Clinical Trial News Archive

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November 2009

November 2

Alnylam Presents New Pre-Clinical Data on ALN-TTR, an RNAi Therapeutic for the Treatment of Transthyretin-Mediated Amyloidosis Avila Presents Data on Its Novel, Orally-Available Protease Inhibitor, AVL-181, Demonstrating Viral Clearance of Hepatitis C Virus in Preclinical Models Salix Pharmaceuticals Reviews American Association for the Study of Liver Diseases Annual Meeting Dynavax's HEPLISAV Shows Increased Protection Rate for Chronic Kidney Disease Patients Results from two Canadian studies confirm sustained viral response rates seen in hepatitis C patients treated with Pegatron Novobiotics - Positive Initial Phase IIa Data GlobeImmune's Hepatitis C Therapeutic Vaccine Combined with Standard of Care Increases End of Treatment Response Rate by 15% Genta Announces Top-Line Results of AGENDA Phase 3 Trial of Genasense in Patients with Advanced Melanoma Æterna Zentaris Announces Positive Preliminary Results for Phase 2 Study with LHRH-Receptor Targeted Cytotoxic Conjugate AEZS-108 in Ovarian Cancer Investigational Sublingual Allergy Immunotherapy Tablet Meets Primary Endpoint in a Study of Adult Subjects With a History of Grass Pollen Allergies Human Genome Sciences and GlaxoSmithKline Announce Positive Results in Second of Two Phase 3 Trials of Benlysta in Systemic Lupus Erythematosus Data Supporting Boceprevir Response Guided Therapy Presented at American Association for the Study of Liver Diseases (AASLD) Annual Meeting Large Study of Anemia Treatment in Chronic Kidney Disease Patients Not on Dialysis Published in the New England Journal of Medicine Failed to Meet Primary Efficacy Endpoints Zosano Pharma, Inc. to Provide Pipeline Updates at the 2009 AAPS Annual Meeting UCL (University College London) Liver Failure Group Present Two Studies on a Novel Treatment Option (OCR-002) for Complications of Hyperammonemia in Liver Failure at the 60th Annual AASLD Meeting Twice Daily Oral Medication Shows Promise in Treating Patients with Hepatitis C YM BioSciences reports positive nimotuzumab four-year survival data presented at ASTRO 2009 Bristol-Myers Squibb and ZymoGenetics Present Final Phase 1b Results for PEG-Interferon Lambda in Hepatitis C Enzo Biochem Reports on Favorable Clinical Trial of EGS21 for Treatment of Non-Alcoholic Steatohepatitis Gilead Announces Long-Term Data from Two Pivotal Phase III Studies Evaluating Viread For Chronic Hepatitis B BARACLUDE (entecavir) Demonstrated Greater Antiviral Efficacy Compared to Adefovir in New Study of Chronic Hepatitis B Patients with Evidence of Decompensated Cirrhosis FibroGen Announces New Research in Anti-CTGF and HIF-PHI Therapeutic Development Programs in Kidney Disease NovaBay's Aganocides Show Penetration and Efficacy in a Pre-Clinical Infected Human Nail Model of Onychomycosis Schering-Plough Reports Potent Antiviral Activity With Narlaprevir (SCH 900518), an Investigational, Once-Daily Protease Inhibitor for Hepatitis C Mayo Clinic Proceedings Publishes Study of NUVIGIL in Patients with Shift Work Disorder

November 3

Sanofi Pasteur Presents Safety Data on Menactra Vaccine Given to Infants at Infectious Disease Society Meeting Study Finds Lack of Diffusible VEGF Growth Factor Can Cause Retinal Defects Similar to Dry Macular Degeneration Idera Pharmaceuticals Presents Preclinical Data on IMO-2125, its Lead Drug Candidate for Chronic Hepatitis C Virus Infection, at Liver Meeting 2009 MagForce Nanotechnologies AG reaches primary study endpoint in pivotal glioblastoma study SCYNEXIS' SCY-635 Demonstrates Positive Antiviral Activity in Combination with Approved and Investigational Anti-HCV Agents ARIAD's AP24534 Featured in Cancer Cell Publication as a Potential First-in-Class Pan BCR-ABL Inhibitor Ironwood and Forest Announce Positive Linaclotide Results from Two Pivotal Phase 3 Trials in Patients with Chronic Constipation INFORM-1 Results: Robust Antiviral Suppression Achieved with Combination of Nucleoside Analog Polymerase Inhibitor RG7128 and Protease Inhibitor RG7227 Data for EntreMed's ENMD-2076 to Be Presented at the Upcoming AACR-NCI-EORTC Conference

November 4

New Phase IIa data on TMC435 in patients with hepatitis C presented at the ongoing AASLD - meeting Long-term Outcomes Data Validates the Utility of PROSTASCINT in Guiding Targeted Prostate Cancer Treatment and Predicting Disease Free Survival Promedior Announces Publication of Preclinical Studies in Science Translational Medicine Demonstrating that hSAP Inhibits Kidney Fibrosis Aeolus Pharmaceuticals' AEOL 10150 Protects Lungs Against Chlorine Gas Exposure in Animal Studies New Data on Attention in Children with ADHD Principal Investigators Association Launches Free Weekly Ezine to Advise Scientists in All Fields of Research on Their Administrative Challenges Concerta in the Classroom: New Data on Attention in Children With ADHD Thirteen Abstracts Featuring Exelixis Compounds Accepted for Presentation at the 2009 AACR-NCI-EORTC International Conference

November 5

Alnylam Presents New Pre-Clinical Data on RNAi Therapeutics at Oligonucleotides Therapeutics Society (OTS) Meeting Significantly More Smokers With Mild-To-Moderate COPD Quit Smoking Using CHANTIX/CHAMPIX (Varenicline) Compared With Placebo Chelation Therapy Drug Found Safe and Beneficial for Children With Autism Short-Term Hormone Therapy Added to Radiation Increases Survival for Medium-Risk, But Not Low-Risk, Prostate Cancer Patients BioVex Announces Publication of Phase 2 Melanoma Results With OncoVEX (GM-CSF) in the Journal of Clinical Oncology Ocera Therapeutics Presents Clinical Data Demonstrating AST-120 Relieves Pruritus in Patients with Liver Cirrhosis at the 60th Annual AASLD Meeting Amgen Announces Overall Survival Results for Vectibix in First-Line Metastatic Colorectal Cancer Approved Lymphoma Drug Shows Promise in Early Tests Against Bone Cancer M. D. Anderson News Release: Early Stage, HER2 Positive Breast Cancer Patients at Increased Risk of Recurrence Pharmaceutical Press empowers users with enhanced MedicinesComplete New Safety Data on Menactra for Infants Valeant Pharmaceuticals Highlights Taribavirin Phase IIb End of Study Data Presentation at American Association for the Study of Liver Disease (AASLD) Annual Meeting Journal Cancer Publishes Pivotal Study of TREANDA in Patients with in Relapsed Indolent NHL New Data on Bendamustine Offers Hope to Non-Hodgkin's Lymphoma Patients Resistant to Standard Therapy

November 9

BrainStorm Stem Cell Therapy Treatment Shown To Be More Effective Than Other Current Potential Stem Cell Treatments ISTA Pharmaceuticals Highlights Bepreve Clinical Data at the 2009 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) Pandemic 2009 Influenza Update: Pandemrix data on co-administration with annual seasonal influenza vaccine (Fluarix) Æterna Zentaris: Scientific Article Supports Perifosine?s Development in Kidney Cancer Halozyme Study Results Demonstrate Significantly Less Absorption Variability for Insulin Lispro Administered with PH20 Enzyme Zosano Pharma, Inc. Announces Publication of Positive Phase 2 Study of Its ZP-PTH Patch for Osteoporosis Therapy DX-88 (ecallantide) Demonstrated Relief of Symptoms in Hereditary Angioedema Acute Attacks in All Attack Locations CEL-SCI Collaborators Present Data Suggesting That LEAPS Technology Has Ability to Modify Immune Response OssulinTM, a Novel Oral Insulin Product, Shows Promising Bioavailability for Advancing Diabetes Therapy NexBio Presents Data Showing Anti-Asthma Activity of DAS181 (Fludase(R)*) at ACAAI 2009 SuperGen Presentations at AACR-NCI-EORTC

November 11

Crinone 8% (progesterone vaginal gel) As Effective as Hormone Injections During IVF? Is Medscape's ?Top News? from The ASRM 65th Annual Meeting More Than 200 Abstracts Evaluating Celgene Products across a Range of Indications to Be Presented at the 51st American Society of Hematology Meeting Geron Collaborators Publish Data on hESC-Derived Glial Progenitor Cell Therapy in Cervical Spinal Cord Injury DUSA's Levulan PDT found to reduce squamous cell carcinomas by 95% in solid organ transplant recipients BioClinica to Host Medical Imaging Symposium for Rheumatoid Arthritis Clinical Trials on November 18, 2009 NanoViricides, Inc. to Present Anti-Influenza Drug Candidate FluCide Studies at the Influenza Congress 2009 Avanir Pharmaceuticals Announces Zenvia Safety and Efficacy Data from Star Trial Open Label Extension Drugs to Treat Anemia in Cancer Patients Linked to Thromboembolism Video: Sanofi Pasteur Announces Final Results of U.S. Clinical Trials of Influenza A (H1N1) Vaccine in Adults and Children Viron to Present Data from Phase II Trial at American Heart Association Conference Landmark Study in The Lancet Oncology Shows Capecitabine (Xeloda) Combination Therapy Reduces Early Breast Cancer Recurrence

November 12

Mersana Therapeutics Publishes Review Article Detailing Advantages of its Lead Cancer Compound in Journal of Advanced Drug Delivery Reviews Shire Reports Findings From an Analysis Examining Emotional Lability in Children With ADHD Taking Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII BioAlliance Pharma Presents Results for Its New Oral Chemotherapy Nanoparticle Innovation at the AAPS Annual Meeting in Los Angeles, November 8 to 12, 2009 Holllis-Eden to Present Interim Data From Its Phase I/II Clinical Studies of Apoptone (HE3235) at Molecular Targets and Cancer Therapeutics Conference Euro RSCG Life Presents Proprietary Survey Insights at Food and Drug Administration Hearing on Pharmaceutical Promotion via Online and Social Media Pharmacyclics Announces Poster Presentations and Clinical Update at the 51st Annual Meeting of the American Society of Hematology Lexicon Announces Positive Phase 2 Results of LX1031 in Non-Constipating Irritable Bowel Syndrome

November 17

Novartis Influenza A(H1N1) 2009 vaccine US interim data show lower doses of antigen may suffice to generate a protective immune response against A(H1N1) NicOx - NCX 6560 meets primary and secondary objectives in first-in-man study The Medicines Company Announces Positive Phase III Data in Two Late-Breakers at AHA and in NEJM Ticagrelor (BRILINTA) Demonstrated Greater Efficacy Over Clopidogrel in the Most Urgent Clinical Setting Shire Announces Publication of Open-Label Study on Coadministration of INTUNIV (guanfacine) Extended-Release Tablets with Stimulants Data from Mipomersen Phase 3 Trial in hoFH Patients Presented at AHA Oncolytics Biotech Inc. Collaborators Present Positive Phase I/II Trial Results in Advanced Solid Cancers with a Focus on the Head and Neck at the AACR-NCI-EORTC Meeting American Heart Association Late Breaking Clinical Trial Report: Treatment for Iron Deficiency Improves Symptoms, Functional Capacity and Quality of Life in Chronic Heart Failure Patients Poniard Pharmaceuticals Announces Updated Positive Clinical Data from Phase 2 Trial of Picoplatin in Colorectal Cancer and New Phase 1 Cardiac Safety Trial Results AVEO's Triple VEGF Receptor Inhibitor Tivozanib in Combination with mTOR Inhibitor Demonstrates Anti-tumor Activity and Tolerability in Advanced Kidney Cancer; Preliminary Results Presented at AACR-NCI-EORTC Meeting ImmunoGen, Inc. Announces Encouraging Clinical Data with Its IMGN901 Compound in the Treatment of Merkel Cell Carcinoma Exelixis Reports Encouraging Phase 1 Data for the PI3K Inhibitor XL147 (SAR245408) in Combination with Paclitaxel and Carboplatin at the AACR-NCI-EORTC Conference Interim Phase 2 Survival Data for PV-10 Will Be Presented by Professor John F. Thompson, MD, on November 21, 2009 Merck's Investigational Anacetrapib Phase IIb Study Results Presented at American Heart Association Annual Scientific Sessions NeoPharm Presents the Phase I Data for Patients with Metastatic Solid Tumors Higher Dose of Merck's Cozaar (losartan potassium tablets) Significantly Reduced Deaths and Hospitalizations Due to Heart Failure In Investigational Study Pluristem Therapeutics Announces Three Month Follow-Up Data from the First Patient to Receive PLX-PAD Aegerion Pharmaceuticals Announces Additional Lomitapide (AEGR-733) Phase III Data Demonstrates Significant Lowering of LDL Cholesterol with Promising Safety Profile BioSante Pharmaceuticals Comments on Boehringer Ingelheim Clinical Test Results in Treatment of Female Sexual Dysfunction Semafore Pharmaceuticals Announces Phase I Data Presentation Highlighting Novel PI3K Pathway Inhibitor at 51st ASH Annual Meeting American Heart Association Late Breaking Clinical Trial Report: High Dose of Angiotensin Receptor Blockers Effective in Heart Failure Patients YM Biosciences Reports Cyt997 Oral Vascular Disrupting Agent Results Presented At AACR-NCI-EORTC Meeting

November 18

Genzyme Announces Results of Phase 2/3 Trial of Advanced Phosphate Binder Alnylam Presents New Pre-clinical Data on ALN-VSP, an RNAi Therapeutic for the Treatment of Liver Cancer Results From Phase 2b Study on Atrial Fibrillation Agent Reviewed at American Heart Association ImmunoGen Announces Encouraging Clinical Data with Its IMGN901 Compound in the Treatment of Merkel Cell Carcinoma Genzyme Announces Results of Phase 2/3 Trial of Advanced Phosphate Binder Viron reports positive Phase II data in Acute Coronary Syndromes (ACS) patients Threshold Pharmaceuticals Presents Interim Prostate Cancer Data From Early Stage Trials of TH-302 Zydena is Efficacious in Once Daily Dosing for Erectile Dysfunction/Positive BPH Results Cardiovascular Outcomes with Ezetimibe and Simvastatin Similar to Statin Alone, Claims Data Suggest Exelixis Reports Encouraging Phase 1 Data for the PI3K Inhibitor Xl147 (SAR245408) in Combination with Erlotinib at the AACR-NCI-EORTC Conference Results From Two Phase II Trials Add to Understanding of Ticagrelor (BRILINTA(TM)) and How it Works in the Body Peregrine Pharmaceuticals Presents Promising Antiviral Data at 2009 Chemical and Biological Defense Science & Technology Conference Sangamo BioSciences Provides Update on Phase 1 Safety Trial of SB-728-T for HIV/AIDS Synta Presents New Data on Mechanism of Action of Elesclomol at AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics Synta Presents Preclinical Data on Next Generation Hsp90 Inhibitor, STA-9090

November 19

Geron Presents Interim Clinical Data on Its Telomerase Inhibitor Drug at AACR-NCI-EORTC Medivir: Epiphany Biosciences Announces Positive Results from Its Phase 2b Trial in Shingles Basilea presents new research data on oncology drug candidate BAL27862 at international cancer conference ImmuPharma announces Positive Ph2b Lupuzor trial results Epiphany Announces Positive Results from Its Phase 2b Trial in Shingles. VIVUS Announces Positive Results From Phase 3 Study of Avanafil in Erectile Dysfunction; Data Demonstrate Robust Efficacy, Favorable Side-Effect Profile Positive Results from Chronic Study with Bayer ?s Rivaroxaban Will be Presented As a Late Breaker at ASH 2009 Notice of YM BioSciences Annual Meeting of Shareholders NeoStem Outlines to Shareholders Near-term and Long-term Business Strategies Following Acquisition of Chinese Pharmaceutical Company Spherix Announces Results of Annual Shareholders Meeting OSI Pharmaceuticals to Webcast its R&D Analyst Day on Thursday, December 3rd Military Study Shows Prevention of Novel A/H1N1 Virus Infection is Vaccine-Type and Age-Dependent Interphase Systems Launches Managed IT Solution for BioPharma Companies Curemark Opens Patient Enrollment for Autism Treatment at Three More Clinical Trial Sites TGaS Advisors Summit: "Best Days are Ahead" ScinoPharm Announces SafeBridge Potent Compound Safety Certification

November 22

ImmuPharma PLC: Encouraging Final Phase IIb Results Seen with LUPUZOR in Systemic Lupus Erythematosus Sciele Pharma, a Shionogi Company, Presents Pivotal Study for PSD502 ? The First Potential Treatment for Premature Ejaculation ? At the Sexual Medicine Society of North America (SMSNA) Ironwood Pharmaceuticals Files Registration Statement for Initial Public Offering Pluristem Therapeutics Presents Three Month Follow-Up Data from First Patient to Receive Placental Derived PLX-PAD at Two Meetings in Germany and France Enzon Presents Data at 2009 EORTC Meeting Vertex Pharmaceuticals Announces Webcasts of its Presentations at Two Investor Conferences NUCRYST Announces Special Meeting of Shareholders Circassia Announces Successful Results From Phase II Clinical Study of ToleroMune Cat Allergy Therapy Cell Therapeutics Wins Federal Appeal to Pursue $22.8 Million Claim Against The Lash Group Ohio Mother Charges Yaz Birth Control Drug Caused Life-Threatening Blood Clot Karolinska Development and EIF Start Landmark Co-Investment Fund for Life Science Innovation KineMed Receives an Investigator-Initiated Study Grant to Further Explore Mechanism(s) of Action Associated with Welchol (colesevelam HCl) in Type 2 Diabetes Mellitus BioCryst Announces Pricing of Public Offering of Common Stock

November 23

NanoViricides Presents FluCide Animal Study Data at Influenza Congress - Now Improved Substantially and Vastly Superior to Current Treatment ARIAD to Present Data on Pan-BCR-ABL Inhibitor AP24534 at 51st American Society of Hematology Meeting Interim Phase 2 Survival Data for PV-10 Shows Markedly Longer Overall and Disease Specific Survival for Subjects Responsive to PV-10 Genasense® Given as High-Dose IV Infusion with Chemotherapy Shows Promising Activity in Advanced Melanoma Merck KGaA to Expand Research and Development Presence in China Pronova BioPharma ASA (NO) - Pronova BioPharma ASA presented at "Aksjedagen Norge" 2009 Ception Therapeutics and Cephalon Provide Initial Results of a Phase IIb/III Study of CINQUIL in Pediatric Eosinophilic Esophagitis Isis Pharmaceuticals (Nasdaq: ISIS) Letter to Shareholders Lexicon to Present Positive Top-Line Phase 2 Results for LX1031 in Non-Constipating Irritable Bowel Syndrome at GASTRO 2009 Biotec Pharmacon ASA (NO) - Phase III Results With SBG for Diabetic Foot Ulcer Not Positive Chiesi Is Top Italian Pharmaceutical Group for Investment In Research Nymox Releases Positive New Clinical Trial Data on Durability of Benefits for Early Responders to Company?s BPH Drug NX-1207 Genfit: Extremely Promising Gft505 Results In Phase Ii NexMed, Inc. to Acquire Bio-Quant, Inc. Nereus Pharmaceuticals Presents Positive Interim Data from the ADVANCE Study, a Randomized Phase 2 Clinical Trial of Plinabulin (NPI-2358) in Non-Small Cell Lung Cancer at the 2009 EORTC-NCI-AACR Conference
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