SAN DIEGO, CALIF. and THE WOODLANDS,
TEXAS – January 6, 2014 – Trovagene, Inc. (NASDAQ: TROV), a developer of cell-free
molecular diagnostics, and US Oncology Research, one of the largest
community-based research programs in the United States, announced today that they have entered into a
Clinical Study Agreement to examine the utility of quantitative
urine-based KRAS mutation detection and monitoring in pancreatic cancer
patients. US Oncology Research draws from a
network of experienced investigators and clinical staff who specialize in Phase
I through Phase IV oncology clinical trials. In addition to the 11 US Oncology
Research affiliated community cancer care sites participating in this study, academic
research institutions that specialize in oncology have also elected to participate.
Metastatic
pancreatic cancer is frequently associated with KRAS gene mutations.
The primary
purpose of the collaborative study is to determine whether KRAS mutations can
be evaluated in urine to monitor treatment response in patients that test
either positive or negative for the tumor marker CA19-9. CT scans and CA19-9
blood levels are currently the only two methods available to clinicians to
monitor metastatic pancreatic cancer tumor burden and response to therapy.
However, approximately 11%-17% of patients will not display elevated CA 19-9,
even with high tumor load. For patients that test negative for CA19-9, Trovagene’s
method to follow disease status could be distinctly beneficial. Patient enrollment
is expected to begin in the first quarter of 2014, and up to 45 patients are
expected to participate in the collaborative study.
“We desperately need new ways to follow our
patients with pancreatic cancer, particularly those without any other markers,”
stated Dr. Daniel Von Hoff, Medical Director of Research and Scientific Medical
Officer, McKesson Specialty Health and The US Oncology Network. “It is important
for our US Oncology Research team to be testing this new approach.”
The prospective
study supports Trovagene’s core objective to demonstrate the clinical value of its
proprietary cell-free DNA platform for the detection and monitoring of oncogene
mutations in urine. In addition to other clinical studies evaluating
Trovagene’s novel molecular diagnostics, the US Oncology Research collaboration
is the first
multi-site study sponsored by Trovagene.
“We are pleased to be collaborating with US
Oncology Research and its network of community cancer care sites. The study is designed
to provide comprehensive qualitative and quantitative clinical results for our multiplexed
KRAS NGS assay, and is an important part of our strategic objective to
integrate the use of our proprietary technology in clinical practice,” stated
Antonius Schuh, Ph.D., President and CEO of Trovagene. “We believe that near real-time
detection and monitoring of KRAS mutations in metastatic cancer patients have potential to improve patient outcomes and impact the standard
of care for cancer monitoring.”
About Pancreatic
Cancer
Pancreatic cancer is considered to be one
of the most deadly cancers due to its aggressive nature and advanced stage at
diagnosis. The American Cancer Society estimates that in 2013, 44,220 people in
the United States will be diagnosed with pancreatic cancer and about 38,460
will die from the disease. An estimated 80 percent of pancreatic cancer
patients have unresectable or metastatic disease, and upwards to 95 percent of
pancreatic cancers are thought to have KRAS mutations. Based on these
statistics, the need for an accurate, cost-effective test to quantify and
monitor KRAS mutational status is high.
About US Oncology Research
Supported by McKesson Specialty Health and The US Oncology Network, US
Oncology Research draws from a network of experienced investigators and
dedicated clinical staff who specialize in Phase I through Phase IV oncology
clinical trials. US Oncology Research serves more than 80 research sites and
225 locations managing about 225 active trials at any given time. Physicians in
the research network have enrolled more than 56,000 patients in nearly 1,300
trials since inception in 1992 and have played a role in 47 FDA-approved cancer
therapies. For more information call (800) 482-6700 or visit www.usoncology.com/oncologists.
About
Trovagene, Inc.
Headquartered in San Diego, California,
Trovagene is leveraging its patented technology for the detection of cell-free
DNA and RNA, short nucleic acid fragments, originating from normal and diseased
cell death that can be isolated and detected from urine. Trovagene has a strong
intellectual property asset as it relates to cell-free DNA and RNA testing in
urine. It has U.S. and European patent applications and issued patents that
cover testing for HPV and other infectious diseases, cancer, transplantation,
prenatal and genetic testing.
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
forward-looking words such as "anticipate," "believe,"
"forecast," "estimated" and "intend," among
others. 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,
substantial competition; our ability to continue as a going concern; our need
for additional financing; uncertainties of patent protection and litigation;
uncertainties of government or fourth party payer reimbursement; limited sales
and marketing efforts and dependence upon fourth parties; and risks related to
failure to obtain FDA clearances or approvals and noncompliance with FDA
regulations. As with any medical diagnostic tests under development, there are
significant risks in the development, regulatory approval and commercialization
of new products. There are no guarantees that future clinical trials discussed
in this press release will be completed or successful or that any product will
receive regulatory approval for any indication or prove to be commercially successful.
Trovagene does not undertake an obligation to update or revise any
forward-looking statement. Investors should read the risk factors set
forth in Trovagene's Form 10-K for the year ended December 31, 2012 and other
periodic reports filed with the Securities and Exchange Commission.
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