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Executive Summary

COCENSYS PLANS MID-1992 IND FILING FOR "EPALON" EPILEPSY COMPOUND to be followed by IND filings for the CNS start-up's "Epalon" compounds for anxiolytic and hypnotic indications. The biopharmaceutical R&D firm's lead compound is intended for the prevention of petit mal seizures and also may prove effective for the treatment of infantile spasms, the company said. CoCensys has characterized and isolated approximately 60 Epalon compounds derived from endogenous metabolites of progesterone. The compounds are said to be highly selective to gamma-aminobutyric (GABA) receptors and therefore have fewer side effects than traditional treatments for epilepsy, insomnia and anxiety, such as sedation and cognitive impairments. In preclinical testing, CoCensys' Epalons demonstrated fewer side effects than the current first-line therapy for petit mal epilepsy, Parke-Davis' Zarontin (ethosuximide), the company said. Epalon compounds are allosteric modulators, which work by enhancing the activity of the GABA inhibitory neurotransmitter to control over-active nerve responses, CoCensys explained. Benzodiazepines and barbituates, which are also allosteric modulators, can cause adverse effects because they bind to other receptors throughout the brain. CoCensys claims that its Epalons are recognized by a unique receptor that is distinct from those for benzodiazepines and barbituates and therefore show "a lower level of toxicity" and side effects. In preparation for moving the start-up into the clinical development phase, CoCensys recruited former Adria Labs North America President Daniel Korpolinski as president and CEO. Korpolinski, who also was with Upjohn for 24 years, succeeds company cofounder Robert McNeil, PhD, who moved to chairman. In other executive moves, former Sigma-Tau VP-Clinical Research Donald Ashbrook, PhD, has joined the firm as VP- scientific affairs. Kelvin Gee, PhD, another CoCensys cofounder, was promoted to chief scientific officer. Privately-held CoCensys, based in Irvine Calif., was founded in 1989 by Gee, McNeil, researchers at the University of Southern California School of Pharmacy and Fred Middleton of Sanderling Ventures. USC holds the domestic patents to the therapeutic uses of Epalon compounds, while CoCensys holds the international patents. CoCensys licenses the rights to Epalons from USC and currently has no other academic or corporate R&D affiliations. However, the company is looking to enter corporate partnerships. CoCensys has raised $ 3.7 mil. since its founding from venture capital firms including Sanderling, Domain Partners, U.S. Venture Partners, Abingworth Management Ltd., Biotechnology Investments Ltd. and Security Pacific Capital Corp.

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