CuraGen Corporation, a biopharmaceutical company advancing a pipeline of promising oncology therapeutics, announced 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-centre, randomized, double-blind, placebo-controlled, Phase II trial will enrol 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 enrolment 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 per cent power to detect a 20 per cent absolute effect size in the reduction of OM assuming a placebo incidence of OM of approximately 40 per cent. 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 per cent power to detect a 30 per cent 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."