EpiCept Corporation – Product Pipeline Review – H2 2011 by GlobalMarketsDirect

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									EpiCept Corporation – Product Pipeline Review




   EpiCept Corporation – Product Pipeline Review – H2
                          2011


                                                                                          Reference Code: GMDHC02135CDB
                                                                                                 Publication Date: DEC 2011




EpiCept Corporation – Product Pipeline Review – H2 2011                                   GMDHC02135CDB / Published DEC 2011
© Global Markets Direct. This report is a licensed product and is not to be photocopied                               Page(1)
EpiCept Corporation – Product Pipeline Review




Table of Contents
Table of Contents ............................................................................................................................................................................... 2
    List of Tables ................................................................................................................................................................................. 5
    List of Figures ................................................................................................................................................................................ 6
EpiCept Corporation Snapshot ........................................................................................................................................................... 7
    EpiCept Corporation Overview ...................................................................................................................................................... 7
    Key Information ............................................................................................................................................................................. 7
    Key Facts....................................................................................................................................................................................... 7
EpiCept Corporation – Research and Development Overview ........................................................................................................... 8
    Key Therapeutic Areas .................................................................................................................................................................. 8
EpiCept Corporation – Pipeline Review............................................................................................................................................ 10
    Pipeline Products by Stage of Development ............................................................................................................................... 10
    Pipeline Products – Monotherapy ............................................................................................................................................... 11
    Pipeline Products – Combination Treatment Modalities .............................................................................................................. 12
EpiCept Corporation – Pipeline Products Glance ............................................................................................................................. 13
    EpiCept Corporation – Late Stage Pipeline ................................................................................................................................. 13
        Phase III Products/Combination Treatment Modalities ........................................................................................................... 13
    EpiCept Corporation Clinical Stage Pipeline Products ................................................................................................................ 14
        Phase II Products/Combination Treatment Modalities ............................................................................................................ 14
        Phase I Products/Combination Treatment Modalities ............................................................................................................. 15
EpiCept Corporation – Drug Profiles ................................................................................................................................................ 16
    Aldesleukin + Ceplene ................................................................................................................................................................. 16
        Product Description................................................................................................................................................................. 16
        Mechanism of Action ............................................................................................................................................................... 16
        R&D Progress ......................................................................................................................................................................... 16
    Ceplene ....................................................................................................................................................................................... 18
        Product Description................................................................................................................................................................. 18
        Mechanism of Action ............................................................................................................................................................... 18
        R&D Progress ......................................................................................................................................................................... 18
    Crolibulin ..................................................................................................................................................................................... 20
        Product Description................................................................................................................................................................. 20
        Mechanism of Action ............................................................................................................................................................... 20
        R&D Progress ......................................................................................................................................................................... 20
    Epicept NP-1 ............................................................................................................................................................................... 21
        Product Description................................................................................................................................................................. 21
        Mechanism of Action ............................................................................................................................................................... 21
        R&D Progress ......................................................................................................................................................................... 21
EpiCept Corporation – Pipeline Analysis .......................................................................................................................................... 22
    EpiCept Corporation – Pipeline Products by Therapeutic Class .................................................................................................. 22
    EpiCept Corporation - Pipeline Products By Target..................................................................................................................... 23
    EpiCept Corporation – Pipeline Products by Route of Administration ......................................................................................... 24
    EpiCept Corporation – Pipeline Products by Molecule Type ....................................................................................................... 25
EpiCept Corporation – Recent Pipeline Updates............................................................................................................................. 26



EpiCept Corporation – Product Pipeline Review – H2 2011                                                                                 GMDHC02135CDB / Published DEC 2011
© Global Markets Direct. This report is a licensed product and is not to be photocopied                                                                                                       Page(2)
EpiCept Corporation – Product Pipeline Review



EpiCept Corporation - Dormant Projects .......................................................................................................................................... 28
EpiCept Corporation - Discontinued Pipeline Products .................................................................................................................... 29
    Discontinued Pipeline Product Profiles ........................................................................................................................................ 29
        LidoPAIN SP ........................................................................................................................................................................... 29
EpiCept Corporation – Company Statement .................................................................................................................................... 30
EpiCept Corporation – Locations And Subsidiaries .......................................................................................................................... 32
    Head Office.................................................................................................................................................................................. 32
    Other Locations & Subsidiaries ................................................................................................................................................... 32
Company's Recent Developments ................................................................................................................................................... 33
    EpiCept Corporation, Recent Developments ............................................................................................................................... 33
        Jun 29, 2010: EpiCept Files NDA For Ceplene For Treatment Of Acute Myeloid Leukemia .................................................. 33
        Oct 28, 2010: EpiCept And FDA Agree On Development Plan For Ceplene .......................................................................... 34
        May 28, 2009: EpiCept Announces Presentation Of New Crinobulin Data At 2009 American Society Of Clinical Oncology
        Annual Meeting ....................................................................................................................................................................... 34
        May 28, 2008: EpiCept Announces Presentation Of EPC2407 Data At 2008 American Society Of Clinical Oncology Annual
        Meeting ................................................................................................................................................................................... 35
        Jun 27, 2011: EpiCept Receives Initial FDA Comments On Application For Ceplene Special Protocol Assessment ............. 36
        Jan 27, 2010: EpiCept Receives Orphan Drug Designation For EpiCept NP-1 In The US ..................................................... 36
        Jan 27, 2009: EpiCept Announces Positive Results From Phase IIbTrial For EpiCept NP-1 .................................................. 37
        May 26, 2010: EpiCept Achieves Targeted Patient Enrollment In Phase IIb Trial Of Epicept NP-1 For Treatment Of CPN ... 37
        Jan 26, 2010: Swedish AML Includes EpiCept's Ceplene In Medical Guidelines ................................................................... 38
        Jun 24, 2003: Maxim Announces Metastatic Ocular Melanoma Clinical Results Using Ceplene Therapy ............................. 39
        Aug 23, 2010: EpiCept Receives Refusal To File Letter From FDA On Ceplene New Drug Application ................................ 39
        Feb 23, 2009: EpiCept Announces EPC2407 Generic Name Is Crinobulin ............................................................................ 40
        Oct 22, 2007: EpiCept Announces Its Plans To Present Preclinical Studies Of EPC2407 In Combination With Anti-
        Angiogenic And Chemotherpeutic Agents At The AACR-NCI-EORTC International Conference ........................................... 40
        Jan 22, 2008: EpiCept Provides Update On Clinical And Regulatory Progress With Ceplene................................................ 41
        Jan 22, 2008: EpiCept Provides Update On Clinical And Regulatory Progress With EpiCept NP-1 Cream ........................... 41
        Dec 21, 2010: EpiCept Wins Israeli Approval For Ceplene ..................................................................................................... 42
        May 21, 2002: Maxim Announces Preclinical Research Suggesting Ceplene May Prevent Liver Damage Caused By Alcohol
        ................................................................................................................................................................................................ 42
        Sep 20, 2004: Maxim Pharmaceutical Phase III Trial For Advanced Malignant Melanoma Fails To Meet Primary Endpoint . 43
        Dec 19, 2006: EpiCept Announces Initiation Of Phase I Study Of EPC2407 For The Treatment Of Cancer.......................... 43
        Apr 19, 2010: EpiCept Announces Commercial Launch Of Ceplene In UK ............................................................................ 44
        Apr 19, 2004: Maxim Pharmaceuticals Presents Preclinical Data On Histamine's Ability To Prevent Liver Damage ............. 45
        Dec 18, 2001: Maxim Pharmaceuticals Initiates Ceplene Phase II Hepatitis C Clinical Trial With Triple-Drug Combination
        Therapy ................................................................................................................................................................................... 46
        Oct 18, 2004: Maxim Pharmaceuticals Announces Restructuring Plan To Support Commercialization And Development
        Efforts ..................................................................................................................................................................................... 46
        Jul 18, 2011: EpiCept Announces Publication Of New Meta-Analysis Examining Lack Of Efficacy Of Interleukin-2 As
        Monotherapy In AML Remission Maintenance In Journal Blood ............................................................................................. 47
        Dec 15, 2010: EpiCept Reports Initiation Of Phase II Trial With Crolibulin In Anaplastic Thyroid Cancer By NCI .................. 48
        Dec 15, 2009: EpiCept Corporation Announces Clinical Study Details Of Ceplene For The Treatment Of Acute Myeloid
        Leukemia ................................................................................................................................................................................ 49
        Sep 12, 2011: EpiCept Provides US Regulatory Update For Ceplene Clinical Development ................................................. 49
        Dec 10, 2010: EpiCept Reports New Analysis Supports Ceplene's Favorable Impact On Overall Survival............................ 50
        Nov 10, 2009: EpiCept Corporation Announces Health Canada Accepts Ceplene Application For Review ........................... 51


EpiCept Corporation – Product Pipeline Review – H2 2011                                                                                    GMDHC02135CDB / Published DEC 2011
©Global Markets Direct.. This report is a licensed product and is not to be photocopied                                                                                                          Page(3)
EpiCept Corporation – Product Pipeline Review



        Apr 10, 2007: EpiCept Initiates Two Phase IIb Trials With NP-1............................................................................................. 51
        May 09, 2011: EpiCept Files Protocol With FDA For Ceplene Phase III Confirmatory Trial ................................................... 52
        Oct 08, 2007: EpiCept Announces Successful Completion Of Enrollment For Phase I Trial Of EPC2407 ............................. 53
        Nov 07, 2003: Maxim Files For European Approval To Market Ceplene For The Treatment Of Advanced Malignant
        Melanoma ............................................................................................................................................................................... 54
        Apr 07, 2008: EpiCept Announces Positive Clinical Data From EPC2407 Phase I Cancer Trial ............................................ 54
        Feb 07, 2011: EpiCept Reports Positive Results From EpiCept NP-1 Trial In Patients With Chemotherapy-Induced
        Peripheral Neuropathy ............................................................................................................................................................ 55
        Feb 07, 2008: EpiCept Announces Encouraging Results Of Phase II Trial For NP-1 Cream In Diabetic Peripheral Neuropathy
        ................................................................................................................................................................................................ 56
        Dec 05, 201
								
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