Trovagene, University of Southern California enter into clinical collaboration agreement

Trovagene, Inc.Sep 6 2013

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.