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Chronological Index of BioCentury, Week in Review: Clinical Status

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  • ATI Neurostimulation System: Pivotal trial started

    Autonomic Technologies Inc., Redwood City, Calif. Product: ATI Neurostimulation System Business: Neurology Molecular target: NA Description: Miniaturized stimulator implantable at the sphenopalatine ganglion (SPG) nerve…

    Published on 3/5/2012
  • AVI-7288: Phase I start

    AVI BioPharma Inc. (NASDAQ:AVII), Bothell, Wash. Product: AVI-7288 Business: Infectious Molecular target: NA Description: Single oligomer nucleic acid analog based on morpholino-modified phosphorodiamidate oligomers (…

    Published on 3/5/2012
  • C: Phase Ib started

    Intercell AG (VSE:ICLL; OTCQX:INRLY), Vienna, Austria Product: C. difficile vaccine (IC84) Business: Infectious Molecular target: NA Description: Clostridium difficile vaccine Indication: Vaccinate against C. difficile …

    Published on 3/5/2012
  • CD34+ stem cell therapy: Phase III started

    Baxter International Inc. (NYSE:BAX), Deerfield, Ill. Product: CD34+ stem cell therapy Business: Cardiovascular Molecular target: Not applicable Description: Autologous hematopoetic CD34+ stem cell therapy Indication: …

    Published on 3/5/2012
  • DNA IL-12: Phase II started

    OncoSec Medical Inc. (OTCBB:ONCS), San Diego, Calif. Product: DNA IL-12 Business: Cancer Molecular target: Interleukin-12 (IL-12) Description: DNA plasmid coding for IL-12 delivered via electroporation Indication: Treat…

    Published on 3/5/2012
  • EGP-437: Phase I started

    EyeGate Pharmaceuticals Inc., Waltham, Mass. Product: EGP-437 Business: Ophthalmic Molecular target: NA Description: Dexamethasone phosphate ophthalmic solution delivered by the EyeGate II Ocular Drug Delivery System …

    Published on 3/5/2012
  • GI-6301: Phase I started

    GlobeImmune Inc., Louisville, Colo. Product: GI-6301 Business: Cancer Molecular target: NA Description: Whole, heat-killed, recombinant Saccharomyces cerevisiae yeast genetically modified (Tarmogen) to express high …

    Published on 3/5/2012
  • Huntexil pridopidine: Completed Phase II enrollment

    NeuroSearch A/S (CSE:NEUR), Ballerup, Denmark Product: Huntexil pridopidine (ACR16) Business: Neurology Molecular target: Dopamine receptor Description: Dopamine stabilizer Indication: Treat Huntington's disease (HD) …

    Published on 3/5/2012
  • Inomax: Completed Phase III enrollment

    Ikaria Inc., Hampton, N.J. Product: Inomax, INOflo Business: Pulmonary Molecular target: NA Description: Nitric oxide (NO) for inhalation Indication: Prevent bronchopulmonary dysplasia (BPD) Endpoint: Survival without …

    Published on 3/5/2012
  • KD025: Phase I started

    Kadmon Corp. LLC, New York, N.Y. Product: KD025 Business: Autoimmune, Cancer, Neurology Molecular target: Rho-associated coiled-coil containing protein kinase 2 (ROCK2) Description: Selective Rho-associated coiled-coil …

    Published on 3/5/2012
  • Leuplin leuprorelin acetate: Phase III started

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Leuplin leuprorelin acetate Business: Cancer Molecular target: NA Description: Analog of LH-RH Indication: Treat prostate cancer Endpoint: Suppression …

    Published on 3/5/2012
  • Leuplin leuprorelin acetate: Phase III started

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Leuplin leuprorelin acetate Business: Cancer Molecular target: NA Description: Analog of LH-RH Indication: Treat premenopausal breast cancer Endpoint: …

    Published on 3/5/2012
  • Mibefradil: Phase I started

    Tau Therapeutics LLC, Charlottesville, Va. Product: Mibefradil Business: Cancer Molecular target: Calcium channel T-type Description: T-type calcium channel blocker Indication: Treat solid tumors Endpoint: Safety; …

    Published on 3/5/2012
  • Mibefradil: Phase Ib start

    Tau Therapeutics LLC, Charlottesville, Va. Product: Mibefradil Business: Cancer Molecular target: Calcium channel T-type Description: T-type calcium channel blocker Indication: Treat recurrent high grade glioma Endpoint…

    Published on 3/5/2012
  • NX-1207: Phase III started

    Nymox Pharmaceutical Corp. (NASDAQ:NYMX), Saint-Laurent, Quebec Recordati S.p.A. (Milan:REC), Milan, Italy Product: NX-1207 Business: Genitourinary Molecular target: Undisclosed Description: Undisclosed Indication: …

    Published on 3/5/2012
  • Provenge sipuleucel-T: Phase II started

    Dendreon Corp. (NASDAQ:DNDN), Seattle, Wash. Product: Provenge sipuleucel-T Business: Cancer Molecular target: Not applicable Description: Autologous dendritic cells loaded with a fusion protein of prostatic acid …

    Published on 3/5/2012
  • PRX167700: Phase I started

    Proximagen Group plc (LSE:PRX), London, U.K. Product: PRX167700 Business: Autoimmune Molecular target: Vascular adhesion protein-1 (VAP-1) (SSAO) Description: VAP-1 antagonist Indication: Treat rheumatoid arthritis (RA)…

    Published on 3/5/2012
  • PSI-7977: Phase II started

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: PSI-7977, GS-7977 Business: Infectious Molecular target: HCV NS5B polymerase Description: Single isomer form of PSI-7851, a nucleotide analog HCV NS5B …

    Published on 3/5/2012
  • Rencarex girentuximab: Phase III ongoing

    Wilex AG (Xetra:WL6), Munich, Germany Product: Rencarex girentuximab (formerly WX-G250) Business: Cancer Molecular target: Carbonic anhydrase IX (CAIX) Description: Chimeric mAb against carbonic anhydrase IX (CAIX) …

    Published on 3/5/2012
  • RFVIII: Phase I/III started

    CSL Ltd. (ASX:CSL), Melbourne, Australia Product: RFVIII (CSL627) Business: Hematology Molecular target: NA Description: Recombinant coagulation single-chain factor VIII (rFVIII) Indication: Treat hemophilia A Endpoint:…

    Published on 3/5/2012
  • TMC435: Phase II started

    Medivir AB (SSE:MVIR B), Huddinge, Sweden Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: TMC435 (formerly TMC435350) Business: Infectious Molecular target: HCV NS3/4A protease complex Description: HCV NS3/4A…

    Published on 3/5/2012
  • Ulimorelin: Completed Phase III enrollment

    Norgine B.V., Amsterdam, the Netherlands Tranzyme Inc. (NASDAQ:TZYM), Durham, N.C. Product: Ulimorelin (TZP-101) Business: Gastrointestinal Molecular target: Ghrelin receptor (GHSR) Description: IV ghrelin receptor …

    Published on 3/5/2012
  • UMK-121: Phase I started

    Proteonomix Inc. (OTCBB:PROT), Mountainside, N.J. Product: UMK-121 Business: Hepatic Molecular target: NA Description: Mobilization of bone marrow stem cells technology Indication: Treat end-stage liver disease (ESLD) …

    Published on 3/5/2012
  • Volitinib: Phase I started

    Hutchison China MediTech Ltd. (LSE:HCM), Hong Kong, China AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Volitinib (HMPL-504) Business: Cancer Molecular target: c-Met receptor tyrosine kinase Description: …

    Published on 3/5/2012
  • XL647: Phase III started

    Exelixis Inc. (NASDAQ:EXEL), South San Francisco, Calif. Kadmon Corp. LLC, New York, N.Y. Symphony Evolution Inc., Rockville, Md. Product: XL647, KD019 Business: Cancer Molecular target: Epidermal growth factor receptor…

    Published on 3/5/2012

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