SAN DIEGO, July 27, 2017 /PRNewswire/ -- Trovagene, Inc.
(NASDAQ: TROV), a precision medicine biotechnology company,
announced today that the U.S. Food and Drug Administration (FDA)
has accepted its Investigational New Drug (IND) Application for
PCM-075, a Polo-like Kinase 1 (PLK1) inhibitor, and has provided
authorization to proceed with the treatment of patients with AML.
Trovagene submitted its IND for a Phase 1b/2 clinical trial of
PCM-075 in patients with AML to the FDA on June 27, 2017.
The Phase 1b/2 clinical trial will be 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.
"The FDA's timely acceptance of our IND application and Phase
1b/2 protocol is an important milestone for Trovagene," said
Bill Welch, Chief Executive Officer
of Trovagene. "We have already received positive indications of
interest from numerous key investigators and clinical institutions
as we make preparations to initiate our trial in the U.S.
Also, we are fortunate to have Dr. Cortes as the Principal
Investigator on our trial given his vast experience in leukemia and
his prior work with PLK1 inhibitors."
Clinical Study Details
The Phase 1b/2 is an open-label trial to evaluate the safety and
anti-leukemic activity of PCM-075 in combination with decitabine in
subjects with AML. The Phase 1b subjects will have relapsed, or
have resistant disease to three or fewer prior therapeutic
regimens. The Phase 2 subjects will have received no more than one
prior regimen for the treatment of their AML, have either relapsed
or refractory disease, and are judged not to be candidates for
re-induction therapy. Newly diagnosed subjects will be included if
they have not received prior therapy for their disease, and are
ineligible for, or have refused, standard intensive induction
therapy.
The Phase 1b is a dose escalation trial of PCM-075 in
combination with decitabine to evaluate drug safety, tolerability,
dose and scheduling, and determine a recommended clinical treatment
dose for the Phase 2 continuation trial. The initial Phase 1b dose
level of 12 mg/m2/day will be increased by 50% increments to reach
the maximum clinical dose for AML patients. Pharmacokinetics of
PCM-075 and correlative biomarker activity will be assessed prior
to the initiation of Phase 2.
The Phase 2 continuation trial is open-label with administration
of the recommended PCM-075 clinical dose in combination with
decitabine. Doses of PCM-075 will be administered orally each day
for five consecutive days in a 28-day cycle in both Phase 1b and
Phase 2. Trovagene expects approximately 60 patients to be dosed
with PCM-075 and evaluated in the Phase 1b/2 trial. PCM-075
will be supplied as hard gelatin capsules and will be manufactured
by NerPharMa, a pharmaceutical manufacturing company and a
subsidiary of Nerviano Medical Sciences.
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 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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SOURCE Trovagene, Inc.