Clinical Trial News Archive

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March 2011

March 2

Cellceutix Cancer Drug Kevetrin Shows No Genotoxicity in Study OncoMed Anti-Cancer Stem Cell Antibody OMP-21M18 Demonstrates Potent Activity in Preclinical Studies Against Human Colon Cancer Tumors Regardless of KRAS Mutation Status Pacira Pharmaceuticals' EXPAREL Data to be Featured at 2011 ASCPT 112th Annual Meeting Positive Phase 2 Interim Data from First Study of Telaprevir in People Co-Infected with Hepatitis C and HIV Presented at CROI Conference ViroStatics Demonstrates Clinical Proof of Concept for Dual Antiviral Anti-Hyperactivation AV-HALT Drugs Merck's ISENTRESS (raltegravir) Demonstrated Durable Reductions in HIV-1 Viral Load and Sustained Tolerability At Three Years of Treatment in Previously Untreated Adult Patients Infected with HIV-1 Non-Steroidal Anti-Inflammatory Drugs Linked to Increased Risk of Erectile Dysfunction Protein Identified That Serves as a Switch in a Key Pathway of Programmed Cell Death CDC: Bloodstream Infections Reduced 58 Percent Nationwide New Drug Regimens Cut HIV Spread from Mother to Infant

March 8

Targacept to Present at the 13th International Congress on Schizophrenia Research Repligen Reports Phase 2b Results for RG2417 for Bipolar Depression Advanced Cancer Therapeutics to Present Preclinical Data on Glycolysis Inhibitors at American Association for Cancer Research Annual Meeting Journal of Clinical Investigation Publishes Data Demonstrating Enhanced Antitumor Efficacy of Second Generation Idenix Announces Data Presentations at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL) Compugen Announces Positive Animal Model Results for Novel Peptide Predicted to Block Protein-Protein Interaction New Data on Multiple Bristol-Myers Squibb Investigational Hepatitis C Compounds to be Presented at The International Liver Congress 2011 Alliqua Successfully Completes Next Milestone in Transdermal Pain Patch Development

March 10

Exenatide Once Monthly Showed Positive Results in Phase 2 Study Phase III Study of Lucentis Showed Rapid Vision Improvements Sustained for Two Years in Patients with Diabetic Macular Edema Vertex Announces Completion of Phase 2 Study of VX-765 in People with Epilepsy who did not Respond to Previous Treatment Sinovac Reports Positive Preliminary Phase I Clinical Trial Results for EV71 Vaccine in Adult Group Promius Pharma Llc Presents Ongoing Data Creabilis Announces Positive Phase IIa Results for TrkA Kinase Inhibitor CT327 in Psoriasis Vulgaris Exercise Performance in Children and Young Adults with Single Ventricle Heart Disease Improves with Use of Drug for Erectile Dysfunction InVivo Therapeutics Announces Data on Novel Hydrogel Technology in Spinal Cord Injury and Neurosurgical Applications Presented at 2011 Annual Meeting of the AANS/CNS Section on Disorders of the Spine and Peripheral Nerves Gene that Mediates Response to Key Cancer Drugs Frequently Mutated in Young Leukemia Patients who Relapse

March 14

ERYtech Pharma to Present Promising Results for the Treatment of Sickle Cell Disease Cornerstone Pharmaceuticals Announces Positive Results of Emulsiphan Safety Study Phadia Positions the Pharmaceutical Industry to Harness the Power of Personalized Medicine with the Introduction of Innovative Immune Response Diagnostics Purdue Research May Lead to Therapy That Delays Onset, Reduces Severity of MS Symptoms Repligen Reports Positive Phase 3 Clinical Trial Results for RG1068 in Pancreatic Imaging Key Mutations Act Cooperatively to Fuel Aggressive Brain Tumor Reported in the Journal of the National Cancer Institute: Long Term AGH Study Supports Breast Conserving Surgery for Women With Most Common Type of Non-Invasive Breast Cancer Study Puts Notch on the Jagged Edge of Lung Cancer Metastasis Alzheimer's and Parkinson's Disease Research Presented by Revalesio at National Scientific Conference

March 15

Incyte's Ruxolitinib (INCB18424) Meets Primary Endpoint in Second Phase III Study GSK Announces Positive Topline Results of Phase Lll Study of IPX066 in Advanced Parkinson?s Disease Galapagos starts Phase Ib clinical study in cancer patients Combination Overcomes Breast Cancer Resistance to Herceptin Adocia reports positive phase I clinical results on HinsBet, a fast-acting human insulin IPX066 Demonstrates Efficacy and Safety in ADVANCE-PD Phase III Study in Treatment of Advanced Parkinson's Disease Inflammation Behind Heart Valve Disease Second Phase III Study of Novartis JAK Inhibitor INC424 Meets Primary Endpoint in Patients With Myelofibrosis Collaborative Care Shown to be Successful for Patients with Opioid Addictions Oxford Biomedica Announces Publication of TroVax Phase III Analyses in Cancer Immunology, Immunotherapy

March 21

Shire Presents Data at ACMG for Fabry and Gaucher Patients Who Switched to Replagal (agalsidase alfa) and VPRIV® (velaglucerase alfa for injection) Silence Therapeutics' Partner Quark Pharmaceuticals Announces Results From Phase 2 PF-04523655 Study in Diabetic Macular Edema Phase III Results Show Mirabegron Improves Key OAB Symptoms XenoPort Reports Results from a Phase 2b Clinical Trial of Arbaclofen Placarbil as Adjunctive Treatment for Patients with GERD Phase III Results Show Mirabegron Improves Key OAB Symptoms Study Demonstrates Relationship Between Subcutaneous IgG (SCIg) Dosage and Clinical Outcomes With Hizentra Treatment in Patients With Primary Immunodeficiencies Phase III Study of Investigational Compound Ipilimumab Achieves Primary Endpoint of Improvement in Overall Survival in Previously-Untreated Patients with Metastatic Melanoma Curis Announces Positive Results in Genentech Pivotal Phase II Clinical Trial of GDC-0449 in Advanced Basal Cell Carcinoma NasVax Announces the Success of a Phase 2a Clinical Trial of a New Oral Immunotherapy for Fatty Liver Disease Results Published in The Lancet Demonstrate Fecal Incontinence Symptoms Improve with Bulking Agent Injection Marshall Edwards Announces Publication of Phase II Clinical Trial Results Highlighting Activity of Intravenous Phenoxodiol VentiRx Pharmaceuticals Presents Positive Clinical and Pre-Clinical Data at American Academy of Allergy Asthma & Immunology Annual Meeting

March 24

Prolia (denosumab) Open-Label Extension Trial Showed Continued Increase in Bone Mineral Density Over Five Years of Treatment With Similar Safety Profile Observed in Pivotal Trial SPIRIVA HandiHaler Prolonged Time To First COPD Exacerbation, New Study In NEJM Shows Unigene's Oral Peptide Drug Delivery Technology Validated with Positive Top-Line Phase 3 Results from Tarsa's ORACAL Trial of Oral Calcitonin Targacept Announces Top-Line Results from Phase 2 Trial of TC-5619 in Adults with ADHD POZEN Reports Superior Platelet Inhibition of PA32540 Regimen Over a Standard of Care Regimen in a Phase 1 Study (?Co-Rx?) Results of Prosensa's Extended Phase I/II Exon-skipping Trial in Duchenne Muscular Dystrophy Published in the New England Journal of Medicine SARcode Corporation to Present Phase 2 Clinical Data for Dry Eye Candidate at the ARVO2011 Annual Meeting

March 28

ActiveSite Pharmaceuticals' Small Molecule Protease Inhibitor Blocks Retinal Blood Vessel Damage in Rodent Model of Diabetes CytRx Announces the Presentation of Bafetinib Study Results at the American Academy for Cancer Research (AACR) Annual Meeting Keryx Biopharmaceuticals Announces Two Poster Presentations on KRX-0401 (Perifosine) at Upcoming American Association for Cancer Research (AACR) Annual Meeting Medtronic to Unveil Pivotal U.S. Data on Resolute Drug-Eluting Stent at ACC.11 Preclinical Data on AVEO Pharmaceuticals' Tivozanib and Monoclonal Antibody Pipeline to be Presented at AACR 102nd Annual Meeting 2011 Regado Biosciences, Inc. Announces Presentation of the Results of the RADAR Phase 2b Clinical Trial of Its Anticoagulant System REG1 at the i2 Summit During the American College of Cardiology 2011 60th Annual Scientific Session & Expo in New Orleans, LA The Regional Analgesia Military Battlefield Pain Outcomes Study (RAMBPOS): A Preliminary Report The Efficacy and Safety of Butrans (buprenorphine) Transdermal System in Opioid-Naive Patients with Moderate to Severe Low Back Pain: A Double-Blind Study Mini-Stroke Doubles Risk of Heart Attack ARIAD And MolecularMD Announce Collaboration for a Companion Diagnostic Test for The T315I BCR-ABL Mutation in Patients With CML Aeterna Zentaris Announces Two Poster Presentations on Lead Anticancer Compound Perifosine at Upcoming American Association for Cancer Research Annual Meeting A Small Study of Patients Suffering With Intractable Pain Benefit From Hormone Therapy Using Human Chorionic Gonadotropin

March 29

Concert Pharmaceuticals Advances Novel Chronic Kidney Disease Treatment, CTP-499, in Phase 1 Clinical Study ARIAD to Present New Preclinical Data on Ponatinib at the American Association for Cancer Research Annual Meeting Phase 3 Study of VX-770 in Children Ages 6 to 11 With a Specific Type of Cystic Fibrosis Showed Profound Improvements in Lung Function (FEV1) and Other Measures of Disease Through 24 Weeks Orexigen Therapeutics Announces Upcoming Data Presentation at the American College of Cardiology Annual Scientific Meeting New Data Show EndoBarrier Triggers Beneficial Hormone Effects; Helps Patients Achieve Rapid Glycemic Control and Weight Loss while Reducing Heart Disease Risk Factors Clinical Trial Offers New Hope for Moderate to Severe Psoriasis Sufferers Interventional Radiologists Provide Hope in Delaying Growth, Spread of Breast Cancer Tibotec Advances Global Clinical Research Program for TMC435 in HCV; Will Present Four Abstracts Evaluating Safety and Efficacy at EASL Marshall Edwards to Report new Data on Mitochondrial Inhibitor Program at American Association for Cancer Research Annual Meeting Pathfinder Cells Demonstrate Ability to Regenerate Damaged Tissue and Restore Pancreatic Function in a Diabetic Mouse Model Boston Scientific Announces Its ACC 2011 Schedule MedImmune to Present 11 Abstracts on Influenza at 45th Annual National Immunization Conference Southern Research Scientists to Present New Data at the American Association for Cancer Research 102nd Annual Meeting in Orlando Avoiding Health Risks Could Prevent More than Half of All Cases of Atrial Fibrillation

March 30

Top-Line Results Announced of Pivotal Phase 3 Motesanib Trial in Advanced Non-Squamous Non-Small Cell Lung Cancer Patients Nile Therapeutics Announces Upcoming Data Presentation at the American College of Cardiology Annual Scientific Meeting Columbia Laboratories' Provides Update on PREGNANT Study Publication Presidio Pharmaceuticals, Inc. Announces Positive Results in a Phase 1b Clinical Trial of PPI-461, a Novel, Potent Broadly-Active Hepatitis C Virus (HCV) Inhibitor Silence Therapeutics' Phase I Atu027 Data Accepted for Presentation at the American Society of Clinical Oncology 2011 Annual Meeting Rexahn Pharmaceuticals to Present Data on Novel Anti-Cancer Small Molecule RX-5902 at AACR 102nd Annual Meeting Curis Announces Presentations at 102nd American Association for Cancer Research Annual Meeting 2011 Webcast Alert: Isis Pharmaceuticals Hosts Expert Panel Conference Call to Discuss Mipomersen Data Presented at ACC's 60th Annual Scientific Session Investigators at The Saban Research Institute of Children's Hospital Los Angeles Discover Enzyme Essential for Healthy Lung Development Study Reveals No Impact of Age on Outcome in Chronic Myeloid Leukemia Patients Treated With Imatinib Benitec Limited (ASX:BLT) Technology Used By University Of Queensland Scientists to Develop a Treatment for Cervical Cancer Tibotec Advances Global Clinical Research Program For TMC435 in HCV; Will Present Four Abstracts Evaluating Safety and Efficacy at EASL Tibotec Advances GLOBAL Clinical Research Program for tmc435 in hcv; Will Present Four Abstracts Evaluating Safety and Efficacy at EASL

March 31

ImmunoCellular Therapeutics' ICT-107 Named One of the 100 Great Investigational Drugs for 2011 VICTRELIS (boceprevir), Merck's Investigational Medicine, Added to Peginterferon Alfa-2a and Ribavirin Achieved Significantly Higher SVR Rates In Treatment-Failure Patients with Chronic HCV Genotype 1 Compared to Control Cellceutix Cancer Drug, Kevetrin, Shows Increased Levels of p21; Biomarker for Cancer Trials The New England Journal of Medicine Publishes Pivotal Studies Showing Potential of New Investigational Treatment for Chronic Infection with Hepatitis C Virus Genotype 1 Results From Phase 3 REALIZE Study Showed Telaprevir-Based Therapy Significantly Improved SVR (Viral Cure) Rates in People Whose Prior Treatment For Hepatitis C Was Unsuccessful Syndax Pharmaceuticals Announces Entinostat Data at 102nd Annual American Association for Cancer Research Meeting Investigational Direct-Acting Antiviral BMS-790052 Plus PEG-Interferon Alfa and Ribavirin Achieved Up to 92% Sustained Virologic Response in Phase II Dose-Ranging Study of Treatment-Naïve Hepatitis C Patients VBL Therapeutics Presents Two Studies on Novel Anti-Angiogenic Vector at 102nd Annual AACR Meeting BioAlliance Pharma: Livatag (Doxorubicin Transdrug) Follow up Demonstrates Significant Survival Increase in Advanced Hepatocellular Carcinoma Patients Intercept Pharmaceuticals Announces Positive Phase II Results for Obeticholic Acid (INT-747) as Monotherapy in Primary Biliary Cirrhosis Data From Phase 3 Studies Showed Substantial Improvements in SVR (Viral Cure) Rates With Telaprevir-Based Therapy Compared to Currently Available Medicines in People With Hepatitis C, Regardless of Their IL28B Genotype Status New Data Analyses with VICTRELIS (boceprevir), Merck's Investigational Medicine, Examined Possible Predictors of Sustained Virologic Response Inhibitex Reports Positive Safety and Antiviral Data from Its Phase 1b Study of HCV Nucleotide Inhibitor INX-189 SuperGen PIM Kinase Presentations at AACR BioAlliance Pharma: Livatag (Doxorubicin Transdrug) Follow up Demonstrates Significant Survival Increase in Advanced Hepatocellular Carcinoma Patients Interim Phase 2 Data Showed Rapid Viral Response to VX-222 in Combination with Telaprevir, Pegylated-Interferon and Ribavirin Among People With Hepatitis C Biocept and Academic Collaborators to Present Posters at AACR on Circulating Tumor Cells (CTCs) Jasco Pharmaceuticals to Present its Preclinical PIM Inhibitor Program at the American Association for Cancer Research Annual Meeting Inhibitex Announces Data Presentation at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL) Novartis first-in-class antiviral DEB025 achieved sustained viral response in 76% of patients with chronic hepatitis C, new phase II study shows Conatus Pharmaceuticals Presents Results From a Phase 2 Clinical Trial of CTS-1027 in HCV Genotype 1 Null-Responders Cannabis Science Reports: National Cancer Institute Updates Confirm Successful Cancer Treatments with Medical Cannabis
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