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Chronological Index of : Clinical Status

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  • AQS1301: Clinical trial started

    Aequus began a Canadian proof-of-concept (POC) trial to evaluate once-weekly transdermal AQS1301 for 4 weeks in 8 healthy male volunteers. Aequus and Corium are partnered to develop AQS1301. Aequus has an exclusive, …

    Published on 1/23/2017
  • AUT00206: Ph Ib started

    Autifony began a double-blind, 4-way crossover, U.K. Phase Ib trial of oral AUT00206 in about 16 healthy male volunteers. Subjects will receive 800 or 2,000 mg AUT00206 or placebo during a ketamine challenge or placebo …

    Published on 1/23/2017
  • CAR-T NKR-2 cells: Ph Ib THINK started

    Celyad began the open-label, international Phase Ib THINK trial to evaluate 3 dose levels of CAR-T NKR-2 cells every 2 weeks for up to 3 infusions in up to 110 patients. The dose-escalation portion will enroll up to 24 …

    Published on 1/23/2017
  • DMT210: Ph II DMT210-003 started

    Dermata began the double-blind, vehicle-controlled, U.S. Phase II DMT210-003 trial to evaluate DMT210 5% topical gel twice daily for 12 weeks in about 104 patients. Dermata has exclusive, worldwide rights to DMT210 from…

    Published on 1/23/2017
  • Durvalumab: Ph III MYSTIC amended

    AstraZeneca amended the primary endpoints of the open-label, international Phase III MYSTIC trial of durvalumab with or without tremelimumab (CP-675) vs. standard of care (SOC) platinum-based chemotherapy. The trial's …

    Published on 1/23/2017
  • Fruquintinib: Ph II started

    Chi-Med began an open-label, Chinese Phase II trial to evaluate oral fruquintinib once daily for the first 3 weeks of each 4-week cycle plus once-daily Iressa gefitinib in about 20 patients with NSCLC harboring …

    Published on 1/23/2017
  • Omadacycline: Completed Ph III enrollment

    Paratek completed enrollment of about 750 patients in a double-blind, international Phase III trial comparing IV to once-daily oral omadacycline vs. IV to oral moxifloxacin. The company has an SPA from FDA for the trial…

    Published on 1/23/2017
  • PLX-PAD cells: Completed Ph II enrollment

    Pluristem completed enrollment of 172 patients in a double-blind, placebo-controlled, international Phase II trial evaluating 150 and 300 million PLX-PAD cells administered via 2 intramuscular injections 12 weeks apart.…

    Published on 1/23/2017
  • ProTmune: Ph I/II started

    Fate began the international Phase I/II PROTECT trial of ProTmune in about 70 patients with hematologic malignancies. The open-label Phase I portion will enroll up to 10 patients and the double-blind Phase II portion …

    Published on 1/23/2017
  • SFX-01: Ph II STEM started

    Evgen began the open-label, European Phase II STEM trial to evaluate 300 mg oral SFX-01 twice daily as an add-on therapy to Faslodex fulvestrant, tamoxifen or a third-generation aromatase inhibitor in about 60 patients …

    Published on 1/23/2017
  • Sulfatinib: Ph II started

    Chi-Med began an open-label, Chinese Phase II trial to evaluate 300 mg oral sulfatinib once daily in up to 32 patients.Hutchison China MediTech Ltd. (LSE:HCM; NASDAQ:HCM), Hong Kong, ChinaProduct: Sulfatinib (HMPL-012)…

    Published on 1/23/2017
  • Tipifarnib: Ph II started

    Kura began an open-label, U.S. Phase II trial to evaluate 1,200 mg oral tipifarnib twice daily on days 1-7 and 15-21 of each 28-day cycle in about 20 patients. The dose may be reduced due to treatment-emergent …

    Published on 1/23/2017
  • Total PSA microfluidic assay cassette: Clinical trial started

    Opko began a U.S. clinical validation trial of the Total PSA microfluidic assay cassette in about 1,000 patients. The assay runs on the companys Claros 1 immunoassay analyzer.Opko Health Inc. (NYSE:OPK; Tel Aviv:OPK), …

    Published on 1/23/2017
  • Tremelimumab: Ph III MYSTIC amended

    AstraZeneca plc (LSE:AZN; NYSE:AZN, London, U.K.) amended the primary endpoints of the open-label, international Phase III MYSTIC trial of durvalumab (MEDI4736) with or without tremelimumab vs. standard of care (SOC) …

    Published on 1/23/2017
  • U3-1402: Ph I/II started

    Daiichi Sankyo began an open-label, Japanese Phase I/II trial of IV U3-1402 every 3 weeks in about 80 patients. A dose-escalation part will evaluate 1.6-9.7 mg/kg U3-1402 in patients who are refractory or intolerant to …

    Published on 1/23/2017
  • VIS410: Ph IIa started

    Visterra began a double-blind, placebo-controlled, international Phase IIa trial to evaluate single IV infusions of 2 and 4 g VIS410 in about 150 ambulatory patients. Visterra is developing VIS410 to treat influenza A …

    Published on 1/23/2017
  • 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

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