- The first U.S. patient in MedTrace’s phase 3 clinical trial has been dosed and scanned using the company’s automated manufacturing system for producing and dosing 15O-water.
- The trial seeks to evaluate the use of 15O-water PET in diagnosing coronary artery disease (CAD).
- It is the first phase 3 trial for a PET Myocardial Perfusion Imaging (MPI) agent that utilizes blood flow quantification as part of the primary endpoint.
MedTrace, a pharma and device company and an innovator in PET diagnostic imaging, announce today that the first U.S. patient has been dosed using the MedTrace point-of-care system (P3 MT-100) as part of the company’s ongoing phase 3 trial. The trial seeks to evaluate the diagnostic accuracy and safety of 15O-water as a myocardial perfusion PET imaging agent.
“The first subject in the U.S. to be dosed with 15O-water using our automated manufacturing system is a pivotal milestone – one that we hope will pave the way for increased access to 15O-water for providers and patients. Cardiology is progressing rapidly and it is exciting for MedTrace to contribute to this movement together with one of our close partners,” says Emily Vandenbroucke, Director of Clinical Affairs at MedTrace.
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. He says:
“As Principal Investigator of the RAPID-WATER-FLOW trial, I am thrilled by the news that the trial has enrolled its first patient in the U.S. Cardiac PET is a powerful noninvasive imaging test to diagnose coronary artery disease and the addition of 15O-water will expand the short list of imaging agents available for clinical use, thereby improving access to PET for patients with cardiovascular disease,” says Marcelo DiCarli.
MedTrace commenced the trial shortly after being greenlighted by the FDA and expects more sites to enroll over the coming months. Rune Wiik Kristensen, COO and U.S. President at MedTrace elaborates:
“MedTrace set out to eliminate diagnostic uncertainty via better perfusion imaging. With the first U.S. patient scanned in our phase 3 trial, we can celebrate that we’ve come a long way. I look forward to the continued progress and pursuing our goal of securing a New Drug Application for the use of 15O-water in diagnosing coronary artery disease,” says Rune Wiik Kristensen.
15O-water at the point of care
The company aim at making 15O-water practically available in a clinical setting and assist healthcare professionals diagnose patients accurately and quickly by bringing together production, dosing, injection, and quantification of myocardial perfusion imaging by 15O-water in one automated solution:
Hospitals produce the 15O-water doses themselves on demand with the use of MedTrace’s P3 MT-100 system and are not dependent on third-party suppliers for radiopharmaceuticals. In addition, MedTrace has a software solution in development (aQuant) that provides a quantitative as well as visual 15O-water image analysis, including quantification of blood flow and segmental perfusion data.
About the RAPID-WATER-FLOW Trial
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. 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).
The first subject was dosed in May last year at Aarhus University Hospital, Denmark. The trial is expected to be complete in 2024.
For more information on the clinical trial, visit: RAdiolabeled Perfusion to Identify Coronary Artery Disease Using WAter To Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW)
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.
Contact:
Emily Vandenbroucke
Director, Clinical Affairs
[email protected]
+1 312 805 0489
Website: https://medtrace.dk/
LinkedIn: https://www.linkedin.com/company/medtrace-a-s
Twitter: https://twitter.com/MedtracePharma
Facebook: https://www.facebook.com/medtrace
