Idenix Pharmaceuticals Successfully Completes Proof-of-Concept Study of IDX184 for the Treatment of Hepatitis C Virus (HCV)
...s were observed in the three higher dose cohorts (50, 75 and 100 mg/day). Post-treatment viral load data suggest no evidence of drug accumulation. The table
below summarizes mean HCV RNA reductions observed in this study per cohort:
End of Treatment Mean Patients w...
Spherix Announces Positive Phase 2 Study Results
...naturally in small amounts in dairy products. It is a highly soluble white crystal or powder, can be produced with a physical bulk similar to ordinary table
sugar, and is 92% as sweet. In the U.S., based on over 10 years of animal, human, and other relevant use and safety data, Naturlose was determined to ...
Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily
.... Registration Trial Number: NCT00125918. Page 31, table
(6)Galie, N., et al. "Tadalafil therapy for p.... Registration Trial Number: NCT00125918. Page 31, table
(9)Galie, N., et al. "Tadalafil therapy for p.... Registration Trial Number: NCT00125918. Page 32, table
(10)Galie, N., et al. "Tadalafil therapy for ...
Pixantrone Produces High Rates of Complete and Partial Remissions Even Among Aggressive NHL Patients With Extensive Prior Doxorubicin Treatment or Prior Rituximab Treatment
...rt failure (CHF). The total cumulative doxorubicin equivalent exposure per treatment cycle for all 68 patients treated with pixantrone is noted in the table
Treatment Cycle No. of Patients Pixantrone Lifetime
Horizon Therapeutics' HZT-501 Significantly Reduces Incidence of NSAID-Induced Upper Gastrointestinal Ulcers in Patients With Mild-to-Moderate Pain
...-week treatment period. The results for each study were analyzed using both life-table and crude-rate statistical methods. Results are listed in the table
REDUCE 1 (n=812) REDUCE 2 (n=570)
HZT-501 Ibuprofen P-value HZT-501 Ibuprofen P-...
Cytopia Concludes Phase I Oral Trial for Vascular-Disrupting Agent, CYT997
... trial report, including a complete list of adverse events and the recommended dose for Phase II studies, within three months.
The following table
provides a summary of the key aspects of this trial.
Name of Trial ...
Observational Study Finds Changes in Medicare Reimbursement for Erythropoiesis-Stimulating Agents Associated With Increased Need for Blood Transfusion
...sion or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers (see WARNINGS: table
To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red bloo...
42 Top U.S. Scientists and Specialists Explore Cutting-Edge Innovations to Defend America From Dangerous Zoonotic Diseases
...oonotic diseases, the FAZD Center announced today.
Among those innovations:
A "Doc in a Box" on every American kitchen table
that detects highly contagious and dangerous zoonotic diseases in people before symptoms appear.
Computer-generated "lab animals" that increas...
Data From Investigational Use of PROCRIT(R) (Epoetin alfa) Presented at American Society of Nephrology Annual Meeting
...currence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers (see WARNINGS: table
-- To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red bl...
Grapes May Aid a Bunch of Heart Risk Factors, U-M Animal Study Finds
... research needs to
The researchers studied the effect of regular table
grapes (a blend of
green, red, and black grapes) that were mixed into the r...en to reduce mild high blood pressure
without medication. The dose of whole table
grape powder that was consumed
in the study was roughly equivalent to a per...
Landmark COPD Trial UPLIFT(R) Shows SPIRIVA(R) HandiHaler(R) Sustained Lung Function Improvements Over Four Years
...ary health statistics for U.S.
adults: National Health Interview Survey, 2003. National Center for Health
Statistics. Vital Health Stat 10(225). 2005. table
Clinical Trial Shows Cardiovascular Benefits of Rooibos, Popular Antioxidant Herbal Tea from South Africa
...qual to about 7 ounces, slightly less than 1
cup), brewing for 5 minutes before consumption. Subjects consumed the
rooibos with or without milk and/or table
sugar, as previous research on
green and black teas (from the tea plant, Camellia sinensis) have
demonstrated that milk does not eliminate the increas...
Cytopia Commences Second Phase II Study in Brain Cancer
abnormal blood supply for growth, rendering them potentially susceptible to
destruction by an anti-vascular agent such as CYT997.
The following table
provides a summary of the key aspects of the Phase II
Name of trial A Phase Ib/II Study of CYT997 in Combination with ...
Amicus Therapeutics Announces Second Quarter 2008 Financial Results
... (617) 897-8294
Source: FOLD -G
1 Amicus Therapeutics, Inc....7,083,748 22,467,198 4,051,709 22,439,893
2 Amicus Therapeutics, Inc....467,198 22,467,198
3 Amicus Therapeutics, Inc....
CellCept(R) and a Reduced Level of CNI Shows Trend Towards Preservation of Kidney Function Versus a Standard-Dose CNI
... equal to 20% of patients in CellCept group in controlled studies in prevention of renal, cardiac or hepatic allograft rejection are listed in table
8 of the ADVERSE REACTIONS section of the complete Prescribing Information. About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N....
Final Results of the CellCept(R) Spare the Nephron (STN) Study Show Maintenance Therapy is Associated with Improved Renal Function
...led events that were reported in greater than or equal to studies in prevention of renal, cardiac or hepatic allograft rejection are listed in table
8 of the ADVERSE REACTIONS section of the complete Prescribing Information.
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J.,...
AstraZeneca Submits sNDA for NEXIUM(R) I.V. for Peptic Ulcer Bleed Indication
...of incidence and outcome of acute upper GI bleeding between 1993/1994 and 2000. American Journal of Gastroenterology 2003;98(7):1494-1499. table
5. (9) Mose et al. Thirty-day mortality after peptic ulcer bleeding in hospitalized patients receiving low-dose aspirin at time of admis...
New Pharma Business Model Increases Pressure on Staff Communicating Trial Data
...uster: Best Practices in
Communicating Clinical Trial Results."
Download the complimentary research summary of this benchmarking study
including the table
of contents, sample best practices and data charts at
The report presents the lessons learned and best pr...
TAP Pharmaceutical Products Inc. Announces Phase 3 TAK-390MR Data Demonstrating Higher Overall Healing Versus Lansoprazole in Patients with Erosive Esophagitis
...he results for each study were analyzed using life table
Results from these trial...rates for patients with EE. In one
study, the life table
analysis showed that 93 percent and 95 percent of
...zole 30 mg patients.
In a second study, the life table
analysis demonstrated that 92 percent
of both 60 m...
Phosphagenics Reports Positive Pre-clinical Results for Targeted Delivery of Lidocaine
...r topical application of TPM/Lidocaine, compared to
Xylocaine(R) alone (see table
In addition, TPM/Lidocaine was able to increase the depth of lidocain...2.23 0.59 +/- 0.10 77.46 +/- 38.38
Dr. Esra Ogru, Executive Vice President of Research and Development at
InterMune Provides Additional Information on ITMN-191 (R7227) MAD Study Results
...ished data describing other HCV protease inhibitors.
The additional information pertains to the Day 14 median reductions in HCV
RNA in this study (see table
Mean Maximum Reduction Day 14 Median ...
InterMune Announces Top-Line Results of Phase 1b Trial of ITMN-191 (R7227) and Provides Program Update
...titis C virus (HCV) genotype 1 infection. InterMune reported
that treatment with ITMN-191 resulted in rapid and significant reductions
in HCV RNA (see table
Total Daily Mean Maximum Reduction Cohort Dose Dose (mg) HCV RNA Log10 IU/mL (range) ...
Alexza's AZ-104 (Staccato(R) Loxapine) Phase 2a Trial Meets Primary Endpoint of 2-Hour Pain Relief in Patients with Migraine Headache
...rug-related side effects (incidence . 5% in at least one drug dose
group) reported across the three drug dose groups and placebo are listed in
Placebo 1.25 mg 2.5 mg 5 mg Side Effects (%) (%) (%) ...
ORTHO EVRA(R) Prescribing Information Updated
risk for VTE of 0.9 (indicating no increase in risk) and 2.4 (indicating an
approximate doubling of risk). This information is presented in a table
the WARNINGS section and is available at http://www.fda.gov and http://www.orthoevra.com .
The results from all of these epidemiologic studies c...
US Oncology Research Network Presents Clinical Studies at San Antonio Breast Cancer Symposium
...indicated that 185 patients with a median age of
50 years (range, 24-84) were treated; 179 underwent definitive surgery.
Results are summarized in the table
Subset Number of Patients Percentage pCR Breast/A...
Rigel's R788 Demonstrates Significant Improvement in Rheumatoid Arthritis in Phase 2 Clinical Study
...of 21) who
had their dose reduced, successfully completed the clinical trial with
minimal safety issues.
The key safety results are shown in the table
Placebo 50mg 100mg 150mg po BID N=47 po BID N=46 po BID N=49 po BID...
Genasense Plus Chemotherapy Is Associated With Prolonged Survival in Patients With Relapsed/Refractory CLL Who Achieve Complete Remission
...a show that this superior survival benefit
for Genasense-treated patients extends to all patients who achieved CR/nPR.
These data are presented in the table
Survival Genasense/Flu/Cy Flu/Cy p-value
1 year 20 8 ...
Ardea Biosciences, Inc. Announces New Clinical Development Program Directed Toward the Treatment of Gout
...ghest plasma drug levels (400 mg
modified-release capsule twice daily), there was a 50.9% placebo-adjusted
reduction in SUA (p < 0.001). The following table
summarizes the results by
Effect of RDEA806 on Serum Uric Acid (SUA) Levels in Phase 1 MAD Study ...
Isis Reports New Data for Mipomersen in Routine High Cholesterol Patients and Provides Cumulative Safety Summary
efficacy profile," concluded Dr. Jonas. table
1: Mipomersen in Routine High Cholesterol Patients...ersus a pooled placebo from all cohorts (n=14)
2: Mipomersen Phase 1 and Phase 2 Summary of On-Tr... ALT reading *** ULN is defined to be 50 IU/L
3: Mipomersen Phase 1 and Phase 2 Summary of Entir...
Isis Reports Positive Results of Phase 2 Study of ISIS 301012 in Heterozygous FH Patients
... beyond the levels they
had already achieved on stable lipid-lowering therapies. ISIS 301012
treatment did not affect HDL-cholesterol (HDL-C) levels. table
1: ISIS 301012 in HeFH Patients on Maximally Tolerated
Lipid-Lowering Therapies, Summary of Results. Median % changes from baseline
at primary endpoi...
Beaumont Patients 1st to get Next Generation of Radiation Treatment
...to moment. Omnibeam(R)
also uses robotic technology to adjust the treatment table
on which a
patient lies to provide pinpoint accuracy of treatment. Adjusting the
radiation field and treatment table
means the radiation treatment is
precisely targeted to kill cancer cells, d...
Syndicom SpineConnect Web Platform Chosen for Applied Spine's Leg and Back Pain Clinical Trial of Its Stabilimax NZ(R) Dynamic Spine Stabilization System
...d learn from each others' experiences in a secure
online environment. "I love the technology, because it brings people from all over the
world to the table
to solve real-world problems in real time," said Richard
Guyer, M.D., co-founder and fellowship director of the Texas Back Institute
and a principal i...
Genasense(R) Data in Melanoma to be Presented in Opening Session at First Worldwide Melanoma Center Meeting of the European Association of Dermato-Oncology
... the upper limit of normal. Efficacy results in this group of
274 patients, which are the focus of the confirmatory AGENDA trial, are
displayed in the table
below. (The hazard ratios indicate that the addition
of Genasense to DTIC was associated with a 42% reduction in the risk of
disease progression and a...
Genta Initiates Phase 3 AGENDA Trial of Genasense(R) for Patients with Advanced Melanoma
... that patients in this
group achieved a significantly superior outcome (see table
below). "Genasense plus dacarbazine yielded superior results in a large
ra...4 patients (who are
the focus of the new AGENDA trial) are displayed in the table
hazard ratios indicate that the addition of Genasense to DTIC wa...
MacroGenics Begins Global Phase 2/3 Protege Study in Recent-onset Type 1 Diabetes Mellitus
...the use of teplizumab as an induction
therapy in pancreatic islet cell transplantation. Additional information regarding the studies is listed in the table
Teplizumab Clinical Trials
Study Brief Description Additional Information
Protege trial Global...
Amicus Therapeutics Announces Second Quarter 2007 Financial Results
...rences between U.S. GAAP EPS, net loss, research and
development and general and administrative and the corresponding non-GAAP
amounts are itemized in table
2, and are due to: -- Pre-tax share-based compensation expense under SFAS 123R of $1.0 million (or $0.14 per share), primarily related to employe...
Isis Pharmaceuticals Reports Positive Phase 2 Data for ISIS 301012
in Familial Hypercholesterolemia Patients Presented at ACC
...results from the study will
be presented in the future, as will data from the ongoing
double-blind, placebo-controlled heterozygous FH study.
1: ISIS 301012 in HoFH, Summary of Results
Lipid values are presented in mg/dL and % change from baseline.
Patient 1 ...
Study Presented at ACC Shows Treatment With ISIS 301012 Added to
Statins for Only 5 Weeks Results in 75% of Patients Achieving LDL-C
Levels Less Than 100 mg/dL and 50% of Patients Achieving LDL-C
Levels of Less Than 70 mg/dL
... 300 mg/week) than the 300 mg/week cohort.
1: ISIS 301012 Coadministered with Statins, Summa...nalysis was 30 days post last dose, Day 59
2: ISIS 301012 Coadministered with Statins, Absol...nalysis was 30 days post last dose, Day 59
3: ISIS 301012 Coadministered with Statins, Patie...
Intarcia Therapeutics Announces Final Results From a Phase 2 Study
of Injectable Omega Interferon plus Ribavirin for the Treatment of
Hepatitis C Genotype-1
...r 12 weeks of treatment, and SVR, defined as undetectable HCV
RNA 24 weeks after the end of 48 weeks of treatment. Response rates
are presented in the table
HCV RNA Results Omega IFN + RBV Omega IFN Alone
(LOQ= 50 IU/ml) N=67 N...
Flu Vaccine Used Last Winter Seems to Have Been Less Effective Than
Vaccines Used in Previous Years
...8% and 21%).
THOSE WHO HAD FLU SHOTS AND THOSE WHO G... 15
HOW MANY OF THOSE WHO GOT OR DID NOT HAV... 24
THE EXPERIENCES OF THOSE WHO BELIEV...