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Chronological Index of : Clinical Status

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  • 99mTc-MIP-1404: Ph III ongoing

    An IDMC recommended continuation of the open-label, North American Phase III proSPECT-AS trial evaluating a single 20 mCi IV injection of 99mTc-MIP-1404 based on an interim analysis. The trial has enrolled 190 of the …

    Published on 1/16/2017
  • ACE-083: Ph II started

    Acceleron began a U.S. Phase II trial to evaluate 150, 200 and 250 mg intramuscular ACE-083 given 3 weeks apart for up to 5 doses in patients with muscle weakness in the bicep or tibialis anterior. An open-label, dose-…

    Published on 1/16/2017
  • ALX-0171: Ph IIb RESPIRE started

    Ablynx began the double-blind, placebo-controlled, international Phase IIb RESPIRE trial to evaluate 3, 6 and 9 mg/kg inhaled ALX-0171 once daily for 3 days in about 180 hospitalized infants ages 1-24 months with a …

    Published on 1/16/2017
  • ARGX-113: Ph II started

    argenx began a double-blind, placebo-controlled Phase II trial to evaluate ARGX-113 plus corticosteroids and/or immunomodulatory agents in up to 24 patients with generalized muscle weakness. The company also plans to …

    Published on 1/16/2017
  • Bempedoic acid: Ph III CLEAR Outcomes started

    Esperion began the double-blind, placebo-controlled, international Phase III CLEAR Outcomes trial to evaluate 180 mg oral bempedoic acid once daily in about 12,600 statin-intolerant patients with hypercholesterolemia …

    Published on 1/16/2017
  • EB8018: Ph I started

    Enterome began a double-blind, placebo-controlled, U.K. Phase I trial to evaluate single and multiple ascending doses of oral EB8018 in about 60 healthy volunteers. Enterome has exclusive, worldwide rights to EB8018 …

    Published on 1/16/2017
  • G1T38: Ph Ib/IIa started

    G1 began an open-label, dose-escalation, dose-expansion, European Phase Ib/IIa trial to evaluate once-daily oral G1T38 plus Faslodex fulvestrant in about 80 patients.G1 Therapeutics Inc., Research Triangle Park, N.C.…

    Published on 1/16/2017
  • HMPL-523: Ph I started

    Hutchison China MediTech Ltd. (LSE:HCM; NASDAQ:HCM), Hong Kong, ChinaProduct: HMPL-523Business: CancerMolecular target: Spleen tyrosine kinase (SYK)Description: Small molecule SYK inhibitorIndication: Treat relapsed or …

    Published on 1/16/2017
  • Jetrea: Ph II CIRCLE amended

    ThromboGenics amended the double-blind, sham-controlled, international Phase II CIRCLE trial of Jetrea to expand the enrollment criteria and decrease enrollment to about 115 patients from 230. CIRCLE will now enroll …

    Published on 1/16/2017
  • Kineret: Ph II anaGO started

    Swedish Orphan Biovitrum began the double-blind, placebo-controlled, North American Phase II anaGO trial to compare 100 and 200 mg subcutaneous Kineret once daily for 5 days plus intramuscular triamcinolone acetonide (…

    Published on 1/16/2017
  • LIPO-202: Ph II LIPO-202-CL-31 started

    Neothetics began the double-blind, placebo-controlled, U.S. Phase II LIPO-202-CL-31 trial to evaluate 0.3 and 3 g doses of subcutaneous LIPO-202 weekly for 8 weeks in about 150 patients.Neothetics Inc. (NASDAQ:NEOT), …

    Published on 1/16/2017
  • OMP-305B83: Ph Ib started

    OncoMed began an open-label, U.S. Phase Ib trial to evaluate 3 and 4 mg/kg doses of IV OMP-305B83 every 2 weeks plus FOLFIRI chemotherapy in 30 patients. The company said a Phase Ib trial in patients with platinum-…

    Published on 1/16/2017
  • Onapristone: Ph II halted

    Arno said it halted enrollment in the Phase II portion of an open-label, U.K. Phase I/II trial evaluating twice-daily onapristone plus Zytiga abiraterone acetate after the company determined further enrollment was not …

    Published on 1/16/2017
  • Oral DS107: Ph IIb ADvance started

    DS BioPharma began the double-blind, placebo-controlled, U.S. Phase IIb ADvance trial to evaluate 1 and 2 g oral DS107 once daily for 8 weeks in about 300 patients.DS Biopharma, Dublin, IrelandProduct: DS107G, oral …

    Published on 1/16/2017
  • RG7916: Ph II started

    PTC said Roche began the open-label, European Phase II FIREFISH trial of once-daily oral RG7916 in about 48 infants ages 1-7 months. A dose-escalation part will test RG7916 in =8 infants for 4 weeks. A pivotal second …

    Published on 1/16/2017
  • RGX-104: Ph I started

    Rgenix began an open-label, dose-escalation, dose-expansion, U.S. Phase I trial to evaluate oral RGX-104 in about 80 patients. Rgenix has exclusive, worldwide rights to RGX-104 from GlaxoSmithKline.Rgenix Inc., New York…

    Published on 1/16/2017
  • Serlopitant: Ph II ATOMIK (MTI-103) started

    Menlo began the double-blind, placebo-controlled, U.S. Phase II ATOMIK (MTI-103) trial to evaluate 2 dose levels of oral serlopitant in about 450 patients. Menlo has exclusive, worldwide rights to serlopitant from Merck…

    Published on 1/16/2017
  • Serlopitant: Ph II AUBURN (MTI-104) started

    Menlo began the double-blind, placebo-controlled, U.S. Phase II AUBURN (MTI-104) trial to evaluate oral serlopitant in about 150 patients. Menlo has exclusive, worldwide rights to serlopitant from Merck under a 2012 …

    Published on 1/16/2017
  • SFX-01: Ph II SAS ongoing

    An independent DSMB recommended continuation of the double-blind, placebo-controlled, U.K. Phase II SAS trial of SFX-01 given as capsules or as a suspension via a nasogastric tube based on an interim safety review. The …

    Published on 1/16/2017
  • SGN-CD352A: Ph I started

    Seattle Genetics began an open-label, dose-escalation, dose-expansion, U.S. Phase I trial to evaluate 8-65 g/kg IV SGN-CD352A every 4 weeks in about 75 patients.Seattle Genetics Inc. (NASDAQ:SGEN), Bothell, Wash.Product…

    Published on 1/16/2017
  • TGR-1202: Ph IIa started

    TG Therapeutics said the University of Nebraska Medical Center began an open-label, U.S. Phase IIa trial to evaluate once-daily oral TGR-1202 plus once-daily oral Imbruvica ibrutinib in 28-day cycles for up to 12 cycles…

    Published on 1/16/2017
  • THX-TS01: Ph IIa started

    Therapix began an open-label, U.S. Phase IIa trial to evaluate once-daily oral THX-TS01 in about 18 patients.Therapix Biosciences Ltd. (Tel Aviv:THXBY; OTCQB:THXBY), Tel Aviv, IsraelProduct: THX-TS01Business: …

    Published on 1/16/2017
  • Topical DS107: Ph IIb ADvantage started

    DS BioPharma began the double-blind, vehicle-controlled, North American Phase IIb ADvantage trial to evaluate 1% and 5% topical DS107 twice daily for 8 weeks in about 300 patients.DS Biopharma, Dublin, IrelandProduct: …

    Published on 1/16/2017
  • Trilaciclib: Ph II started

    G1 began an open-label, international Phase II trial to compare IV trilaciclib plus gemcitabine and carboplatin vs. gemcitabine plus carboplatin alone in about 90 patients. Patients will receive trilaciclib either on …

    Published on 1/16/2017
  • ATI-50001: Ph I started

    Aclaris began a Phase I trial to evaluate oral ATI-50001 in 12 healthy volunteers. Aclaris has exclusive, worldwide rights to ATI-50001 from Rigel under a 2015 deal (see BioCentury, Sept. 14, 2015).Aclaris Therapeutics …

    Published on 1/9/2017

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