CureTech Ltd. Announces Encouraging Phase I Clinical Trial Results In Cancer Patients With Its Monoclonal Antibody CT-011
10/19/2005 5:13:15 PM
YAVNE, Israel--(BUSINESS WIRE)--April 11, 2005--
CT-011 Was Well Tolerated with No Treatment Related Toxicities; Clinical Responses Were Observed in Several Patients Seven to Eight Months Post Treatment
CureTech Ltd, a biotechnology company focused on the research, development and commercialization of novel, broad-spectrum, immune-modulating products for the treatment and control of cancer, announced today completion of its Phase I clinical trial of CT-011, a humanized monoclonal antibody directed against a B7 family-associated protein, in patients with advanced hematological malignancies. The purpose of this first in human clinical study, which took place at the Chaim Sheba Medical Center in Tel-Hashomer, Israel, was to evaluate the safety and determine the maximal tolerated dose of CT-011 single intravenous administration in cancer patients.
The safety profile of CT-011 was evaluated in 17 patients suffering from advanced-stage hematological malignancies. CT-011 was given in a single 5h IV infusion at escalating doses. One patient, at the lowest level, was re-enrolled five months subsequent to the first administration at a higher dose level. Results showed that CT-011 was safe and well tolerated with no treatment-related toxicities. Common adverse events included minimal allergic reactions and low grade fever. No single maximal tolerated dose was found in this study.