Glioblastoma Multiforme (GBM) is a malignant tumor that originates from the supportive tissues of the brain. It accounts for 80% of primary brain tumors and results in more years of life lost than any other tumor. It has been reported that 21,000 US patients will be diagnosed with glioblastoma in 2008 and 13,000 die annually from the disease. It is estimated that the disease has a worldwide incidence of 176,000 cases. Current treatment of GBM surgical removal of the tumor followed by radiotherapy and chemotherapy with temozolomide (Temodar, Schering Plough; TMZ). This results in a modest survival benefit because the chemotherapy, while effective, is toxic to bone marrow stem cells, resulting in anemia and lymphocytopenia. This limits the use of Temodar as an effective drug to treat GBM.

LG631 is a stem cell therapy product expressing a variant of methyl guanine methyl transferase (MGMT) enzyme. LG631 is expected be used in combination therapy with the chemotherapeutic drugs temozolomide and benzylguanine (BG), which target the tumor, while alleviating stem cell cytotoxicity. The Company's goal for LG631 is to enable increased dosing and duration of TMZ/BG treatment to levels that significantly improve treatment outcome and prognosis for these patients.

LG631 is scheduled to for phase I clinical trial testing in 2010 at Case University Hospital in Cleveland, Ohio. Information on the clinical trial can be found here.