MedTrace Pharma Announces First Subject Scanned in the Company’s RAPID-WATER-FLOW Phase 3 Clinical Trial
- First Subject Scanned in RAPID-WATER-FLOW Trial at Aarhus University Hospital, Denmark
- Multiple Sites Involved Across the United States, Denmark, Sweden, and The Netherlands
- The Global Trial is Expected to Continue for 12 Months
MedTrace Pharma A/S, a pharma and device company and an innovator in PET diagnostic imaging, announced today that it has scanned the first subject in its RAPID-WATER-FLOW Phase 3 clinical trial.
The global trial enrolls adults with suspected Coronary Artery Disease (CAD) and seeks to evaluate the use of 15O-water PET in diagnosing CAD.
The first subject scan took place at Aarhus University Hospital (AUH) in Denmark just two months after MedTrace received FDA approval of the company’s Investigational New Drug (IND) application and the approval to commence the trial.
Marcelo Di Carli, MD, Professor of Radiology and Medicine, at Brigham and Women’s Hospital and Harvard Medical School, is leading the trial as Principal Investigator.
– I am thrilled by the recruitment of the first subjects into the RAPID-WATER-FLOW study. This is a significant milestone for this exciting and important study and the first step towards bringing 15O-water as a clinical myocardial perfusion agent in the United States. The practical real-time production of 15O-water with MedTrace’s novel technology promises to revolutionize the practice of cardiac PET imaging by improving patient access to the most accurate approach to the non-invasive diagnosis of coronary artery disease, says Marcelo DiCarli.
15O-water at the point of care
MedTrace’s technology automatically produces and administers 15O-water to patients at the point of care. The automated software solution also provided by MedTrace (aQuant, in development) makes available a fully quantitative as well as visual 15O-water image analysis, including quantification of blood flow and segmental perfusion data, aiming to allow healthcare professionals to diagnose patients accurately and quickly.
The innovative solution allows for absolute blood flow imaging and quantification based upon the PET tracer 15O-water, which has long been acknowledged as the gold standard tracer for quantitative myocardial perfusion imaging.
Hospitals produce the radioactivity themselves on demand and are not dependent on third-party suppliers for radiopharmaceuticals.
Lars Christian Gormsen, Consultant, Professor at the Department of Nuclear Medicine & PET Center at AUH is the PI for the trial at AUH and is happy to be the first site to enroll a subject in this milestone study.
– Thanks to the excellent work by our colleagues at the Department of Cardiology and the staff at the department of Nuclear Medicine, the recruitment and subsequent examination of the first patient in the project progressed as planned. We are confident that this will also be the case in the remaining part of the project, says Lars Christian Gormsen.
At MedTrace the first subject enrolled is celebrated throughout the organization.
– I am beyond impressed with the dedication from the MedTrace clinical team and from our partners at AUH. They made it possible to reach this significant milestone in less than two months after we received the green light from the FDA. It shows that our company is moving at an incredible pace which is made possible by the talented and passionate people onboard, says Martin Stenfeldt, CEO of MedTrace.
The company is currently exploring clinical applications outside of cardiology and looking into research areas such as oncology and neurology. MedTrace’s clinical department will be growing significantly by the end of the year.
For more information on the 15O-water RAPID-WATER-FLOW clinical trial, visit: Radiolabeled Perfusion to Identify Coronary Artery Disease Using Water To Evaluate Responses of Myocardial Flow – Full-Text View – ClinicalTrials.gov
About the RAPID-WATER-FLOW Trials
The trial is a Phase 3, prospective, open-label, multicenter study of 15O-H2O injection for PET imaging of subjects with suspected CAD. 182 evaluable participants with suspected CAD will be included in the study at an estimated 10 study sites in the United States and Europe. Approximately 215 participants will be enrolled in total to account for an estimated 15% drop-out rate. All participants will receive two doses of 15O-H2O as part of a single PET imaging session (one dose at rest and one during pharmacological stress with adenosine).
About MedTrace Pharma A/S
Headquartered in Copenhagen, Denmark, MedTrace Pharma A/S was founded in 2015 by Martin Stenfeldt, Rune Wiik Kristensen and Peter Larsen. In 2018 MedTrace merged with the software company aQuant founded by Jens Soerensen, Hendrik (Johannes) Harms, Mark Lubberink, and Lars Poulsen Tolbod that had developed a unique analytic software platform specifically for radioactive water. The company today is a privately held pharmaceutical company focused on PET imaging technologies with a particular emphasis on blood flow and perfusion quantification. The company has a late-stage pipeline including 15O-water as a radiopharmaceutical and aQuant as a medical device software (under development) for the image analysis and quantification of blood flow and perfusion data from cardiac PET scans. In addition to the described trial, the company is pursuing regulatory certification in the EU.
Amongst the company’s key shareholders are The Danish pension fund ATP, SwissCanto Private Equity Invest, The European Innovation Council and BankInvest. The team at MedTrace are committed to bringing 15O-water PET into clinical routine and to explore the potential in other disease areas such as oncology and neurology.
Forward looking statement
This news release by MedTrace Pharma A/S (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. The company offers no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Director, Clinical Affairs
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