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YM BioSciences, Inc. Ordinary S Message Board

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  • mr_ssssamsa mr_ssssamsa Jan 22, 2011 7:43 PM Flag

    Randomized phase II study of nimotuzumab

    Well they already had a phase 2 colorectal trial that failed a couple of years ago. I think they later determined that that was because the patient population wasn't EGFR-positive. It's unclear to me from things they've said whether that was because colorectal patients in general aren't EGFR-positive or because the patients in that trial were pre-administered irinotecan, which suppresses EGFR. (I realize the patients in the gastric trial also got irinotecan, but it appears from the poster that they got it concurrently with nimo.)

    According to YMI's corporate presentation, its partner in Southeast Asia, Kuhnil Pharma/Innogene Kalbiotech, is conducting a randomized P3 trial in head and neck. If it's successful I'm not sure in which countries registration could occur, but I believe YMI would share in the revenues.

    I don't have time to research it now but I believe gastric is a major cancer in Japan and elsewhere in Asia. I'm not sure why FDA approval would be needed if they wanted to market nimo only in that area.

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    • I believe you are correct in regards to revenue sharing.

      colon cancer is currently being investigated by AMGEN's product as well as erbitux, both of which are EGRF antibodies and have increased rash.

      The issue here is that it really doesn't matter what other cancers are treated with this...Just the erbitux market is about a billion...and even if we cut that in half...and we get the same indications as other cancers that are EGRF positive, we will make more.

      The problem is still the issue that we need FDA approval, and the company does not appear to be pursuing this.

      thanks for your post.