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Chronological Index of : Clinical Results

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  • BGB-A317: Additional Ph I data

    Data from 99 evaluable patients with advanced solid tumors in an open-label, dose-escalation Phase Ia/Ib trial showed that IV BGB-A317 every 2 or 3 weeks led to 15 confirmed partial responses and 23 cases of stable …

    Published on 1/9/2017
  • CAM2038: Ph III data

    Top-line data from a double-blind, U.S. Phase III trial in 428 patients with moderate to severe opioid use disorder showed that subcutaneous CAM2038 met the FDA- and EMA-defined primary endpoints of non-inferiority to …

    Published on 1/9/2017
  • CB-839: Updated Ph I CX-839-001 data

    Updated data from a cohort of 16 evaluable patients with metastatic triple-negative breast cancer (TNBC) in the open-label, dose-escalation U.S. Phase I CX-839-001 trial showed that twice-daily 600 and 800 mg oral CB-…

    Published on 1/9/2017
  • GAP3KO vaccine: Ph I data

    An open-label, U.S. Phase I trial in 10 healthy volunteers showed that GAP3KO administered via the bite of 150-200 GAP3KO-infected mosquitoes under controlled conditions prevented malaria infection in all subjects. …

    Published on 1/9/2017
  • Glasdegib: Ph Ib/II data

    Data from 132 patients with previously untreated AML or high-risk MDS who were ineligible for intensive chemotherapy in the Phase II portion of an open-label, international Phase Ib/II trial showed that once-daily 100 …

    Published on 1/9/2017
  • GLPG1837: Ph II SAPHIRA 1 data

    Top-line data from 26 CF patients with the G551D mutation in the open-label, international Phase II SAPHIRA 1 trial showed that twice-daily oral GLPG1837 significantly reduced mean sweat chloride levels from 98 mmol/L …

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

    A double-blind, international Phase III trial in 203 adults with GHD showed that once-weekly injections of hGH-CTP missed the primary endpoint of improving trunk fat mass from baseline to week 26 vs. placebo. After …

    Published on 1/9/2017
  • HS-410: Additional Ph I/II data

    Data from 94 patients with intermediate- or high-risk non-muscle invasive bladder cancer who have undergone transurethral resection of bladder tumor in the Phase II portion of a double-blind, U.S. Phase I/II trial …

    Published on 1/9/2017
  • IONIS-GCGRRx: Ph II data

    Top-line data from the a double-blind, U.S. Phase II trial in 79 Type II diabetics uncontrolled on a stable metformin dose of =1,500 mg/day showed that once-weekly 50 and 75 mg IONIS-GCGRRx each met the primary endpoint…

    Published on 1/9/2017
  • Otiprio: Ph III data

    Top-line data from a double-blind, U.S. and Canadian Phase III trial in 262 pediatric and adult patients with acute otitis externa showed that a single treatment with 12 mg Otiprio met the primary endpoint of improving …

    Published on 1/9/2017
  • Revlimid: Ph III Myeloma XI data

    Data from 1,551 evaluable patients with newly diagnosed MM in the open-label, U.K. Phase III Myeloma XI trial showed that maintenance treatment with once-daily 10 mg oral Revlimid for 21 days of each 28-day cycle led to…

    Published on 1/9/2017
  • Revlimid: Ph III StaMINA data

    The open-label, U.S. Phase III BMT CTN 0702 StaMINA trial in 758 MM patients who received high-dose melphalan plus an autologous peripheral blood stem cell transplant showed that maintenance treatment with once-daily …

    Published on 1/9/2017
  • SL-701: Preliminary Ph II STML-701-0114 data

    Preliminary data from 42 evaluable patients with relapsed or refractory GBM in stage 1 of the 2-stage, open-label, U.S. Phase II STML-701-0114 trial showed that second-line treatment with subcutaneous SL-701 plus GM-CSF…

    Published on 1/9/2017
  • Sollpura: Ph III SOLUTION data

    Top-line data from the open-label, international Phase III SOLUTION trial in 129 patients showed that oral Sollpura missed the primary endpoint of non-inferiority to oral porcine-derived pancreatic enzyme replacement …

    Published on 1/9/2017
  • TAR-200: Preliminary Ph Ib data

    Preliminary data from 10 patients with muscle invasive bladder cancer in an open-label, U.S. Phase Ib trial showed that TAR-200 inserted into the bladder during days 1-7 and days 21-28 following initial transurethral …

    Published on 1/9/2017
  • Toraymyxin: Ph III EUPHRATES data

    Last October, Spectral reported top-line data from the double-blind, North American Phase III EUPHRATES trial in 450 patients with endotoxemic septic shock showing that 2 columns of Toraymyxin plus standard of care (SOC…

    Published on 1/9/2017
  • Trabodenoson: Ph III MATrX-1 data

    Top-line data from the double-blind, U.S. Phase III MATrX-1 trial in 303 patients with primary open-angle glaucoma or ocular hypertension showed that once-daily 3% and 6% and twice-daily 4.5% topical trabodenoson for 3 …

    Published on 1/9/2017
  • BGB-3111: Additional Ph I data

    Data from 46 evaluable patients with chronic lymphocytic lymphoma (CLL) or small lymphocytic leukemia (SLL) in an open-label, dose-escalation, international Phase I trial showed that BGB-3111 led to an ORR of 96%, …

    Published on 1/2/2017
  • Bosulif: Ph III BFORE data

    Top-line data from the open-label, international Phase III BFORE trial in 536 patients with chronic phase Ph+ CML showed that first-line treatment with once-daily 400 mg oral Bosulif met the primary endpoint of a …

    Published on 1/2/2017
  • BTI320: Ph II SG01 data

    Top-line data from the double-blind, Chinese Phase II SG01 trial in 60 high-risk prediabetes patients who are otherwise healthy showed that thrice-daily 4 and 8 g oral doses of BTI320 for 16 weeks were well tolerated. …

    Published on 1/2/2017
  • CERC-501: Ph II data

    Top-line data from a double-blind, 2-way crossover, U.S. Phase II trial in 71 heavy smokers who are not seeking treatment for tobacco use disorder showed that once-daily 15 mg CERC-501 for 8 days missed the primary …

    Published on 1/2/2017
  • DSP-7888: Preliminary Ph I data

    Preliminary data from 12 patients with low- or high-risk MDS in the Phase I portion of an open-label, Japanese Phase I/II trial showed that intradermal DSP-7888 every 2-4 weeks was well tolerated and led to 8 cases of …

    Published on 1/2/2017
  • Emicizumab: Ph III HAVEN 1 data

    The open-label, international Phase III HAVEN 1 trial in 109 patients ages =12 with hemophilia A with Factor VIII inhibitors who were previously treated with episodic or prophylactic bypassing agents showed that …

    Published on 1/2/2017
  • Fitusiran: Additional Ph I data

    Data from 16 patients with hemophilia A or B with inhibitors in the open-label fourth part of a 4-part, international Phase I trial showed that 3 once-monthly doses of 50 or 80 mg subcutaneous fitusiran reduced median …

    Published on 1/2/2017
  • Fitusiran: Interim Ph II data

    Interim data from 16 patients with hemophilia A or B without inhibitors in an open-label, international Phase II extension of a 4-part, international Phase I trial showed that once-monthly 50 or 80 mg subcutaneous …

    Published on 1/2/2017

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