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RSSArchived Drug Trial News Stories - February 2011

Date Title Comments Rating
2011-02-28 Omni Bio to expand Type 1 diabetes Phase I/II trial from 15 to 50 patients 0 None
2011-02-28 TCD announces first patient treated in its TCD-717 Phase I trial 0 None
2011-02-28 ACT Biotech files SPA with FDA for telatinib combination Phase 3 trial for stomach cancer 0 None
2011-02-28 Regeneron's ARCALYST meets primary, secondary endpoints in second Phase 3 gout flare study 0 None
2011-02-28 Aeterna Zentaris receives $2.5M net sales milestone payment from Cowen Royalty 0 None
2011-02-28 Celgene's ISTODAX sNDA granted FDA Priority Review classification for progressive/relapsed PTCL 0 None
2011-02-28 Positive results from Trius torezolid Phase 1 lung study 0 None
2011-02-28 Immunitor to present latest results from imm01 trial in tuberculosis patients at African conference 0 None
2011-02-28 MEPs, OETC visit new TB vaccine trial site to express support for candidate development 0 5
2011-02-28 Preliminary top-line results from cariprazine 8-week Phase II trial against major depressive disorder 0 None
2011-02-28 First patient treated in KUR-023 pilot clinical trial to assess safety and efficacy of product candidate 0 None
2011-02-28 Final data from 4SC vidofludimus ENTRANCE Phase IIa trial against IBD presented at ECCO IBD Conference 0 None
2011-02-27 Phase III trial results: Erlotinib has comparable efficacy to chemotherapy with better tolerability against lung cancer 0 None
2011-02-27 Encouraging preliminary results from Synta's ganetespib Phase 2 trial against non-small cell lung cancer 0 None
2011-02-25 Less-toxic combination of immune-based drug and chemotherapy drug produce long-term remissions in CLL 0 None
2011-02-25 Neoprobe's Lymphoseek Phase 2 study data published in Annals of Surgical Oncology 0 None
2011-02-25 Preclinical data of Zalicus sodium channel compound published in journal PAIN 0 None
2011-02-25 Medwell commits $2,000,000 investment in Mimetogen 0 None
2011-02-25 U.S.-Chile collaborate to study new long-acting local anesthetic derived from algae 0 None
2011-02-25 Targets against MRSA in microgravity 0 None
2011-02-25 Protalix receives FDA CRL for taliglucerase alfa NDA for Gaucher disease 0 None
2011-02-25 Journal of Clinical Virology publishes positive outcome from CMX001 treatment against AdV infection 0 None
2011-02-25 Radioactive tracing agent can identify tumor-draining sentinel nodes in breast cancer, melanoma patients 0 None
2011-02-25 The Lancet journal publishes XGEVA Phase 3 study results against prostate cancer, bone metastases 0 3
2011-02-25 Enobia completes patient enrollment in ENB-0040 Phase II study for HPP 0 None
2011-02-25 Lux initiates pivotal voclosporin Phase 3 trial in non-infectious uveitis 0 None
2011-02-25 Zoledronic acid demonstrates anti-angiogenic effects in metastatic lung cancer 0 None
2011-02-25 Stemline licenses clinically active oncology vaccine for dual targeting of tumor bulk and cancer stem cells 0 None
2011-02-25 BioCryst receives HHS contract to complete peramivir Phase 3 study in patients with influenza 0 None
2011-02-24 PolyMedix completes PMX-30063 Phase 1 exposure-escalation clinical study to treat Staph infections 0 None
2011-02-24 BioSante completes patient enrollment in LibiGel Phase III trial for treatment of FSD 0 None
2011-02-24 Isis Pharma announces ISIS-CRPRx Phase 1 trial results in diseases with elevated CRP 0 None
2011-02-24 Onyx, Bayer initiate patient enrollment in Nexavar Phase 3 trial for breast cancer treatment 0 None
2011-02-24 Positive results from Vertex VX-770 Phase 3 STRIVE study in patients with CF 0 None
2011-02-24 First patient enrolled in TXA127 Phase 2 clinical study to stimulate engraftment following transplant 0 None
2011-02-23 Oncolytics completes patient enrollment in REOLYSIN trial to treat metastatic colorectal cancer 0 None
2011-02-23 PCI Biotech completes patient inclusion in PC-A11 phase I/II study to treat cancer 0 None
2011-02-23 Trevena commences TRV120027 Phase 2a trial in patients with acute heart failure 0 None
2011-02-23 Aestus commences ATx08-001 phase 2 trial to evaluate efficacy of novel pain therapeutic 0 None
2011-02-23 Aeterna to present two novel anticancer compounds at Bio Partnering North America conference 0 None
2011-02-23 Norgine, Tranzyme commence dosing in ulimorelin Phase 3 study for restoring GI function after surgery 0 None
2011-02-23 ISCTM 7th annual meeting to discuss drug development based on amyloid hypothesis of Alzheimer's disease 0 None
2011-02-23 Scientists receive HHS grant to investigate DSC127 in treatment of skin injuries linked with radiation exposure 0 None
2011-02-23 Survey: 67% of pharma and biotech companies outsource more than half of all clinical trials 0 None
2011-02-23 Amgen announces publication of XGEVA Phase 3 study results against solid tumors in Journal of Clinical Oncology 0 None
2011-02-23 American Journal of Clinical Oncology publishes CTI's OPAXIO phase II results against esophageal cancer 0 None
2011-02-23 Positive results from Harbor BioSciences' Triolex initial preclinical study for treatment of PD 0 4
2011-02-22 Regeneron submits VEGF Trap-Eye BLA to FDA for treatment of wet AMD 0 None
2011-02-22 TransPharma completes ViaDor-GLP1 agonist Phase 1b trial for treatment of type II diabetes 0 None
2011-02-22 Infinity commences IPI-926 Phase 2 trial in patients with pancreatic cancer 0 None
2011-02-22 KemPharm commences KP201 Phase 1 trial for pain 0 None
2011-02-22 Pieris: New interim PRS-050 Phase I data against cancer to be presented at Tri-Conference in California 0 None
2011-02-22 Positive preliminary data from Fate Therapeutics FT1050 Phase 1b trial in patients with life-threatening conditions 0 None
2011-02-22 Pharming, Santarus begin RHUCIN Phase IIIb study in patients with Hereditary Angioedema 0 None
2011-02-22 Positive results from TMC435 phase 2b PILLAR study in treatment-naive patients with HCV 0 None
2011-02-21 Advancell announces positive results from Acadra clinical study in Chronic Lymphocytic Leukemia 0 None
2011-02-21 Synexus creates specialist vaccines team to help pharma and biotech companies 0 None
2011-02-20 Bangladesh cholera vaccine trial 0 None
2011-02-19 Protalix: New data from taliglucerase alfa, oral GCD trials to be presented at Lysosomal Disease Network Symposium 0 None
2011-02-19 Genzyme reports 3-year follow-up data from eliglustat tartrate Phase 2 trial for Gaucher disease 0 None
2011-02-19 Phase I/II safety, efficacy data for Bellicum's BPX-101 presented at 2011 Genitourinary Cancers Symposium 0 None
2011-02-19 EMA grants Prima BioMed Scientific Advice for CVac ovarian cancer vaccine Phase III trial 0 5
2011-02-19 FDA grants CSL Behring marketing approval for Corifact in treatment of congenital FXIII deficiency 0 None
2011-02-19 Novavax announces final safety, immunogenicity results from H1N1 VLP vaccine at WHO meeting 0 4.5
2011-02-18 Tibotec begins enrollment in TMC435 phase 3 trial for treatment of HCV 0 None
2011-02-18 Positive interim data from cabozantinib Phase 2 metastatic castration-resistant prostate cancer trial 0 None
2011-02-18 BDSI announces over 50% enrolled in BEMA Buprenorphine Phase 3 study in chronic pain 0 None
2011-02-18 Urocidin Phase III non-muscle-invasive bladder cancer trial interim results to be presented at EAU, AUA conferences 0 None
2011-02-18 Apricus Bio in discussions with FDA for PrevOnco SPA Phase III protocol 0 None
2011-02-18 FDA grants miRagen's MGN-4893 orphan drug designation for treatment of polycythemia vera 0 None
2011-02-18 Conatus commences multi-center CTS-1027 Phase 2b trial for HCV treatment 0 None
2011-02-17 Cytochroma initiates CTAP101 repeat-dose safety, efficacy study in vitamin D insufficiency, SHPT and CKD 0 None
2011-02-17 Positive preliminary data from ongoing PSMA ADC phase 1 study against prostate cancer 0 None
2011-02-17 Clinical trial finds atorvastatin may inhibit HIV progression, help in infection's management 0 None
2011-02-17 FDA, Threshold enter agreement on SPA for TH-302 Phase 3 trial in patients with soft tissue sarcoma 0 None
2011-02-17 Amicus to present additional positive data from Amigal Phase 2 extension study for Fabry disease 0 None
2011-02-17 Oncolytics begins enrollment in 2-Arm carboplatin Phase II randomized study for pancreatic cancer 0 None
2011-02-16 Endo Pharmaceuticals, Bioniche announce first patient enrollment in Urocidin second Phase III trial 0 None
2011-02-16 Endologix announces initial PEVAR Trial presentation at 2011 iCON annual meeting 0 None
2011-02-16 Halozyme-Roche announce initiation of Phase 3 subcutaneous MabThera trial in follicular NHL 0 2
2011-02-15 The Lancet publishes Baxter's PREFLUCEL phase III trial results against seasonal influenza 0 None
2011-02-15 Raptor reopens enrollment in DR Cysteamine Phase 3 trial to treat patients with nephropathic cystinosis 0 None
2011-02-15 Almac's Director plans to speak on adaptive trial designs at CTS Europe conference 0 None
2011-02-15 Idera: IMO-3100 in lupus preclinical model suppressed several key disease progression parameters 0 None
2011-02-15 Oncolytics' REOLYSIN/gemcitabine combination Phase 2 pancreatic cancer trial meets primary endpoint 0 None
2011-02-14 Kamada reports positive interim results from Alpha-Antitrypsin Phase 2-3 trial to treat Alpha-1 deficiency 0 None
2011-02-14 FDA waives NDA filing fee for Antares' Anturol NDA 0 None
2011-02-14 FDA grants BrainStorm's NurOwn orphan drug designation for treatment of ALS 0 None
2011-02-14 Neoprobe achieves accrual goal in Lymphoseek Phase 3 study in breast cancer/melanoma 0 5
2011-02-14 Tarsa completes oral calcitonin Phase III trial for treatment of postmenopausal osteoporosis 0 None
2011-02-14 OXiGENE, NCI/CTEP and GOG collaborate on ZYBRESTAT Phase 2 study in relapsed ovarian cancer 0 None
2011-02-14 Positive results from Glenmark's crofelemer Phase 2 study in acute watery diarrhea 0 2
2011-02-14 Independent Safety Monitoring Board recommends Vical's Allovectin-7 Phase 3 trial to continue as per protocol 0 None
2011-02-14 SynthRx to become wholly-owned subsidiary of ADVENTRX 0 None
2011-02-14 Study shows beneficial anti-fibrotic effects of Pentraxin-2 in idiopathic pulmonary fibrosis 0 None
2011-02-14 Phase III RISE study of Lucentis for DME meets primary endpoint 0 None
2011-02-14 Last patient in EU Diamyd Phase III clinical study completes 15-month visit for type 1 diabetes 0 None
2011-02-14 JTH publishes positive TB-402 Phase II trial results for VTE treatment after orthopaedic surgery 0 None
2011-02-13 Positive safety data from BioSante's ongoing LibiGel Phase III study in women with HSDD 0 None
2011-02-11 FDA grants Inhibitex Fast Track Designation for INX-189 in treatment of chronic hepatitis C viral infection 0 None
2011-02-11 Promedior initiates Phase 1b clinical study of PRM-151 in patients with IPF 0 None
2011-02-10 Medivir initiates phase 1a clinical trial of TMC649128 for chronic HCV infection 0 None
2011-02-10 Genta initiates new Phase 2 clinical trial of tesetaxel in patients with advanced prostate cancer 0 None
2011-02-10 Gilead resubmits NDA for single-tablet regimen of Truvada/TMC278 0 None
2011-02-10 Zogenix completes enrollment in ZX002 Phase 3 study in opioid-experienced adults with moderate to severe pain 0 None
2011-02-10 EMA grants QLT positive opinions for Orphan Drug Designation of QLT091001 to treat inherited blindness 0 5
2011-02-10 Vical 2010 net loss increases to $30.4 million 0 None
2011-02-10 Afinitor plus BSC doubles progression-free survival in patients with advanced pancreatic neuroendocrine tumors 0 None
2011-02-10 Diamyd's NP2 Enkephalin Phase II study in cancer pain posted on ClinicalTrials.gov 0 None
2011-02-10 Hormone 17-Hydroxyprogesterone does not reduce rate of preterm delivery in twin pregnancies: Study 0 None
2011-02-10 Teva reports positive results from QNAZE Phase III perennial allergic rhinitis trial 0 None
2011-02-09 Everolimus phase III study shows improved progression-free survival in patients with pNET 0 None
2011-02-09 Targacept initiates TC-6987 Phase 2 study in patients with asthma, Type 2 diabetes 0 None
2011-02-09 PolyMedix commences PMX-60056 Phase 2 clinical trial in patients undergoing PCI 0 None
2011-02-09 GeoVax opens second HIV clinical trial site at Alabama Vaccine Research Clinic 0 None
2011-02-09 CeNeRx announces FDA approval of CXB909 IND for neuroprotection and neurodegenerative disorders 0 None
2011-02-09 A.P. Pharma provides update on response to APF530 Complete Response Letter 0 None
2011-02-09 R-Tech commences RK-023 Phase I study for treatment of eyelash hypotrichosis 0 None
2011-02-09 Gentium completes Defibrotide clinical studies, plans to file for regulatory approval 0 None
2011-02-09 Medicago granted FDA clearance for clinical development of seasonal flu vaccine 0 None
2011-02-09 Pervasis' Vascugel granted Fast Track review status for prevention of hemodialysis access failure in ESRD patients 0 None
2011-02-08 CytRx's bafetinib helps reduce skeletal complications in cancer patients 0 None
2011-02-08 Rib-X commences Phase 2b trial to assess delafloxacin, linezolid, vancomycin for treatment of ABSSSI 0 None
2011-02-08 Scientists develop low cost, nanometer-sized drug to treat chronic wounds 0 None
2011-02-08 Genentech's OCEANS Phase III study of Avastin in platinum-sensitive ovarian cancer meets primary endpoint 0 5
2011-02-08 Cleveland Clinic, JumpStart Ventures invest $500,000 in SironRX Therapeutics 0 None
2011-02-08 Transition reports second quarter 2011 net income of $24.28M vs. $6.05M net loss for second quarter 2010 0 None
2011-02-07 PharmaMar initiates PM060184 Phase I clinical trial in patients with solid tumors 0 None
2011-02-07 Harbor BioSciences closes U.S.-based Apoptone Phase I/IIa clinical trial for castration resistant prostate cancer 0 None
2011-02-07 AstraZeneca, Targacept commence TC-5214 Phase 2b clinical trial for major depressive disorder 0 None
2011-02-07 The Lancet journal publishes BENLYSTA BLISS-52 study against SLE 0 None
2011-02-07 Positive results from EpiCept NP-1 Phase IIb trial in patients with CPN 0 None
2011-02-05 Phase II results of VELCADE in patients with aggressive lymphoma published in Journal of Clinical Oncology 0 None
2011-02-05 Amgen, Pfizer present Enbrel new trial results against psoriasis at 69th AAD meeting in New Orleans, LA 0 None
2011-02-04 Anacor initiates dosing in AN2728 Phase 2b trial for psoriasis 0 None
2011-02-04 Positive results from Photocure's Allumera RevitAll study to improve skin's appearance 0 None
2011-02-04 EntreMed announces publication of ENMD-2076 Phase 1 results against solid tumors in AACR journal 0 None
2011-02-04 Positive results from KYTHERA's ATX-101 Phase IIb study for reduction of submental fat 0 None
2011-02-04 FDA sets new PDUFA date for AstraZeneca's ticagrelor 0 None
2011-02-04 CVBT seeks FDA 'fast track' designation for CVBT-141B to treat ischemic diabetic wounds 0 None
2011-02-04 MicroCHIPS commences first hPTH clinical study in women with osteoporosis 0 None
2011-02-04 Alimera reports 36-month results from ILUVIEN Phase 3 FAME study for DME 0 None
2011-02-04 Positive top-line results from ILUVIEN Phase 3 trial in patients with DME 0 5
2011-02-03 Ceregene initiates enrollment and dosing in CERE-120 Phase 2b trial for Parkinson's disease 0 None
2011-02-03 Positive results from Derma Sciences' Phase 2 trial with DSC127 in patients with diabetic foot ulcers 0 None
2011-02-03 New England Journal publishes fidaxomicin Phase 3 trial results against CDI 0 5
2011-02-03 Inspiration presents IB1001 PK data for treatment of hemophilia B 0 None
2011-02-03 First therapeutic vaccine designed from dendritic cells of patient achieves significant response 0 None
2011-02-03 Shionogi-ViiV Healthcare initiates 572-Trii fixed-dose combination therapy study for HIV 0 None
2011-02-03 Fidaxomicin demonstrates 45% reduction in recurrences vs. existing treatment for C. difficile infection 0 None
2011-02-03 Concert and WRAIR enter CRADA to evaluate novel compound for seizure protection associated with TBI 0 None
2011-02-03 Inspiration presents IB1001 PK data at European haemophilia congress 0 None
2011-02-03 Merck announces publication of GARDASIL pivotal Phase III study data in NEJM 0 1
2011-02-03 Isotechnika closes licensing deal with ILJIN Life Science to advance development of voclosporin 0 None
2011-02-03 FDA lifts clinical hold on Icagen's IND for ICA-105665 epilepsy drug candidate 0 None
2011-02-03 ImmunoCellular Therapeutics initiates enrollment in ICT-107 Phase II trial for GBM 0 None
2011-02-03 Enrollment stopped in one of two global necitumumab Phase III studies in NSCLC 0 None
2011-02-03 Positive results from Factor IX-CTP comparative study in hemophilic mice 0 None
2011-02-02 EGEN receives 4-year, $1.6M FDA grant for EGEN-001 Phase II clinical study in ovarian cancer 0 None
2011-02-02 Isis commences ISIS-FXIRx Phase 1 study for treatment of clotting disorders 0 None
2011-02-02 DARA BioSciences' KRN5500 Phase 2 study in advanced cancer selected for presentation at ADEPT 2011 0 None
2011-02-02 Inovio publishes scientific paper detailing SynCon DNA vaccine preclinical study for prostate cancer 0 None
2011-02-02 FDA to inspect Lannett's manufacturing facility for review of Morphine Sulfate NDA 0 None
2011-02-02 Sanofi-aventis announces GetGoal-X Phase III study of lixisenatide against type 2 diabetes 0 None
2011-02-02 FDA issues Complete Response Letter for approval of Eisai's rabeprazole sodium extended-release capsules 0 None
2011-02-02 Antares initiates dosing in VIBEX MTX clinical study for rheumatoid arthritis 0 5
2011-02-01 BioMarin commences GALNS Phase 3 trial in patients with Morquio A Syndrome 0 3
2011-02-01 Positive interim results from H5N1 Avian Influenza VLP vaccine Phase II human clinical trial 0 None
2011-02-01 Positive interim results from Medicago's Phase II clinical trial of H5N1 Avian Influenza VLP vaccine 0 None
2011-02-01 Orexigen, Takeda announce FDA's issue of complete response letter for Contrave NDA 0 None
2011-02-01 Discovery Labs provides expanded update on efforts to gain FDA marketing authorization for Surfaxin in RDS 0 None
2011-02-01 AVEO commences enrollment in tivozanib Phase 2 study in renal cell carcinoma 0 5
2011-02-01 Circassia Phase II clinical trial confirms safety profile of ToleroMune cat allergy treatment 0 None
2011-02-01 Highly favorable final results from ERGOFLEX initial clinical study for joint pain relief 0 None
2011-02-01 Positive results from NRM8499 phase I clinical study in patients with Alzheimer's disease 0 None
2011-02-01 FDA grants Onyx fast track designation for carfilzomib in treatment of relapsed and refractory multiple myeloma 0 None

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