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CuraGen and TopoTarget Announce Cooperative Research and Development Agreement With the National Cancer Institute for PXD101

Posted on: Thursday, 12 May 2005, 09:00 CDT

NEW HAVEN, Conn., May 12 /PRNewswire-FirstCall/ -- CuraGen Corporation announced today that TopoTarget A/S signed a Cooperative Research and Development Agreement (CRADA) with the Division of Cancer Treatment and Diagnosis (DCTD) at the National Cancer Institute (NCI) relating to PXD101, a histone deacetylase (HDAC) inhibitor. PXD101, which is being co- developed by CuraGen and TopoTarget for the treatment of solid and hematologic cancers, is currently in a Phase II clinical trial for the treatment of advanced multiple myeloma.

Under the CRADA, the DCTD, NCI, and TopoTarget will collaborate to conduct preclinical and non-clinical studies on PXD101 in order to better understand the anti-tumor activity of PXD101 and to provide supporting information for clinical trials of the therapy. An additional goal will be to select the best next-generation of HDAC inhibitors to be developed as potential drug candidates from TopoTarget's library of HDAC inhibitors, including compounds exhibiting HDAC subtype selectivity. Under the license and collaboration agreement between CuraGen and TopoTarget, CuraGen has an exclusive option to select additional HDAC compounds from TopoTarget's library for clinical development, including those identified under the CRADA with the DCTD.

"We are very pleased that the NCI and TopoTarget have signed a CRADA for the preclinical evaluation of PXD101, and future HDAC inhibitors, as the data generated will help guide and support the clinical trials being conducted by CuraGen," stated Timothy M. Shannon, Executive Vice President Research and Development and Chief Medical Officer at CuraGen. "The CRADA also complements the Clinical Trial Agreement (CTA) signed by CuraGen and the NCI last August, as both collaborative relationships will assist in developing PXD101 for the treatment of solid and hematologic cancers."

About PXD101

PXD101 is a small molecule HDAC inhibitor being investigated for its role in the treatment of a wide range of solid and hematologic malignancies either as a single-agent, or in combination with other active anti-cancer agents, and is currently being evaluated in a Phase II clinical trial for the treatment of multiple myeloma. HDAC inhibitors represent a new mechanistic class of anti- cancer therapeutics that target HDAC enzymes, and have been shown to: arrest growth of cancer cells (including drug resistant subtypes); induce apoptosis, or programmed cell death; promote differentiation; inhibit angiogenesis; and sensitize cancer cells to overcome drug resistance when used in combination with other anti-cancer agents. In August 2004, CuraGen signed a Clinical Trials Agreement with the National Cancer Institute (NCI) under which the NCI will sponsor several additional clinical trials to investigate PXD101 for the treatment of various cancers, both as a single-agent and in combination chemotherapy regimens.

About CuraGen

CuraGen Corporation is a genomics-based pharmaceutical company dedicated to improving the lives of patients by developing a pipeline of novel protein, antibody, and small molecule therapeutics in the areas of oncology, inflammatory diseases, and diabetes. CuraGen has established broad development alliances with Abgenix, TopoTarget, and Bayer, and its experienced preclinical and clinical teams are advancing the Company's pipeline of products for unmet medical needs. The Company is located in New Haven and Branford, CT. For additional information please visit http://www.curagen.com/.

About TopoTarget

TopoTarget is a Danish biopharmaceutical company with UK and Germany subsidiaries. The company is dedicated to the discovery, development and clinical progression of new and improved therapeutics for the cancer patient and it is a leader in the field of HDAC inhibition, an exciting and promising area of oncology research. TopoTarget develops novel pharmaceuticals and aims to identify and market new indications for existing compounds. It applies its precise and in-depth understanding of the molecular mechanisms of cancer with its wide experience in clinical oncology practice to develop new and effective medicines to combat the disease. TopoTarget is based in Copenhagen, Denmark; Oxford, UK; and Frankfurt, Germany. For more information refer to http://www.topotarget.com/.

About the NCI

The National Cancer Institute (NCI), one of the National Institutes of Health (NIH), conducts and supports research, training, education, and programs focused on the cause, diagnosis, prevention, treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and their families.

Safe Harbor

This press release contains forward-looking statements including statements about CuraGen's expectation that the collaboration among DCTD and TopoTarget will lead to a better understanding of the anti-tumor activity of PXD101, provide supporting information for clinical trials of the therapy, and assist in the selection of the best next-generation of HDAC inhibitors to be developed as potential drug candidates from TopoTarget's library of HDAC inhibitors; the ability of data generated by the CRADA to help guide and support the clinical trials being conducted by CuraGen; that both the CRADA and the CTA between CuraGen and NCI will assist in developing PXD101 for the treatment of solid and hematologic cancers; NCI's sponsorship of several additional clinical trials to investigate PXD101 for the treatment of various cancers, both as a single-agent and in combination chemotherapy regimens; and TopoTarget's aim to identify and market new indications for existing compounds. We caution investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors, including, but not limited to, the following: the success of the collaboration between DCTD and TopoTarget; the risk that any one or more of the drug development programs of CuraGen, CDTD, NCI and/or TopoTarget will not proceed as planned for technical, scientific or commercial reasons or due to patient enrollment issues or based on new information from nonclinical or clinical studies or from other sources; the success of competing products and technologies; technological uncertainty and product development risks; uncertainty of additional funding; CuraGen's history of incurring losses and the uncertainty of achieving profitability; CuraGen's stage of development as a genomics-based pharmaceutical company; government regulation; patent infringement claims against CuraGen's products, processes and technologies; the ability to protect CuraGen's patents and proprietary rights; uncertainties relating to commercialization rights; and product liability exposure. Please refer to CuraGen's Annual Report on Form 10-K for the period ended December 31, 2004 for a complete description of these risks. CuraGen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

Contacts:

CuraGen Corporation TopoTarget A/S

Glenn Schulman, PharmD, MPH Dr. Peter Buhl Jensen, MD, PhD, CEO

gschulman@curagen.com + 45 39 17 83 92

(888) GENOMICS NB Public Relations

Nicki Brimicombe + 44 (0) 1883 73 23 53

CuraGen Corporation

CONTACT: Glenn Schulman, PharmD, MPH of CuraGen Corporation, +1-888-GENOMICS, gschulman@curagen.com; or Dr. Peter Buhl Jensen, MD, PhD, CEO ofTopoTarget A/S, + 45 39 17 83 92; or Nicki Brimicombe of NB Public Relations,+ 44 (0) 1883 73 23 53

Web site: http://www.curagen.com/


Source: PRNewswire-FirstCall

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