Lentigen Corporation announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug status to P140K methylguanine methyltransferase (MGMT) transduced human CD34 cells (product name: LG631-CD34) for bone marrow protection in the treatment of glioblastoma multiforme. Orphan drug designation qualifies Lentigen for seven years of market exclusivity following marketing approval by the FDA and provides other development-related incentives. LG631-CD34 is currently being evaluated in a NIH grant-funded Phase I clinical trial at University Hospitals (UH) Case Medical Center under the leadership of Stanton Gerson, MD, Director of the Seidman Cancer Center at UH Case Medical Center, Director of the National Center for Regenerative Medicine and Case Comprehensive Cancer Center and Asa, Patricia Shiverick - Jane Shiverick (Tripp) Professor of Hematological Oncology at Case Western Reserve University School of Medicine and Andrew Sloan MD, Associate Professor & Vice-Chairman, Department of Neurological Surgery and the Peter D. Cristal Chair of Neurosurgical Oncology at Case Western Reserve University School of Medicine, Director, Brain Tumor and Neuro-Oncology Center, UH Case Medical Center and a member of the Case Comprehensive Cancer Center.

Lentigen Corporation Presents at EBD Group, Inc.'s Biotech Showcase 2012, Jan-10-2012 01:45 PM. Venue: Parc 55 Wyndham San Francisco ­ Union Square, 55 Cyril Magnin Street, San Francisco, 94102, California, United States.

University Hospitals Case Medical Center, Case Western Reserve University School of Medicine and Lentigen Corporation announced 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 2% 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.