NeuroGenomeX, Inc. Announces Pre-IND Meeting with FDA
May 2012, Madison, WI -- NeuroGenomeX, Inc, a bio-pharmaceutical company developing treatments for epilepsy and related neurological diseases, announced today that the Company has completed a pre-investigational new drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) to determine the regulatory and clinical pathway to advance its anti-epilepsy compound, 2-deoxy-D-glucose (2DG), for the treatment of intractable epilepsy. Approximately half of epilepsy patients do not receive adequate relief from current anti-epilepsy drugs.
"Despite the availability of many anti-epilepsy drugs on the market, approximately 1.5 million people with epilepsy still suffer a few seizures a month to hundreds of seizures each day," said Jacqueline Doeler, President of NeuroGenomeX. "In pre-clinical models of epilepsy, 2DG has been demonstrated to be an effective inhibitor of epilepsy, and by a completely different mechanism of action compared to existing anti-epilepsy drugs."
"We are very pleased with the outcome of our Pre-IND interaction with the FDA," commented Dr. Thomas Sutula, CSO of NeuroGenomeX. "The FDA was very supportive of our efforts to advance a novel treatment for epilepsy. As a result of the feedback we received on our Pre-IND package, we believe we have clear visibility for the required pathway to complete our toxicity testing for 2DG."
Founded in 2001, Madison, Wisconsin-based NeuroGenomeX has advanced the use of 2DG for epilepsy, including epilepsy resulting from traumatic brain injury (TBI). 2DG has previously completed Phase I and Phase II clinical trials as an anti-cancer agent, and has been used in human studies for over two decades.