CuraGen and TopoTarget Announce Presentation of Belinostat Clinical Trial Results at AACR-NCI-EORTC International ... (d tumors were presentedby Dr. Rhoda Moli...)

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CuraGen and TopoTarget Announce Presentation of Belinostat Clinical Trial Results at AACR-NCI-EORTC International Conference

Date:10/25/2007

d tumors were presented by Dr. Rhoda Molife and Dr. Jooern Ang, investigators at the Royal Marsden Hospital, Sutton, United Kingdom. The Phase I trial is being led by Dr. W. Kevin Kelly, Associate Professor of Medicine in the Section of Medical Oncology and head of The Prostate & Urologic Oncology Program at the Yale Cancer Center, New Haven, CT.

The Phase I study is an open-label, multi-center dose-escalation trial designed to establish the maximum tolerated dose (MTD) for oral belinostat administered once or twice daily in one of two regimens (either continuous daily dosing or dosing days one through 14 in a 21-day cycle). Primary objectives for the study include evaluation of the safety, tolerability and pharmacokinetics of oral belinostat. Secondary objectives include assessment of the pharmacokinetic profile of oral belinostat administered once or twice daily at various dose levels and evaluation of anti-tumor activity. Comprehensive serial ECGs to evaluate the effect of belinostat on QTc interval were also performed.

At the time of the poster presentation, data were available on 60 patients enrolled into the dose-escalation study with 46 patients on the continuous daily regimen and 14 patients dosed days one through 14 in a 21-day cycle. Patients received a median of two treatment cycles (range 1 - 11) with fifteen patients ongoing. The most frequent adverse events reported were fatigue, anorexia and nausea. More than 2400 ECGs were collected in this trial, with no grade 3 or 4 QTc changes noted.

During the study, 15 patients (25%) achieved SD for greater than or equal to 12 weeks, with no RECIST-defined objective responses currently reported. Dose-escalation performed with 250 mg capsules of oral belinostat resulted in a presumptive continuous dosing MTD of 250 mg twice daily. The MTD for dosing of oral belinostat on days one through 14 in a 21-day cycle has not yet been reached. The investigators concluded that oral belinostat has been safe
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CuraGen and TopoTarget Announce Presentation of Belinostat Clinical Trial Results at AACR-NCI-EORTC International ...(d tumors were presentedby Dr. Rhoda Moli...),Health