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Chronological Index of : Clinical Results

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  • ABO-102: Interim Ph I/II data

    Interim data from 3 patients with MPS IIIA in an open-label, U.S. Phase I/II trial showed that a single IV injection of 5x1012 vg/kg ABO-102 was well tolerated with no treatment-related serious adverse events through 30…

    Published on 12/5/2016
  • Ad-RTS-hIL-12: Preliminary Ph Ib/II data

    Preliminary data from 9 evaluable patients with locally advanced or metastatic breast cancer in an open-label, U.S. Phase Ib/II trial showed that 1x1012 viral particles per injection of intratumoral Ad-RTS-hIL-12 plus …

    Published on 12/5/2016
  • Ampion: Preliminary Ph I data

    Preliminary data from the double-blind, placebo-controlled, U.S. Phase I AP-011 trial in 15 patients showed that a single intra-articular injection of up to 3 mL Ampion was well tolerated with no serious adverse events …

    Published on 12/5/2016
  • Ampyra: Ph III data

    Acorda said it will discontinue development of dalfampridine to improve post-stroke walking difficulties after the candidate failed to show sufficient efficacy to support further development in the double-blind, U.S. …

    Published on 12/5/2016
  • ASN-002: Interim Ph I/IIa data

    Interim data from 9 patients with nodular BCC in an open-label, Australian Phase I/IIa trial showed that once-weekly intratumoral ASN-002 for 3 weeks led to an overall response rate (ORR) of 100%, comprising 67% …

    Published on 12/5/2016
  • Atacicept: Ph IIb ADDRESS II data

    The double-blind, international Phase IIb ADDRESS II trial in 306 SLE patients receiving standard of care (SOC) showed that once-weekly 75 and 150 mg subcutaneous atacicept each missed the primary endpoint of a greater …

    Published on 12/5/2016
  • bb2121: Interim Ph I data

    Interim data from 9 evaluable patients in the open-label, dose-escalation, U.S. Phase I CRB0491 trial showed that 5107 cells/kg bb2121 led to an overall response rate (ORR) of 33%, with 1 partial response (PR) and 1 …

    Published on 12/5/2016
  • Blisibimod: Ph III CHABLIS-SC1 data

    Top-line data from the double-blind, international Phase III CHABLIS-SC1 trial in about 442 patients with SLE despite ongoing stable corticosteroid therapy showed that once-weekly subcutaneous blisibimod missed the …

    Published on 12/5/2016
  • BLU-554: Preliminary Ph I data

    Preliminary data from 8 evaluable patients in an open-label, dose-escalation, international Phase I trial showed that once-daily oral BLU-554 led to an unconfirmed partial response at the 280 dose level and 1 case of …

    Published on 12/5/2016
  • CB-839: Updated Ph I data

    Updated data from a cohort of 15 evaluable patients with renal cell carcinoma (RCC) in the open-label, dose-escalation, U.S. Phase I CX-839-001 trial showed that 400-800 mg CB-839 twice daily plus 10 mg oral Afinitor …

    Published on 12/5/2016
  • ErepoXen: Additional Ph II data

    Top-line data from 14 patients with CKD in the third cohort of an open-label, South African and Australian Phase II trial showed that ErepoXen every 2 weeks led to increased hemoglobin levels in 79% of patients with 71%…

    Published on 12/5/2016
  • Glecaprevir/pibrentasvir: Additional Ph II SURVEYOR-2 data

    Data from 203 non-cirrhotic patients with chronic HCV genotypes 2, 4, 5 or 6 infection in the open-label, international Phase II SURVEYOR-2 trial showed that once-daily 300/120 mg oral glecaprevir/pibrentasvir for 8 …

    Published on 12/5/2016
  • Glecaprevir/pibrentasvir: Ph III ENDURANCE-1 data

    Top-line data from 351 non-cirrhotic patients with chronic HCV genotype 1 infection in the open-label, international Phase III ENDURANCE-1 trial showed that once-daily 300/120 mg oral glecaprevir/pibrentasvir for 8 …

    Published on 12/5/2016
  • Glecaprevir/pibrentasvir: Ph III ENDURANCE-3 data

    Top-line data from 157 treatment-nave, non-cirrhotic patients with chronic HCV genotype 3 infection in the open-label, international Phase III ENDURANCE-3 trial showed that once-daily 300/120 mg oral glecaprevir/…

    Published on 12/5/2016
  • GLPG1837: Phase IIa SAPHIRA 2 data

    Data from 7 patients with S1251N mutation-positive CF in the open-label, international Phase IIa SAPHIRA 2 trial showed that twice-daily oral GLPG1837 was generally well tolerated with no serious adverse events reported…

    Published on 12/5/2016
  • Guselkumab: Ph IIa data

    Top-line data from a double-blind, international Phase IIa trial in 149 patients with active psoriatic arthritis and a plaque psoriasis body surface area (BSA) of =3% showed that 100 mg subcutaneous guselkumab met the …

    Published on 12/5/2016
  • IONIS-FXIRx: Ph II data

    A double-blind, Canadian Phase II trial in 43 patients with ESRD receiving hemodialysis showed that 200 and 300 mg doses of subcutaneous IONIS-FXIRx dosed twice weekly for 2 weeks and then once weekly for 10 weeks …

    Published on 12/5/2016
  • LuMeBlue: Ph III data

    Top-line data from a double-blind, international Phase III trial in about 1,270 patients undergoing a colonoscopy showed that oral LuMeBlue met the primary endpoint of improving the detection of adenomas vs. placebo.…

    Published on 12/5/2016
  • M923: Ph III data

    Top-line data from a double-blind, international Phase III trial in 516 patients with moderate to severe chronic plaque psoriasis showed that M923 met the primary endpoint of equivalence to Humira adalimumab from AbbVie…

    Published on 12/5/2016
  • Meloxicam: Ph III data

    Top-line data from a double-blind, U.S. Phase III trial in 219 patients showed that 30 mg IV meloxicam every 24 hours for up to 3 doses following abdominoplasty met the primary endpoint of improving SPID24 vs. placebo (…

    Published on 12/5/2016
  • MSC-100-IV: Interim Ph III data

    Mesoblast said first-line treatment with MSC-100-IV passed a pre-specified interim futility analysis conducted by an independent DSMB for the primary endpoint of ORR at day 28 in an open-label, U.S. Phase III trial in …

    Published on 12/5/2016
  • Nucala: Ph III MEA115921 data

    Top-line data from the double-blind, international Phase III MEA115921 trial in 136 patients receiving standard of care (SOC) including background corticosteroids with or without immunosuppressive therapy showed that …

    Published on 12/5/2016
  • Orkambi: Ph III data

    Top-line data from a double-blind, international Phase III trial in 204 CF patients ages 6-11 with 2 copies of the F508 del mutation in the CFTR gene showed that twice-daily 250/200 mg Orkambi ivacaftor/lumacaftor met …

    Published on 12/5/2016
  • Ornithine phenylacetate: Ph IIa STOP-ALF data

    Data from 36 evaluable patients with minimal renal dysfunction or with compromised renal function in the open-label, U.S. Phase IIa STOP-ALF trial showed that IV OCR-002 given for up to 5 days was well tolerated at all …

    Published on 12/5/2016
  • Otiprio: Ph II data

    A single-blind, U.S. Phase II trial in 95 patients with acute otitis media with tympanostomy tubes showed that a single treatment of 6 and 12 mg Otiprio each significantly improved clinical cure rate at day 15 vs. sham …

    Published on 12/5/2016

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