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Chronological Index of BioCentury, Week in Review: Clinical Status

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  • Afatinib: Phase III started

    Boehringer Ingelheim GmbH, Ingelheim, Germany Product: Afatinib (Tomtovok) (BIBW 2992) Business: Cancer Molecular target: Epidermal growth factor receptor (EGFR); Epidermal growth factor receptor 2 (EGFR2) (HER2) (ErbB2…

    Published on 1/30/2012
  • Afatinib: Phase III started

    Boehringer Ingelheim GmbH, Ingelheim, Germany Product: Afatinib (Tomtovok) (BIBW 2992) Business: Cancer Molecular target: Epidermal growth factor receptor (EGFR); Epidermal growth factor receptor 2 (EGFR2) (HER2) (ErbB2…

    Published on 1/30/2012
  • AMG 386: Suspended Phase III enrollment

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: AMG 386 Business: Cancer Molecular target: Angiopoietin 1 (ANG1) (ANGPT1); Angiopoietin 2 (ANG2) (ANGPT2…

    Published on 1/30/2012
  • AMR-001: Phase II started

    NeoStem Inc. (NYSE-A:NBS), New York, N.Y. Product: AMR-001 Business: Cardiovascular Molecular target: NA Description: Autologous bone marrow-derived stem cells Indication: Treat acute myocardial infarction (AMI) …

    Published on 1/30/2012
  • AT9283: Phase I started

    Astex Pharmaceuticals Inc. (NASDAQ:ASTX), Dublin, Calif. Product: AT9283 Business: Cancer Molecular target: Aurora kinase A (AURKA) (Aurora-A); Aurora kinase B (AURKB) (Aurora-B) Description: Small molecule inhibitor of…

    Published on 1/30/2012
  • Collagenase clostridium histolyticum: Phase Ib started

    Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL), Malvern, Pa. BioSpecifics Technologies Corp. (NASDAQ:BSTC), Lynbrook, N.Y. Product: Collagenase clostridium histolyticum (Xiaflex) Business: Dermatology Molecular target: …

    Published on 1/30/2012
  • DM-1992: Phase II started

    Depomed Inc. (NASDAQ:DEPO), Menlo Park, Calif. Product: DM-1992 Business: Neurology Molecular target: NA Description: Gastric retentive extended-release formulation of levodopa/carbidopa Indication: Treat Parkinson's …

    Published on 1/30/2012
  • Esprit bioresorbable vascular scaffold update

    Abbott Laboratories (NYSE:ABT), Abbott Park, Ill. Product: Esprit bioresorbable vascular scaffold Business: Cardiovascular Molecular target: NA Description: Everolimus-eluting bioabsorbable scaffold made of polylactic …

    Published on 1/30/2012
  • MA09-hRPE cells: Phase I/II started

    Advanced Cell Technology Inc. (OTCBB:ACTC), Santa Monica, Calif. Product: MA09-hRPE cells (hESC-derived hRPE cells) Business: Ophthalmic Molecular target: Not applicable Description: Human embryonic stem cell-derived …

    Published on 1/30/2012
  • OncoHist: Phase I/II started

    SynBio LLC, Moscow, Russia Xenetic Biosciences plc (LSE:XEN), London, U.K. Product: OncoHist Business: Cancer Molecular target: NA Description: Recombinant human histone H1 Indication: Treat non-Hodgkin's lymphoma (NHL)…

    Published on 1/30/2012
  • Oncotype DX prostate cancer assay update

    Genomic Health Inc. (NASDAQ:GHDX), Redwood City, Calif. Product: Oncotype DX prostate cancer assay Business: Diagnostic Molecular target: NA Description: Prostate biopsy test to guide selection of active surveillance or…

    Published on 1/30/2012
  • RhuDex: Phase I started

    Active Biotech AB (SSE:ACTI), Lund, Sweden MediGene AG (Xetra:MDG), Martinsried, Germany Product: RhuDex Business: Autoimmune Molecular target: CD80 (B7-1) Description: Disease-modifying antirheumatic drug (DMARD) that …

    Published on 1/30/2012
  • Sphingomab: Phase Ib halted

    Lpath Inc. (OTCBB:LPTN), San Diego, Calif. Product: Sphingomab (iSONEP) Business: Ophthalmic Molecular target: Sphingosine 1-phosphate (S1P) receptor Description: Ocular formulation of humanized mAb against sphingosine …

    Published on 1/30/2012
  • Sphingomab: Phase IIa halted

    Lpath Inc. (OTCBB:LPTN), San Diego, Calif. Product: Sphingomab (iSONEP) Business: Ophthalmic Molecular target: Sphingosine 1-phosphate (S1P) receptor Description: Ocular formulation of humanized mAb against sphingosine …

    Published on 1/30/2012
  • Symphony Transdermal Continuous Glucose Monitoring System update

    Echo Therapeutics Inc. (NASDAQ:ECTE), Philadelphia, Pa. Product: Symphony Transdermal Continuous Glucose Monitoring System (Symphony tCGM System) Business: Diagnostic Molecular target: NA Description: Transdermal …

    Published on 1/30/2012
  • Tasquinimod: Phase I started

    Active Biotech AB (SSE:ACTI), Lund, Sweden Ipsen Group (Euronext:IPN), Boulogne-Billancourt, France Product: Tasquinimod (TASQ) (ABR-215050) Business: Cancer Molecular target: Thrombospondin-1 (TSP-1) (THBS1) …

    Published on 1/30/2012
  • Tysabri natalizumab: Phase IIIb started

    Biogen Idec Inc. (NASDAQ:BIIB), Weston, Mass. Elan Corp. plc (NYSE:ELN), Dublin, Ireland Product: Tysabri natalizumab Business: Autoimmune Molecular target: Integrin alpha(4) (VLA-4 ) (CD49D) Description: Humanized mAb …

    Published on 1/30/2012
  • Arikace: Development ongoing

    Insmed Inc. (NASDAQ:INSM), Monmouth Junction, N.J. Product: Arikace (formerly SLIT amikacin) Business: Infectious Molecular target: Ribosomal 30S subunit Description: Sustained-release lipid inhaled targeting (SLIT) …

    Published on 1/23/2012
  • Autologous human umbilical cord blood: Phase I started

    Memorial Hermann Healthcare System, Houston, Texas Product: Autologous human umbilical cord blood Business: Other Molecular target: NA Description: Patient's autologous human umbilical cord blood Indication: Treat …

    Published on 1/23/2012
  • CDX-301: Phase I started

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Celldex Therapeutics Inc. (NASDAQ:CLDX), Needham, Mass. Product: CDX-301 Business: Transplant Molecular target: FMS-like tyrosine kinase 3 ligand (FLT3LG) Description: FMS…

    Published on 1/23/2012
  • DPK-060: Phase II started

    Pergamum AB, Stockholm, Sweden Product: DPK-060 Business: Infectious Molecular target: NA Description: Antimicrobial peptide Indication: Treat acute external otitis Endpoint: Safety; clinical cure and microbiological …

    Published on 1/23/2012
  • Elacytarabine: Phase III ongoing

    Clavis Pharma ASA (OSE:CLAVIS), Oslo, Norway Product: Elacytarabine (CP-4055) (formerly Elacyt) Business: Cancer Molecular target: DNA polymerase Description: Lipid Vector Technology (LVT) derivative of cytarabine (Ara-…

    Published on 1/23/2012
  • Factor IX-albumin fusion protein: Phase II/III started

    CSL Ltd. (ASX:CSL), Melbourne, Australia Product: Factor IX-albumin fusion protein, rIX-FP (CSL654) Business: Hematology Molecular target: NA Description: Recombinant fusion protein linking human coagulation Factor IX …

    Published on 1/23/2012
  • I-131-CLR1404: Phase Ib started

    Novelos Therapeutics Inc. (OTCBB:NVLT), Newton, Mass. Product: I-131-CLR1404 (HOT) Business: Cancer Molecular target: Phosphoinositide 3-kinase (PI3K) Description: Iodine-radiolabeled small molecule phosphoinositide 3-…

    Published on 1/23/2012
  • Isoniazide: Phase IIa started

    Bridge Bioresearch plc, London, U.K. Product: Isoniazide (BBR-012) Business: Dermatology Molecular target: NA Description: Chronic wound treatment Indication: Treat diabetic foot ulcers Endpoint: Percent reduction in …

    Published on 1/23/2012

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