NicOx Announces TOPIGEN Initiates Phase 2 Proof of Concept Study in COPD for TPI 1020

... TPI 1020 and budesonide on the change in sputum neutrophil counts between baseline and day 42 and the safety ... TPI 1020 and budesonide on the change in sputum neutrophil counts between baseline and day 42. A secondary endpoint will also measure the change in sputum neutrophil counts between baseline and day 21. Neutrophils ...

Study Finds DOXIL(R) Combination Therapy Delays Disease Progression for Patients With Metastatic Breast Cancer

... hematologic toxicity (based on platelet count or absolute neutrophil count) may require dose reduction or delay in administration of ... hematologic toxicity (based on platelet count, absolute neutrophil count, hemoglobin level, or neutropenia with fever) may require ...

Bayer Announces Upcoming Presentations of Campath(R) and Leukine(R) Data at the 50th Annual Meeting of the American Society of Hematology

... and older with acute myelogenous leukemia (AML) to shorten the time to neutrophil recovery and to reduce the incidence of severe and life-threatening ... older adults with acute myelogenous leukemia (AML) to shorten the time to neutrophil recovery and reduce the incidence of severe and life-threatening ...

Long-Term Pegylated Interferon Alfa-2b Therapy in Stage III Melanoma Demonstrated Significant and Sustained Impact on Relapse-Free Survival

... cell count), thrombocytopenia (low platelet count) and neutropenia (low neutrophil count); thyroiditis (inflammation of the thyroid gland); and autoimmunity ... less than or equal to one percent with PEGINTRON(TM): Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, ...

Study Shows Need to Test More COPD and Asthma Patients for Underdiagnosed Pulmonary Disease

... roles is to shield the delicate tissues of the lungs by binding to neutrophil elastase, an enzyme released by certain white blood cells that digests ... levels of AAT inhales irritants or contracts a lung infection, the neutrophil elastase released to protect the lungs is uncontrolled and can injure ...

IMPACT Study Showed Longer Valcyte(R) (valganciclovir hydrochloride tablets) Treatment Demonstrated Better Protection Against Cytomegalovirus (CMV) Disease One Year Post-Transplant

... studies, ganciclovir was carcinogenic, teratogenic, and caused aspermatogenesis. Valcyte tablets should not be administered if the absolute neutrophil count is less than 500 cells/micro liter, the platelet count is less than 25,000/micro liter, or the hemoglobin is less than 8 g/dL. Severe ...

Bayer Announces Leukine(R) Data Presentations at 45th American Society of Clinical Oncology (ASCO) Annual Meeting

... in the U.S. for use following induction chemotherapy in older adults (older than 55) with acute myelogenous leukemia (AML) to shorten the time to neutrophil recovery and reduce the incidence of severe and life-threatening infections and infections resulting in death. Leukine also has been approved in the ...

Dacogen(R) (decitabine for injection) Data Presented on a Phase II Clinical Trial in Elderly Patients with Acute Myeloid Leukemia (AML)

... designation requires that the patient have less than 5 percent blasts in the marrow, no evidence of disease outside of the bone marrow and absolute neutrophil and platelet counts of more than 1,000/uL and 100,000/uL, respectively. The majority of patients in the trial had intermediate or poor risk ...

Schering-Plough Provides Update on Boceprevir Clinical Development and Introduces Potent Next-Generation Oral HCV Protease Inhibitor for Treating Patients With Chronic Hepatitis C

... or clinically significant adverse events have been reported at a frequency less than 1% with PEGINTRON or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of ...

Boceprevir Phase II Study Showed High Rate of Sustained Response With 28- and 48-Week Regimens in Genotype 1 Treatment-Naive Hepatitis C Patients

... or clinically significant adverse events have been reported at a frequency less than 1% with PEGINTRON or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of ...

Top-Line Results of Boceprevir Phase II Study Showed High Rate of Sustained Response (SVR) in Genotype 1 Treatment-Naive Hepatitis C Patients

... or clinically significant adverse events have been reported at a frequency less than 1% with PEGINTRON or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of ...

Insmed Announces First Human Bioequivalence Data for a Follow-on Biologic by a U.S. Company

... ratio of AUCs was 94-103%. These data demonstrate that the pharmacokinetic behaviour of the products was statistically indistinguishable. Absolute neutrophil count, the primary pharmacodynamic marker for G-CSF products, exhibited the same response profile to dosing with INS-19 as with Neupogen(R). About ...

Journal of Clinical Oncology Publishes Leukine(R) Study Demonstrating Positive Survival Outcomes in Patients with High-Risk Melanoma

... factor approved in the U.S. for use following induction chemotherapy in older adults with acute myelogenous leukemia (AML) to shorten the time to neutrophil recovery and reduce the incidence of severe and life-threatening infections and infections resulting in death. Leukine also has been approved in the ...

Study Supports Possible Use of Leukine(R) as a Potential Adjuvant Therapy for High-Risk Melanoma Patients

... use following induction chemotherapy in older adults (greater than or equal to 55 years) with acute myelogenous leukemia (AML) to shorten the time to neutrophil recovery and reduce the incidence of severe and life-threatening infections and infections resulting in death. Leukine also has been approved in the ...

CellCept(R) and a Reduced Level of CNI Shows Trend Towards Preservation of Kidney Function Versus a Standard-Dose CNI

... levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness. -- Severe neutropenia [absolute neutrophil count (ANC) cardiac, and up to 3.6% of hepatic transplant patients receiving CellCept 3 g daily. Patients receiving CellCept should be ...

Final Results of the CellCept(R) Spare the Nephron (STN) Study Show Maintenance Therapy is Associated with Improved Renal Function

... levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness. -- Severe neutropenia [absolute neutrophil count (ANC) 10cubed/microL] developed in up to 2.0% of renal, up to 2.8% of cardiac, and up to 3.6% of hepatic transplant patients receiving ...

Two DOXIL(R) Studies to be Presented at American Society of Clinical Oncology (ASCO) Annual Meeting

... at least prior to each dose of DOXIL -- In patients with multiple myeloma, hematologic toxicity (based on platelet count, absolute neutrophil count, hemoglobin level, or neutropenia with fever) may require dose reduction, delay in administration, or suspension of DOXIL ...

Schering-Plough To Initiate Phase III Studies With HCV Protease Inhibitor Boceprevir in Previously Untreated Hepatitis C Patients and Those Who Failed Prior Treatment

... or clinically significant adverse events have been reported at a frequency less than 1% with PEGINTRON or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of ...

Schering-Plough Highlights PEGINTRON(TM) and Boceprevir Hepatitis C Data Presentations at Digestive Disease Week (DDW) Annual Meeting

... or clinically significant adverse events have been reported at a frequency less than 1% with PEGINTRON or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of ...

AstraZeneca Submits sNDA for SEROQUEL XR(TM) for the Treatment of Generalized Anxiety Disorder - a First for the Atypical Antipsychotic Class of Medicines

... causative factors. Patients with neutropenia should be carefully monitored, and SEROQUEL XR should be discontinued in any patient if the absolute neutrophil count is less than 1000 per cubic millimeter. Warnings and Precautions also include the risk of orthostatic hypotension, cataracts, seizures, ...

New Data on SEROQUEL XR(TM) in Treatment of Both Major Depressive Disorder and Generalized Anxiety Disorder Presented at APA Annual Meeting

... causative factors. Patients with neutropenia should be carefully monitored, and SEROQUEL XR should be discontinued in any patient if the absolute neutrophil count is less than 1000/mm3. Warnings and Precautions also include the risk of orthostatic hypotension, cataracts, seizures, hyperlipidemia, and ...

Interim Results from Boceprevir Phase II Study in Genotype 1 Treatment-Naive Hepatitis C Patients Presented At EASL

... or clinically significant adverse events have been reported at a frequency less than 1% with PEGINTRON or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of ...

Final Results of Ideal Study Presented at Annual Meeting of the European Association for the Study of the Liver (EASL)

... or clinically significant adverse events have been reported at a frequency less than 1% with PEGINTRON or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of ...

Schering-Plough Highlights PEGINTRON(TM) and Boceprevir Data Presentations at European Association for the Study of the Liver (EASL) Annual Meeting

... or clinically significant adverse events have been reported at a frequency less than 1% with PEGINTRON or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of ...

Pegintron(TM) Plus Weight-Based Rebetol(R) Resulted in Higher SVR Than Flat Dosing; Low Relapse Rates in Patients With Chronic Hepatitis C

... or clinically significant adverse events have been reported at a frequency less than 1% with PEGINTRON or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of ...

Schering-Plough Reports Top-Line Results of the IDEAL Study

... or clinically significant adverse events have been reported at a frequency less than 1% with PEGINTRON or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of ...

Maxygen Announces Positive Progress in Phase IIa Clinical Trial of Novel PEG-GCSF

... infections. Worldwide sales of GCSF products were approximately $4 billion in 2006. About Neutropenia Neutropenia is a severe decrease in neutrophil cell counts in the blood. Neutropenia is a common side effect of chemotherapeutic treatments for many forms of cancer, including breast cancer, lung ...

Rigel's R788 Demonstrates Significant Improvement in Rheumatoid Arthritis in Phase 2 Clinical Study

... (GI) side effects. Dose reduction (to one half the assigned dose, by taking the drug once per day) was pre-specified in the protocol, contingent on neutrophil counts and/or liver function tests. Notably, a vast majority of the patients (19 out of 21) who had their dose reduced, successfully completed the ...

Twelve DOXIL(R) Clinical Studies to be Presented at American Society of Hematology Annual Meeting

... count), at least prior to each dose of DOXIL -- In patients with multiple myeloma, hematologic toxicity (based on platelet count, absolute neutrophil count, hemoglobin level, or neutropenia with fever) may require dose reduction, delay in administration, or suspension of DOXIL and/or ...

Schering-Plough Highlights PEGINTRON(TM) Clinical Data Presentations at the American Association for the Study of Liver Diseases (AASLD) 2007 Annual Meeting

... or clinically significant adverse events have been reported at a frequency less than 1% with PEGINTRON or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of ...

Initial Results of Phase II Study with HCV Protease Inhibitor Boceprevir in Treatment-Naive Hepatitis C Patients Show a High Rate of Early Virologic Response

... or clinically significant adverse events have been reported at a frequency less than 1% with PEGINTRON or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of ...

European Union's CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy

... or clinically significant adverse events have been reported at a frequency less than 1% with PEGINTRON or interferon alpha: Severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of ...

Dr. Gabriel Sosne to Present New TB4 Data at 2007 ARVO Meeting

... 9th to discuss TB4's ability to inhibit corneal neutrophil infiltration. neutrophil infiltration is a process closely associated with inflammation that, if ... substantial tissue and organ damage. According to Dr. Sosne, TB4 inhibits neutrophil infiltration by decreasing and/or suppressing the expression of several ...

IR BioSciences Announces Data Demonstrating Radilex Stimulation of Stem Cells Results in Hematopoietic Recovery Following Lethal Irradiation

... to enable survival of a number of Radilex-treated, but no untreated, animals. Blood cell quantitation showed trends in the surviving animals toward neutrophil replenishment as well. ImmuneRegen has since filed a provisional patent entitled "Method to Treat Blood Cell Depletion" to provide intellectual ...

Biosite Reports on Presentation of Preliminary Data From Sepsis Program

... second quarter of 2007 to validate the clinical utility of this panel and compile data needed for an FDA submission." The biomarkers on the panel, neutrophil gelatinase-associated lipocalin (NGAL), c-reactive protein (CRP), and macrophage inflammatory protein-3 (MIP-3), were selected from 150 ...

Schering-Plough Addresses Major Milestones and Challenges in Treatment of Patients With Chronic Hepatitis C

... clinically significant adverse events have been reported at a frequency less than 1 percent with PEGINTRON or interferon alpha: severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of ...

Schering-Plough Announces Hepatitis C Data Presentations at Digestive Disease Week (DDW) 2007 Annual Meeting

... clinically significant adverse events have been reported at a frequency less than 1 percent with PEGINTRON or interferon alpha: severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of ...

New Data for Cytogen's QUADRAMET Reported at Annual ASCO Meeting

... who received the combination regimen including patients who received the full FDA approved doses of each agent. Further, all patients' platelet and neutrophil counts recovered to protocol defined levels and times allowing for re-treatment after cycle one. At baseline, median Gleason Score was eight, median ...

Eloxatin (oxaliplatin injection)-Based Chemotherapy Sets New Treatment Benchmark in Patients With Metastatic Colorectal Cancer

... overall survival as well as time to progression. Those factors that were predictive of a worse outcome were: higher baseline performance status, neutrophil count, and alkaline phosphatase, as well as a greater number of disease sites. While being 70 years or older was associated with poorer survival, it ...