CuraGen Corporation have signed a Clinical Trials Agreement (CTA) with the Division of Cancer Treatment and Diagnosis (DCTD) at the National Cancer Institute (NCI) for PXD101, a histone deacetylase (HDAC) inhibitor currently in Phase I clinical trials.

Under the agreement, the NCI will sponsor several clinical trials evaluating the activity of PXD101, either alone or in combination with other anti-cancer therapies, for the treatment of solid and hematologic cancers. CuraGen licensed PXD101 from TopoTarget A/S and both companies are jointly developing PXD101 and additional HDAC inhibitors for use in oncology and other indications. As part of the DCTD mission to improve cancer care, the Cancer Therapy Evaluation Program works to advance new anticancer therapies and has been involved with the development of numerous anticancer drugs, company said in a release.

"We are delighted by the NCI's interest in PXD101 as it enhances our ability to fully explore the potential of this exciting cancer agent. This collaboration will enable us to leverage the NCI's expertise, resources, and broad network of clinical researchers and sites," stated Timothy M Shannon, executive vice president of Research and Development and chief medical officer at CuraGen Corporation. "As we look to transition PXD101 to Phase II, we are pleased to have the NCI contribute to our understanding of the types of cancer patients that can receive the greatest benefit from PXD101 and the most appropriate regimens," Timothy added.

Peter Buhl Jensen, chief executive officer of TopoTarget, added, "We believe PXD101 to be a promising cancer therapy and are extremely pleased to be working with the NCI. Establishing this CTA is an important step to advance the research and understanding of PXD101 and its potential role for treating patients with solid and hematologic cancers.

Clinical research activities will be coordinated with the NCI to identify which patient populations may benefit from PXD101 and develop PXD101 for these cancer populations, either as a single-agent or in combination with other cancer treatments. This Agreement provides CuraGen access to the expertise at the NCI for the design, implementation, and monitoring of clinical trials through the NCI's network of investigators and trial sites. NCI-sponsored clinical trials will occur in parallel to those sponsored by CuraGen with all data generated available for use in future registration, the release added.

PXD101 is a Phase I HDAC inhibitor being investigated for the treatment of various solid and haematologic cancers. PXD101 has been shown in preclinical studies to have a favourable therapeutic window based on PXD101's targeted activity on cancer cells versus normal cells. PXD101 will be investigated for its role in the treatment of a wide range of solid and haematologic malignancies either as a monotherapy, or in combination with other active anti-cancer agents.

A growing body of research highlights the role of histone deacetylases (HDAC) in regulating gene expression, particularly the expression of cancer- related genes. HDAC inhibitors represent a new mechanistic class of anti- cancer therapeutics that target HDAC enzymes. HDAC inhibitors are believed to play a role in a wide range of solid malignancies such as breast, colon, lung and ovarian cancers, and haematological malignancies, such as lymphomas, leukaemia and myeloma.