CuraGen and TopoTarget Initiate Clinical Program Evaluating Oral Administration of PXD101

Phase I trial to establish the dose and frequency for oral PXD101 in patients with advanced solid tumors

14-Aug-2006

CuraGen Corporation and TopoTarget A/S announced the initiation of a Phase I clinical trial evaluating the administration of oral PXD101, a small molecule histone deacetylase (HDAC) inhibitor, in patients with advanced solid tumors. The Phase I trial will be 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 trial designed to establish the maximum tolerated dose (MTD) for oral PXD101 administered once or twice daily. Patients will be treated with oral PXD101 in a dose-escalation regimen and may continue to receive up to eight or more treatment cycles depending on disease response. Primary objectives for the study include evaluation of the safety, tolerability and pharmacokinetics of oral PXD101. Secondary objectives include assessment of the pharmacokinetic profile of oral PXD101 administered once or twice daily at various dose levels and evaluation of anti-tumor activity. The study is being conducted at sites both in the United States and Europe, with preliminary results expected to be available by the end of 2007.

In a previously conducted pilot clinical study, oral PXD101 was demonstrated to achieve significant plasma concentrations and have an oral bioavailability of approximately 33%. These data, in part, support the continued evaluation of PXD101 in this comprehensive Phase I trial.

CuraGen and TopoTarget continue to evaluate IV PXD101 in a number of Phase II trials including PXD101 monotherapy in patients with multiple myeloma (MM), T-cell lymphomas, and acute myelogenous leukemia. In addition, multiple Phase Ib/II clinical trials are being conducted to evaluate the combination of PXD101 with 5-fluorouracil for colorectal cancer, with carboplatin and paclitaxel for ovarian cancer, with cis-retinoic acid for advanced solid tumors, and with Velcade(R) (bortezomib) for Injection for MM.

https://www.bionity.com/en/news/57033/curagen-and-topotarget-initiate-clinical-program-evaluating-oral-administration-of-pxd101.html