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Chronological Index of : Clinical Status

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  • BGB-A317: Ph I started

    BeiGene began an open-label, dose-escalation, dose-expansion, Chinese Phase I trial to evaluate 200 and 300 mg BGB-A317 every 3 weeks in about 300 patients.BeiGene Ltd. (NASDAQ:BGNE), Beijing, ChinaProduct: BGB-…

    Published on 1/9/2017
  • BPX-01: Completed Ph II enrollment

    BioPharmX completed enrollment of 225 patients with moderate to severe inflammatory, non-nodular acne vulgaris in the double-blind, placebo-controlled, U.S. Phase IIb OPAL trial evaluating about 1 g of 1% or 2% BPX-01 …

    Published on 1/9/2017
  • CardiAMP: Ph III CardiAMP Heart Failure started

    BioCardia began the double-blind, sham-controlled, U.S. Phase III CardiAMP Heart Failure trial to evaluate CardiAMP in up to 260 patients.BioCardia Inc. (Pink:BCDA), San Carlos, Calif.Product: CardiAMPBusiness: …

    Published on 1/9/2017
  • CV-301: Ph I/II started

    Bavarian Nordic began an open-label, U.S. Phase I/II trial of CV-301 in about 120 patients who have failed prior therapy. The dose-escalation Phase I portion will evaluate CV-301 alone in 40 patients and the Phase II …

    Published on 1/9/2017
  • DCVax-L: Ph III ongoing

    Northwest Biotherapeutics said it will not enroll the last 17 patients of a planned 348 into a double-blind, placebo-controlled, international Phase III trial of intradermal DCVax-L. Last year, FDA placed a partial hold…

    Published on 1/9/2017
  • hGH-CTP: Ph III started

    Opko began an open-label, U.S. Phase III trial to evaluate once-weekly subcutaneous hGH-CTP vs. once-daily subcutaneous Genotropin somatropin in about 220 pre-pubertal children ages =3. Pfizer and Opko are partnered on …

    Published on 1/9/2017
  • IFX-1: Ph II started

    InflaRx began an open-label, Greek Phase II trial to evaluate once-weekly IV IFX-1 for 8 weeks in 12 patients who have failed previous antibiotic or biological treatment.InflaRx GmbH, Jena, GermanyProduct: CaCP29, IFX-…

    Published on 1/9/2017
  • IMP321: Ph I TACTI-mel ongoing

    A DSMB recommended continuation of the open-label, Australian Phase I TACTI-mel trial of subcutaneous IMP321 every 2 weeks plus Keytruda pembrolizumab after 1 mg IMP321 showed no safety concerns. The trial is evaluating…

    Published on 1/9/2017
  • IVA337: Ph IIb NATIVE started

    Inventiva began the double-blind, placebo-controlled, European Phase IIb NATIVE trial to evaluate 800 and 1,200 mg oral IVA337 once daily for 24 weeks in up to 225 NASH patients with liver steatosis and moderate to …

    Published on 1/9/2017
  • Jakafi: Ph II REACH-1 started

    Incyte began the open-label, pivotal, U.S. Phase II REACH-1 trial to evaluate twice-daily oral Jakafi in combination with corticosteroids in about 70 patients. Incyte markets Jakafi in the U.S. for intermediate or high-…

    Published on 1/9/2017
  • Lupuzor: Completed Ph III enrollment

    ImmuPharma completed enrollment of 200 patients in a double-blind, placebo-controlled, international Phase III trial evaluating 200 ug subcutaneous Lupuzor every 4 weeks plus standard of care (SOC) for 48 weeks.…

    Published on 1/9/2017
  • LYC-55716: Ph I/IIa ARGON started

    Lycera began the open-label, U.S. Phase I/IIa ARGON trial of twice-daily oral LYC-55716 given in 28-day cycles. The dose-escalation Phase I portion will enroll about 30 patients to determine the dose for the Phase IIa …

    Published on 1/9/2017
  • ND0612H: Completed Ph II Trial 006 enrollment

    NeuroDerm completed enrollment of 38 patients in the observer-blind, international Phase IIa Trial 006 comparing 2 dosing regimens of continuous subcutaneous infusions of ND0612H over 14 or 24 hours vs. the baseline …

    Published on 1/9/2017
  • NRX-101: Ph IIb/III started

    NeuroRx began a double-blind Phase IIb/III trial to compare twice-daily oral NRX-101 containing 175 or 237.5 mg D-cycloserine and 8.25, 16.5 or 33 mg lurasidone vs. Latuda lurasidone for up to 6 weeks in about 120 …

    Published on 1/9/2017
  • Oliceridine: Completed Ph III APOLLO-1 enrollment

    Trevena completed enrollment of about 375 patients who underwent a bunionectomy in the double-blind, U.S. Phase III APOLLO-1 trial comparing 3 dose levels of IV oliceridine given via a patient-controlled analgesia …

    Published on 1/9/2017
  • Oliceridine: Completed Ph III APOLLO-2 enrollment

    Trevena completed enrollment of about 375 patients who underwent an abdominoplasty in the double-blind, U.S. Phase III APOLLO-2 trial comparing 3 dose levels of IV oliceridine given via a patient-controlled analgesia …

    Published on 1/9/2017
  • Olumacostat glasaretil: Ph III CLAREOS-1 and CLAREOS-2 started

    Dermira began the identical, double-blind, vehicle-controlled, international Phase III CLAREOS-1 and CLAREOS-2 trials to evaluate twice-daily 5% topical olumacostat glasaretil for 12 weeks in about 1,400 total patients.…

    Published on 1/9/2017
  • PEN-221: Ph I/IIa started

    Tarveda began an open-label, dose-escalation, U.S. Phase I/IIa trial to evaluate IV PEN-221 every 3 weeks in about 120 patients.Tarveda Therapeutics Inc., Watertown, Mass.Product: PEN-221 (formerly BTP-277)Business: …

    Published on 1/9/2017
  • RBX7455: Ph I started

    Rebiotix began an open-label, U.S. Phase I trial to evaluate twice-daily oral RBX7455 for 2 or 4 days in about 20 patients.Rebiotix Inc., Roseville, Minn.Product: RBX7455Business: InfectiousMolecular target: …

    Published on 1/9/2017
  • RHB-104: Ph III MAP US ongoing

    In December, Redhill said an independent DSMB recommended continuation of the double-blind, placebo-controlled, international Phase III MAP US trial of twice-daily oral RHB-104 based on a safety review. The company said…

    Published on 1/9/2017
  • SAGE-547: Ph II PPD-202B amended

    Sage converted the double-blind, placebo-controlled Phase II PPD-202B and PPD-202C trials of SAGE-547 to Phase III trials and increased enrollment in the studies to support an NDA submission next year. The changes …

    Published on 1/9/2017
  • SAGE-547: Ph II PPD-202C amended

    Sage converted the double-blind, placebo-controlled Phase II PPD-202B and PPD-202C trials of SAGE-547 to Phase III trials and increased enrollment in the studies to support an NDA submission next year. The changes …

    Published on 1/9/2017
  • SPR741: Ph I started

    Spero began a double-blind, placebo-controlled Phase I trial to evaluate single and multiple ascending doses of SPR741 in 96 healthy volunteers. Spero in-licensed SPR741 from Northern Antibiotics.Northern Antibiotics …

    Published on 1/9/2017
  • TLC599: Ph II start

    Next month, TLC will begin a double-blind, placebo-controlled, international Phase II trial to evaluate single intra-articular injections of 12 and 18 mg TLC599 in about 72 patients.Taiwan Liposome Co. Ltd. (TPEx:4152),…

    Published on 1/9/2017
  • 514G3: Completed Ph I/II enrollment

    In December, XBiotech completed enrollment of 36 patients hospitalized with bacteremia due to S. aureus in the Phase II portion of a double-blind, placebo-controlled, international Phase I/II trial evaluating 514G3 plus…

    Published on 1/2/2017

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