SAN DIEGO, Feb. 9, 2018 /PRNewswire/ -- Trovagene, Inc.
(NASDAQ: TROV), a precision medicine biotechnology company,
developing targeted cancer therapeutics, today announced that
preclinical data demonstrating the synergy of PCM-075, its
highly-selective Polo-like kinase 1 (PLK1) Inhibitor, in
combination with abiraterone acetate (Zytiga® – Johnson &
Johnson), will be featured as a Poster Presentation at the 2018
Genitourinary Cancers Symposium on February 9th, from 12:15 –
1:45 PM and 6:00 – 7:00 PM PST, in San
Francisco, California.
The poster entitled, Combination of Selective Polo-like
Kinase 1 (PLK1) Inhibitor PCM-075 with Abiraterone in
Prostate Cancer and Non-Androgen-Driven Cancer Models,
showcases data from Dr. Michael
Yaffe's lab at the Koch Institute for Integrative Cancer
Research at Massachusetts Institute of
Technology and will be presented by Dr. Jesse Patterson.
The underlying mechanism of synergy was further examined by
performing gene-expression comparison across more than 30 different
synergistic and non-synergistic cell lines across multiple tumor
types. From this analysis, multiple hypothesis-generating
mechanisms were identified, one of which was the retinoic acid
pathway, which when activated is predictive of synergy.
Polo-like Kinase 1 (PLK1) is known to be over-expressed in many
hematologic and solid tumor cancers, including Castration-Resistant
Prostate Cancer. PLK1 inhibition by PCM-075 induces cell-cycle
arrest and apoptosis, or tumor cell death in numerous tumor cell
lines, including prostate cancer cell lines. The presentation data
indicates that PCM-075 in combination with anti-androgen,
abiraterone acetate (Zytiga® - Johnson & Johnson), is
synergistic in inducing cell death within prostate cancer cell
lines.
"We are seeing significant synergy when PCM-075 is combined with
chemotherapeutics and targeted therapies in xenograft models and
believe that combination regimens that include PCM-075 may lead to
improving patient outcomes in CRPC," said Mark Erlander, Chief Scientific Officer of
Trovagene.
To further evaluate the potential of the combination of PCM-075
and Zytiga to improve treatment and extend patient response to
Zytiga, Trovagene is initiating a Phase 2 clinical trial in
patients with metastatic Castration-Resistant Prostate Cancer
(mCRPC). This clinical study is called UNITE, "A Phase 2 Study
to Understand the Novel Combination of PCM-075 and Abiraterone and
the Opportunity to Improve Treatment and Extend Response in
Patients with Metastatic Castration-Resistant Prostate Cancer."
The Harvard Medical Cancer Centers will conduct this Phase 2 study
that is expected to enroll approximately 25 patients with mCRPC who
are showing early signs of disease progression while on
abiraterone/prednisone therapy and will evaluate the proportion of
patients achieving disease control after 12 weeks of study
treatment. This study was accepted by the National Library of
Medicine (NLM) and is now publicly viewable on
www.clnincaltrials.gov. The NCT number assigned to this trial by
clinicaltrials.gov is NCT03414034.
Details of the poster presentation are provided
below:
Title: Combination of Selective Polo-like
Kinase 1 (PLK1) Inhibitor PCM-075 with Abiraterone in Prostate
Cancer and Non-Androgen-Driven Cancer Models
Session Name: Prostate Cancer, Urothelial
Carcinoma, and Penile, Urethral, and Testicular Cancers
Location: Poster Session B
Date and Time: Friday,
February 9th – 12:15 – 1:45 pm and 6:00 – 7:00 pm
PST
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 2 trial of PCM-075 in
combination with Zytiga® (abiraterone acetate) and
prednisone in metastatic Castration-Resistant Prostate Cancer that
was accepted by the National Library of Medicine (NLM) and is now
publicly viewable on www.clnincaltrials.gov. The NCT number
assigned by clinicaltrials.gov for this study is NCT03414034.
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 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
View original content with
multimedia:http://www.prnewswire.com/news-releases/trovagene-presents-data-showing-synergy-of-pcm-075-in-combination-with-zytiga-in-castration-resistant-prostate-cancer-model-at-2018-genitourinary-cancers-symposium-300595172.html
SOURCE Trovagene, Inc.