BRANFORD, Conn., Feb. 1 /PRNewswire-FirstCall/ -- CuraGen Corporation and TopoTarget A/S (Copenhagen Stock Exchange: TOPO) announced today the initiation of patient dosing in a Phase II 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 (PTCL) and other T-cell non-Hodgkin's lymphomas (NHL). Preliminary results from this open-label, multi-center study are expected by mid-2007.
The Phase II study aims to establish the efficacy and safety of PXD101 as a single-agent treatment for CTCL, PTCL, and other T-cell NHL. Patients with T-cell NHL will be enrolled into one of two parallel arms depending on disease classification. Approximately 25 patients will initially be enrolled into the study with up to an additional 70 patients 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.
"We are excited to be exploring the role of PXD101 in the treatment of this disease. 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," stated Timothy M. Shannon, M.D., Executive Vice President of Research and Development, and Chief Medical Officer at CuraGen. "Despite advances in the treatment of cancer, there has been no significant improvement in survival rates for patients with NHL. We look forward to exploring the role of PXD101 to address this unmet medical need and its potential benefit for patients with T-cell lymphomas."
About T-cell Lymphoma
T-cell lymphomas are a type of NHL which arise from malignant T- lymphocytes, also known as T-cells, and account for approximately 15% of all NHL cases diagnosed in the U.S. CTCL is a slow-growing form of cancer where malignant T-cells are drawn to the skin and are usually deposited. CTCL is typically diagnosed in patients age 50 and older. There are approximately 1,500 new cases of CTCL diagnosed annually in the United States with nearly 20,000 patients living with the disease. PTCL and other T-cell NHL also involve malignant T-lymphocytes, and generally tend to be a more aggressive disease. Approximately 5,000 cases of PTCL and other T-cell NHL are diagnosed annually in the United States.
About PXD101
PXD101 is a promising 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. 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.
PXD101 is currently being evaluated in multiple clinical trials as a potential treatment for multiple myeloma, T-cell lymphoma, and colorectal and ovarian cancers, either alone or in combination with anti-cancer therapies. 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. In May 2005, TopoTarget signed a Cooperative Research and Development Agreement (CRADA) with the NCI to conduct pre-clinical and non-clinical studies on PXD101 in order to better understand its anti-tumor activity and to provide supporting information for clinical trials of the therapy.
About CuraGen
CuraGen Corporation is a biopharmaceutical 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 its pipeline of products for unmet medical needs. CuraGen is headquartered in Branford, Connecticut. For additional information please visit http://www.curagen.com.
About TopoTarget
TopoTarget (CSE: TOPO) is a fully integrated biopharmaceutical company with facilities in Denmark, UK and Germany and dedicated to finding "Answers for Cancer." TopoTarget combines in-depth understanding of the molecular mechanisms of cancer with broad experience from clinical cancer practice and has developed highly predictive cancer models. The platform covers key cancer enzyme regulators (HDAC and topoisomerase II inhibitors) and a broad portfolio of small molecule preclinical drug candidates has been built. TopoTarget has eight drugs in clinical development, consisting of both novel anti-cancer therapeutics and new cancer indications for existing drugs. The most advanced drug candidate, Savene(TM) for extravasations is expected to be launched in the US and Europe end 2006. In addition to organic growth, TopoTarget consistently looks for opportunities to strengthen and expand its activities through acquisitions and in-licensing. In selected markets, an own specialist oncology sales force is being established. For more information, please refer to http://www.topotarget.com.
Safe Harbor
This press release contains forward-looking statements including statements about CuraGen's expectation that preliminary results from the Phase II clinical trial will be available in mid-2007; the ability of the Phase II study to establish the efficacy and safety of PXD101 as a single-agent treatment for CTCL, PTCL and other T-cell NHL; enrollment in the Phase II study; the role of PXD101 in addressing the need to treat NHL and its potential benefit for patients with T-cell lymphomas; and NCI's sponsorship of clinical trials for PXD101. 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 risk that any one or more of the drug development programs of CuraGen 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 biopharmaceutical 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 Quarterly Report on Form 10-Q for the period ended September 30, 2005 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.
Contact: CuraGen Corporation Glenn Schulman, Pharm.D. gschulman@curagen.com (888) 436-6642
CuraGen CorporationCONTACT: Glenn Schulman, Pharm.D. of CuraGen Corporation, +1-888-436-6642,gschulman@curagen.com
Web site: http://www.curagen.com//
