Trovagene and Catholic Health Initiatives Center for Translational Research Partner to Clinically Evaluate Non-Invasive Genomic Diagnostics to Improve Cancer Care Partnership Seeks To Establish Clinical and Health Economic Benefits of Trovagene's Urine-Based Cell-Free Molecular Diagnostics for Potential Adoption in Cancer Management Strategies
SAN DIEGO and BALTIMORE, March 19, 2014 /PRNewswire/ -- Trovagene, Inc. (NASDAQ: TROV) and Catholic Health Initiatives Center for Translational Research (CTR) today announced they have entered into a strategic partnership to conduct clinical validation studies, clinical utility studies, health economic studies, and other activities to determine the effectiveness of Trovagene's urine-based cell-free DNA cancer monitoring diagnostics in clinical practice. CTR is a limited liability company whose sole corporate member is Catholic Health Initiatives Institute for Research and Innovation (CIRI), a direct subsidiary of Catholic Health Initiatives (CHI). Englewood Colorado-based CHI is one of the nation's largest health systems, operating in 18 states and comprising 87 hospitals, including four academic medical centers and teaching hospitals and 24 critical-access facilities.
"The ability to non-invasively track the benefit a patient receives through their course of treatment could dramatically shape the way oncology care is delivered, potentially saving time and money by ensuring that a given therapy is having the desired effect," stated Jeffrey Otto, Ph.D. MBA, National Director for the CTR. "One of our goals at the CTR is to advance personalized medicine by investigating leading edge technologies, and this partnership will allow us to evaluate, and explore the potential to include Trovagene's cancer monitoring platform in CHI's treatment strategies."
Under the agreement, research activities will be conducted via the CTR's partnered network of CHI hospitals and the CTR's state-of-the-art research facility. The facility, located on the University of Maryland Biopark Campus was formed to support the discovery, development, and clinical implementation of innovative personalized medicine technologies. Key goals of this partnership are to investigate integration of Trovagene's platform technology into effective clinical management strategies, and to evaluate its potential for improvements in the overall disease management of cancer.
"We will work closely with clinicians and researchers within CHI's healthcare system to demonstrate how our technology can be used in a clinical setting to impact patient care," said Antonius Schuh, Ph.D., chief executive officer of Trovagene. "This unique partnership brings our technology together with clinicians, research subjects, and CHI's healthcare network to potentially improve the standard-of-care for cancer treatment, and accelerate adoption of our urine-based cell-free DNA diagnostics into clinical practice."
Based on the partnership agreement, the first of multiple clinical research studies is anticipated to commence in the second quarter of 2014. If study results from the research programs prove validity and evidenced-based utility of Trovagene's urine-based cell-free DNA tests for the management of cancer, the parties will explore further opportunities with the potential to implement the technology into CHI's healthcare system, which treats approximately 22,000 cancer patients annually.
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; 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, 2012 and other periodic reports filed with the Securities and Exchange Commission.
About Catholic Health Initiatives Center For Translational Research
Headquartered in Baltimore Maryland, Catholic Health Initiatives Center for Translational Research (http://www.chiresearch.org/CTR) is a Colorado LLC whose sole member is Catholic Health Initiatives Institute for Research and Innovation (CIRI; http://www.chiresearch.org/). CTR partners with biomedical scientists to facilitate the development of next-generation drugs, diagnostics and devices, thus catalyzing precision medicine. Its state-of-the-art research facility, coupled with CHI's 80+ hospital network and three academic medical centers was formed to engage in programs and activities to advance medical and translational research and health care innovation focused on the improvement of health outcomes. Together with its partners, CTR advances personalized medicine by translating scientific advances into real clinical solutions. CTR accomplishes this by leveraging the access and reach of CHI, one of the largest health systems in the United States.
About Catholic Health Initiatives
Catholic Health Initiatives (http://www.catholichealthinit.org/), a nonprofit, faith-based health system formed in 1996 through the consolidation of four Catholic health systems, expresses its mission each day by creating and nurturing healthy communities in the hundreds of sites across the nation where it provides care. One of the nation's largest health systems, Englewood, Colo.-based CHI operates in 18 states and comprises 87 hospitals, including four academic medical centers and teaching hospitals and 24 critical-access facilities; community health-services organizations; accredited nursing colleges; homehealth agencies; and other facilities that span the inpatient and outpatient continuum of care. In fiscal year 2013, CHI provided $762 million in charity care and community benefit, including services for the poor, free clinics, education and research. Learn more at www.catholichealthinitiatives.com
SOURCE Trovagene, Inc.