SAN DIEGO, Nov. 13, 2017 /PRNewswire/ -- Trovagene, Inc.
(NASDAQ: TROV), a precision medicine biotechnology company,
today announced the activation of its clinical trial site for its
Phase 1b/2 multicenter trial of PCM-075 in patients with AML, with
Virginia Cancer Specialists and Principal Investigator, Dr.
Alexander Spira. This trial will
enroll subjects in the Phase 1b who have relapsed or have resistant
disease to no more than three prior regimens. The Phase 1b is a
dose escalation study to determine a recommend phase 2 dose.
The Phase 2 continuation study will provide preliminary evaluation
of anti-leukemic activity and will enroll newly diagnosed subjects,
judged to be ineligible for, or who have refused, standard
intensive induction therapy, as well as subjects who have relapsed
after treatment with no more than one prior regimen.
"PCM-075 is the first highly PLK1-selective competitive
inhibitor administered orally to enter clinical trials with
potential activity in both hematologic and solid tumor cancers,"
said Bill Welch, Chief Executive
Officer of Trovagene. "We are excited to have Virginia Cancer
Specialists as our first clinical trial site ready to screen and
enroll subjects in our PCM-075 AML trial."
The Phase 1b/2 clinical trial in AML is being led by
Hematologist Jorge Eduardo Cortes, M.D., Deputy Department Chair,
Department of Leukemia, Division of Cancer Medicine, The
University of Texas MD Anderson Cancer
Center.
"As the only dedicated Phase 1 oncology research facility in
Northern Virginia, we are pleased
to be a part of this important clinical trial and to investigate
this promising alternative therapy in AML patients," said Dr.
Alexander Spira, Co-Director
Clinical Research, Director Phase 1 Program, Virginia Cancer
Specialists. "Through this Phase 1b/2 clinical trial, we look
forward to gaining insight into the safety, tolerability and
initial efficacy of 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 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 is initiating 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 Virginia Cancer Specialists
Together: A Better Way to Fight Cancer. For over 40 years,
Virginia Cancer Specialists has been dedicated to the fight against
cancer and diseases of the blood. Our highly skilled
physicians offer a consultative approach to care, by using the most
up-to-date therapies and treatment options available, in a
convenient, community-based setting. Our integrated treatment
approach provides access to expanded services, including medical
oncology and hematology, radiation therapy, breast surgery,
orthopedic oncology and surgery, genetic counseling, palliative
medicine and the only dedicated oncology research facility in
Northern Virginia to include Phase
1 clinical trials. Our physicians treat all cancer types, with
subspecialists in areas such as Breast, GI, Lung, Genitourinary,
Sarcoma, and Hematologic Malignancies, to name a few.
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.