SAN DIEGO, Oct. 24, 2018 /PRNewswire/ -- Trovagene,
Inc. (NASDAQ: TROV), a clinical-stage oncology therapeutics
company, taking a precision medicine approach to develop drugs that
target cell division (mitosis) for the treatment of leukemias,
lymphomas and solid tumor cancers, today announced that the U.S.
Patent and Trademark Office (USPTO) has allowed claims that affirms
broad coverage of NPM1 mutation testing; Patent Application
14/750331, entitled "Nucleophosmin Protein (NPM) Mutants,
Corresponding Gene Sequences and Uses Thereof." This patent
encompasses broad claims around the assessment of NPM1 mutational
status in any cancer type, including acute myeloid leukemia
(AML).
"We are pleased with the recent claim allowances by the USPTO,
because this is not only aligned with our current biomarker play
and clinical development of Onvansertib in AML, but also
strengthens the revenue generating potential for Trovagene," said
Thomas Adams, PhD, Executive
Chairman of Trovagene. "Importantly, NPM1 testing is within the
National Comprehensive Cancer Network (NCCN) guidelines to aid in
treatment decisions and there is growing use of testing to monitor
minimal residual disease (MRD) in AML."
About Onvansertib
Onvansertib is a first-in-class, 3rd generation, oral
and highly-selective adenosine triphosphate (ATP) competitive
inhibitor of the serine/threonine polo-like-kinase 1 (PLK 1)
enzyme, which is over-expressed in multiple cancers, including
leukemias, lymphomas and solid tumors. Separate studies with other
PLK inhibitors 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 of up to 31% were
observed when combined 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 Onvansertib has been completed in patients with advanced
metastatic solid tumor cancers and published in Investigational
New Drugs. The maximum tolerated dose (MTD) or recommended
Phase 2 dose (RP2D) in this trial was 24 mg/m2.
Trovagene has an ongoing Phase 1b/2
clinical trial with Onvansertib 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. Onvansertib has
been granted Orphan Drug Designation by the FDA in the U.S. and by
the EC in the European Union (EU) for the treatment of patients
with AML.
Onvansertib targets the PLK1 isoform, only (not PLK2 or PLK3),
is orally administered, has a 24-hour drug half-life with only mild
to moderate side effects reported. Trovagene believes that
targeting only PLK1 and having a favorable safety and tolerability
profile, along with an improved dose/scheduling regimen will
significantly improve on the outcome observed in previous studies
with a former panPLK inhibitor in AML.
Onvansertib has demonstrated synergy in preclinical studies with
numerous chemotherapies and targeted therapeutics used to treat
leukemias, lymphomas and solid tumor cancers, including FLT3 and
HDAC inhibitors, taxanes, and cytotoxins. Trovagene believes the
combination of its targeted PLK1 inhibitor, Onvansertib, with other
compounds has the potential to improve clinical efficacy in Acute
Myeloid Leukemia (AML), metastatic Castration-Resistant Prostate
Cancer (mCRPC), Non-Hodgkin Lymphoma (NHL), Triple Negative Breast
Cancer (TNBC), as well as other types of cancer.
About Trovagene, Inc.
Trovagene is a clinical-stage, oncology therapeutics company,
taking a precision medicine approach to develop drugs that target
mitosis (cell division) to treat various types of cancer, including
leukemias, lymphomas and solid tumors. Trovagene has intellectual
property and proprietary technology that enables the Company to
analyze circulating tumor DNA (ctDNA) and clinically actionable
markers to identify patients most likely to respond to specific
cancer therapies. Trovagene plans to continue to vertically
integrate its tumor genomics technology with the development of
targeted 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. 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, 2017,
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.