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Chronological Index of : Clinical Results

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  • BMN 270: Updated Ph I/II data

    BioMarin said updated data from 7 patients with severe hemophilia A in an open-label, dose-escalation, U.K. Phase I/II trial showed that a single IV infusion of the highest dose (6x10 13 vg/kg) of BMN 270 produced …

    Published on 1/16/2017
  • Brigatinib: Updated Ph II ALTA data

    Updated data from 110 patients ages =18 with locally advanced or metastatic ALK-positive NSCLC whose disease has progressed on Xalkori crizotinib in the open-label, international, pivotal Phase II ALTA trial showed that…

    Published on 1/16/2017
  • Cefiderocol: Ph II APEKs-cUTI data

    Top-line data from 371 hospitalized adult patients with Gram-negative cUTI with or without pyelonephritis in the microbiological intent-to-treat (mITT) population of the double-blind, international Phase II APEKs-cUTI …

    Published on 1/16/2017
  • Cimzia: Ph III CIMPASI-1 data

    Top-line data from the double-blind, international Phase III CIMPASI-1 trial in 234 patients with moderate to severe chronic plaque psoriasis showed that 200 and 400 mg doses of subcutaneous Cimzia every 2 weeks each …

    Published on 1/16/2017
  • CV9104: Ph IIb data

    Top-line data from the Phase IIb portion of a double-blind, European Phase I/IIb trial in 197 chemotherapy-nave, asymptomatic or minimally symptomatic patients with metastatic CRPC showed that intradermal CV9104 missed …

    Published on 1/16/2017
  • Duvelisib: Additional Ph II DYNAMO data

    Additional data from the open-label, international Phase II DYNAMO trial in 129 patients with follicular lymphoma (n=83), small lymphocytic lymphoma (SLL) (n=28) or marginal zone lymphoma (n=18) who are refractory to …

    Published on 1/16/2017
  • Evenamide: Preliminary Ph IIa data

    Newron said preliminary data from a 4-week, double-blind, U.S. and Indian Phase IIa trial in 89 schizophrenic patients experiencing breakthrough psychotic symptoms while on stable and adequate doses of risperidone or …

    Published on 1/16/2017
  • IMP321: Interim Ph IIb AIPAC data

    Interim data from 15 patients with hormone receptor-positive metastatic breast cancer in the open-label portion of the European Phase IIb AIPAC trial showed that 6 and 30 mg doses of subcutaneous IMP321 on days 2 and 16…

    Published on 1/16/2017
  • IV Debio 1450: Ph II data

    Top-line data from 284 evaluable patients with ABSSSIs due to Staphylococcus, including methicillin-sensitive or methicillin-resistant S. aureus (MSSA or MRSA), in the microbiological intent-to-treat (mITT) population …

    Published on 1/16/2017
  • LB-100: Ph I data

    An open-label, dose-escalation, U.S. Phase I trial in 20 evaluable patients with solid tumors showed that once-daily IV LB-100 on days 1-3 of each 21-day cycle led to 1 partial response in a patient with pancreatic …

    Published on 1/16/2017
  • Myl-1401O: Additional Ph III HERITAGE data

    Additional data from the double-blind, international Phase III HERITAGE trial in 458 evaluable patients with HER2-positive metastatic breast cancer without prior chemotherapy or trastuzumab for metastatic disease showed…

    Published on 1/16/2017
  • Nintedanib: Ph II LUME-Meso data

    Data from 87 treatment-nave patients with unresectable MPM in the double-blind, international Phase II LUME-Meso trial showed that first-line treatment with twice-daily 200 mg oral nintedanib plus pemetrexed/cisplatin …

    Published on 1/16/2017
  • Oral Debio 1450: Ph II data

    Top-line data from 284 evaluable patients with ABSSSIs due to Staphylococcus, including methicillin-sensitive or methicillin-resistant S. aureus (MSSA or MRSA), in the microbiological intent-to-treat (mITT) population …

    Published on 1/16/2017
  • PEGPH20: Additional Ph II HALO 202 data

    Data from 231 evaluable patients in both stages of the open-label, U.S. Phase II HALO 202 trial showed that PEGPH20 plus Abraxane nab-paclitaxel and gemcitabine met the primary endpoint for the overall study of …

    Published on 1/16/2017
  • Pracinostat: Final Ph II data

    Final data from a 2-stage, open-label, U.S. Phase II trial in 50 patients ages =65 with newly diagnosed AML who are unsuitable for intensive induction chemotherapy showed that 60 mg oral pracinostat given thrice weekly …

    Published on 1/16/2017
  • SEL-212: Ph Ib data

    Selecta said an open-label, U.S. Phase Ib trial in 63 patients with hyperuricemia showed that a single dose of IV SEL-212 controlled serum uric acid levels for up to 30 days and prevented the formation of anti-drug …

    Published on 1/16/2017
  • Solanezumab: Additional Ph III EXPEDITION3 data

    Additional data from the double-blind, international Phase III EXPEDITION3 trial in =2,100 patients with mild dementia due to AD showed that 400 mg IV solanezumab every 4 weeks for 76 weeks slowed cognitive decline as …

    Published on 1/16/2017
  • SYN-004: Ph IIb data

    Top-line data from a double-blind, U.S. Phase IIb trial in 412 patients hospitalized for a lower respiratory tract infection and receiving IV ceftriaxone with or without a macrolide showed that once-daily 150 mg oral …

    Published on 1/16/2017
  • TPX-100: Ph II data

    Top-line data from a double-blind, U.S. Phase II trial in 115 patients with mild to moderate patella-femoral OA in both knees showed that once-weekly intra-articular injections of TPX-100 for 4 weeks led to no …

    Published on 1/16/2017
  • TTP273: Ph II LOGRA data

    Top-line data from the double-blind, U.S. Phase II LOGRA trial in 174 Type II diabetics on stable doses of metformin showed that once- and twice-daily 150 mg oral TTP273 each met the primary endpoint of reducing mean …

    Published on 1/16/2017
  • VT-1161: Additional Ph IIb RENOVATE data

    Additional data from the double-blind, U.S. Phase IIb RENOVATE trial in 259 patients with distal lateral subungual onychomycosis of the large toenail showed that 300 and 600 mg doses of oral VT-1161 once daily for 2 …

    Published on 1/16/2017
  • VT-1161: Additional Ph IIb REVIVE data

    Additional data from the double-blind, U.S. Phase IIb REVIVE trial in 215 patients with recurrent vulvovaginal candidiasis showed that 150 and 300 mg doses of oral VT-1161 once daily for 7 days and then once weekly for …

    Published on 1/16/2017
  • Abraxane: Ph II tnAcity data

    Top-line data from 191 women with metastatic TNBC who received no prior systemic chemotherapy in the Phase II portion of the double-blind, international Phase II/III tnAcity trial showed that first-line treatment with …

    Published on 1/9/2017
  • Aldoxorubicin: Additional Ph III data

    Additional data from an open-label, international Phase III trial in 433 patients with metastatic, locally advanced or unresectable STS showed that 350 mg/m2 IV aldoxorubicin on day 1 of each 21-day cycle met the …

    Published on 1/9/2017
  • Arimoclomol: Ph II data

    A double-blind, placebo-controlled, U.S. and Canadian Phase II trial in 36 patients with rapidly progressive familial ALS due to mutations in the superoxide dismutase 1 (SOD1) gene showed that thrice-daily 200 mg oral …

    Published on 1/9/2017

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