Trovagene to Study Transrenal BRAF Mutations in Primary and Metastatic Cancers

Trovagene to Study Transrenal BRAF Mutations in Primary and Metastatic Cancers

Study with MD Anderson will compare detection of BRAF mutations in urine to
biopsy samples, and monitor therapeutic response, outcomes

PR Newswire

SAN DIEGO, Jan. 3, 2013

SAN DIEGO, Jan. 3, 2013 /PRNewswire/ --Trovagene, Inc. (Nasdaq:TROV), a
developerof transrenal molecular diagnostics, announced that it has entered
into a clinical collaboration with The University of Texas MD Anderson Cancer
Center to detect transrenal BRAF mutations in the urine of patients with
advanced or metastatic cancers.

(Logo: http://photos.prnewswire.com/prnh/20120620/LA28014LOGO)

Researchers will use Trovagene's proprietary transrenal DNA (TrDNA) detection
technology to evaluate BRAF mutation status in urine as compared to tissue
biopsy. The study also calls for monitoring of mutation levels in the urine at
planned intervals during and after treatment to assess outcomes including:
response rate (RR); stable disease (SD); progression-free survival (PFS); and
overall survival (OS). Results from patients who receive therapy that reflects
their BRAF mutation status (e.g., BRAF inhibitors, MEK inhibitors) will be
compared to outcomes for patients who receive standard-of-care therapy
regardless of mutation status.

According to recent estimates, BRAF mutations are present in more than 20% of
all cancers, and in 40% and 43% of all thyroid and skin cancer samples,
respectively^1. Several targeted therapies for BRAF-mutated melanomas are
already on the market and in development, including BRAF inhibitors
vemurafenib (Zelboraf^®) and dabrafenib; and trametinib, a MEK inhibitor.

"One of thepotential benefits of TrDNA would be its utility as a systemic,
liquid biopsy, providing real-time information that may help guide targeted
therapy decisions, and then help clinicians more easily monitor a patient's
therapeutic response and disease state," said Filip Janku, MD, PhD, principal
investigator for the study at MD Anderson. "A urine-based assay that reliably
and cost-effectively detects mutations would be extremely useful as an aid in
personalized medicine."

"This study represents a first-of-its kind look at how urine-based mutation
detection can be used to track patients from initial diagnosis through
therapy, and then to monitor for early signs of progression," said Dr. Charlie
Rodi, chief technology officer at Trovagene. "We are pleased to sponsor this
study with MD Anderson, and look forward to learning more about the unique
properties and clinical utilities of our transrenal mutation assays."

1. Prevalence of BRAF mutations in various cancers. Sanger COSMIC site.
http://cancer.sanger.ac.uk/cosmic/gene/overview?ln=BRAF

About Trovagene, Inc.

Headquartered in San Diego, California, Trovagene is developing its patented
technology for the detection of transrenal DNA and RNA, short nucleic acid
fragments, originating from normal and diseased cell death that cross the
kidney barrier and can be detected in urine. Trovagene is leveraging its
intellectual property in oncogene mutations via out-licensing and use of its
transrenal technologies to extend oncogene mutation detection using urine as a
sample. As a non-invasive and abundant sample, urine may overcome many of the
cost and collection challenges associated with biopsy, as well as the volume
limitations of blood.

Trovagene has a strong patent position as it relates to transrenal molecular
testing. 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. In addition, it owns worldwide rights to
nucleophosmin-1 (NPM1), an informative biomarker for acute myelogenous
leukemia (AML) and mutations in the SF3B1 gene, which have been shown to be
associated with chemotherapy response in chronic lymphocytic leukemia (CLL)
patients, as well as other hematologic malignancies.

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 third party payer reimbursement; limited sales
and marketing efforts and dependence upon third 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, 2011 and other periodic reports filed with the
Securities and Exchange Commission.

Contacts

Trovagene, Inc.
Keith McCormick
VP, Commercial Operations
+1 (858) 952-7640
kmccormick@trovagene.com
http://www.trovagene.com

SOURCE Trovagene, Inc.

Website: http://www.trovagene.com