Dr. Jelle Barentsz: Combidex

jelleBDr. Jelle Barentsz, Professor of Radiology and Chairman of the Prostate MR Center of Excellence at Radboud University Nijmegen Medical Center in The Netherlands, is the driving force behind the resurrection of the Combidex-enhanced MRI for prostate cancer.

Dr. Barentsz is keenly interested in developing functional and molecular MRI techniques for prostate, breast and bladder cancer and, in particular, the fusion of functional MRI, CT, and ultrasound techniques.

Prostate Forum recently spoke with him about MRI and Combidex-enhanced MRI for prostate cancer. To read the rest of our conversation with Dr. Barentsz when it is released next week, subscribe to Prostate Forum.

PROSTATE FORUM: You are well known for your work on Combidex-enhanced MRI. The development of Combidex is quite a story. I was wondering if you could discuss some of the barriers you faced in developing this imaging agent.

DR. BARENTSZ: I think the most important barrier was the fact that AMAG Pharmaceuticals, the company who made Combidex, and Guerbet in France, didn’t at that time comprehend how important it was for patients. The company had some problems with the FDA. Not about safety, but about technical issues like image reading. The image readings were performed by non-radiological monitors, so not according to good radiological practice.

Not surprisingly, the results of the last study in France were not good enough. The results were just about to be significant, but not good enough.

Then, unfortunately, the economic crisis forced the companies to abandon Combidex. As of April 1, 2010, Combidex was not available to patients anymore.

I found that unacceptable.

At first, I looked unsuccessfully for alternatives like Feraheme.
Recently, I came back from the annual meeting of the Society of Abdominal Radiology in Boca Raton, Florida where NIH investigators presented their first results with Feraheme MRI. Even when going to as high as triple the dose we use with Combidex, the results were just not good enough. There were a lot of false positives because the iron uptake is less in lymph nodes with Feraheme compared to Combidex.

And so I started Mission Impossible, which was how to resurrect Combidex. Radboud University Nijmegan Medical Center bought AMAG Pharmaceuticals’ documents and we started to manufacture the agent in The Netherlands.

We have produced exactly the same compound as the original Combidex. Under Dutch law and meticulous quality control, we are able to offer the agent to cancer patients again.

We have used Combidex on about 16 patients in the past few weeks. It’s fantastic.
Combidex is back!

PROSTATE FORUM: What do you see as the best path for obtaining approval for Combidex in both Europe and the United States?

DR. BARENTSZ: First, we will distribute the agent in the Netherlands, then most probably we may get approval in the Russian federation within the next years. Finally, we will try to get the agent approved in Europe and the US.

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