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Nyxis Neurotherapies Announces the Submission of an Investigational New Drug Application (IND) to the FDA for Its Lead Glyxin, NT-13.

CHICAGO -- Nyxis Neurotherapies Inc. ( ) today announced that on July 26, 2002, it submitted an Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) in preparation for beginning clinical trials of NT-13, its lead compound in development for the treatment of neuropathic pain and cognitive enhancement.

NT-13, which is derived from a family of compounds discovered by Nyxis Neurotherapies called glyxins, represents a novel therapeutic approach in the treatment of neurological disorders. The drug was designed as a partial agonist with the ability to both stimulate (agonist) and inhibit (antagonist) the activity of the central nervous system's NMDA receptors. These receptors are known to play a significant role in multiple neurological conditions, but prior attempts to modulate them have been plagued by lack of efficacy, specificity and/or serious side effects. In pre-clinical studies, NT-13 demonstrated significant efficacy extending beyond its plasma half-life and a favorable side effect profile at up to 100 times the therapeutic dose level. Based on these results, Nyxis plans to initiate two clinical trials: 1) a Phase I safety study to evaluate NT-13 in healthy volunteers -- leading to a Phase II study in neuropathic pain patients 2) a Phase I/IIa study to test the efficacy of NT-13 as a cognitive enhancer in healthy volunteers.

"Nyxis has made substantial technical progress over the past 18 months. We have filed patents, proven efficacy in animal models, completed the pre- clinical studies and now filed our first IND. We are extremely encouraged with both our NT-13 pre-clinical results and our favorable interactions with the FDA regarding its continued development," said Christopher Price, Nyxis' CEO. "Our next step is to seek financial investors to support the financing of these trials. With that goal in mind, we have identified a venture capital firm that has committed to trying to organize an appropriate financial syndicate."

Worldwide more than 400 million people suffer from neurological disorders, associated with, hypo or hyper-activity of the NMDA receptor. These conditions include: memory loss associated with Alzheimer's disease and normal aging, withdrawal from heroin and alcohol addiction, depression, neuropathic pain and stroke.

Nyxis Neurotherapies is a privately-held, research-driven biotechnology company focused on the discovery, development and commercialization of therapeutics to treat a wide variety of neurological conditions. Nyxis Neurotherapies uses a proprietary, monoclonal antibody-derived custom peptide (MADCP) technology platform to produce highly-targeted neuro-therapeutic compounds. Headquartered in Chicago, Nyxis Neurotherapies is affiliated with both Northwestern University's I-Tech Center and its biomedical engineering department's Falk Center for Molecular Therapeutics.


Contact: investors, Christopher Price, +1-703-314-2801, or Joseph Moskal, +1-773-551-6395, both of Nyxis Neurotherapies Inc.; or media, Wendy Emanuel, +1-773-255-9580, for Nyxis Neurotherapies Inc.

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Publication:PR Newswire
Date:Jul 31, 2002
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