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New Data On Zogenix (ZGNX)’s ZX008 For Lennox Gastaut Syndrome & Dravet Syndrome To Be Presented At 70th Annual American Epilepsy Society Meeting



11/23/2016 7:44:27 AM

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  • Interim Results of Investigator Initiated Phase 2 study of ZX008 in Lennox Gastaut Syndrome to be Presented

  • Update from Ongoing Open-Label Prospective Study of ZX008 in Dravet Syndrome Will Also be Presented

EMERYVILLE, Calif., Nov. 22, 2016 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of orphan and central nervous system (CNS) disorders, today announced the presentation of four clinical and scientific posters, and the hosting of a scientific exhibit room at the 70th Annual American Epilepsy Society (AES) meeting, which will take place at the George R. Brown Convention Center in Houston, Texas, from December 2 - 6, 2016.

Four posters highlighting the results of investigator initiated studies will be available in the main exhibitor hall of the congress.  One poster will highlight the interim results for patients who have completed at least 8 weeks of treatment in a Phase 2 study of ZX008 (low-dose fenfluramine) in Lennox Gastaut syndrome (LGS).  The second poster will provide an update from the ongoing open-label prospective study of ZX008 in Dravet syndrome. A third poster will be the first to evaluate the potential protective effect of fenfluramine in an accepted pre-clinical model of Sudden Unexpected Death in Epilepsy (SUDEP).  The fourth poster will discuss findings from roundtable discussions with parents and caregivers of children with Dravet syndrome that sought to identify those aspects of caregivers’ lives that are most impacted by caring for a child with Dravet syndrome.

In addition, on Sunday, December 4, from 8:00am to 5:00pm, Zogenix will be hosting a Scientific Exhibit Room entitled, “Evolution of Low-Dose Fenfluramine in the Treatment of Epileptic Encephalopathies: New Understandings of the Mechanisms, Basic Science, and Clinical Data.”  In this Scientific Exhibit Room, the Company will highlight important ZX008-related research that has been conducted over the last year, including scientific posters that will not be available in the main exhibitor hall of the AES meeting. Poster authors will be available to answer questions on their data at specified times.  An agenda of the events in the Scientific Exhibit Room can be found here: http://www.zogenix.com/aes2016scientificpresentations.

Zogenix at the 70th Annual American Epilepsy Society Meeting
  
Title:Fenfluramine Blocks Seizure-Induced Death in the DBA/1
Mouse Model of SUDEP
Presenter:Carl Faingold, Ph.D., Distinguished Professor & Chairman of Department
of Pharmacology, Southern Illinois University School of Medicine
Date:Poster Session 1, Saturday, December 3, 2016
Poster Session #:  1.365
  
Title:Effectiveness and Tolerability of Low Dose Fenfluramine (ZX008) In
Lennox Gastaut Syndrome: A Pilot, Open-Label Dose Finding Study
Presenter:Lieven Lagae, M.D., Ph.D., Professor at the University of Leuven,
Belgium, Head of the Pediatric Neurology Department and Director of the
Childhood Epilepsy Program at the University of Leuven Hospitals
Date:Poster Session 1, Saturday, December 3, 2016
Poster Session #:1.369
  
Title:How Does Caring for a Child With Severe, Refractory Epilepsy Affect
Lives of Caregivers? Results From Focus Groups and Interviews
with Caregivers
Presenter:Dagmar Amtmann, Ph.D., Research Professor, Department of
Rehabilitation Medicine, University of Washington
Date:Poster Session 2, Sunday, December 4, 2016
Poster Session #:2.266
  
Title:Low-Dose Fenfluramine Significantly Reduces Seizure Frequency In
Dravet Syndrome: Update of the Prospective Study
Presenter:Dr. An-Sofie Schoonjans, Department of Neurology, Paediatric
Neurology, Antwerp University Hospital, University of Antwerp, Belgium
Date:Poster Session 3, Monday, December 5, 2016
Poster Session #:3.366
  
ZX008 Scientific Exhibit Room: Evolution of Low-Dose Fenfluramine in the Treatment of
Epileptic Encephalopathies: New Understandings of the Mechanisms, Basic Science, and
Clinical Data
  
Date:Sunday, December 4, 2016
Time:8:00 AM to 5:00 PM
Location:  Scientific Exhibit Room 340A
 Level 3 of the George R. Brown Convention Center

About Zogenix

Zogenix, Inc. (Nasdaq:ZGNX) is a pharmaceutical company committed to developing and commercializing CNS therapies that address specific clinical needs for people living with orphan and other CNS disorders who need innovative treatment alternatives to improve their daily functioning.

For more information, visit www.zogenix.com.

Forward Looking Statements

Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding ZX008’s potential as a treatment for seizures associated with Dravet syndrome; the enrollment of patients in the two on-going Phase 3 clinical trials for ZX008; the timing of top line results for the two on-going Phase 3 clinical trials; the timing of any NDA submission; the timing of the commencement of Cohort 2 of Study 1504; the presentation of data at the American Epilepsy Society Annual Meeting ; and revised 2016 financial guidance. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: the uncertainties associated with the clinical development and regulatory approval of product candidates such as ZX008, including potential delays in the commencement, enrollment and completion of clinical trials; the potential that earlier clinical trials and studies may not be predictive of future results; Zogenix's reliance on third parties to conduct its clinical trials, enroll patients, manufacture its preclinical and clinical drug supplies and manufacture commercial supplies of its drug products, if approved; unexpected adverse side effects or inadequate therapeutic efficacy of ZX008 that could limit approval and/or commercialization, or that could result in recalls or product liability claims; Zogenix's ability to fully comply with numerous federal, state and local laws and regulatory requirements, as well as rules and regulations outside the United States, that apply to its product development activities; Fast Track designation may not result in an expedited regulatory review process; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

CONTACT: Investors: Andrew McDonald Founding Partner, LifeSci Advisors LLC 646-597-6987 | Andrew@lifesciadvisors.com

Read at BioSpace.com


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