BRANFORD, Conn., April 6 /PRNewswire-FirstCall/ -- CuraGen Corporation and TopoTarget A/S announced today that new preclinical data on PXD101, a histone deacetylase (HDAC) inhibitor being investigated for the treatment of cancer, were presented at the 97th Annual Meeting of the American Association for Cancer Research (AACR) in Washington, D.C. PXD101 is currently being evaluated in several Phase II and Phase Ib/II clinical trials for the treatment of multiple myeloma, T-cell lymphomas, ovarian cancer and colorectal cancer. Preclinical results on PXD101 were reported at AACR in two separate poster presentations.
Researchers from CuraGen and TopoTarget presented a poster entitled, "Activity of the HDAC Inhibitor, PXD101, in Preclinical Lung Cancer Studies." Preclinical results demonstrated that PXD101 potently inhibited the growth of numerous lung cancer cell lines in vitro, and reduced the growth of human lung cancer in animal xenografts. When used in combination with erlotinib (Tarceva(R)), PXD101 displayed synergistic growth-inhibitory activity in vitro and caused greater tumor growth inhibition than did the respective monotherapies in animal xenografts of human lung cancer. PXD101 decreased the expression of epidermal growth factor receptor family members EGFR and ErbB3, a finding that may help to explain the synergistic activity of PXD101 and erlotinib. PXD101 also demonstrated strong synergistic activity with pemetrexed (Alimta(R)), an effect potentially related to down regulation of thymidylate synthase by PXD101.
In a second poster presentation entitled, "Plasma and Cerebrospinal Fluid (CSF) Pharmacokinetics of the Histone Deacetylase (HDAC) Inhibitor, PXD101, in Non-Human Primates," researchers from the NCI, CuraGen, and TopoTarget reported preclinical pharmacokinetic results. PXD101 displayed a half-life of approximately one hour with cerebrospinal fluid (CSF) penetration by PXD101 of approximately 1%. These results suggest that the concentration of PXD101 achieved in the CSF may be sufficient to inhibit the growth of certain cancers.
"These preclinical studies continue to highlight the potential of PXD101, both as a single agent and in combination with currently used anti-cancer therapies," stated Dr. Frank M. Armstrong, President and Chief Executive Officer of CuraGen. "As we continue to evaluate PXD101 for the treatment of multiple myeloma, T-cell lymphomas, ovarian and colorectal cancers, we look forward to the initiation of additional NCI-sponsored clinical trials throughout 2006 and reporting preliminary results from our studies beginning in mid-2006 and throughout 2007.
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, including 5-fluorouracil (5-FU), carboplatin, paclitaxel, and Velcade(R). 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 several 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 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 signed a 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 and its experienced drug development teams are advancing the Company's pipeline of products that aim to address the unmet medical needs of patients. 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, headquartered in Denmark and with subsidiaries in the UK and Germany, and 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 key cancer enzyme regulators (mainly HDAC, mTOR, and topoisomerase II inhibitors) and a strong development foundation of proprietary, highly predictive cancer models has been built. TopoTarget has a broad portfolio of small molecule preclinical drug candidates and eight drugs are 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 on the market end 2006. 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.
Safe Harbor
This press release contains forward-looking statements, including statements about the potential effects of PXD101, both as a single agent and in combination with currently used anti-cancer therapies. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. CuraGen cautions 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: CuraGen's stage of development as a biopharmaceutical company, uncertainties of clinical trials, government regulation and healthcare reform, technological uncertainty and product development risks, product liability exposure, uncertainty of additional funding, CuraGen's history of incurring losses and the uncertainty of achieving profitability, reliance on research collaborations and strategic alliances, competition, patent infringement claims against CuraGen's products, processes and technologies, CuraGen's ability to protect its patents and proprietary rights and uncertainties relating to commercialization rights. Please refer to our Annual Report on Form 10-K for the period ended December 31, 2005 for a description of these risks. We disclaim 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: Glenn Schulman, Pharm.D. Assistant Director of Investor Relations gschulman@curagen.com (888) 436-6642
CuraGen CorporationCONTACT: Glenn Schulman, Pharm.D., Assistant Director of InvestorRelations of CuraGen Corporation, gschulman@curagen.com, 1-888-436-6642
