Oncology

Product	Indication	Status
Stem Ex® (with Gamida-Cell)	Hemato-oncological indications	Phase III
Talampanel	Gliblastoma	Phase II
Various other programs		Research & Clinical

StemEx™

StemEx™ is a cell therapy product, composed of cord blood-derived allogeneic stem cells. A proprietary technology, developed by GamidaCell, an Israeli start-up company, enables preferential expansion of hematopoietic stem and early progenitor cells, to be applied as an alternative for bone marrow transplants in patients with hematological malignancies undergoing myeloablative high dose chemotherapy. A phase I/II clinical study has been completed by GamidaCell with encouraging results. A Phase III study with StemEx™ has been recently approved by the FDA�s Special Protocol Assessment procedure and is recruiting. Teva has entered into a Joint Venture with GamidaCell for the co-development and marketing of StemEx™ for global markets.

Selected publications :

Peled T. et al. Br. J. Hematol (2002); 116 :655 - 661
Peled T. et al. Exp. Hematol.(2004); 32: 547-55

Talampanel for gliblastoma

Talampanel's ability to block AMPA receptors may act against malignant gliomas, both slowing their growth and reducing their ability to invade brain tissues. An ongoing Phase II study is currently being conducted by a consortium of nine clinical centers in the U.S. (NABTT) with 72 patients with newly diagnosed glioblastomas being treated with talampanel as an adjuvant therapy (in addition to their standard treatment) throughout their course of chemoradiotherapy. The Phase II study is scheduled to end by the third quarter of 2008. Interim results seem promising and were presented in ASCO on May 2008. A Phase III study is planned for 2009.

Selected publications:

Takano T, Lin J H-C, Arcuino G, et. al. Glutamate release promotes growth of malignant gliomas. Nature Med (2001);7:1010-1015
Ishiuchi S et al. Blockade of Ca2+-permeable AMPA receptors suppresses migration and induces apoptosis in human glioblastoma cells. Nature Med. (2002);8, 971-978.
S. A. Grossman, X. Ye, M. C. Chamberlain, T. Mikkelsen, T. T. Batchelor, S. Desideri, S. Piantadosi, H. A. Fine. Phase II trial of talampanel in conjunction with standard radiation (RT) and temozolomide (TMZ) in patients with newly diagnosed glioblastoma (GBM). J Clin Oncol 26: 2008 (May 20 suppl; abstr 2014).