SAN DIEGO, Feb. 6, 2018 /PRNewswire/ -- Trovagene, Inc.
(NASDAQ: TROV), a precision medicine biotechnology company,
today announced that the first patient has completed the first
cycle of dosing with PCM-075 in combination with low-dose
cytarabine in its Phase 1b/2
multicenter trial of patients with Acute Myeloid Leukemia (AML).
Two clinical trial sites are currently screening and enrolling
patients and five additional sites are planned to be activated by
the end of the first quarter. PCM-075 is the first oral
PLK1-selective adenosine triphosphate competitive inhibitor to
enter clinical trials with proven antitumor activity in hematologic
and solid tumor preclinical models.
"This is an important milestone for Trovagene and for AML
patients," said Bill Welch, Chief
Executive Officer of Trovagene. "There has been little improvement
in the treatment of AML for the past several decades, and survival
rates for these patients lag behind many other blood cancers.
Treatment with PCM-075 represents a promising therapeutic option
for AML patients who are ineligible for intensive induction
therapy, or who have relapsed or refractory disease. Our goal is to
rapidly advance our development of PCM-075 in combination with
standard-of-care chemotherapy for these patients."
"We are excited to be leading off the clinical evaluation of
PCM-075, a potential new treatment option for patients with Acute
Myeloid Leukemia," said Alex Spira,
M.D., Principal Investigator, Virginia Cancer Specialists, in
Fairfax, Virginia. "Our initial
patient enrolled in the Phase 1b/2
trial completed his first cycle of treatment with PCM-075 in
combination with low-dose cytarabine, and we are pleased with how
well this patient tolerated the combination regimen."
The Phase 1b/2 trial is a
multi-center, open-label trial exploring the safety and efficacy of
PCM-075 in combination with standard-of-care chemotherapy in AML
patients who are ineligible for intensive induction therapy or
whose disease is relapsed or refractory. This trial 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.
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.
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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