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Biotech / Medical : Millennium Pharmaceuticals, Inc. (MLNM)

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From: Icebrg	8/7/2007 2:57:34 AM
	of 3044

Belinostat in combination with Velcade® (bortezomib) for Injection against Multiple Myeloma (MM): [From a CRGN PR of yesterday. I am surprised that they are reporting these renal problems, as I was under the opinion that Velcade was supposed to be "gentle" on the kidneys (at least when compared to Revlimid)] In the Phase II open-label clinical trial evaluating intravenous belinostat in combination with Velcade® (bortezomib) for Injection in patients with advanced, refractory MM, two out of four patients enrolled developed acute deterioration in already existing renal insufficiency (ARI) in the first cycle of combination treatment. ARI is a common complication in the treatment of MM patients due to deposition of myeloma protein in the kidney. Three similar events were seen in previously conducted single agent studies with belinostat in patients with MM. No ARI has been observed in any other indication for which intravenous or oral belinostat is being evaluated. An ongoing Phase I NCI-sponsored clinical trial evaluating intravenous belinostat plus Velcade® (bortezomib) for Injection against solid tumors and lymphoma remains open for enrollment and is continuing to treat patients with the combination. This trial is being conducted under a Clinical Trials Agreement between the NCI and CuraGen. Dr. Shannon further commented, "Our data show that this finding is limited to patients with multiple myeloma, a population known to be at risk of this complication due to pre-existing renal changes. Until we know more about how to prevent the complication in this specific patient population, we have decided not to enroll further patients and will focus our resources onto the other ongoing studies in cancer indications where belinostat is demonstrating a therapeutic benefit. We have reported positive preliminary safety and efficacy data from three indications including single agent activity against peripheral T-cell lymphoma and cutaneous T-cell lymphoma, as well as the combination of IV belinostat with carboplatin and paclitaxel in the treatment of ovarian cancer. We are very excited about the activity reported in these indications, as we feel they represent potential registrational paths for belinostat and look forward to reporting updated results in the fourth quarter of 2007."

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