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Chronological Index of BioCentury, Week in Review: Clinical Status

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  • BAY 86-6150: Phase II/III discontinued

    Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: BAY 86-6150 Business: Hematology Molecular target: Factor VIIa Description: Human recombinant Factor VIIa protein Indication: Treat hemophilia A or B Endpoint: …

    Published on 5/20/2013
  • BromSite: Phase III started

    InSite Vision Inc. (OTCBB:INSV), Alameda, Calif. Product: BromSite (ISV-303) Business: Ophthalmic Molecular target: NA Description: Low-dose bromfenac, an NSAID, delivered via InSite's DuraSite sustained delivery …

    Published on 5/20/2013
  • DermaPACE: Phase III start

    Sanuwave Health Inc. (OTCBB:SNWV), Alpharetta, Ga. Product: DermaPACE Business: Dermatology Molecular target: NA Description: Extracorporeal shock wave therapy delivered using Pulsed Acoustic Cellular Expression (PACE) …

    Published on 5/20/2013
  • Effient prasugrel: Phase III started

    Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568), Tokyo, Japan Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Effient prasugrel (Efient) Business: Hematology Molecular target: Purinergic receptor P2Y G …

    Published on 5/20/2013
  • ErepoXen: Phase III started

    SynBio LLC, Moscow, Russia Xenetic Biosciences plc (LSE:XEN; OTCBB:XENEF), London, U.K. Serum Institute of India Ltd., Pune, India Product: ErepoXen Business: Hematology Molecular target: Erythropoietin (EPO) receptor …

    Published on 5/20/2013
  • Hylenex: Phase IV started

    Halozyme Therapeutics Inc. (NASDAQ:HALO), San Diego, Calif. Product: Hylenex (rHuPH20) Business: Endocrine/Metabolic Molecular target: Hyaluronan Description: Recombinant human PH20 hyaluronidase enzyme Indication: …

    Published on 5/20/2013
  • ISIS-SMNRx: Phase II started

    Isis Pharmaceuticals Inc. (NASDAQ:ISIS), Carlsbad, Calif. Product: ISIS-SMNRx Business: Musculoskeletal Molecular target: Survival of motor neuron 2 centromeric (SMN2) Description: Antisense oligonucleotide that …

    Published on 5/20/2013
  • Livatag doxorubicin Transdrug: Phase III ongoing

    BioAlliance Pharma S.A. (Euronext:BIO), Paris, France Product: Livatag doxorubicin Transdrug (BA-003) Business: Cancer Molecular target: DNA Description: Nanoparticle formulation of doxorubicin Indication: Treat …

    Published on 5/20/2013
  • LX4211 tablet: Phase II ongoing

    Lexicon Pharmaceuticals Inc. (NASDAQ:LXRX), The Woodlands, Texas Product: LX4211 tablet Business: Endocrine/Metabolic Molecular target: Sodium-glucose cotransporter 1 (SGLT1); Sodium-glucose cotransporter 2 (SGLT2) …

    Published on 5/20/2013
  • MOR208: Phase II started

    MorphoSys AG (Xetra:MOR; Pink:MPSYF), Martinsried, Germany Xencor Inc., Monrovia, Calif. Product: MOR208 (formerly XmAb5574) Business: Cancer Molecular target: CD19 Description: Fc-optimized human mAb against CD19 …

    Published on 5/20/2013
  • MRX34: Phase I started

    Mirna Therapeutics Inc., Austin, Texas Product: MRX34, miR-34 (formerly miR-Rx34) Business: Cancer Molecular target: NA Description: Synthetic mimic of miR-34, a naturally occurring tumor suppressor, formulated with …

    Published on 5/20/2013
  • Nepicastat: Phase II started

    Biotie Therapies Corp. (HSE:BTH1V), Turku, Finland Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Nepicastat (SYN-117, SYN117) Business: Neurology Molecular target: Dopamine beta-hydroxylase (DBH) Description…

    Published on 5/20/2013
  • OMP-59R5: Phase Ib/II amended

    OncoMed Pharmaceuticals Inc., Redwood City, Calif. Product: OMP-59R5 (Anti-Notch2/3) Business: Cancer Molecular target: Notch 2 (NOTCH2); Notch 3 (NOTCH3) Description: Human HuCAL antibody that binds selected Notch …

    Published on 5/20/2013
  • OMP-59R5: Phase Ib/II started

    OncoMed Pharmaceuticals Inc., Redwood City, Calif. Product: OMP-59R5 (Anti-Notch2/3) Business: Cancer Molecular target: Notch 2 (NOTCH2); Notch 3 (NOTCH3) Description: Human HuCAL antibody that binds selected Notch …

    Published on 5/20/2013
  • Patiromer: Completed Phase III enrollment

    Relypsa Inc., Redwood City, Calif. Product: Patiromer (RLY5016) Business: Endocrine/Metabolic Molecular target: NA Description: High-capacity potassium binder Indication: Treat hyperkalemia in chronic kidney disease (…

    Published on 5/20/2013
  • Proleukin aldesleukin: Phase IV started

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Proleukin aldesleukin Business: Cancer Molecular target: Interleukin-2 (IL-2) receptor Description: Interleukin-2 (IL-2) Indication: Treat metastatic …

    Published on 5/20/2013
  • Sarilumab: Phase III started

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN), Tarrytown, N.Y. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Sarilumab (REGN88, SAR153191) Business: Autoimmune Molecular target: Interleukin-6 (IL-6) receptor (…

    Published on 5/20/2013
  • Sarilumab: Phase III started

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN), Tarrytown, N.Y. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Sarilumab (REGN88, SAR153191) Business: Autoimmune Molecular target: Interleukin-6 (IL-6) receptor (…

    Published on 5/20/2013
  • SGX203: Phase I started

    Soligenix Inc. (OTCBB:SNGX), Princeton, N.J. Product: SGX203 Business: Autoimmune Molecular target: Corticoid receptors Description: Oral beclomethasone 17,21-dipropionate (BDP) Indication: Treat pediatric Crohn's …

    Published on 5/20/2013
  • Stivarga regorafenib: Phase III started

    Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Stivarga regorafenib (fluoro-sorafenib) (BAY 73-4506) Business: Cancer Molecular target: Vascular endothelial growth factor (VEGF) receptor 2 (KDR/Flk-1) (VEGFR-2); …

    Published on 5/20/2013
  • Treanda: Phase II started

    InnoPharmax Inc. (GreTai-E:4172), Taipei, Taiwan SymBio Pharmaceuticals Ltd. (JASDAQ:4582), Tokyo, Japan Teva Pharmaceutical Industries Ltd. (NYSE:TEVA), Petah Tikva, Israel Eisai Co. Ltd. (Tokyo:4523; Osaka:4523), …

    Published on 5/20/2013
  • 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

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