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Lentigen Receives U.S. Orphan Drug Designation for Novel Gene Therapy for glioblastoma multiforme
Date:2/13/2013

GAITHERSBURG, Md., Feb. 13, 2013 /PRNewswire/ -- Lentigen Corporation, a biotechnology company specializing in the development and manufacture of lentiviral gene delivery products, announced today that 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.

"We are very pleased that the FDA has granted our brain cancer product orphan drug status," said Tim Ravenscroft CEO of Lentigen Corporation. "The market exclusivity which this designation provides, together with our intellectual property rights, gives us increased impetus to advance the development of this product, enabling us to play our part in improving the lives of patients with glioblastoma."

"LG631-CD34 consists of the patients' adult hematopoietic stem cells genetically modified with a Lentiviral vector expressing a human MGMT gene variant, which is designed to protect the cells from the toxic side-effects of Temodar*, a standard of care treatment for glioblastoma multiforme" said Dr. Boro Dropulic , the Chief Scientific Officer of Lentigen Corporation. "Protection of blood-forming hematopoietic stem cells from the side-effects effects of Temodar would provide immediate benefits to patients. It  potentially enables higher doses and more intensive drug treatment with reduced toxicity, resulting in improved clinical outcomes.

LG631-CD34 is currently being evaluated in a NIH grant-funded Phase I clinical trial (http://www.clinicaltrials.gov/ct2/show/NCT01269424) at University Hospitals (
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SOURCE Lentigen Corporation
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