-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, NGNWtYL6Ip3CWKI10feVQOaZnEFFk/QsyHaYfNtzodbJgDefJMOUNUf4Y/ilgWqH cS27gD22Jd71OSaYRlTShg== 0001047469-98-038027.txt : 19981026 0001047469-98-038027.hdr.sgml : 19981026 ACCESSION NUMBER: 0001047469-98-038027 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19981016 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19981023 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: COCENSYS INC CENTRAL INDEX KEY: 0000895034 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330538836 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-20954 FILM NUMBER: 98729843 BUSINESS ADDRESS: STREET 1: 201 TECHNOLOGY DR CITY: IRVINE STATE: CA ZIP: 92618 BUSINESS PHONE: 9497536100 MAIL ADDRESS: STREET 1: 201 TECHNOLOGY DRIVE STREET 2: 201 TECHNOLOGY DRIVE CITY: IRVINE STATE: CA ZIP: 92618 8-K 1 FORM 8-K SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ------------ FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of report (Date of earliest event reported): OCTOBER 16, 1998 ---------------- COCENSYS, INC. -------------- (Exact Name of Registrant as Specified in Charter) DELAWARE 0-20954 33-0538836 - -------- ------- ---------- (State or Other (Commission (IRS Employer Jurisdiction of File Number) Identification No.) Incorporation) 201 TECHNOLOGY DRIVE, IRVINE, CALIFORNIA 92618 - ---------------------------------------- ----- (Address of Principal Executive Office) (Zip Code) Registrant's telephone number, including area code: (949) 753-6100 -------------- ITEM 5. OTHER EVENTS. Attached hereto as Exhibit 99.1 is a copy of a Press Release issued on behalf of the Registrant announcing clinical results from the Registrant's Phase II trial of ganaxolone for acute migraine. ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS. (a) Not applicable. (b) Not applicable. (c) EXHIBITS. The following exhibits are attached to this Current Report on Form 8-K:
Sequential Exhibit Description Page Start ------- ----------- ---------- 99.1 Press Release entitled "CoCensys Announces Clinical 3 Results from Phase II Migraine Trial" dated October 16, 1998
SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. COCENSYS, INC. -------------- (Registrant) Date: October 20, 1998 By: /s/ Robert R. Holmen ------------------------------------ Robert R. Holmen, Vice President, General Counsel and Secretary EX-99.1 2 EXHIBIT 99.1 CONTACT: F. RICHARD NICHOL, PH.D. LUCY MORRISON PRESIDENT & CHIEF EXECUTIVE OFFICER DIRECTOR COCENSYS, INC. FEINSTEIN KEAN PARTNERS 949/753-6110 OR 753-6122 617/577-8110 JOANN L. DATA, M.D., PH.D. EXECUTIVE VICE PRESIDENT, PRODUCT DEVELOPMENT & REGULATORY AFFAIRS COCENSYS, INC. 949/753-6110 OR 753-6122 COCENSYS ANNOUNCES CLINICAL RESULTS FROM PHASE II MIGRAINE TRIAL CORPORATE STRATEGY TO LEVERAGE PIPELINE FOR NEAR-TERM VALUE AND LONG-TERM FINANCIAL STABILITY IRVINE, CALIFORNIA/PR NEWSWIRE/OCTOBER 16, 1998 - CoCensys, Inc. (Nasdaq: COCN) today announced results from its Phase II clinical trial using a tablet formulation of ganaxolone for acute migraine. While the patients receiving ganaxolone reported pain relief at a rate in excess of those receiving placebo, the difference was not statistically significant. The Company did achieve statistically significant results in pain relief at two hours in a subset of forty-five female patients who were dosed with ganaxolone or placebo within five days following start of menses. Based on the results of the trial, the Company intends to seek a collaboration partner to develop ganaxolone for migraine prophylaxis as well as for epilepsy, for which the drug has shown promising results in previous clinical trials. The Company also will seek a collaboration partner to develop backup compounds to ganaxolone for acute migraine therapy. The migraine trial was a double-blind, placebo-controlled study involving 325 female and male migraine patients at 19 clinical sites throughout the United States. The out-patient trial was designed to assess the safety, tolerability and efficacy of a single dose of a tablet formulation of ganaxolone, building on the encouraging results seen in a prior Phase II clinical trial using a liquid suspension formula of ganaxolone for acute migraine therapy. Primary endpoints for the trial were pain relief at two and four hours post-dosing. Joann L. Data, M.D., Ph.D., Executive Vice President, Product Development and Regulatory Affairs, reported: "Ganaxolone is a synthetic version of naturally occurring neuroactive compounds known as epalons which bind to the GABAA receptors in the brain. This trial once again supported the safety of ganaxolone and the epalons in general; we did not see any serious adverse events nor any cardiovascular side effects associated with ganaxolone. The only statistically relevant side effects that occurred in patients receiving ganaxolone were, as predicted, somnolence, dizziness and fatigue." "Based on the results of the trial, we have initiated a strategy for CoCensys designed to leverage the Company's very broad scientific and clinical resources through collaborations," said F. Richard Nichol, Ph.D., President and Chief Executive Officer of CoCensys. "As of September 30, 1998, we had in excess of $15 million in cash, which will keep us funded well into 1999. To capitalize on the value of our portfolio and to ensure the long-term financial stability of the Company, we will: - - First, focus immediately on identifying a corporate partner to proceed with development of ganaxolone for epilepsy. This will capitalize on the positive results achieved in previous adult and pediatric epilepsy trials. - - Second, seek a partner to develop ganaxolone for migraine prophylaxis. Ganaxolone may have a similar mechanism of action to another drug approved for migraine prophylaxis (divalproex sodium). - - Third, seek a partner to develop epalon analogs for acute migraine. - - Fourth, identify a corporate partner for our program to develop sodium channel blockers for the treatment of neuropathic pain and epilepsy." Dr. Nichol noted that CoCensys currently has development programs with the Wyeth-Ayerst Laboratories Division of American Home Products to develop epalons for the treatment of anxiety and with Warner-Lambert Company to identify and develop sub-type selective NMDA receptor antagonists for the treatment of a variety of neurological and psychiatric diseases such as cerebral ischemia, Parkinson's disease, epilepsy and chronic pain. CoCensys is a biopharmaceutical company that discovers and develops products for the treatment of neurological and psychiatric disorders. The Company's product development programs focus on novel small molecule compounds for the treatment of epilepsy, anxiety, Parkinson's and other neurodegenerative diseases, neuropathic pain, migraine, insomnia and stroke. More information about the Company is available on its web site: http://www.cocensys.com. This press release includes forward looking statements that involve a high degree of technological, regulatory and competitive risks and uncertainties inherent to early stage biopharmaceutical companies. Actual results may differ due to a number of factors, including the fact that preclinical testing and clinical trial results are not necessarily predictive of whether future testing and trials will replicate or confirm these results or whether a therapeutic agent will succeed in subsequent clinical trials or be approved by the FDA or other regulatory agency as a drug, as well as those factors that are more fully discussed in the Company's most recent Form 10-K and Form 10-Q. ### -----END PRIVACY-ENHANCED MESSAGE-----