institute (NCI)-designated
cancer center since 2012. It is the only such center in the
state, and one of only 69 in the United
States. Kansas University Cancer
Center is dedicated to the eradication of cancer. We continue to
offer our patients many new options for cancer treatment and
prevention.
About Yale Cancer Center
Yale Cancer Center (YCC) is one of only 49 National Cancer
Institute (NCI-designated comprehensive cancer) centers in the
nation and the only such center in southern New England.
Comprehensive cancer centers play a vital role in the advancement
of the NCI's goal of reducing morbidity and mortality from cancer
through scientific research, cancer prevention, and innovative
cancer treatment.
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.