CureTech Ltd. - a portfolio company of Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) and Clal Biotechnology Industries Ltd. (TASE: CBI) - today announced preliminary successful results of its Phase II clinical trial of CT-011 stem cell treatment of Diffuse Large B Cell Lymphoma. The trial achieved it primary endpoint of improved progression-free survival, and its secondary endpoint of overall survival.
The trial included 72 patients with aggressive lymphoma at 30 centers in the US, Asia, South America and Israel. 70% of the patients had no progression in the disease at the end of the follow-up period, compared with 47% in the historical control. 84% of patients were alive at the end of the follow-up period, compared with 62% in the historical control.
The final results are due in the third quarter, and will be presented at international scientific meetings.
CureTech CEO Dr. Michael Schickler said, "We are very pleased to have achieved this major milestone in the clinical development of CT-011. "Following the final results, CureTech will be ready to commence Phase III regulatory studies for the high unmet need in this severe indication."
Dr. Jacob Rowe, director of the Department of Hematology, Shaare Zedek Medical Center in Jerusalem said, "Diffuse Large B Cell Lymphoma “DLBCL is an aggressive type of non-Hodgkin's Lymphoma, affecting about 40% of all these patients. I am very encouraged by the results of this trial and am certain that if these results will be confirmed in future controlled Phase III studies, CT-011, a truly novel anti cancer therapy will improve the lives of many lymphoma patients."
Teva acquired 33% of CureTech in 2006, following the Phase I trial of CT-011, and it has an option to increase the stake. Teva said that the success of the Phase II trial encourages it to continue investing in Israeli science.
Teva Innovative Ventures head Dr. Aharon Schwartz said, “When we expanded our collaboration with CureTech in 2008, we did so with the intention of building on CT-011’s success up to that point, and we are incredibly pleased with the Phase II data announced today. Our collaboration with CureTech is just one of many oncology investments and alliances that we have made over the last several years in an effort to build out our portfolio of specialty products within niche therapeutic areas like oncology."
More than 400 patients have participated in seven phase II and Phase I/II studies with CT-011 for different cancers, including colon cancer, multiple myeloma, acute leukemia, and pancreatic cancer. CureTech has submitted a protocol to the US Food and Drug Administration (FDA) for a Phase II trial for metastatic melanoma, a severe solid tumor indication with very few treatment options.
Clal Biotech, the life sciences arm of Nochi Dankner-controlled IDB Holding Corp. Ltd. (TASE:IDBH), owns 37% of CureTech.
Published by Globes [online], Israel business news - www.globes-online.com - on May 17, 2011
© Copyright of Globes Publisher Itonut (1983) Ltd. 2011