For safety and efficacy in targeted abdominal MR Imaging

Oral CMC-001 offers a prolonged diagnostic time window

Posted April 22, 2010 by

At the recent European Congress of Radiology in Vienna new data on the non-gadolinium based oral contrast agent CMC-001 for liver MRI was presented by Dr. Matthias Reif, Institut Für Radiologie, Charité – Universitetätsmedicin, Berlin, Germany. Using multiple MR-imaging for up to 6 hours post contrast, it was shown that already one hour after oral administration of CMC-001 the signal intensity of the liver parenchyma was increased. Increase of liver signal intensity was observed until 3 hours and sustained up to 6 hours after contrast agent administration. Only mild adverse events occurred in 6 out of the 20 patients that participated in the study (1).

With regards to liver MRI, CMC-001 should be considered an alternative to the current gadolinium based contrast agents. Manganese is an essential trace element without risk of nephrogenic systemic fibrosis, and the oral administration route minimizes systemic exposure to manganese (2). Due to the unique formulation of CMC-001, the manganese is absorpted from the gastrointestinal tract and accumulated in the liver, which provides a broad time window for post-contrast imaging. Administration of CMC-001 is simple with no need of injections or staff involvement. Compared to the gadolinium based contrast agents, CMC-001 offers a short MR machine time of only 10 minutes (3), and a corresponding image evaluation time by the radiologist.

Both the non-clinical development and the clinical phase II program for CMC-001 will be finalized within the next few months, and the contrast agent will be ready for the final clinical evaluation in phase III.

For further information on CMC-001 please contact:
Director of Business Development Thomas Grönberg - E-mail:
or
Director of Medical Affairs Jan Trøst Jørgensen – E-mail:

References:

1. M. Rief, A. Huppertz, B. Hamm, M. Taupitz, W. Moritz. Diagnostic time window for liver MRI after administration of an oral manganese-based contrast agent (CMC-001). Abstract, ECR 2010, March 4-8, 2010, Vienna, Austria.
2. Thomsen HS, Svendsen O, Klastrup S. Increased manganese concentration in the liver after oral intake. Acad Radiol 2004;11:38-44
3. Brismar T, Aspelin P, Kylander C, Albiin N. A New Oral Contrast Media to Detect Liver Metastases: Results from a Phase 3 Study. Abstract,, RSNA 2009, RSNA Annual Meeting, Chicago, November 29 – December 4, 2009.


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CMC 001 delivers manganese orally, resulting in excellent liver enhancement in MRI.

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