SAN DIEGO, Jan. 24, 2018 /PRNewswire/ -- Trovagene, Inc.
(NASDAQ: TROV), a clinical-stage precision medicine
biotechnology company, engaged in the development of targeted
cancer therapies, today announced the initiation of its Phase 2
clinical trial, evaluating the combination of PCM-075 and
abiraterone acetate (Zytiga® - Johnson & Johnson), in patients
with metastatic Castration-Resistant Prostate Cancer (mCRPC). This
clinical trial 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 study will enroll 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.
"Initiation of the UNITE trial in mCRPC marks an important
milestone in the clinical development of PCM-075 and builds upon
the promising data from our completed and published Phase 1 trial
in metastatic solid tumor cancers, as well as preclinical data
demonstrating significant synergy for the combination of PCM-075
and abiraterone in CRPC tumor cells," said Bill Welch, Chief Executive Officer of
Trovagene. "We are excited to be working with leading prostate
cancer specialists and the Harvard Medical Institutions to conduct
this trial and believe that the highly synergistic combination of
PCM-075 and Zytiga® has the potential to address the medical need
to extend the benefit of response to treatment in patients with
mCRPC."
Trovagene filed its Phase 2 metastatic Castration-Resistant
Prostate Cancer protocol to the FDA and its active solid tumor IND
in December, 2017. The Company successfully passed the 30-day
FDA review period and has selected PRA Health Sciences as the
Clinical Research Organization (CRO) to facilitate the trial.
About the Phase 2 mCRPC Clinical Study
In the UNITE multi-center, open-label, Phase 2 trial, the
combination of PCM-075 with the standard dose of abiraterone and
prednisone, all administered orally, will be evaluated to determine
the proportion of patients achieving disease control after 12 weeks
of study treatment. Disease control is defined by the lack of
Prostate Specific Antigen (PSA) progression in patients who are
showing signs of early progressive disease (rise in PSA, but
minimally symptomatic or asymptomatic) while currently receiving
androgen deprivation therapy (ADT) plus abiraterone and
prednisone.
The Phase 2 UNITE trial will enroll 25 patients with metastatic
Castration-Resistant Prostate Cancer showing signs of disease
progression demonstrated by two rising PSA values separated by at
least one week, while on abiraterone/prednisone therapy. The
follow-up of patients will occur approximately every six weeks
until disease progression in patients with stable disease, or
better at the end of treatment assessments.
The Phase 2 trial also includes the following secondary
observation endpoints:
- The effects of PCM-075 in combination with abiraterone and
prednisone on time to PSA progression in subjects with mCRPC;
- The effects of PCM-075 in combination with abiraterone and
prednisone on time to radiographic progression, based on the
Prostate Cancer Working Group 3 (PCWG3) guidelines; and
- The effects of PCM-075 in combination with abiraterone and
prednisone on radiographic response (per Response Evaluation
Criteria in Solid Tumors [RECIST] 1.1 criteria) in subjects with
mCRPC and measurable disease.
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.
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 Zytiga (abiraterone), 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
Castration-Resistant Prostate Cancer (CRPC), Acute Myeloid Leukemia
(AML), Non-Hodgkin Lymphoma (NHL), Triple Negative Breast Cancer
(TNBC) and Adrenocortical Carcinoma (ACC).
About Castration-Resistant Prostate Cancer (CRPC)
Castration-Resistant Prostate Cancer (CRPC) is defined by
disease progression despite androgen-deprivation therapy (ADT) and
may present as one or any combination of a continuous rise in serum
levels of prostate-specific antigen (PSA), progression of
pre-existing disease, or appearance of new metastases. Prognosis is
associated with several factors, including performance status,
presence of bone pain, extent of disease on bone scan, and serum
levels of alkaline phosphatase. Bone metastases occur in 90% of men
with CPRC and can produce significant morbidity, including pain,
pathologic fractures, spinal cord compression, and bone marrow
failure. Paraneoplastic effects are also common, including anemia,
weight loss, fatigue, hypercoagulability, and increased
susceptibility to infection. Institution of treatment and the
choice of systemic or local therapy depend on a number of
factors.
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 potentially 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-announces-initiation-of-unite-phase-2-clinical-trial-of-pcm-075-in-patients-with-metastatic-castration-resistant-prostate-cancer-mcrpc-300587179.html
SOURCE Trovagene, Inc.