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Chronological Index of BioCentury, Week in Review: Clinical Status

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  • OGX-427: Phase II started

    Isis Pharmaceuticals Inc. (NASDAQ:ISIS), Carlsbad, Calif. OncoGenex Pharmaceuticals Inc. (NASDAQ:OGXI), Bothell, Wash. Product: OGX-427 Business: Cancer Molecular target: Heat shock protein 27 (Hsp27) Description: …

    Published on 5/13/2013
  • OPN-305: Phase II started

    Opsona Therapeutics Ltd., Dublin, Ireland Product: OPN-305 Business: Transplant Molecular target: Toll-like receptor 2 (TLR2) Description: Humanized IgG4 mAb against the toll-like receptor 2 (TLR2) Indication: Prevent …

    Published on 5/13/2013
  • Proellex telapristone: Phase II start

    Repros Therapeutics Inc. (NASDAQ:RPRX), The Woodlands, Texas Product: Proellex telapristone (CDB-4124) Business: Cancer Molecular target: Progesterone receptor Description: Oral selective progesterone receptor modulator…

    Published on 5/13/2013
  • RQ-00000004: Phase II started

    CJ Group, Seoul, South Korea RaQualia Pharma Inc. (JASDAQ:4579), Aichi, Japan Product: RQ-00000004 Business: Gastrointestinal Molecular target: H+/K ATPase pump Description: Potassium competitive acid pump antagonist …

    Published on 5/13/2013
  • Selexipag: Phase III ongoing

    Actelion Ltd. (SIX:ATLN), Allschwil, Switzerland Nippon Shinyaku Co. Ltd. (Tokyo:4516; Osaka:4516), Kyoto, Japan Product: Selexipag (NS-304, ACT-293987) Business: Cardiovascular Molecular target: Prostacyclin (IP) …

    Published on 5/13/2013
  • Tirasemtiv: Phase IIb expanded

    Cytokinetics Inc. (NASDAQ:CYTK), South San Francisco, Calif. Product: Tirasemtiv (formerly CK-2017357) Business: Neurology Molecular target: Sarcomere Description: Fast skeletal muscle troponin activator Indication: …

    Published on 5/13/2013
  • TM-400: Phase I/II started

    TikoMed AB, Viken, Sweden Product: TM-400 Business: Cancer Molecular target: NA Description: Low molecular weight dextran sulfate Indication: Treat hematologic cancers Endpoint: Mobilization of stem cell and lymphocytes…

    Published on 5/13/2013
  • Tropicamide: Phase II started

    NeuroHealing Pharmaceuticals Inc., Newton, Mass. Product: Tropicamide (NH004) Business: Other Molecular target: NA Description: Intra-oral mucoadhesive dissolving film for the local delivery of tropicamide, an …

    Published on 5/13/2013
  • TRU-016: Completed Phase Ib/II enrollment

    Emergent BioSolutions Inc. (NYSE:EBS), Rockville, Md. Product: TRU-016 Business: Cancer Molecular target: CD37 Description: Humanized small modular immunopharmaceutical (SMIP) that targets the CD37 antigen Indication: …

    Published on 5/13/2013
  • Vyvanse lisdexamfetamine dimesylate: Development discontinued

    Shire plc (LSE:SHP; NASDAQ:SHPG), Dublin, Ireland Product: Vyvanse lisdexamfetamine dimesylate (S-877489) Business: Neurology Molecular target: Not available Description: Prodrug of amphetamine Indication: Treat …

    Published on 5/13/2013
  • Adult stem cells: Phase II start

    Mesoblast Ltd. (ASX:MSB; Pink:MBLTY), Melbourne, Australia Product: Adult stem cells, Mesenchymal precursor cells (MPC) Business: Autoimmune Molecular target: Not applicable Description: Allogeneic adult mesenchymal …

    Published on 2/18/2013
  • All-In-One: Clinical trial started

    Svelte Medical Systems Inc., New Providence, N.J. Product: All-In-One, Integrated Delivery System (IDS) Business: Cardiovascular Molecular target: NA Description: Sirolimus-eluting cobalt chromium stent Indication: …

    Published on 2/18/2013
  • Androxal enclomiphene: Completed Phase III enrollment

    Repros Therapeutics Inc. (NASDAQ:RPRX), The Woodlands, Texas Product: Androxal enclomiphene Business: Endocrine/Metabolic Molecular target: Androgen receptor Description: Trans-isomer of clomiphene citrate Indication: …

    Published on 2/18/2013
  • Dermagraft: Phase III started

    Shire plc (LSE:SHP; NASDAQ:SHPG), Dublin, Ireland Product: Dermagraft (ABH001) Business: Dermatology Molecular target: Not available Description: Engineered skin substitute containing live human fibroblasts grown on an …

    Published on 2/18/2013
  • Flublok: Phase III started

    Protein Sciences Corp., Meriden, Conn. UMN Pharma Inc. (Tokyo:4585), Akita, Japan Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Ildong Pharmaceutical Co. Ltd., Seoul, South Korea Product: Flublok (UMN-0502, ASP7374) …

    Published on 2/18/2013
  • GLV-1h68: Phase I started

    Genelux Corp., San Diego, Calif. Product: GLV-1h68 (GL-ONC1) Business: Pulmonary Molecular target: NA Description: Genetically stable modified vaccinia virus that incorporates green fluorescent protein (GFP) to enable …

    Published on 2/18/2013
  • Infradure: Phase I/II started

    Medgenics Inc. (LSE:MEDU; NYSE-M:MDGN), Vienna, Va. Product: Infradure Business: Infectious Molecular target: NA Description: Autologous tissue explants that deliver sustained interferon (IFN) alpha using Medgenics' …

    Published on 2/18/2013
  • LAI287: Phase I started

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO), Bagsvaerd, Denmark Product: LAI287, NN1436 Business: Endocrine/Metabolic Molecular target: NA Description: Long-acting insulin analog Indication: Treat Type I diabetes Endpoint: …

    Published on 2/18/2013
  • Lysine acetylsalicylate glycine: Phase II started

    Activaero GmbH, Gemuenden, Germany Product: Lysine acetylsalicylate glycine (LASAG) Business: Infectious Molecular target: NA Description: LASAG delivered using Activaero's FAVORITE inhalation delivery technology …

    Published on 2/18/2013
  • MK-3102: Phase III started

    Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: MK-3102 Business: Endocrine/Metabolic Molecular target: Dipeptidyl peptidase-4 (DPP-4) Description: Once-weekly, oral dipeptidyl peptidase-4 (DPP-4) …

    Published on 2/18/2013
  • OGX-427: Phase II start

    Isis Pharmaceuticals Inc. (NASDAQ:ISIS), Carlsbad, Calif. OncoGenex Pharmaceuticals Inc. (NASDAQ:OGXI), Bothell, Wash. Product: OGX-427 Business: Cancer Molecular target: Heat shock protein 27 (Hsp27) Description: …

    Published on 2/18/2013
  • Omega-3 Cardiac Panel: Clinical trial started

    Nanomix Inc., Emeryville, Calif. Product: Omega-3 Cardiac Panel Business: Diagnostic Molecular target: NA Description: Mobile in vitro diagnostic platform to quantitatively determine cardiac troponin I, myoglobin and …

    Published on 2/18/2013
  • Oral omecamtiv mecarbil: Phase II started

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Cytokinetics Inc. (NASDAQ:CYTK), South San Francisco, Calif. Product: Oral omecamtiv mecarbil Business: Cardiovascular Molecular target: Cardiac myosin Description: …

    Published on 2/18/2013
  • OTX015: Phase I started

    Oncoethix S.A., Lausanne, Switzerland Mitsubishi Tanabe Pharma Corp. (Tokyo:4508; Osaka:4508), Osaka, Japan Product: OTX015 Business: Cancer Molecular target: Bromodomain containing 2 (BRD2); Bromodomain containing 3 (…

    Published on 2/18/2013
  • PledOx calmangafodipir: Phase IIb started

    PledPharma AB (SSE:PLED), Stockholm, Sweden Product: PledOx calmangafodipir Business: Hematology Molecular target: Superoxide dismutase 2 mitochondrial (SOD2) (MNSOD) Description: Pyridoxyl ethyldiamine (PLED) analog in…

    Published on 2/18/2013

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