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News Release - November 16, 2006
CuraGen and TopoTarget Announce Initiation of NCI-sponsored Phase II Clinical Trial of PXD101 for Myelodysplastic SyndromeBRANFORD, Conn., Nov. 16 (HSMN NewsFeed) -- CuraGen Corporation (Nasdaq: CRGN ) and TopoTarget A/S (Copenhagen Stock Exchange: TOPO) announced today the initiation of patient dosing in a Phase II open-label, multi-center clinical trial evaluating the efficacy and safety of intravenous PXD101, a small molecule histone deacetylase (HDAC) inhibitor, for the treatment of Myelodysplastic Syndromes (MDS). This trial is being sponsored by the National Cancer Institute (NCI) under a Clinical Trials Agreement with CuraGen for PXD101.
The Phase II clinical trial is being led by Amanda Cashen, M.D., Assistant Professor at the Washington School of Medicine in St. Louis, MO. Patients with MDS that have received no more than one prior therapy are eligible for enrollment. Up to 55 patients will be enrolled and receive five daily treatments of PXD101 administered by intravenous infusion every three weeks (one cycle). Patients demonstrating complete or partial response will continue to receive treatment with PXD101 for up to eight cycles or until disease progression.
The primary endpoint for the study is the proportion of confirmed responses as defined by the International Working Group. Secondary endpoints include the time to progression, overall survival, duration of response, and toxicity. The pharmacodynamic activity of PXD101 will also be evaluated by the assessment of histone acetylation, gene expression profiling and DNA methylation. Patients will be enrolled at multiple sites in the United States.
"HDAC inhibitors are believed to modulate the expression of genes and have previously shown activity in eliciting a positive effect on MDS. Given the promising activity of HDAC inhibitors, and the safety and efficacy profile of PXD101, we are very excited to begin evaluating this agent in the treatment of MDS and look forward to further characterizing its activity and pharmacodynamic profile in this patient population," stated Dr. Cashen.
About Myelodysplastic Syndromes
Myelodysplastic syndromes (MDS) comprise a collection of neoplastic bone marrow diseases characterized by abnormal bone marrow and cytopenias, or low blood counts. MDS are characterized into specific classifications based on the appearance of bone marrow and blood cells. Age is the greatest risk factor for developing MDS, with the disease typically occurring in patients older than 60 years of age. However, prior treatment with certain chemotherapy drugs is a major risk factor for the development of secondary MDS. It is estimated by the American Cancer Society that ten to fifteen thousand new cases of MDS will be diagnosed in the U.S. in 2006. Staging of MDS are performed using the International Prognostic Scoring System (IPSS) which is used to help define survival. The only potentially curative therapy for MDS is allogeneic stem cell transplantation, although this treatment option is limited by the availability of donors and the high-treatment related mortality. There remains a significant need for new therapeutics to treat MDS.
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, including 5-FU, carboplatin, paclitaxel, cis-retinoic acid, azacitidine and VelcadeŽ (bortezomib) for Injection. 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.
Intravenous PXD101 is currently being evaluated in multiple clinical trials as a potential treatment for multiple myeloma, T- and B-cell lymphomas, AML, mesothelioma, liver, colorectal, ovarian cancers, either alone or in combination with anti-cancer therapies. An oral formulation of PXD101 is also being evaluated in a Phase I clinical trial for patients with advanced solid tumors. In August 2004, CuraGen signed a Clinical Trials Agreement with the NCI under which the NCI will sponsor several 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 announced the signing of a Cooperative Research and Development Agreement (CRADA) with the NCI to conduct preclinical and nonclinical studies on PXD101 in order to better understand its anti-tumor activity and to provide supporting information for clinical trials.
CuraGen Corporation (NASDAQ: CRGN ) is a biopharmaceutical company developing diverse approaches, including novel protein, antibody, and small molecule therapeutics, that aim to offer hope for patients with cancer, inflammatory diseases, and diabetes. CuraGen's strategic alliances have resulted in a deep pipeline of potential therapeutics that is being developed by the Company's experienced research and development teams. By leveraging the drug development strengths cultivated over the years, CuraGen expects to make a difference in the lives of patients by bringing forward promising therapeutics that address unmet medical needs. To further capitalize on CuraGen's extensive research and development expertise, CuraGen founded a majority-owned subsidiary, 454 Life Sciences, which has developed and is commercializing advanced technologies for the sequencing of DNA. CuraGen is headquartered in Branford, Connecticut. For additional information please visit http://www.curagen.com.
TopoTarget (CSE: TOPO ) is a biopharmaceutical company, headquartered in Denmark and with subsidiaries in the UK and Germany, dedicated to finding "Answers for Cancer" and developing improved cancer therapies. TopoTarget is founded and run by clinical cancer specialists and combines years of hands-on clinical experience with in-depth understanding of the molecular mechanisms of cancer. Focus lies on highly predictive cancer models and key cancer enzyme regulators (mainly HDAC, mTOR, and topoisomerase II inhibitors) and a strong development foundation has been built. TopoTarget has a broad portfolio of small molecule preclinical drug candidates and seven drugs are in clinical development, including both novel anti-cancer therapeutics and new cancer indications for existing drugs. Savene(TM) is TopoTarget's first product on the market. In addition to organic growth, TopoTarget consistently looks for opportunities to strengthen and expand its activities through acquisitions and in-licensing. For more information, please refer to http://www.topotarget.com.
This press release contains forward-looking statements that are subject to certain risks and uncertainties. These forward-looking statements include statements regarding future expectations, beliefs, intentions, goals, strategies, plans or prospects regarding the future, including statements about the expected benefits of PXD101, and our plans to further characterize the activity and pharmacodynamic profile of PXD101 in MDS. 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 PXD101 or any other CuraGen drug development program 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 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 Annual and Quarterly Reports on Forms 10-K and 10-Q 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.
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