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CuraGen Provides Update on Velafermin, Belinostat and CR011-vcMMAE Clinical Development Programs
Date:8/19/2007

gous bone marrow transplantation (BMT). Patients enrolled in the trial were randomized to receive a single infusion of either placebo or one of three doses of velafermin (10 mcg/kg, 30 mcg/kg or 60 mcg/kg) administered 24 hours after BMT.

"We believe that the ability to recruit nearly 400 patients in 13 months speaks to the unmet need in the severe OM market, and feel there is a substantial opportunity for a product like velafermin, which could provide a convenient single dose regimen for the prevention of severe OM," commented Dr. Shannon. "We look forward to reporting top-line efficacy and safety results in mid-October, which we hope will confirm the data observed previously with 30 mcg/kg velafermin in our first Phase II trial for the prevention of severe OM."

Belinostat in combination with Velcade(R) (bortezomib) for Injection against Multiple Myeloma (MM):

In the Phase II open-label clinical trial evaluating intravenous belinostat in combination with Velcade(R) (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(R) (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
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SOURCE CuraGen Corporation

Copyright©2007 PR Newswire.

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