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Trovagene Expands Clinical Program with New Study Evaluating its Precision Cancer Monitoring Platform in Lung Cancer
Date:9/29/2014

SAN DIEGO, Sept. 29, 2014 /PRNewswire/ -- Trovagene, Inc., (NASDAQ:   TROV) a developer of cell-free molecular diagnostics, announced today that it has expanded its clinical program to include a study designed to evaluate use of the Company's precision cancer monitoring technology in the management of  lung cancer patients. The primary objective of the study is to detect and monitor EGFR mutations in urine, plasma and tissue to determine concordance. Secondary objectives include correlating quantitative EGFR mutational load over time with tumor burden, and demonstrating detection of the resistant EGFR T790M mutation prior to clinical or radiographic progression in lung cancer patients treated with tyrosine kinase inhibitor therapy. Approximately 225 patients are anticipated to be enrolled in the study.

"While it is standard of care to perform molecular testing on all patients with newly diagnosed metastatic lung adenocarcinoma, it is often difficult to obtain sufficient tissue from a non-surgical biopsy," stated Dr. Helena Yu, M.D., Assistant Attending Physician in the Thoracic Oncology Service at Memorial Sloan Kettering Cancer Center (MSK) and principal investigator of the study. "The use of urinary cell-free DNA to non-invasively detect tumor mutations could have multiple applications in the treatment of patients with EGFR-mutant lung cancer, including the potential to track disease burden and modify treatment at the first sign of resistance, which may improve patient outcomes."

In a prior collaborative study, clinicians at MSK demonstrated that Trovagene's urine-based precision cancer monitoring platform performed better than biopsy for the detection of BRAF mutations in patients with certain histiocytic diseases. These results were presented at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting and, as a result of the clinical utility demonstrated in the study, the technology is referenced in published Multi-Disciplinary Clinical Consensus Guidelines for histiocytic diseases. Similar to the challenges of diagnosing histiocytic disease and monitoring treatment, obtaining a sufficient biopsy in metastatic lung cancer patients can be difficult, if not impossible, in some cases. Researchers believe that if EGFR mutations can be identified and tracked accurately in a urine sample, this form of liquid biopsy could become an important tool for the management of metastatic lung cancer.

Mark Erlander, Ph.D., chief scientific officer of Trovagene stated, "Our ongoing collaboration with Memorial Sloan Kettering demonstrated the advantages of our cell-free molecular diagnostics over traditional tissue-based molecular testing in terms of mutation detection and the ability to monitor tumor dynamics over time. We are confident that our platform can help clinicians by providing timely detection and tracking of EGFR mutational status in metastatic lung cancer patients, and we look forward to working closely with Dr. Yu and her team in this investigational study."

About EGFR Mutations In Metastatic Lung Cancer

Non-small cell lung cancer (NSCLC) has become increasingly classified into molecular subsets as new treatments focus on targeting specific driver mutations of the disease. Crizotinib, erlotinib and afatinib are approved for first-line treatment of ALK-positive and EGFR-mutant advanced NSCLC, respectively, and have proven to be superior to standard cytotoxic chemotherapy in these molecular subsets of patients. Based on NCCN guidelines, it is standard of care to perform molecular testing on all patients with newly diagnosed metastatic lung cancer. Currently, tumor tissue is required to perform molecular analysis on metastatic patients, which are the majority of lung cancer patients utilizing targeted therapies. A non-invasive method to detect the driver mutations associated with non-small cell lung cancer may offer important benefits to physicians and patients including the ability to determine mutational status when tissue biopsy cannot be obtained or when results are inconclusive. Comprehensive molecular analysis of tissue biopsy often requires 2-3 weeks, and symptomatic patients often cannot wait for results before initiating treatment. Therefore, a sensitive screening assay with a relatively quick turnaround time could allow physicians to make molecularly based treatment recommendations in a more expedient manner. Presently, there is no tumor marker or similar assay available in lung cancer to track disease, and a non-invasive quantitative marker that tracks with disease burden could allow physicians to tailor treatment to specific changes in mutational status over time, potentially improving patient outcomes.

About Trovagene, Inc.

Headquartered in San Diego, California, Trovagene is leveraging its proprietary technology for the detection and monitoring of cell-free DNA in urine and plasma.  The Company's technology detects and quantitates oncogene mutations in cancer patients for improved disease management. Trovagene's precision cancer monitoring platform is designed to provide important clinical information beyond the current standard of care, and is protected by significant intellectual property including multiple issued patents and pending patent applications globally.

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; 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; 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, 2013 and other periodic reports filed with the Securities and Exchange Commission.

ContactInvestor RelationsMedia RelationsDavid Moskowitz and Amy Caterina

Investor RelationsIan Stone

Account DirectorTrovagene, Inc.Canale Communications, Inc.858-952-7593619-849-5388ir@trovagene.comian@canalecomm.com Logo - http://photos.prnewswire.com/prnh/20120620/LA28014LOGO


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