Cleveland, OH. and Gaithersburg, MD. University Hospitals (UH) Case Medical Center, Case Western Reserve University School of Medicine and Lentigen Corporation announced today the initiation of a novel Phase I clinical trial of LG631 gene therapy for the protection of hematopoietic stem cells (HSCs) from the dose limiting toxicity of chemotherapy with Temodar.
Approximately 17,000 Americans are diagnosed with glioblastoma every year and only two percent of them survive longer than five years even with aggressive treatment. Glioblastoma (GBM) treatment generally begins with a surgical resection, followed by radiation therapy and then chemotherapy to destroy any remaining cancer cells. Temodar (temozolomide, Merck and Co., Inc.) is a standard treatment of glioblastoma, but dose-limiting bone marrow toxicity often accompanies such therapy.
In this first-of-its-kind study, researchers are investigating if LG631 can potentially improve tolerance and effectiveness of chemotherapy for GBM by preventing damage to bone marrow. The study will evaluate the safety of this treatment and its potential to enhance current GBM treatments.
For this study, HSCs will be isolated from participating patients, transduced with LG631, an altered human-Methylguanine Methyltransferase (MGMT) gene to make them resistant to Temodar, and then infused back into the patient. The MGMT gene has been shown to repair damaged DNA. The specially designed Lentiviral vector (LG631) will be used to deliver the gene specifically to bone marrow stem cells that are susceptible to damage by drugs commonly used to treat cancer, thereby enabling patients to receive higher doses of Temodar with less severe side effects.
"Glioblastoma is a devastating disease and many patients do not benefit from standard therapy," notes Dr. Andrew Sloan, Director of the Brain Tumor and Neuro-Oncology Center, UH Case Medical Center and Associate Professor of Neurological Surgery and
|Contact: Alicia Reale|
University Hospitals Case Medical Center