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Chronological Index of BioCentury Extra, The Daily News: Clinical News

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  • CLINICAL NEWS: Genfit jumps as GFT505 meets Phase II endpoints

    Genfit S.A. (Euronext:ALGFT) gained EUR 1.57 (84%) to EUR 3.45 on Friday after GFT505 met the co-primary endpoints of improving insulin sensitivity in the liver and peripheral tissues in the Phase II GFT505-210-6 trial …

    Published on 2/3/2012
  • CLINICAL NEWS: AB gains on masitinib data in GIST

    AB Science S.A. (Euronext:AB) jumped EUR 4.42 (72%) to EUR 10.60 on Thursday after releasing data late Wednesday from a Phase II trial of masitinib to treat gastrointestinal stromal tumors (GIST). Second-line treatment …

    Published on 2/2/2012
  • CLINICAL NEWS: Astellas' JAK inhibitor meets Phase IIa psoriasis endpoint

    Astellas Pharma Inc. (Tokyo:4503) said oral JAK inhibitor ASP015K met the primary endpoint of significantly improving Psoriasis Area and Severity Index (PASI) score from baseline to day 42 vs. placebo in a Phase IIa …

    Published on 2/2/2012
  • CLINICAL NEWS: OncoGenex reports preliminary data for OGX-427 in CRPC

    OncoGenex Pharmaceuticals Inc. (NASDAQ:OGXI) said a greater proportion of patients receiving OGX-427 plus prednisone were progression free at 12 weeks, the primary endpoint, vs. prednisone alone in a Phase II trial to …

    Published on 2/2/2012
  • CLINICAL NEWS: Sucampo gains on Phase III lubiprostone data

    Sucampo Pharmaceuticals Inc. (NASDAQ:SCMP) gained $1 (23%) to $5.39 on Thursday after it and partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said lubiprostone met the primary endpoint in a Phase III trial to treat …

    Published on 2/2/2012
  • CLINICAL NEWS: AB Science reports OS data for masitinib in GIST

    AB Science S.A. (Euronext:AB) said second-line treatment with masitinib significantly improved median overall survival (OS), a secondary endpoint, vs. Sutent sunitinib at a median follow-up of 14 months in a Phase II …

    Published on 2/1/2012
  • CLINICAL NEWS: Medivation, Astellas report additional AFFIRM data

    Medivation Inc. (NASDAQ:MDVN) and partner Astellas Pharma Inc. (Tokyo:4503) said once-daily oral MDV3100 met the secondary endpoints of radiographic and prostate specific antigen (PSA) response rates and time to disease…

    Published on 1/31/2012
  • CLINICAL NEWS: BTG's Varisolve meets Phase III endpoint

    BTG plc (LSE:BGC) said Varisolve met the primary endpoint in the U.S. Phase III VANISH-2 trial to treat varicose veins. In 235 patients with symptomatic and visible varicose veins and saphenofemoral junction …

    Published on 1/30/2012
  • CLINICAL NEWS: Infinity falls on saridegib data

    Infinity Pharmaceuticals Inc. (NASDAQ:INFI) fell $3.97 (40%) to $5.98 on Friday after an interim analysis showed saridegib plus gemcitabine would not meet the primary endpoint of median overall survival vs. gemcitabine …

    Published on 1/27/2012
  • CLINICAL NEWS: Lpath stops iSONEP dosing due to cGMP issues

    Lpath Inc. (OTCBB:LPTN) suspended dosing of ophthalmic product iSONEP in two trials because the company's fill/finish contractor, Formatech Inc. (Andover, Mass.), did not meet cGMP requirements. Lpath said the move is …

    Published on 1/27/2012
  • CLINICAL NEWS: Advanced Cell reports first data from stem cell trials

    Advanced Cell Technology Inc. (OTCBB:ACTC) said the sub-retinal transplantation of human embryonic stem cell-derived retinal pigment epithelium (RPE) cells in two patients with ophthalmic disease showed no adverse …

    Published on 1/23/2012
  • CLINICAL NEWS: CHMP adopts opinion on AD biomarker

    EMA's CHMP adopted a final qualification opinion that low hippocampal volume is predictive of Alzheimer's disease-type dementia in patients with cognitive impairment. The MRI-detected biomarker can now be used in …

    Published on 1/23/2012
  • CLINICAL NEWS: EMA releases draft on biosimilars for interferon beta

    EMA's CHMP released draft guidance on the development of biosimilar versions of multiple sclerosis (MS) drug interferon beta. The draft outlines non-clinical and clinical requirements, including comparative in vitro …

    Published on 1/19/2012
  • CLINICAL NEWS: Bayer, Onyx unveil OS data for regorafenib

    Bayer AG (Xetra:BAYN) and partner Onyx Pharmaceuticals Inc. (NASDAQ:ONXX) reported additional data from the Phase III CORRECT trial in 760 metastatic colorectal cancer (mCRC) patients who have progressed after standard …

    Published on 1/18/2012
  • CLINICAL NEWS: ArQule gains on tivantinib data in HCC

    ArQule Inc. (NASDAQ:ARQL) gained $0.71 (12%) to $6.67 on Tuesday after oral tivantinib met the primary endpoint of significantly improving time to progression vs. placebo in a Phase II trial to treat unresectable …

    Published on 1/17/2012
  • CLINICAL NEWS: Medivation, Pfizer end Dimebon development

    Medivation Inc. (NASDAQ:MDVN) and Pfizer Inc. (NYSE:PFE) discontinued development of Dimebon latrepirdine for all indications and terminated a 2008 deal after reporting data from the Phase III CONCERT trial to treat …

    Published on 1/17/2012
  • CLINICAL NEWS: FDA to discuss anti-NGF safety in March

    FDA's Arthritis Advisory Committee will meet on March 12 to discuss safety issues possibly related to anti-nerve growth factor (NGF) compounds. The agency will ask the committee to determine whether reports of joint …

    Published on 1/10/2012
  • CLINICAL NEWS: Biocon's anti-CD6 mAb meets Phase III psoriasis endpoint

    Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) said itolizumab met the primary endpoint of a significantly greater proportion of patients achieving a PASI 75 response at week 12 vs. placebo in the Phase III TREAT-PLAQ trial to …

    Published on 1/9/2012
  • CLINICAL NEWS: Theravance falls after Relovair data

    Theravance Inc. (NASDAQ:THRX) fell $3.81 (19%) to $16.39 on Monday after it and partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) released top-line data from nine trials of Relovair fluticasone furoate/vilanterol to treat…

    Published on 1/9/2012
  • CLINICAL NEWS: Durect falls on pain data

    Durect Corp. (NASDAQ:DRRX) fell $0.44 (38%) to $0.74 on Friday after reporting top-line data from the Phase III BESST trial of Posidur to treat post-operative pain. In patients undergoing laparoscopically assisted …

    Published on 1/6/2012
  • CLINICAL NEWS: ProFibrix's Fibrocaps meets hemostasis endpoint

    ProFibrix B.V. (Leiden, the Netherlands) said topical Fibrocaps followed by the Gelfoam absorbable gelatin sponge met the primary endpoint of reducing mean time to hemostasis vs. Gelfoam alone in a U.S. Phase II trial …

    Published on 1/5/2012
  • CLINICAL NEWS: Aveo falls after tivozanib data

    Aveo Pharmaceuticals Inc. (NASDAQ:AVEO) fell $3.37 (20%) to $13.83 on Tuesday despite reporting that oral tivozanib met the primary endpoint of median progression-free survival (PFS) vs. sorafenib in the Phase III TIVO-…

    Published on 1/3/2012
  • CLINICAL NEWS: Osiris off after Prochymal data

    Osiris Therapeutics Inc. (NASDAQ:OSIR) fell $0.18 to $5.17 on Tuesday after reporting that there was no significant difference between Prochymal and placebo in the rate of disease progression as measured by stimulated C…

    Published on 1/3/2012
  • CLINICAL NEWS: Scripps names Marletta CEO

    The Scripps Research Institute named Michael Marletta president and CEO. Marletta, who joined the Scripps faculty in July 2011, was formerly a professor of biochemistry and chair of the Department of Chemistry at the …

    Published on 1/3/2012
  • CLINICAL NEWS: Avastin misses OS endpoint in ovarian cancer trial

    Avastin bevacizumab missed the secondary endpoint of overall survival in the Phase III GOG-0218 trial in patients with previously untreated advanced ovarian cancer, according to data published Thursday in the New …

    Published on 12/29/2011

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