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Clinical Trials Week

Susan Hasty, Publisher

Table of Contents . . . August 16th, 2004

Non-Subscriber - Summaries Only

Related Areas: Other Issues in Clinical Trials Week | Other Publications

Clinical Trials - Agency announces standard format to submit human drug clinical trial data

Morbid Obesity - Abdominoplasty safe in morbidly obese patients

Obesity Survival & Mortality - Body mass index predicts mortality in kidney transplant recipients

Obesity and Diabetes - High-dose atorvastatin improves lipid profile in type 2 diabetic patients

Pain Medicine - Capsicum plaster at hand acupuncture point can prevent sore throat

Alzheimer Disease - Alzhemed highlighted at Alzheimer's Association news conference

Alzheimer Disease - Companies announce results from phase IIa clinical trial of AN-1792

Alzheimer Disease - Data supports SEROQUEL use to reduce agitation associated with Alzheimer disease

Alzheimer Disease - Pharmaceutical company presents findings on PAN-811 for Alzheimer disease

Angiology - FDA grants approval for trial of its Liberte paclitaxel-eluting stent

Antiretroviral Therapy - Atazanavir suppresses HIV with extended use and in nelfinavir-switched patients

Antiretroviral Therapy - Previous immunosuppression predicts incomplete immune reconstitution after HAART

Antiretroviral Therapy - Sustained HIV virological response better with triple nucleoside therapy

Artery Punctures - Enrollment completed in trial for vascular closure technology

Awards - Contract research organization CEO receives Entrepreneur of the Year honors

Awards - Electronic clinical trials software company receives industry awards

Axillary Hyperhidrosis - FDA approves BOTOX for treatment of severe underarm sweating

Benign Prostate Hyperplasia - Andrin trial launched in Australia

Bifurcated Lesions - AXXESS PLUS clinical study begins

Breast Cancer Vaccine - Dendritic cell vaccine safe in patients with advanced breast cancer

Business & Finance - Biopharmaceutical company announces second quarter financial results

Business Update - Osel names president, announces new board members and start of Phase I trial

Cancer Therapy - Assessment recommends against chemotherapy sensitivity and resistance assays

Cancer Therapy - Pharma company reports progress in aurora kinase program for treatment of cancer

Cancer Tumor Therapy - Phase I trial initiated for new anticancer agent

Central Nervous System - Data prove potential of GSK3Beta inhibitors as effective treatment CNS disorders

Clinical Trial - Patient enrollment for Fibrostat Phase IIb trial for hypertrophic scars complete

Clinical Trial - Phase II trial enrollment completed to evaluate BronchitolTM on bronchiectasis

Clinical Trials - Attracting top investigators requires planning, execution, and dedication

Collaborations - Deal signed to manufacture Ibuprofen for use in human trials

Collaborations - Integration of new systems for clinical data management delivers tangible benefits

Collaborations - Stroke recovery product candidate licensed for phase II development

Colorectal Cancer - Update provided on polymer platinate AP5346

Congestive Heart Failure - FDA gives conditional approval for trial of heart failure treatment

Constipation - Study results for constipation therapy to be presented at GI group meeting

Coronary Artery Bypass - Enrollment initiated in pivotal phase III PRIMO-CABG-2 trial

Coronary Bypass Surgery - Blood transfusions during heart surgery may increase death risk

Data Exchange - FDA announces standard format for submission of trials data

Databases - Canadians join international registration of randomized controlled trials

Drug Development - Pharmaceutical company presents data at International Immunology Congress

Drug Development - Phase 1 clinical trial with bivalent anthrax vaccine initiated

Emergency Medicine - Phase II trial of Hemopure initiated in trauma patients in South Africa

Eye Health - Medical device company reports clinical trials results of Presbyopia treatment

Finance - Diagnostics firm reports earnings grew in excess of 30%

Finance - Pharma company announces second quarter results

Geriatrics - Agitation in elderly patients with dementia addressed at Alzheimer conference

HIV Diagnostic - Clinical trial commences for HIV rapid test

HIV/AIDS Therapy - Immune recovery slows after 3 years HAART and reaches plateau after 4-5 years

Healthcare Delivery - Chemotherapy at home? - The future of cancer treatment

Heart Failure - Australian device maker comments on progress

Heart Failure - Clinical trial of BiDil treatment of African Americans with heart failure halted

Hemophilia - Analysis of European Acquired Haemophilia Registry underway

Hepatitis - Application filed with U.S. FDA to market hepatitis C medication for hepatitis B

Hepatitis - New hepatitis B indication filed for PEGASYS filed in U.S., E.U. and Switzerland

Hepatitis C Therapy - Phase II clinical study initiated for IDN-6556 in hepatitis C

Infectious Diseases - African office of clinical trials collaborative partnership opened

Inflammation - Phase I study of anti-inflammatory compound CTI-01 to begin

Information Technology - Cardiology network database surpasses 3 million patient medical records

Information Technology - Pharmaceutical companies use Recruitment Manager software

Lung Cancer, Melanoma - Kahalalide F enters phase II trials in lung cancer and melanoma

Mergers & Acquisitions - Medical device company acquires artificial cervical disc developer SpineCore

Myocardial Infarction - Clinical trial of TG100-115 for heart attacks to proceed under active IND

Onychomycosis - FDA approves Penecure antifungal trial

Ovarian Cancer - Phase II ovarian cancer trial commences

Patents - Patent issued for immunological method to reduce HIV activity

Peripheral Vascular Disease - Company concludes Liprostin phase II clinical trial

Solid Tumors - Second KOS-862 phase Ib combination trial initiated in advanced solid tumors

Solid Tumors - Second-generation Hsp90 inhibitor to be studied in advanced solid tumor patients

Stroke - IND application filed for Axosine for stroke recovery

Systemic Lupus Erythematosus - Phase 1b clinical trial underway to study potential immunotherapy

Thrombocythemia - Thromboreductin registrations obtained in central Europe

Urinary Tract Infections - NDA submitted for Proquin XR - Ciprofloxacin GR

Vaccine Safety - Case cross-over design useful to find link between vaccine and safety

West Nile Virus - Clinical trial begins for Procleix West Nile virus blood screening assay

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