CuraGen, TopoTarget begin phase 2 clinical trial of PXD101 for lymphoma

By Lisa Kerner

Erie, Pa., Feb. 1 - CuraGen Corp. and TopoTarget A/S announced the start of patient dosing in a phase 2 clinical trial evaluating the efficacy and safety of PXD101, a small molecule histone deacetylase (HDAC) inhibitor for the treatment of cutaneous T-cell (CTCL), peripheral and other T-cell non-Hodgkin's lymphomas.

Preliminary results from this open-label, multi-center study are expected by mid-2007, according to a company news release.

Patients with T-cell non-Hodgkin's lymphoma will be enrolled into one of two parallel arms depending on disease classification. The study will initially enroll about 25 patients. An additional 70 patients will be enrolled following demonstration of activity.

The primary endpoint for the trial is objective disease response using standardized criteria. Secondary objectives for the study include evaluation of safety, time to response, duration of response and survival following single-agent therapy with PXD101, the company said.

"PXD101 has demonstrated excellent preclinical activity against T-cell lymphoma cancer cell lines, and HDAC inhibitors have been shown to have clinical activity against CTCL," Timothy M. Shannon, executive vice president of research and development, and chief medical officer of CuraGen, said in the release. "Despite advances in the treatment of cancer, there has been no significant improvement in survival rates for patients with [non-Hodgkin's lymphomas]."

PXD101 is being evaluated in several clinical trials as a potential treatment for multiple myeloma, T-cell lymphoma, and colorectal and ovarian cancers, either alone or in combination with anticancer therapies, the company said.

The National Cancer Institute will sponsor several additional clinical trials to investigate PXD101 for the treatment of various cancers, both as a single-agent and in combination chemotherapy as the result of a clinical trials agreement with CuraGen.

TopoTarget signed a Cooperative Research and Development Agreement with the National Cancer Institute to conduct pre-clinical and non-clinical studies on PXD101 to better understand its antitumor activity and to provide supporting information for clinical trials.

CuraGen is a biopharmaceutical company developing a pipeline of novel protein, antibody and small molecule therapeutics in the areas of oncology, inflammatory diseases and diabetes. The company is based in Branford, Conn.

TopoTarget is a biopharmaceutical company focused on cancer treatments based in Copenhagen, Denmark.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.