BRANFORD, Conn., May 30 /PRNewswire-FirstCall/ -- CuraGen Corporation , a biopharmaceutical company advancing a pipeline of promising oncology therapeutics, announced today the initiation of patient dosing in a Phase II clinical trial evaluating a single dose of velafermin for the prevention of oral mucositis (OM). This clinical trial, the second Phase II study of velafermin, is designed to assess the safety and efficacy of velafermin for the prevention of OM in cancer patients receiving high-dose chemotherapy, with or without radiotherapy, in the setting of autologous bone marrow transplantation (BMT).
"Based on the data generated in our initial Phase II trial, which we believe demonstrated the activity of a single dose of velafermin, CuraGen and our investigators are very excited to begin enrolling patients in this potentially pivotal trial that is designed to confirm the safety and activity of 30 micrograms/kilogram (mcg/kg) velafermin for the prevention of severe oral mucositis. CuraGen is committed to advancing this promising program through development, and we look forward to the availability of data from this clinical trial during the third quarter of 2007," stated Dr. Frank M. Armstrong, President and Chief Executive Officer of CuraGen.
This multi-center, randomized, double-blind, placebo-controlled, Phase II trial will enroll approximately 400 patients. The primary endpoint is the incidence of severe (WHO Grade 3 or 4) OM following intravenous administration of 30 mcg/kg velafermin compared to placebo. Secondary endpoints being evaluated include duration of OM, patient self-reported pain score, use of pain medications, the incidence and duration of febrile neutropenia, and use of enteral or parenteral nutrition. Patients receiving one of three common myeloablative regimens prior to autologous BMT for the treatment of multiple myeloma, Hodgkin's lymphoma, or non-Hodgkin's lymphoma will be eligible for enrollment at approximately 30 to 40 sites across the United States.
Approximately 150 patients will be enrolled into each of the 30 mcg/kg velafermin and placebo arms. The trial is designed to have 90% power to detect a 20% absolute effect size in the reduction of OM assuming a placebo incidence of OM of approximately 40%. In addition to the primary goal, the trial design includes two secondary comparison arms that will evaluate the effects of a single dose of 10 mcg/kg velafermin and 60 mcg/kg velafermin for the prevention of OM. Approximately 50 patients will be enrolled into each of the secondary arms, which will have 80% power to detect a 30% absolute reduction in OM compared to placebo.
The trial will evaluate the safety and efficacy of velafermin for the prevention of severe OM through 30 days post-dosing, and follow patients for one year to evaluate any potential effects of velafermin on the outcome of cancer treatment. CuraGen anticipates the primary OM efficacy and safety results will be available by the third quarter of 2007, and the one year follow-up data will be available in the third quarter of 2008.
Dr. Armstrong further commented, "In addition to velafermin, we look forward to initiating a Phase I program with CR011vcMMAE, an antibody-drug conjugate that will be evaluated for the treatment of metastatic melanoma, in the coming weeks. We continue to evaluate PXD101 in multiple proof-of-concept trials, and we anticipate that important clinical results from all of these advanced oncology programs will be generated over the next twelve to eighteen months."
About CuraGen
CuraGen Corporation 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 and 454 Life Sciences are headquartered in Branford, Connecticut. For additional information on the companies please visit http://www.curagen.com and http://www.454lifesciences.com.
Safe Harbor
This press release contains forward-looking statements including statements regarding the potential of velafermin for the prevention of oral mucositis, that the Company anticipates that primary OM efficacy and safety results will be available by the third quarter of 2007, and one year follow-up data will be available in the third quarter of 2008, that the Company expects to initiate a Phase I program with CR011 in the coming weeks, and that the Company anticipates important clinical results from all of its advanced programs over the next twelve to eighteen months. 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 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 Report 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.
CuraGen 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, +1-888-436-6642, gschulman@curagen.com
Web site: http://www.curagen.com//
