Clinical Trial News Archive

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January 2008

January 7

Amicus Therapeutics Announces Positive Interim Results From Phase 2 Clinical Trial of Plicera for Gaucher Disease OREXIGEN Therapeutics Reports 48-Week Results of Phase IIb Trial of Empatic to Treat Obesity Biogen Idec and Elan Provide Update on Utilization, Safety and Total Patient Exposure of Tysabri in Patients with Multiple Sclerosis Santarus Announces Positive Clinical Results with Zegerid Capsules in Controlling Gastric Acidity Over 24 Hours Xeloda Combination Therapy in Esophagogastric Cancer Highlighted in New England Journal of Medicine Not Only Lipids and Inflammation: Insight Into a New Cause of Heart Attack and Other Vascular Disease Pharmasset Announces R7128 Achieves 85% Rapid Virologic Response in a 4-week Combination Study for the Treatment of Chronic Hepatitis C Idenix Pharmaceuticals Provides Update on Hepatitis C Pipeline at JP Morgan Healthcare Conference Maxygen Announces Positive Progress in Phase IIa Clinical Trial of Novel PEG-GCSF Evotec AG (DE) - Phase I Safety and Tolerability Study with EVT 302 Successfully Completed Study of Sugars on Cell Surface Identifies Key Factor in Flu Infection Oncolytics Biotech Inc. Announces Publication of Research on Combination Reovirus and Cyclophosphamide Treatment Researchers Uncover an Error in Immature Brain Cells in Lab and Animal Studies that May Promote the Growth of Some Brain Tumors Confounding Factors Escape Authors of Recent Study Examining California Numbers of Autistic Children

January 8

Arena Pharmaceuticals Announces APD668 Initial Clinical Study Results Suggest Glucose-Dependent Insulinotropic Receptors May Improve Glucose Control in Patients With Type 2 Diabetes Watson Announces Positive Results From Its Pivotal Study of Oxybutynin Topical Gel for the Treatment of Overactive Bladder Researchers Use Magnetism to Target Cells to Animal Arteries Sirtris Announces Positive Results with Proprietary Version of Resveratrol, SRT501, in a Phase 1b Type 2 Diabetes Clinical Study Halozyme Therapeutics Announces Peer-Reviewed Publications of the INFUSE-LR Clinical Trial Results and Clinical Practice Experience With Hylenex Incyte to Report Positive Clinical Results from JAK Inhibitor and 11beta-HSD1 Inhibitor Programs and Introduce New Metabolic Program at JPMorgan Healthcare Conference Emergent BioSolutions Announces That the Final Phase II Clinical Study Results for Typhoid Vaccine Reaffirms Clinical Endpoints Met; Immune Response Seen in 97% of Treated Subjects Surface Logix Achieves Objectives With SLx-2101 in Phase 2a Clinical Trial in Hypertension Pluristem Announces Second Clinical Indication Revascularization Effect After PLX-PAD Therapy Benezra Report in Nature Biotechnology Validates AngioGenex's Drug Development Platform by Demonstrating Tumor Suppression Through Id Protein Inhibition Intercell’s Results on a Novel Pneumococcal Protein-based Vaccine Published in the Journal of Experimental Medicine Scientists Use Virus to Wipe Out Cancer Cells Javelin Pharmaceuticals' Latest Study of Dyloject Confirms Minimal Effect on Platelet Function, Differentiating Dyloject from Ketorolac and Aspirin Newer Meningitis Vaccine Appears Safe and Effective for Infants

January 14

ADVENTRX Announces ANX-530 Safety Data and Provides NDA Submission Guidance Radiesse More Effective Than Restylane As Reported In a 60-Patient Clinical Trial Phase III Data Published for Once Monthly Dose of Risedronate to Treat Postmenopausal Osteoporosis APR Applied Pharma Research S.A. (“APR”) and Labtec GmbH (“Labtec”) Announce the Successful Completion of the Pivotal Bioequivalence Study for Their Proprietary Ondansetron RapidFilm Merck/Schering-Plough Pharmaceuticals Provides Results of the ENHANCE Trial Nventa Completes Evaluation of Second Cohort in HspE7 Phase 1 Cervical Dysplasia Trial Merck/Schering-Plough Pharmaceuticals Provides Results of the ENHANCE Trial Nventa Completes Evaluation of Second Cohort in HspE7 Phase 1 Cervical Dysplasia Trial Schering-Plough Reports Top-Line Results of the IDEAL Study Researchers Uncover New Piece to the Puzzle of Human Height International Effort Finds New Genetic Variants Associated with Lipid Levels, Risk for Coronary Artery Disease Patients Treated with Lipitor Were Significantly Less Likely to Have a Cardiovascular Event Than Those Treated with Simvastatin, New Observational Study Shows Progress Report from RVX-208 Phase 1 Clinical Study Roche Responds to Announcement of 'IDEAL' Hepatitis C Trial Results

January 15

Anthera Announces Preliminary Positive Results From Once-Daily A-002 Phase II Cardiovascular Trial Rituximab Added to Six Cycles of Chemotherapy Improves Survival in Elderly Patients with Aggressive POZEN Submits Human Lymphocyte Study for Treximet (Formerly Known as Trexima) Tolerx Achieves Milestone with Completion of Phase Ib Clinical Study of TRX1 in Cutaneous Lupus Erythematosus XenoPort and GlaxoSmithKline Report Positive Top-Line Results of Second Phase 3 Restless Legs Syndrome Trial for XP13512/GSK1838262 Kamada Announces Successful Completion of Phase I Studies With Aerosolized AAT for the Treatment of Lung Diseases Study Published in the Journal of Vascular and Interventional Radiology Concludes That Embosphere Microspheres Should Be the Preferred Agent for Uterine Fibroid Embolization When Compared to Boston Scientific's Contour SE PVA Microspheres

January 16

Zetia Does Not Reduce Carotid Plaque Size When Added to Zocor EPIX Pharmaceuticals Announces Updated Results from Phase 2a Clinical Trial of PRX-03140 in Alzheimer's Disease Inhibiton Therapeutics Provides Update for ICA-1 Compound in-Vitro Testing in Breast Cancer Cell Lines New Study Results Show Asenapine More Effective Than Placebo in the Treatment of Acute Schizophrenia GelVac Nasal Powder H5N1 (Bird Flu) Influenza Vaccine Passes Preclinical Toxicology Studies CeNeRx BioPharma Announces Successful Completion of Phase l Clinical Program for Novel Antidepressant Agent Tyrima Study Shows Carperitide Significantly Reduces Cardiac Death and Improves Outcomes in Acute Myocardial Infarction Morria Biopharmaceuticals Plc Announces Preliminary Safety and Tolerability Results From Its Phase I Clinical Study of MRX-4 in Allergic Rhinitis Patients Nymox to Report Results of New Phase 2 Study of NX-1207 for BPH Adding Lipitor Early to Effective Blood Pressure Treatment Provided a Significant Reduction in Heart Attacks or Deaths from Heart Attacks over Five Years HemoBioTech, Inc. Featured in New Scientist Magazine TRADE NEWS: Agilent Technologies Microarrays Enable Baylor Researchers to Discover a Mechanism of Genomic ''Errors'' Associated with Certain Diseases XenoPort and GlaxoSmithKline Report Positive Top-Line Results of Second Phase 3 Restless Legs Syndrome Trial for XP13512/GSK1838262 St. Jude Defines Eye Cancer Gene's Role in Retinal Development Can-Fite and NIH Signed a Continuation of M-CRADA to Further Investigate CF101 for the Treatment of Uveitis

January 17

CollaGenex Pharmaceuticals Announces Results of Phase 4 Clinical Study Showing Oracea Equally Effective as 100 mg Doxycycline in Treatment of Rosacea Zevalin Combined With High-Dose Chemotherapy and Autologous Stem-Cell Transplantation (ASCT) Produces High Overall Survival and Progression-Free Survival Rates in Patients With Relapsed Non-Hodgkin's Lymphoma No Bones About It New Study Reports Enbrel (Etanercept) Significantly Improved Moderate to Severe Plaque Psoriasis in Children and Adolescents Insulin News That's Easy To Swallow Nymox to Report Results of New Phase 2 Study of NX-1207 for BPH Quality of Life, As Important As Life Itself Nuvelo Announces Alfimeprase NAPA-2 Acute Peripheral Arterial Occlusion Data Presentation Webcast and Conference Call Karo Bio Progress in Eprotirome (KB2115) Development

January 18

The Lancet Publishes Vasogen's ACCLAIM Results Enlarged Prostate Treatment Study Shows Combination of Avodart and Tamsulosin Provides Greater Benefit Than Either Medication Alone ProMetic and MacoPharma Announce Successful Completion of P-Capt Prion Reduction Filter Clinical Studies Prana Announces Publication in Neurobiology of Aging Journal Modified-Release Prednisone Reduces Morning Stiffness in Patients with Rheumatoid Arthritis (CAPRA-1 TRIAL) Non-Specific Immunomodulation Could Be Used to Treat Patients with Heart Failure (Acclaim Trial) LifeCycle Pharma Announces Transplantation Programs on Track MGI Pharma Announces Results from Study Involving the Dual Implantation of Gliadel Wafer and Radioactive Seeds for Treatment of Recurrent Glioblastoma Multiforme Threshold Updates Glufosfamide Clinical Development Program Schering-Plough Canada Reports Top-Line Results of First Head-to-Head Study in Hepatitis C In Response to a New England Journal of Medicine Article Published Yesterday and Subsequent Media Coverage, Eli Lilly and Company Issued the Following Statement: Mayo Clinic Proceedings January Tip Sheet

January 22

Preclinical Study Published in Cancer Research Demonstrates Anti-Tumor Activity of Micromet's BiTE Antibody at Well Tolerated Doses Insmed Completes External Assessment of Myotonic Muscular Dystrophy Market Vyteris Announces First Successful Non-Invasive Delivery of Peptide Using Smart Patch Technology Top-Line Data from Oculus Innovative Sciences' Phase II Trial to Be Presented at DFCon 08 (Diabetic Foot Global Conference) on March 14, 2008 Novel Akt Inhibitor VQD-002 Shown to Reverse Cisplatin Resistance in Ovarian Cancer Indevus Reports Additional Positive Phase III Trial Data for Nebido Scientists Discover Why Animal Studies May Lead to Ineffective ALS Drugs PhytoMedical's Patented Anti-Cancer Compounds Kill Lung Cancer Cells, a Significant New Finding Celera Publishes Three Papers Demonstrating That Carriers of a Gene Variant are at Elevated Risk of Coronary Heart Disease Which is Virtually Eliminated by Statin Therapy Phase II Study of Zevalin Consolidation Following Fludarabine and Mitoxantrone Chemotherapy Results in 100 Percent Complete Remission Rate and 89 Percent Three-Year Progression Free Survival in Patients with Previously Untreated Non-Follicular Indolent Lymphoma Synosia Announces Encouraging Results of Proof-of-Concept Clinical Trial for Epilepsy Drug rufinamide as a Treatment for Mood Disorders Super-Thin Drug-Free Coating 'Hides' Stent as It Unblocks Heart Arteries Nanobac Announces European Heart Journal Publication of Association Between Calcifying Nanoparticles and Aortic Stenosis Ambrilia: Conference call and webcast for Octreotide Phase III prelimi... Steps Toward Stopping Autoimmune Disease: International Consortium Identifies Genes Linked to Lupus CeloNova BioSciences Announces Positive Results from European Study of Embozene Microspheres for Treatment of Uterine Fibroids FibroGen Reports New Research on Development of HIF Prolyl Hydroxylase Inhibitors Related to Endothelial Progenitor Cells, Anti-Inflammation, Cytoprotection and Erythropoiesis Study Says Allergy Shots Help Children, Reduce Health Care Costs BioMedEcon Study, First of its Kind in US, Finds Allergy Immunotherapy Beneficial Even When Treatment Not Completed

January 23

Alnylam Reports Positive Phase II Data for ALN-RSV01, an RNAi Therapeutic for the Treatment of Respiratory Syncytial Virus (RSV) Infection Protein Hormone in Body Fat Clue to Breast Cancer Spread Nitec's Phase III Results with Lodotra in RA Published in Current Issue of The Lancet Sirtris Pharmaceuticals to Present at Keystone Symposia's Diabetes Mellitus, Insulin Action and Resistance Conference Advaxis to Host Dinner Reception For Members of the Gynecologic Oncology Group (GOG) pSivida's BrachySil in Pancreatic Cancer Study Results to be Presented at the ASCO Gastrointestinal Cancers Symposium New Survey Finds Majority of Americans in Pain; Acute Pain Sufferers Reluctant to Treat Mayo Clinic Study Finds Further Association Between Diabetes and Pancreatic Cancer Clinical Trial Best Practices: Savvy Marketers Plan Ahead with Early Communication Strategies

January 24

BioCryst Updates Peramivir Clinical Development Plan African Americans Should Not Stop Taking Vytorin or Zetia Without Consulting Their Healthcare Providers Genaera Corporation Presents Promising Preclinical Type 2 Diabetes Data for Trodusquemine (MSI-1436) at Keystone Symposia Sirtris Pharmaceuticals: Novel, Potent SIRT1 Activator Reduces Fat, Boosts Endurance and Improves Insulin Sensitivity in a Pre-clinical Model of Type 2 Diabetes StemCells, Inc. Enters Research Collaboration with Casey Eye Institute Positive Primary Endpoint from FIRST-STEP Study with Stalevo in Early Parkinson's Disease KRAS Gene Status May Impact Vectibix (Panitumumab) Efficacy and Patient Reported Outcomes in Advanced Colorectal Cancer Patients Boston Scientific Comments on New England Journal of Medicine Article Technology License with Transgene: Product TG4010 Interim Results

January 25

Over 30 New Studies of Oral Xeloda Featured at the 2008 Gastrointestinal Cancers Symposium Genentech and Biogen Idec Announce Positive Results from a Phase III Trial of Rituxan in Patients with Rheumatoid Arthritis Who Inadequately Responded to Methotrexate Merck and Schering-Plough Respond To Issues Raised About Enhance Clinical Trial Denosumab Osteoporosis Study Met Primary and All Secondary Bone Mineral Density Endpoints in a Head-to-Head Comparison with Weekly Alendronate (Fosamax) Nuvelo Announces Results from Phase 3 NAPA Program in Acute Peripheral Arterial Occlusion Phase I Study with uPA Inhibitor WX-UK1 Successfully Completed MediGene to Present Recent Data Obtained in a Clinical Trial of Oncolytic Virus NV1020 on the Occasion of the ASCO GI Symposium MabThera Increases the Time Patients with the Most Common Form of Adult Leukaemia Live Without Their Cancer Progressing MabThera Meets Study Primary Endpoint in Improving Disease Symptoms When Used as First Biologic Therapy in Patients with Rheumatoid Arthritis Oral Contraceptives Give Substantial Long-Term Protection Against Ovarian Cancer Stroke Prevention: Idraparinux Causes Significantly More Bleeding Than Vitamin K Antagonists

January 28

BioLineRx Presents Pre-Clinical Data Demonstrating That BL-1021 Is Safe and Effective in Treating Neuropathic Pain EntreMed Presents Interim Results for Phase 2 Carcinoid Tumor Study Vasogen's Research Published in European Journal of Neuroscience Acorda Therapeutics Announces Successful Thorough QT Study of Fampridine-SR Medivation Plans to Initiate Pivotal Confirmatory Phase 3 Trial of Dimebon for Alzheimer's Disease in Second Quarter of 2008 Study Shows Coronado Biosciences' Bcl-2 Inhibitor, Apogossypol, is More Efficacious, Less Toxic than Gossypol in Animal Models pSivida Pancreatic Cancer Study Results Released Lipid Sciences Announces Positive HIV Program Results Anti-Inflammatory Drug Improves Glycemia, Lowers Inflammation in Obese, Young Adults Interim Safety Data Presented on Vectibix (Panitumumab) in Combination with Standard Chemotherapy Poniard Pharmaceuticals Announces Picoplatin Safety Data in Colorectal Cancer Studies Demonstrate Increased Efficacy of Erbitux in Metastatic Colorectal Cancer Patients with KRAS Wild-Type Tumors

January 29

Compugen Announces In-Vivo Results for Two Peptide Anti-Inflammatory and Cardio-Protective Drug Candidates Viventia Biotech to Explore Strategic Alternatives - Reports Positive Pivotal Phase III Interim Efficacy Data Amgen Statement on Aranesp Manuscript in the Journal of Clinical Oncology Inverseon Announces Positive Phase IIa Asthma Study Myriad Genetics Announces Completion of Phase 1 Trial of Anti-Thrombin Drug MPC-0920 Phase 1 Studies Show Promise of QuatRx's Novel Compound, Sobetirome, for Lowering LDL Cholesterol Levels Ardea Biosciences to Present Preclinical Data on Three HIV Non-Nucleoside Reverse Transcriptase Inhibitors During 15th Annual Conference on Retroviruses and Opportunistic Infections Surface Logix Achieves Objectives With SLx-4090 in Phase 2a Clinical Trial Pro-Pharmaceuticals Phase II Trial Shows Davanat Improves Median Progression Free Survival with Fewer Side Effects as Compared to Recent Similar Studies APR Applied Pharma Research s.a. (“APR”) and Labtec GmbH (“Labtec”) Announce the Successful Completion of the Pilot Bioequivalence Study of Their Donepezil RapidFilm Further Confirming the Validity and Adaptability of This Innovative Proprietary Technology DOR BioPharma Reports Achievement of Two-Year Stability Milestone for RiVax, its Vaccine Against Ricin Toxin Accentia Biopharmaceuticals Announces that Revimmune is Profiled in Hopkins Medicine Magazine

January 30

Therapeutic DNA Vaccine Delivery via Inovio's Electroporation Technology Featured in Nature Reviews Cancer New Class of Highly Selective 5-HT4 Receptor Agonists Provides the Next Generation of GI Treatments Argos Therapeutics Publishes Novel Approach to Amplifying HIV Genes for Personalized Immunotherapy Treatments for HIV 91 Percent of Oncologists Polled Report Adverse Patient Events as Result of CMS National Coverage Decision on ESAs Kidney Cancer Drug Attacks a Major Type of Acute Myeloid Leukemia Phosphagenics Reports Superior Pre-clinical Cholesterol Results from APA-01 and Atorvastatin Combination Historic Breakthrough in Fighting Children's Batten Disease as China Stem Cells Give New Lease on Life to 6 Year Old California Boy Intensive Insulin Therapy Protects Kidneys In Critically Ill Patients Babies Excrete Vaccine-Mercury Quicker than Originally Thought
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