Clinical Trial News Archive

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June 2011

June 1

Novartis highlights extensive data on numerous compounds at ASCO in multiple cancers, including Phase III studies in GIST and myelofibrosis GlobeImmune presents cancer clinical trial data at ASCO Analysis of Surfaxin Data Presented in First Peer-Reviewed Manuscript Describing the Consequences of Reintubation in Preterm Neonates Bavarian Nordic Announces Presentation of PROSTVAC Data at the 2011 ASCO Annual Meeting MDxHealth's Methylation Based Companion Diagnostics Enables Better Personalized Treatment in Brain Cancer Zealand Pharma - Additional positive Phase III results with Lyxumia® (lixisenatide) for the treatment of Type 2 diabetes Novel First-in-Class Anti-Cancer Agent in Development by Niiki Pharma Shows Promising Phase I Results Argos Therapeutics' Arcelis Immunotherapy for the Treatment of Renal Cell Carcinoma (RCC) in Combination With Sunitinib Demonstrates Strong Immunologic Response That Correlates to Improved Clinical Outcomes Additional Data From Multiple Phase 1 and 2 Studies of S*BIO's Novel JAK2 Inhibitor SB1518 Demonstrate Safety and Efficacy for Treatment of Symptomatic Myelofibrosis (MF) AMRI Announces Successful Completion of Phase I Clinical Study of Obesity Compound Teva Announces Data on Granulocyte Colony Stimulating Factor Compounds for the Prevention of Chemotherapy-Induced Neutropenia in Breast Cancer Patients

June 2

Zalicus to Present at the 10th Annual World Pharma Conference Fraunhofer USA CMB Announces Positive Phase 1 Interim Results for Its Plant-Produced H1N1 Influenza Vaccine AVEO's Ficlatuzumab in Combination with Gefinitib Well Tolerated in Patients with Non-Small Cell Lung Cancer; Phase 1b Data Presented at ASCO GSK and Theravance Announce Results of Two Pivotal Phase III Studies for Relovair in COPD Biovest Announces that BiovaxID Personalized Cancer Vaccine is Featured in Journal of Clinical Oncology Final Analysis from AVEO Pharmaceuticals' Phase 2 Trial of Tivozanib in Patients with Advanced Renal Cell Carcinoma Presented at ASCO iBio Announces Positive H1N1 Influenza Vaccine Clinical Trial Results Phase II Study Results Showed Eisai's Lenvatinib (E7080) Demonstrated an Objective Response Rate of 59% in Radioiodine (RAI)-Refractory Differentiated Thyroid Cancer New Data Underscore Nausea is Significantly Debilitating Symptom of Migraine, Potentially Impacting Millions of Patients, Particularly Women

June 3

ARIAD Announces Initial Clinical Data on Ponatinib in Patients with Relapsed or Refractory Acute Myeloid Leukemia Tarceva Nearly Doubled the Time People With a Genetically Distinct Type of Lung Cancer Lived Without Their Disease Getting Worse ZYTIGA Data to be Presented at 2011 American Society of Clinical Oncology (ASCO) Annual Meeting Many migraine sufferers can predict their migraine attack -- may create new treatment possibilities New Strategy to Combat Cystitis Novel 'Prodrug' Alleviates Symptoms in Huntington's and Alzheimer's Mice Older Men More Likely to Lose the Ability to Orgasm Due to Gabapentin According to Busm Researchers EntreMed's ENMD-2076 Demonstrates Clinical Activity in Recurrent, Platinum-Resistant Ovarian Cancer Patients YM BioSciences Reports Interim Phase I/II Data for its JAK1/JAK2 Inhibitor CYT387 at ASCO Five-Year Follow-Up Data for SPRYCEL (dasatinib) 100 mg Once Daily Demonstrated 78 Percent Overall Survival in Patients with Chronic-Phase Chronic Myeloid Leukemia Resistant or Intolerant to Gleevec®*

June 6

Second Phase 3 Study of YERVOY (ipilimumab) in Metastatic Melanoma Meets Primary Endpoint of Overall Survival Genentech Announces Vemurafenib Improved Survival in People With Metastatic Melanoma Who Have BRAF V600 Mutations Bayer's Investigational Compound Radium-223 Chloride Met its Primary Endpoint of Significantly Improving Overall Survival in a Phase III Trial in Patients with Castration-Resistant Prostate Cancer That Has Spread to the Bone Algeta Announces Radium-223 Chloride Met its Primary Endpoint of Significantly Improving Overall Survival in a Phase III Trial in Patients With Castration-Resistant Prostate Cancer That Has Spread to the Bone Biogen Idec Reports Positive Data from AVONEX Dose Titraion Study at 2011 Annual Meeting of the Consortium of Multiple Sclerosis Centers Merck and ARIAD Announce Presentation of Results of Phase III SUCCEED Trial at American Society of Clinical Oncology Annual Meeting Geron Highlights ASCO/AACR Joint Session: Telomeres and Telomerase in Cancer Biogen Idec Reports Positive Data from AVONEX Dose Titration Study at 2011 Annual Meeting of the Consortium of Multiple Sclerosis Centers Onconova Presents Positive Data on ESTYBON (rigosertib, ON 01910.Na), a Novel Phase III Anti-Cancer Agent, at ASCO 2011 Ligand Presents Phase IIa Data on Captisol-Enabled, Propylene Glycol-Free Melphalan at ASCO 2011 Phase III Study of Dacogen (decitabine) for Injection in Acute Myeloid Leukemia (AML) Presented at ASCO Researchers Report New Data on TB4's Ability to Reduce Heart Attack Damage Seattle Genetics and Millennium Present Updated Brentuximab Vedotin (SGN-35) Data at ASCO Annual Meeting Eisai and Janssen Announce the Presentation of DACOGEN (decitabine) Data at ASCO from a Phase III Study in Patients with Acute Myeloid Leukemia Exelixis' Cabozantinib Phase 2 Data Demonstrate Encouraging Clinical Activity in Patients with Metastatic Castration-Resistant Prostate Cancer Regulus Therapeutics and Collaborators from NYU Langone Medical Center Publish New Data Demonstrating Clearance of Cholesterol from Bloodstream and Reduction of Atherosclerotic Plaques through Inhibition of microRNA-33 New Approaches Open up in Spinal Muscular Atrophy

June 7

Cipher Pharmaceuticals Announces Top-Line Results of Cip-Isotretinoin Phase III Safety Study Data from Phase 1 Study of NKTR-181 Demonstrate Proof-of-Concept for Nektar's Novel Opioid Analgesic Candidate Tocagen's First-in-Human Clinical Trial of Toca 511 Enrolling Patients with High Grade Glioma Teva Announces Successful Results of Phase III Study of Its Long-Acting G-CSF Product (Lipegfilgrastim) in Breast Cancer Patients Corlux Significantly Improves Clinical and Metabolic Manifestations of Cushing's Syndrome Antisense Presents Excellent Safety Profile of Trabedersen at ASCO 2011 Late-Breaking ASCO Data Demonstrate Circulating Tumor Cells As Potential Biomarker for Metastatic Prostate Cancer Clinical Trials Silence Therapeutics? Atu027 Demonstrates Promising Antitumor Activity in Phase I Study Presented at ASCO Dacogen (decitabine) showed an overall survival advantage compared with the accepted standard therapies in older patients with newly diagnosed de novo or secondary acute myeloid leukemia

June 8

Otonomy Announces Preclinical Results Supporting Intra-operative Use of OTO-201 for Common Childhood Procedure RXi Pharmaceuticals Presents Additional Positive Phase 2 Efficacy Results for Combination of NeuVaxTM (E75) and Trastuzumab Breast Cancer at ASCO 4SC Announces Topline Results of Phase IIb Trial of Vidofludimus in Rheumatoid Arthritis VentiRx Pharmaceuticals Presents Results from Phase 1 Clinical Trial of VTX-2337, a Novel TLR8 Agonist, in Patients with Advanced Solid Tumors at American Society of Clinical Oncology Annual Meeting ZIOPHARM Announces Initial Positive Data Presented at 2011 ASCO Annual Meeting from First-Ever Treatment Demonstrating Small Molecule-Controlled Production of Anticancer Protein in Humans Vical - Vical Presents Positive Correlation Between Response and Survival at ASCO for Completed Allovectin Melanoma Trials FOLOTYN Data to be Presented at the Congress of the European Hematology Association and the International Conference on Malignant Lymphoma Oncolytics Biotech Inc. Collaborators to Present Reovirus Research at the 14th World Conference on Lung Cancer Trifunctional Antibody Catumaxomab Triggers Vaccination Effect Against Cancer Rho Contributes to a Major Advance in Treating Severe Form of Vasculitis Four New Studies Presented at the World Congress of Dermatology Show Potential in Treating Precancerous Skin Disease, Actinic Keratosis

June 9

Neurologix Presents New Confirmatory Results for Phase 2 Study of NLX-P101 in Parkinson's Disease to Recombinant DNA Advisory Committee Novartis Candidate Vaccine Bexsero Shows Significant Potential in Providing Broad Coverage Against Meningococcal Serogroup B Infections Mesoblast Limited Revascor Increases Blood Supply to Damaged Heart Muscle XOMA Announces Phase 2a Six-Month Top Line Trial Results Support Safety and Biological Activity BioTime Reports First Complete Sequencing of the Nuclear Genome of Five GMP-Compliant Human Embryonic Stem Cell Lines at Jefferies 2011 Global Healthcare Conference Post Hoc Analysis from RECOVER Study Examined Effects of Neupro (Rotigotine Transdermal System) on Surrogate Markers of Mood and Anhedonia in Parkinson's Disease Abbott Reports Interim Results From Phase III Open-Label Study of Investigational Treatment for Advanced Parkinson's Disease

June 10

the Combination of Palonosetron and Aprepitant Shows Superior Protection From Significant Nausea and Vomiting Than Daily Granisetron in Patients Receiving High Dose Chemotherapy As Conditioning Prior to Stem Cell Transplantation Chelsea Therapeutics Announces New Data from Northera Phase III Program in Neurogenic Orthostatic Hypotension Presented at MDS 15th International Congress of Parkinson's Disease and Movement Disorders Tesetaxel Results from Multiple Dose-Ranging Clinical Trials Updated at ASCO New Data On Xeomin (IncobotulinumtoxinA) To Be Presented At The 15th International Congress Of Parkinson's Disease And Movement Disorders (MDS) Insmed's ARIKACE Demonstrates Sustained Benefit Through Six Cycles of Treatment for Cystic Fibrosis Patients With Pseudomonas Lung Infections Approved Biologic Therapies in Rheumatoid Arthritis Show Further Evidence of Efficacy and Reduction in Joint Damage at the 2011 European League Against Rheumatism's Congress Avila Therapeutics Presents Data Demonstrating the Relevance of its Btk Inhibitor, AVL-292, in B Cell Malignancies such as CLL Symphogen Presents Preliminary Results from Phase 2 Clinical Trial with Rozrolimupab at the Annual European Hematology Association New Post Hoc Analyses Examined the Effects of Neupro (Rotigotine Transdermal System) on Daytime Functioning, Daytime Symptoms, Pain and Mood in Restless Legs Syndrome Millennium and Seattle Genetics Present Clinical Data on ADCETRIS (Brentuximab Vedotin) in Systemic ALCL at EHA Annual Meeting Phase 3 STRIVE Study of VX-770 Showed Durable Improvements in Lung Function (FEV1) and Other Measures of Disease Among People With a Specific Type of Cystic Fibrosis

June 14

Interim Data From Phase 2 Trial of AC220 Monotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia With FLT3-ITD Activating Mutations CytRx Reports Positive Phase 2 Preliminary Drug Trial Results for B-Cell Leukemia Patients Randomized Study Combining L-Methylfolate with Antidepressant Shows Significant Boost in Patient Response Positive Results from Phase IIa Study Pave Way for Phase IIb Trial of AC-201 for the Treatment of Type II Diabetes DP-b99 Phase III MACSI Study Protocol Published in International Journal of Stroke Circassia's Rapid Four-Dose ToleroMune Treatment Maintains Significant Reduction in Allergy Symptoms During 12-Month Follow-up Novartis candidate vaccine Bexsero shows significant potential in providing broad coverage against meningococcal serogroup B infections

June 15

Palatin Technologies, Inc. Announces Presentation and Publication on Validation of Scale for Subjective Male Sexual Arousal LifeSource Announces New Study Findings Available on Deaths Related to Prescription Opioid Therapy OHSU Research Finds Botox Treats Wrinkles with Less Frequent Injections MEDA: New Positive Study Results Presented for Dymista Peregrine Reports Promising 12.4 Month Overall Survival Data From Phase II Trial in Non-Small Cell Lung Cancer Seattle Genetics to Present Brentuximab Vedotin and Dacetuzumab Clinical Data at International Conference on Malignant Lymphoma Alkermes Initiates Clinical Study of ALKS 5461 for Treatment-Resistant Depression Best of ASCO Features Two Studies Led by US Oncology Research Affiliated Physicians Phase 2 Data on Provectus's PV-10 for Metastatic Melanoma to Be Presented at Two Upcoming Conferences Phase 2 Study of SKP-1041 for Sleep Maintenance Insomnia Shows Significant Reduction of Mid-Night Awakenings without Next-Day Cognitive Impairment

June 22

Multiple Presentations Featuring Long-term QNEXA Data at the American Diabetes Association 71st Scientific Sessions Oxford BioMedica Announces Ocular Programme Update Texas Children's Fetal Center Study Shows Perinatal Management Improves Outcomes for Babies with Congenital Diaphragmatic Hernia Lipid Therapeutics Announces Positive Topline Phase IIb Results With LT-02 in Patients With Ulcerative Colitis Intensive-Dose Statin Therapy Associated With Increased Risk of Diabetes Proceedings of the National Academy of Sciences (PNAS) Publishes Roche Manuscript on Production of Bispecific IgG Antibodies Ambrx to Present Data from Antibody Drug Conjugate Program at Upcoming Scientific Conferences Certain Drugs Lower Risk of Diabetes for Patients With Rheumatoid Arthritis or Psoriasis Gold nanoparticles help earlier diagnosis of liver cancer Particle Sciences Develops Proprietary Nasal Delivery Formulation Used in Neurelis' Recently Announced Successful Phase I Pharmacokinetic Study of NRL-01 (intranasal diazepam)

June 23

MAP Pharmaceuticals to Present Data on LEVADEX at the 15th Congress of the International Headache Society MacroGenics Announces Presentation of Protege Phase 3 Clinical Data at ADA in San Diego on June 28 CureFAKtor Pharmaceuticals Demonstrates that Novel Focal Adhesion Kinase (FAK) Inhibitors Decrease Pancreatic Cancer Tumor Blood Flow and Reduce Blood Vessel Density Arno Therapeutics Reports Positive Interim Results from Glioblastoma Study; Phase II Enrollment to Continue Avila Therapeutics Presents Preclinical Data with AVL-292, its Btk Inhibitor, Demonstrating Suppression of Autoimmune Disease Activity New England Journal of Medicine Publishes Data From Two Phase 3 Studies of Incivek (telaprevir) in Hepatitis C Eliquis (apixaban) Meets Primary and Key Secondary Endpoints in Phase 3 ARISTOTLE Study Curcumin is Key to Unlocking Cancer Epigenetic Code - EuroPharma Angioplasty With Stents May Be Safe in Long-Term for Low-Risk Heart Patients Data on MLN8237, an Investigational Aurora A Kinase Inhibitor, Presented at International Lymphoma Conference Positive Results for Unprotected Left Main Coronary Artery PCI With Drug-Eluting Stents

June 28

Diamyd Medical: TrialNet Presents Results From a Study with Diamyd Unigene Presents Positive Advanced Preclinical Data for UGP281 a Potent, Orally Delivered Anorexigenic Peptide in a Late-Breaking Poster Presentation at the American Diabetes Association 71st Scientific Sessions Vical Provides Allovectin and Herpes Simplex Vaccine Updates at BIO International Convention Celladon Corporation Announces Publication of Advanced Heart Failure Clinical Trial Results With Mydicar Enzyme Replacement Therapy in the Journal Circulation Nile Therapeutics Provides Update on Ongoing Phase I Clinical Trial of Cenderitide Lexicon Presents LX4211 Mechanism of Action Data at American Diabetes Association Meeting and Announces Commencement of Phase 2b Clinical Trial in Type 2 Diabetes Investigational Ultra-Long-Acting Insulin Degludec Reduces Hypoglycemia and Improves Long-Term Control in Patients With Type 1 and Type 2 Diabetes New Data Shows Victoza Helped Reduce Blood Sugar When Patients With Type 2 Diabetes Switched From Sitagliptin or Exenatide Phase III prophlaxis trial for CS-8958 Investigational Study Reported ONGLYZA (saxagliptin) Added to Insulin Significantly Improved Blood Sugar Levels in Adults with Type 2 Diabetes Compared to Placebo Added to Insulin Investigational Compound Dapagliflozin Added to Metformin Sustained Reductions in Blood Sugar Levels in Adult Patients with Type 2 Diabetes in Two-Year Study Investigational Compound Dapagliflozin with Metformin Extended-Release (XR) as Initial Combination Therapy Significantly Improved Blood Sugar Control in Previously-Untreated Adult Type 2 Diabetes Patients with High Blood Sugar Levels Lantus/Apidra SoloSTAR Help to Improve Patient Satisfaction Syndax Pharmaceuticals Announces Entinostat Data from Two Lung Cancer Clinical Trials at Upcoming World Lung Conference Sunshine Biopharma's Lead Anti-Cancer Compound, Adva-27a, Performs Exceptionally Well in Human Microsome Stability Assays Zealand Pharma presented new preclinical data on ZP2929 in disease models for diabetes and obesity at the American Diabetes Association?s 71st Annual Scientific Sessions New data for linagliptin to be presented at the ADA

June 29

Newly Published Study Showed Axiron (testosterone) Topical Solution Restored Testosterone Levels to Normal Range in Hypogonadal Men Amsterdam Molecular Therapeutics' Glybera Significantly Reduces the Risk of Pancreatitis in LPLD Patients Resverlogix Presents New Findings on RVX-208 at European Atherosclerosis Society Late Breaking Data Presented at the American Diabetes Association 71st Annual Scientific Sessions Evaluate the Safety and Tolerability of TAK-875, Takeda's Investigational Compound for the Treatment of Type 2 Diabetes Two Pivotal Phase III Lucentis Studies Showed Patients With Diabetic Macular Edema Experienced Significant Improvements in Vision and Fewer Developed More Advanced Retinopathy Additional Data on Provectus's PV-10 for Metastatic Melanoma Presented at Prominent Melanoma Conferences Mount Sinai Researchers Develop New Gene Therapy for Heart Failure QRxPharma Releases Additional Data on Phase 3 Comparative Safety Study for MoxDuo IR

June 30

Vectura Group plc email alerting service Medicago reports positive Phase II final results for its avian flu pandemic vaccine GTx Announces Upcoming Presentations of Effects of Ostarine in Non-Small Cell Lung Cancer Patients at World Conference on Lung Cancer Phase III Study Shows Once-Daily NVA237 is Superior to Placebo and Similar to Tiotropium in Improving Lung Function in COPD Auxilium Pharmaceuticals Announces Results from Three Year CORDLESS Extension Study in Dupuytren's Contracture Nuvo Research Announces Positive Top-Line Results for Pennsaid Viscous Solution Phase 2 Trial Intarcia Presents Positive Phase 2 48-week Results From ITCA 650 Study at the American Diabetes Association 71st Scientific Sessions Scancell Develops New Vaccine for the Treatment of Lung Cancer Endo Announces Topline Results From Phase 2 Study of Axomadol in Chronic Low Back Pain The Lancet Publishes Data from Protege, MacroGenics' Phase 3 Clinical Study of Teplizumab in Type 1 Diabetes Patients ACORN Research Reports Positive Findings of Phase 2b Metastatic Breast Cancer Trial at ASCO
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