CuraGen Corporation has announced results presented from a Phase I clinical trial with CG53135 for the prevention of oral mucositis (OM) in patients receiving high dose chemotherapy (HDCT) followed by autologous hematopoietic stem cell transplantation (AHSCT) at the ASH 46th Annual Meeting in San Diego, CA.
Results from this Phase I study suggest that CG53135 is well tolerated following intravenous administration and support the company's strategy to investigate in Phase II the safety and efficacy of a single dose of CG53135 for the prevention of oral mucositis.
"Oral mucositis is a severe side effect experienced by patients undergoing bone marrow transplants receiving high-dose chemotherapy. A drug with the ability to prevent and treat this condition has the potential to avoid complications associated with OM and improve patients' quality of life," stated Michael W. Schuster, M.D., Principal Investigator, Professor of Clinical Medicine in the Division of Hematology/Oncology at the Weill Medical College of Cornell University, and Director of Stem Cell Transplantation at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. "Based on the results from this Phase I study, I look forward to investigating the efficacy of this molecule in an expanded Phase II clinical trial."
"We are very pleased with the results from this Phase I safety study and look forward to establishing the efficacy of CG53135 for the prevention of oral mucositis in our recently initiated Phase II program," stated William Hahne, M.D., Vice President of Clinical Development. "We are also excited to initiate an additional Phase I program that will evaluate the safety and potential efficacy of CG53135 for the treatment of active OM."
Data available on 22 of the 30 patients dosed to date with CG53135 were presented in a poster entitled, "Phase I Trial of CG53135-05 to Prevent Mucositis in Patients Undergoing High-Dose Chemotherapy (HDCT) and Autologous Hematopoietic Stem Cell Transplantation (AHSCT)." Primary objectives for the study were the evaluation of safety, tolerability, and pharmacokinetics following a single-dose of CG53135. As a secondary objective, the study assessed the development of OM using the WHO oral mucositis assessment scale. Patients received a single-dose of 0.03, 0.1, 0.2, or 0.33 mg/kg CG53135 administered intravenously one day after infusion of blood stem cells following high-dose chemotherapy.