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Oncology

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 in advanced stages of preparation.

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 glioma

Talampanel is an orally active antagonist of the alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionate (AMPA) neuronal excitatory glutamate receptor, the expression of which has been shown to be upregulated in malignant glioma cells. Talampanel's ability to block AMPA receptors may confer anti-tumor activity against malignant gliomas both in slowing their growth and reducing their ability to invade surrounding brain.

In an on-going phase II study, patients with newly-diagnosed glioblastomas are being treated with talampanel in addition to the current standard treatment which consists of radiation and temozolomide. Talampanel is then continued as an adjuvant therapy following completion of their course of chemoradiotherapy. The trial has completed accrual and the cohort is being followed for the primary endpoint of overall survival.

Talampanel was discovered at the Institute for Drug Research in Budapest, Hungary and was developed by Ivax Research, Inc.

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