Trovagene collaborates with USC in clinical study evaluating cancer monitoring
Study to investigate Trovagene's non-invasive cancer monitoring technology
using cell-free DNA from urine samples
SAN DIEGO, Sept. 6, 2013
SAN DIEGO, Sept. 6, 2013 /PRNewswire/ --Trovagene, Inc. (NASDAQ:TROV), a
developer of molecular diagnostics for cancer monitoring, today announced that
the Company has entered into a clinical collaboration agreement with the
University of Southern California to study genomic characterizations of
metastatic colorectal cancers using Trovagene's proprietary cell-free DNA
assays. The study is designed to demonstrate that cell-free DNA obtained from
urine is a viable systemic sample for colorectal cancer disease monitoring,
which includes measuring therapy response, identifying cancer genomic changes
and monitoring disease progression.
"The current gold standard for monitoring response to treatment in metastatic
colorectal cancer patients is radiographic assessment, typically by CT–scan.
Although robust, it lacks the ability to assess the dynamic changes in the
tumor tissue undergoing treatment. Thus development of chemo-resistance may be
un-detected for months before progression is seen on CT-scans. Trovagene
technology has the potential to assess the effectiveness of chemotherapy in
real time. Our study evaluates the role of using molecular testing of the
tumor DNA in urine as a tool for monitoring the disease and detecting
development of resistant clones of the tumor on chemotherapy. The information
may be critical to change the treatment strategy early before progression is
documented on CT-scans, resulting in more effective outcomes for our
patients," said Dr. Heinz-Josef Lenz, Associate Director of Clinical Research
at the USC Norris Comprehensive Cancer Center.
"We are delighted to be collaborating with one of the recognized leaders in
the molecular analysis and treatment of colorectal cancer," stated Mark
Erlander, CSO of Trovagene. "Our technology offers the possibility for
clinicians to obtain more frequent clinically actionable information to drive
treatment decisions, with the goal of complementing more invasive, difficult
and expensive tests that require blood, tissue biopsy or CT-scans."
Using cell-free DNA obtained from urine of patients with colorectal cancer
undergoing therapy, the primary objectives of the study are to assess
correlation of mutation frequencies in BRAF, KRAS and PIK3CA oncogenes with
tumor load, to monitor disease progression and to assess genomic changes as a
patient undergoes therapy.
Colorectal cancers are considered to be among the most challenging cancers to
treat. There are approximately 140,000 newly diagnosed colorectal cancer
patients annually in the US. Mutations of KRAS, BRAF or PIK3CA oncogenes are
present in over 50% of colorectal cancers and frequently occur during the
course of therapy, thereby effecting response to treatment and/or prognosis.
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
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.
Chief Financial Officer
SOURCE Trovagene, Inc.
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