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Clinical Trials Week

Susan Hasty, Publisher

Table of Contents . . . November 29th, 2004

Non-Subscriber - Summaries Only

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

Allergy Medicine - Company gets IRB approval for phase III clinical trials for PreHistin

Anemia - Aranesp trial launched to evaluate impact of treating anemia on cardiovascular risks

Cardiovascular Disease - African American heart failure trial data submitted to the U.S. FDA

Clinical Trial - New data from hyponatremia treatment trials released

Vaccine Development - DNA vaccine aids chronic hepatitis B carrier non-responders

Adverse Drug Events - Trial aims for safer drug prescribing for institutionalized elderly

Breast Cancer - Pilot study examines new radiofrequency ablation-assisted lumpectomy

Breast Cancer - Survival benefit confirmed in patients with brain metastases from breast cancer

Business & Finance - ATryn maker reports third-quarter net loss of $7.2 million

Business & Finance - Drug delivery company announces total revenue increase for third quarter

Business & Finance - Drug delivery company reports third quarter 2004 financial results

Business & Finance - Pharma company reports third quarter 2004 results

Business & Finance - Q3 update: Phase III trial enrollment complete; Thelin shows promise

Cancer Research - Negative outcome on malignant melanoma trial reported

Cancer Research - Pharma company offers data on Yondelis and Aplidin at conference

Cancer Therapy - Company achieves commercial scale of antigen for Provenge

Cancer Therapy - Company initiates phase I trial with cancer drug candidate GX15-070

Cancer Therapy - Pharma company presents data on Xcytrin Injection trial

Cancer Thereapy - NeoRecormon may reduce risk of tumor progression in patients with anemia

Cardiovascular Health - Thrombin inhibitor used in coronary intervention lowers costs, study shows

Central Nervous System Disease - Stem cell focused biotech completes equity financing to support clinical trial

Clinical Trial - New product to shorten clinical trial stage introduced

Clinical Trials - Integrated technology platform for clinical studies presented at CSSG conference

Clinical Trials - NDA for anticancer therapeutic drug submitted to U.S. FDA by two drug companies

Clinical Trials - Results of preclinical, clinical studies of investigational antibiotic reported

Clinical Update - Company details clinical development plan for CG53135 and CR002

Colon Cancer - U.S. FDA clears second stage of CoFactor phase II trial

Congestive Heart Failure - New medication dramatically decreases CHF in African American patients

Congestive Heart Failure - PAC device appears to have little effect on morbidity, mortality

Crohn Disease - Analysis shows Remicade reduces pain associated with Crohn disease

Crohn Disease - Crohn therapy remains stable with maintenance over 2-year period, study shows

Depression - Technology could be first non-drug procedure to treat depression since the 1930s

Dermatology - Coramsine Psoriasis trial enters final stage

Diabetes Treatment - HPB-84 double-blinded, placebo-controlled clinical studies to begin soon

Diabetes Treatment - U.S. FDA gives nod to OTC use of insulin-dosing technology

Drug Delivery - Transdermal delivery gel technology compared to testosterone patch

Eating Disorders - Investigators look at psychiatric treatment in large trial

Finance - Biopharma announces $13.0 million direct equity placement

Finance - Biopharmaceutical company announces third quarter 2004 financial results

Finance - Biopharmaceutical company reports Q3 2004 financial results

Finance - Biopharmaceutical company reports loss of $0.22 per share

Finance - Biopharmaceutical company reports third quarter results

Finance - Biosciences company reports 2004 third quarter, 9-month financial results

Finance - Biosciences company reports improved third quarter results

Finance - Diagnostics maker reports strong Q3, raises full-year guidance

Finance - Pharma company announces improved third quarter 2004 financial results

Finance - Pharma company reports third quarter and 9 month 2004 financial results

Finance - Pharmaceutical company announces revenues of $1M due to Plenaxis sales

Finance - Pharmaceutical company reports loss of $0.16 per share

Finance - Pharmaceutical company reports third quarter results

Finance - Zyflo maker reports $6.6 million net loss for Q3, provides clinical update

Gastric Ulcer - Biopharma company initiates phase II trial with TB4 for chronic pressure ulcers

Gastric Ulcer - Study finds new treatment option for moderately active ulcerative colitis

Gastroesophageal Reflux Disease - Clinical trial results of nocturnal gastric acidity drugs comparison reported

Graft-versus-Host Disease - Cyclosporin and MMF for GVHD prophylaxis associated with faster engraftment

HIV/AIDS - New information on TRIZIVIR presented at conference

HIV/AIDS - Phase II data for HIV drug presented at conference

HIV/AIDS - Phase IIa study show Reverset potentially reduces HIV viral load

Hepatitis - PEGASYS provides lasting remission compared to lamivudine

Hepatitis - Trial results for spi-VECTM oral immunotherapeutic vaccine reported

Hepatitis B - European authorities give positive opinion for Fendrix vaccine

Hepatitis B Virus - Phase II trial data announced on new HBV vaccine

Hepatitis B Virus - Trials show hepatitis B agent a statistical improvement in infected patients

Hepatitis C Therapy - Hepatitis C viral load reduction reported in phase IB trial of isatoribine

Hepatitis C Virus - Peginterferon alfa-2B studies show positive data in treatment of hepatitis C

Herpesvirus - Pre-IND contact initiated with U.S. FDA for clinical trials of CY301 for herpes

Immunosuppressive drugs - Study results announced for immunosuppressive drug

Influenza Vaccine - Enrollment complete for intranasal influenza vaccine trial

Informed Consent - Communication in the early era of gene transfer trials was unclear

Invasive Fungal Infections - Data on drug for treating invasive fungal infection in at-risk patients reported

Irritable Bowel Syndrome - Data show cilansetron improves quality of life in patients with IBS-D

Kidney Disease - Pharmaceutical company presents results from clinical trials of lupus treatment

Mergers & Acquisitions - Drug development company to merge with PharmaNet, Inc.

Multiple Myeloma - FDA issues approvable letter for Thalomid sNDA

Neurology - BrainGate Neural Interface translates neural activity into computer control

Oncology - Study results show anti-tumor activity

Organ Transplant - NDA submitted immunosuppressant for chronic lung-transplant rejection

Ovarian Cancer - Controversies over treatments reviewed

Pain Therapy - Company launches phase II clinical program for postoperative pain relief

Paroxysmal Nocturnal Hemoglobinuria - Treatment initiated in phase III Eculizumab study

Personnel - Central laboratory services provider appoints VP business development

Personnel - Clinical trials company names executive VP and chief financial officer

Personnel - Global research organization appoints head of Latin American expansion

Personnel - Global research organization appoints medical device consultant

Pneumonia - Avelox study reports faster symptom relief, earlier hospital discharge

Prognostics - Clinical data shows eTag's potential in predicting response to cancer treatment

Prostate Cancer - Company to initiate phase II study with Quinamed in prostate cancer

Prostate Cancer - Pharma companies awarded NIH grants for prostate cancer immunotherapies

Respiratory Infections - Studies show single-dose azithromycin as effective as multi-dose for infections

Synthetic Blood - Red blood cell substitute in trials with Virginia Commonwealth for U.S. Navy

Thyroid Cancer - Company seeks new therapeutic indication for Thyrogen

Ulcerative Colitis - New treatment option offered for patients with moderate ulcerative colitis

Urethritis - Positive phase II results reported on Rifalazil

Vaccine Development - Company says skin immunization may expand flu vaccine supply

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