Clal Biotechnology Industries Ltd. (TASE: CBI) today announced that portfolio company CureTech Ltd. achieved encouraging results in a Phase II clinical trial of CT-011 for the treatment of metastatic melanoma, but that a second Phase II clinical trial of the same drug for the treatment of metastatic colorectal cancer failed to achieve its primary and secondary endpoints.
The melamona efficacy study included 103 patients in the US and Israel who had failed to respond to previous therapies, including new therapies that are considered the best in the market. The study did not include a control group, because cancer patients in clinical trials are not given placebos. The study's primary endpoint was the objective response rate in the number of tumors, which showed a moderate positive response of 10%. The secondary endpoint, the 12-month survival rate following the study, was a very good rate of 65%.
Clal Biotech said that the results were good compared with similar treatments undergoing Phase II studies, which had a survival rate of 60%.
Clal Biotech said that the results of the study, together with previous good results in a lymphoma clinical trial, were sufficient to support efforts to find a partner to commercialize CT-011. It added that the primary endpoint in a Phase III clinical trial would be the survival rate. A different primary endpoint had originally been envisioned, because of the difficulty in proving substantial survivability over 12 months in cancer patients.
The Phase II clinical trial of CT-011 for metastatic colorectal cancer included 171 patients in the US, Romania, Bulgaria, India, and Peru. In this trial, both the objective response rate and the progression free survival rate were highly variable, and failed to meet the endpoints.
CureTech is one Clal Biotech's most promising drug development portfolio companies. It previously had a cooperation agreement with Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA), which terminated the agreement as part of former CEO Jeremy Levin's reassessment. Time will tell whether Teva made the right decision when it decided to forego CT-011.
Published by Globes [online], Israel business news - www.globes-online.com - on November 7, 2013
© Copyright of Globes Publisher Itonut (1983) Ltd. 2013