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CureTech Announces Encouraging Phase I Clinical Trial Results in Cancer Patients With Its Monoclonal Antibody CT-011

Posted on: Monday, 11 April 2005, 09:00 CDT

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.

Furthermore, despite the advanced stage of their disease, clinical responses were observed, to date, in five patients. One patient is exhibiting partial response for over eight months, and two additional patients have seen no disease progression for more than seven months. Minimal response to treatment has been observed in two additional patients. Four other patients, with an average of three months of follow up, are alive with active disease. Follow up on the patients continues.

"To have achieved clinical responses in patients that have failed all other available therapies is very encouraging," said Dr. Michael Schickler, CEO of CureTech. "CureTech's mission is to extend the life of cancer patients and to offer them the best quality of life. These results are heartening because they show the tremendous potential for CT-011."

Professor Arnon Nagler, Director of the Division of Hematology Bone Marrow Transplantation and Cord Blood Bank at the Chaim Sheba Medical Center was the senior investigator of the study. Prof. Nagler commented, "It appears that safety and toxicity issues were extremely well managed in the study. The clinical responses observed in the study are encouraging, for example, the one patient who became platelet transfusion-independent. When we first met the patient, she was diagnosed with a few weeks to live. Today, the patient is eight months post first CT-011 infusion. These results clearly support further clinical development of CT-011. One possibility is to evaluate the combination of CT-011 and donor lymphocyte infusion for patients with hematological malignancies having minimal residual disease after stem cell transplantation."

CureTech is developing a series of antibodies and peptide-based vaccines designed to enhance the immune response, directing it against the developing cancer. CT-011 is the first product to enter human clinical evaluation.

About CureTech

CureTech, initiated its operations in 2001, focuses on the research, development and commercialization of novel, broad-spectrum, immune modulating products for the treatment and control of cancer. CureTech products offer an alternative approach to current biological cancer treatment by directly affecting specific functions of the immune system thus providing the safety inherent to antibody-based therapy and the ability to target a wide spectrum of malignancies. CureTech's lead drug, CT-011, a humanized monoclonal antibody directed against a B7 family-associated protein, has completed Phase I clinical testing. For further information about the company, please visit www.curetechbio.com.

Source: Business Wire

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