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Clinical Trials Week

Susan Hasty, Publisher

Table of Contents . . . November 14th, 2005

Non-Subscriber - Summaries Only

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

Chronic Daily Headache - High-dose Botox shows promise as prophylactic treatment

Clinical Trials - Study shows interferon treatment delays MS onset in patients showing clinical signs

Crohn Disease - Phase II Trial results for treatment of Crohn Disease with Cimzia are positive

Drug Development - Data being analyzed in phase II CoFactor trial in patients with metastatic colorectal cancer

Erectile Dysfunction - Tadalafil effective during thiazide diuretic hypertension therapy

Adverse Drug Reaction - Tysabri safety evaluation complete; no new confirmed cases of PML

Alcoholism Therapy - Increasing leptin levels precede relapse in detoxified alcoholics

Allergy & Immunology - Hepatitis C virus therapy alters the efforts of natural killer T cells

Angiology - C-reactive protein elevation correlates with accelerated atherogenesis in rheumatoid arthritis

Angiology - Computed tomography is of limited diagnostic value in evaluating CAD

Breast Cancer - Researchers report details of new studies and findings in the area of breast cancer

Angiology - Coronary artery stenoses detected using multi-detector computed tomography

Angiology - Flow cytometry of platelet-leukocyte aggregates may permit monitoring of platelet function

Angiology - Flow-mediated vasodilation predicts the presence and extent of coronary artery disease

Angiology - Phenylephrine increases blood flow in the radial artery used as a coronary bypass conduit

Asthma Therapy - Research add new data to asthma therapy body of knowledge

Bioterrorism - Positive data presented from preclinical and clinical studies with Neumune

Blood Clotting - Coagulation system is activated in Duchenne muscular dystrophy patients with cardiac dysfunction

Breast Cancer - Data shows Herceptin plus chemotherapy reduces risk of breast cancer recurrence

Breast Cancer - Reports add new data to breast cancer research

Breast Cancer Risk Factors - Mammographic density indicated as marker of breast cancer risk

Business & Finance - Avid Bioservices to provide development services for monoclonal antibody

Business & Finance - Cancer-focused biopharmaceutical company raises $11.6 million in private funding

Business & Finance - Defibrotid maker completes $10.9 million private placement

Business & Finance - Drug-delivery company returns to profitability in the third quarter

Business & Finance - Pharmaceutical company updates program for lupus renal disease drug candidate

Cancer Research - National council research assistance program gets support from national program

Cancer Therapy - New trial to investigate combination of HYB2055 with chemotherapy

Cancer Therapy - Preliminary results reported from randomized phase II trial of Avastin and Tarceva in kidney cancer

Cardiology - Basis of paroxysmal atrial fibrillation can be predicted by gender and left atrial enlargement

Cardiology - Catheter ablation sites identified in patients with ventricutar tachycardia

Cardiovascular Disease - Analysis suggests Cypher Stent more cost effective than bypass surgery

Cardiovascular Disease - Phase 1 study underway of rFXIII for patients undergoing cardiac surgery

Caregiving - Patient/caregiver symptom control intervention evaluated

Chemotherapy - Irinotecan plus temozolomide was well tolerated in malignant glioma patients

Chemotherapy - Temsirolimus used to treat relapsed mantle cell lymphoma

Clinical Trials - Clevidipine phase 3 program resumes, phase 3 interim data affirms safety profile

Clinical Trials - Clinical trials data show excellent long-term safety, efficacy of stent system

Clinical Trials - Clinical trials should adopt routine genetic testing and risk stratification

Clinical Trials - Complete clinical, angiographic data confirm patient safety of drug-eluting stent

Clinical Trials - DNA 'prime-boost' vaccine technology enters phase 2 clinical trial for HIV

Clinical Trials - Data from four studies finds multiple overlapping stents better for high-risk patients

Clinical Trials - Enrollment complete in phase 3 study of Evamist for treating menopausal symptoms

Clinical Trials - Health Canada grants clearance to initiate phase 2 cancer trial for Proxinium

Clinical Trials - Phase 2 clinical trial of drug candidate for allergic asthma patients initiated

Clinical Trials - Phase 2 testing of HIV vaccine developed with Vaccine Research Center initiated

Clinical Trials - Prostate cancer trial ended, metastatic breast cancer trial continues, company reports

Clinical Trials - Recruitment strategies for Osteoporotic Fractures in Men Study discussed

Clinical Trials - Results of phase 3 trial on immunotherapy Virulizin for pancreatic cancer reported

Clinical Trials - Stent system clinical trial shows reduction of restenosis in diabetic patients

Clinical Trials - Value of websites on cancer clinical trials need further study

Collaborations - ABC(2) and collaborator announce second brain cancer collaboration

Collaborations - Electronic data management partnership signed for managing clinical trial data

Colon Cancer - Genasense Injection increases anticancer activity of radiation

Colorectal Cancer - Carbohydrate compound company begins phase II trail of Davanat /5-FU

Colorectal Cancer - TroVax trial achieves primary endpoints for cancer immunotherapy treatment

Contraception - First scientific data for Lybrel presented at ASRM meeting

Dermatology - Data: Remicade can quickly and significantly improve psoriasis symptoms

Dermatology - Few patients with lichen planus in Iran have underlying hepatitis C infections

Diabetes Therapy - Tesaglitazar improves metabolic abnormalities linked to insulin resistance

Diabetic Neuropathy - Studies show QR-333 safe for topical use

Diagnostics - Endometrial cytology diagnosed endometrial cancer with normal curettage findings

Diagnostics - Myocardial perfusion imaging is imperfect in the absence of post-test referral bias

Diagnostics - Noninvasive scintigraphy is useful in the etiologic diagnosis of cardiac amyloidosis

Diagnostics - PET/CT with intravenous contrast used for PET attenuation correction

Disease Associations - Cardiac troponin I predicts adverse events in stable coronary disease

Disease Associations - Coronary microembolization ultrasonically detected during percutaneous coronary interventions

Disease Associations - Elevated brain natriuretic peptide is diagnostic of chronic obstructive pulmonary disease

Disease Associations - Epithelioid hemangioendothelioma of the mitral valve may be diagnostic of valve tumors

Disease Associations - Intima-media thickness score from carotid and femoral arteries predicts extent of CAD

Disease Associations - Palmoplantar keratoderma associated with esophagus squamous cell cancer

Disease Associations - Prior aspirin use is not a marker of increased mortality in elderly patients with acute MI

Dosimetry - Amifostine allows additional delivery of paclitaxel in patients undergoing radiotherapy

Drug Development - ACT 4 study initiated in acute treatment of atrial fibrillation

Drug Development - Enrollment strong in Phase III trials of treatment for pulmonary fibrosis

Drug Development - First patients enrolled, treated in IRX-2 phase II head and neck cancer study

Drug Development - Malaria drug positioned for treatment in pregnant, lactating women

Drug Development - Phase I trial for CHIR-12.12 initiated in multiple myeloma

Drug Development - Phase I trial of AG-707 therapeutic vaccine for genital herpes initiated

Drug Development - Phase II trial of PPI-0903 initiated in patients with bacterial infections

Drug Development - U.S. FDA maintains clinical hold on IND application for RESUS phase II/III trial of Hemopure

Duchenne Muscular Dystrophy - Development-stage biopharma targets January 2006 to submit IND application for Myodur In DMD

Eczema - Research shows benefits of Elidel in eczema patients as alternative to steroids for eczema patients

Endocrinology - Researchers publish new studies and findings in the area of endocrinology

Eye Health - Results affirm safety of treatment for post-Lasik presbyopic patients

Fibromyalgia - Dehydroepiandrosterone proves ineffective in treatment of fibromyalgia symptoms

Finance - California biosciences company announces $14.7 million private placement

Finance - Pharmaceutical company reports 45% increase in revenue for fiscal Q3 2005

Finance - PhosLo revenues exceed expectations; set stage for StaphVax launch

Finance - Venture capital firm announces EUR 7 million investment in Kika Medical, SA

Fitness & Wellness - Peripheral forearm vasodilatation in CAD is not improved by mild endurance exercise and pravastatin

Genetics & Genomics - Increased genomic instability leads to higher cancer incidence in elderly

Genotoxicity - Handling of antineoplastic drugs associated with genotoxic risks in oncology nurses

Glaucoma - Approval granted for studies of DeepLight gold micro-shunt implant for glaucoma

HIV/AIDS Prevention - Vaginal microbicide phase III trial underway, 10,000 women to be enrolled

HIV/AIDS Research - Procyon announces positive preclinical results for lead HIV protease inhibitor

HIV/AIDS-Related Lipodystrophy - Metformin improves lipid profiles in HIV-related lipodystrophy

Headache - Research suggests headaches caused by oral contraceptives improve with continued use

Healthcare Costs - Cost analysis should be planned and interpreted under meaningful scenarios

Heart Disease - Cardiac magnetic resonance imaging is reproducible in chronic coronary artery disease

Heart Disease - Left atrial circumferential ablation decreases left atrial transport function

Hemodialysis - Prosthetic graft implants improve vascular access in poor forearm vessels

Hepatitis C Therapy - Lactoferrin has no effect on the response of chronic hepatitis C to standard therapy

Hepatocellular Carcinoma - Research in hepatocellular carcinoma provides new insights

High Cholesterol - Children's hospital to participate in study of single nucleotide polymorphisms

Hormones - Sex hormones show gender-specific pattern after abdominal surgery

Hypertension - High blood pressure is inversely related to the presence and extent of coronary collaterals

Hypoxia - Cerebral vascular processes are hindered by intermittent hypoxia

Imaging - Doppler echocardiography is useful in evaluating aortic coarctation

Imaging - Long-scan-time CT deemed effective in planning of stereotactic radiation therapy

Imaging - Three-dimensional outline of the heart and conduction pathway constructed

Immunotherapy - Study confirms synergy of Coramsine and immune-stimulating agent

Information Technology - Alert system associated with increased clinical trial recruitment

Intracranial Aneurysm Rupture - Endovascular coiling confers improved survival compared to neurosurgery

Irritable Bowel Syndrome - Tegaserod improves work and daily activity in IBS patients with constipation

Leukemia - Findings advance knowledge in leukemia research

Leukemia - Initial study yields positive results from drug for acute myeloid leukemia

Leukemia - Multicenter study to assess combination treatment for acute myelogenous leukemia

Leukemia - U.S. Food and Drug Administration grants fast track designation for Troxatyl

Lipid Research - Raloxifene positively affects lipid profile and body fat distribution

Liver Cancer - New findings in the area of liver cancer detailed

Lung Cancer - New research shows Onconase inhibits tumor growth in non-small cell lung cancer

Lymphoma - Researchers report details of new studies and findings in the area of lymphoma

Medical Devices - Bifurcation stenting presents an increased risk of stent thrombosis

Medical Devices - Frequency of late incomplete stent apposition after sirolimus-eluting stent implantation determined

Menopause - Novel class of estrogen receptor-subtype modulators identified

Migraine - Implant developer receives U.K. approval for migraine intervention study

Myocardial Infarction - Endothelial nitric oxide synthase polymorphism is important during myocardial infarction

Nephrology - Baboon shown to be good model for studies of human kidney development

Non-Small Cell Lung Cancer - Enrollment opens in Phase III study of treatment for non-small cell lung cancer

Obesity Therapy - Study shows 25 pound weight loss with diet delivered entirely over the phone

Obesity Treatment - A new kind of appetite suppressant may mean hope for the obese

Oncology - Study shows AEOL 10150 protects against radiation-induced lung injury

Oral Mucositis - Pharma company successfully concludes Phase II of oral mucositis drug trial

Osteoporosis - Indices of bone formation increase with teriparatide

Osteoporosis - Study reveals vertebral deformities misdiagnosed as vertebral fractures

Ovarian Cancer - Women at high risk of ovarian cancer are ready subjects for chemoprevention trials

Pain Management - Positive preliminary results announced from phase II study for postoperative-pain-relief depot

Pain Management - Radiofrequency ablation and cementoplasty relieved pain from bone metastases

Patents - Biotech company announces patent for reovirus for the treatment of neoplasia

Patents - Patents for rheumatoid arthritis compound granted by European Patent Office

Personnel - Jan Wilson named VP, chief information officer, of clinical trials software company

Personnel - Roy C. Levitt, MD, resigns as CEO; John L. Armstrong, Jr., to take the helm

Pharmaceutical Research - RiVax maker provides business and clinical update; RiVax phase I trial complete

Physiology - Reference value for asymmetric dimethylarginine determined

RNA Research - Phase 1 trial data on RNA molecule for age-related macular degeneration updated

Restless Legs Syndrome - Studies show sustained efficacy in treatment for restless legs syndrome

Retinoblastoma - Investigators demonstrate potential treatment for retinoblastoma

Rheumatoid Arthritis - Patient enrollment complete in study of the safety and efficacy of MM-093

Seasonal Allergic Rhinitis - Cetirizine more effective than fexofenadine at 5-12 hours posttreatment

Sepsis Therapy - Drotrecogin alfa not beneficial for severe sepsis with low risk of death

Stroke - Circulating beta amyloid protein is elevated in patients with acute ischemic stroke

Stroke - Three-year feasibility trials demonstrate durability of carotid artery stenting

Stroke Risk Factors - Serum homocysteine increases and folate decreases the risk of stroke

Surgical Technology - BSC safe for surgical wound treatment, but healing time results are inconclusive

Surgical Technology - Gamma probe-guided surgery used in revision thyroidectomy

Surgical Technology - Pivotal trial of percutaneous alternative to open-heart mitral valve surgery begins

Surgical Technology - Stent placement is an alternative to complex arterial bypass surgery or reconstruction

Surgical Technology - Study shows stent less prone to target vessel failure than brachytherapy

Thrombosis Therapy - Aprotinin needed to accurately monitor hemostatic system during desmoteplase treatment

Tobacco Use - Smokeless tobacco may contribute to coronary heart disease

Transmissible Spongiform Encephalopathy - Technology shown to remove transmissible spongiform encephalopathy infectivity

Transplant Medicine - Matrix-assisted autologous chondrocyte transplantation improves previous methods

Ulcerative Colitis - Trials show Remicade effective for mucosal healing in ulcerative colitis

Virology - Liver enzyme flares require scrutiny in HIV-HCV coinfected patients beginning therapy

Weight Loss - Pharma company initiates recruitment process for clinical trial of obesity drug

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