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Chronological Index of : Clinical Status

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  • Viaskin rPT: Ph I ongoing

    An independent DSMB recommended continuation to the 50 g cohort of Viaskin rPT in a double-blind, placebo-controlled, Swiss Phase I trial evaluating 48-hour applications of 25 and 50 g Viaskin rPT given twice 2 weeks …

    Published on 12/5/2016
  • ABTL0812: Ph II started

    Ability began an open-label, Spanish and French Phase II trial to evaluate 1,500-3,900 mg oral ABTL0812 as first-line therapy in combination with paclitaxel and carboplatin in 80 patients with advanced or recurrent …

    Published on 11/28/2016
  • Bryostatin-1: Completed Ph II enrollment

    Neurotrope completed enrollment of 148 patients in a double-blind, placebo-controlled Phase II trial evaluating 20 and 40 g IV Bryostatin-1 given as 7 doses over 12 weeks.Neurotrope Inc. (OTCQB:NTRP), Newark, N.J.…

    Published on 11/28/2016
  • Cavosonstat: Completed Ph II enrollment

    Nivalis completed enrollment of 19 patients in a double-blind, placebo-controlled, U.S. Phase II trial evaluating 400 mg oral N91115 twice daily for 12 weeks plus Kalydeco ivacaftor. The trial enrolled adult CF patients…

    Published on 11/28/2016
  • MAT2203: Ph II started

    Matinas began a single-blind, U.S. Phase II trial to compare 200 and 400 mg doses of oral MAT2203 to oral fluconazole in about 75 females with moderate to severe vulvovaginal candidiasis.Matinas BioPharma Holdings Inc.…

    Published on 11/28/2016
  • MS1819: Ph IIa started

    AzurRx began an open-label, dose-escalation, Australian and New Zealand Phase IIa trial to evaluate 280, 560, 1,120 and 2,240 mg doses of MS1819 daily for 48-60 days in about 12 patients. Under an amended 2010 deal, …

    Published on 11/28/2016
  • OPT-302: Completed Ph I/IIa enrollment

    Opthea completed enrollment of 31 patients in the dose-expansion Phase IIa portion of a single-blind, U.S. Phase I/IIa trial evaluating once-monthly 2 mg intravitreal OPT-302 as monotherapy or in combination with …

    Published on 11/28/2016
  • Praluent: Ph III ongoing

    An IDMC recommended for the second time continuation of the double-blind, placebo-controlled, international Phase III ODYSSEY OUTCOMES trial evaluating 75 mg subcutaneous Praluent every 2 weeks plus background optimized…

    Published on 11/28/2016
  • ARC-520: Ph IIb hold

    Arrowhead said FDA placed a clinical hold on the double-blind, placebo-controlled, U.S. Phase IIb Heparc-2004 trial of IV ARC-520. Arrowhead said FDA placed the hold after deaths occurred in a non-human primate …

    Published on 11/21/2016
  • BC007: Ph I started

    Berlin Cures began a dose-escalation, German Phase I trial of BC007 given as an IV bolus plus infusion in about 44 healthy volunteers. A double-blind, placebo-controlled part will evaluate single doses of 15, 50 and 150…

    Published on 11/21/2016
  • Emricasan: Ph IIb started

    Conatus began the double-blind, placebo-controlled, international Phase IIb ENCORE-PH trial to evaluate 5, 25 and 50 mg oral emricasan twice daily for 24 weeks in about 240 patients with compensated or early …

    Published on 11/21/2016
  • H.P. Acthar Gel: Ph IV started

    Mallinckrodt began a U.S. Phase IV trial of H.P. Acthar Gel in about 230 patients. Patients will receive 1 mL H.P Acthar Gel twice weekly for 12 weeks in an open-label part, after which patients who achieved low disease…

    Published on 11/21/2016
  • HTS-519: Ph II started

    Hallux began an open-label, U.S. Phase II trial to evaluate subungual HTS-519 in about 30 patients with distal lateral subungual onychomycosis of the great toe.Hallux Inc., Laguna Hills, Calif.Product: HTS-519Business: …

    Published on 11/21/2016
  • NEO-PV-01: Ph Ib started

    Neon began an open-label, U.S. Phase Ib trial to evaluate subcutaneous NEO-PV-01 plus Opdivo nivolumab in about 90 patients with melanoma, non-small cell lung cancer (NSCLC) or bladder cancer. Patients will first …

    Published on 11/21/2016
  • Nuplazid: Ph II started

    Acadia began the double-blind, placebo-controlled, international Phase II ADVANCE trial to evaluate once-daily oral Nuplazid in combination with ongoing antipsychotic treatment for 26 weeks in about 380 patients. …

    Published on 11/21/2016
  • SB-061: Completed Ph I/IIa enrollment

    Symic and Nordic completed enrollment of 147 patients in the double-blind, placebo-controlled, European Phase I/IIa MODIFY-OA trial evaluating 2 intra-articular injections of SB-061. Last year, Symic and Nordic …

    Published on 11/21/2016
  • Sevuparin: Ph II ongoing

    Modus said an independent DSMB recommended continuation of a double-blind, placebo-controlled, international Phase II trial evaluating continuous IV sevuparin for 2-7 days based on safety and pharmacokinetic data from …

    Published on 11/21/2016
  • Subcutaneous elamipretide: Ph I started

    Stealth began the open-label, U.S. Phase I ReCLAIM trial to evaluate 40 mg subcutaneous elamipretide once daily for 12 weeks in about 40 patients ages =55.Stealth BioTherapeutics Inc., Newton, Mass.Product: Subcutaneous…

    Published on 11/21/2016
  • Wilate: Ph III start

    Next month, Octapharma will begin the double-blind, U.S. Phase III INITIATE trial to compare an individualized lot selection of Wilate vs. a random lot selection in about 120 congenital hemophilia patients with a Factor…

    Published on 11/21/2016
  • Wilate: Ph III start

    Next month, Octapharma will begin an open-label, international Phase III trial to evaluate Wilate in about 55 previously treated male patients. In the U.S., Wilate is approved for use in children and adults with von …

    Published on 11/21/2016
  • ABI-H0731: Ph I started

    Assembly began a single-blind, placebo-controlled, New Zealand Phase I trial of oral ABI-H0731 in about 114 subjects. The first part will evaluate multiple doses of oral ABI-H0731 for 1, 7 or 28 days in healthy …

    Published on 11/14/2016
  • Adcetris: Completed Ph III enrollment

    Seattle Genetics and Takeda completed enrollment of 452 patients with CD30-positive mature T cell lymphomas in the double-blind, placebo-controlled, international Phase III ECHELON-2 trial comparing Adcetris plus …

    Published on 11/14/2016
  • BI-505: Ph II hold

    BioInvent said FDA placed a clinical hold on an open-label, U.S. Phase II trial of IV BI-505 as an add-on therapy in about 90 patients undergoing autologous stem cell transplantation (ASCT) with high-dose melphalan. The…

    Published on 11/14/2016
  • Carbidopa/levodopa GR: Ph III amended

    Intec amended the ongoing, double-blind, double-dummy, U.S. Phase III Accordance Study of oral AP-CDLD to reduce enrollment to 328 patients from 460. Intec said the amendment reflects input from "key opinion leaders and…

    Published on 11/14/2016
  • IMG-7289: Ph I/II started

    Imago began an open-label, Australian Phase I/II trial to evaluate oral IMG-7289 with and without tretinoin in 30 patients. The dose-escalation Phase I portion will identify the selected dose of IMG-7289 for the dose-…

    Published on 11/14/2016

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