Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patients Compared to Zometa(R)
...sion) compared with those receiving Zometa (hazard
ratio 0.84, 95 percent CI: 0.71-0.98), which is statisti... statistically superior compared to Zometa (hazard
ratio 0.90, 95 percent CI: 0.77-1.04) (secondary endpoin...event-driven study were randomized in a one-to-one
ratio to receive either 120 mg of denosumab subcutaneous...
Unlikely Treatment Identified by BrainCells Neurogenesis Platform Improved Clinical Outcomes in Patients Suffering From Depression
... the compound's neurogenic properties," said Jim Schoeneck, chief executive officer of BrainCells Inc. "The platform was able to identify the pathway,
ratio of drug and dosing that shaped the clinical trial protocol, directing the first rational approach to drug development in the area of psychiatry."
...
New Results From ARTEN Study of Nevirapine Plus Tenofovir and Emtricitabine (TDF/FTC) Versus Boosted Protease Inhibitor Regimen of Atazanavir/Ritonavir Plus TDF/FTC Revealed
...e from baseline in HDL levels was 9.7 mg/dL among nevirapine patients and 3.9 mg/dL among ATV/r patients (p<0.0001). The mean total cholesterol/HDL
ratio in patients receiving nevirapine decreased from baseline (-0.24) and increased in patients receiving ATV/r (+0.13) (p =0.0001). The mean triglyceride ...
Analysis of Edoxaban Phase II Data Provides Insight Into Reduced Bleeding Events Seen in Once-Daily Dosing
...istered once daily; 30mg/N=244 or 60mg/N=180 administered twice daily), or warfarin (N=250) dose-adjusted locally to a target International Normalized
ratio (INR) of 2.0-3.0 for 12 weeks. The INR was determined weekly for four weeks and every two weeks thereafter. Investigators, sponsors and study subjec...
Denosumab Demonstrates Superiority Over Zometa(R) in Pivotal Phase 3 Head-to-Head Trial in Breast Cancer Patients With Bone Metastases
...rgery to bone, or spinal cord compression) (hazard
ratio 0.82, 95 percent CI: 0.71, 0.95), and delaying the time to the first-and-subsequent SREs (hazard
ratio 0.77, 95 percent CI: 0.66, 0.89). Both results wer...olled in the study were randomized in a one-to-one
ratio to receive either 120 mg of denosumab subcutaneous...
Transave Receives $2.2 Million Cystic Fibrosis Foundation Award for Development of ARIKACE(TM)
...e formulated into small (0.3 micron), neutral liposomes that enable penetration of the biofilm and are highly efficient, with a very low lipid-to-drug
ratio (0.65). ARIKACE can be delivered through nebulization, which enables the small aerosol droplet size (1 to 5 microns) to facilitate more effective di...
Spherix Announces Positive Phase 2 Study Results
...reased serum LDL by an average -13 mg/dl by the end of the first month on therapy, while serum HDL was essentially unchanged (+0.9 mg/dl). The LDL:HDL
ratio was improved for two of the three dose groups by an average of 0.3.
"The results of this ongoing Phase 2 study are encouraging and reaffirm our b...
DOR BioPharma Receives EMEA Agreement on the Design of its Confirmatory Phase 3 Clinical Trial of orBec(R) in GI GVHD
...ients (29%) in the orBec(R) group and 28 patients (42%) in the placebo group died within one year of randomization (46% reduction in mortality, hazard
ratio 0.54, 95% CI: 0.30, 0.99, p=0.04, stratified log-rank test).
In the Phase 2 study, the primary endpoint was the clinically relevant determinati...
Merz Pharmaceuticals Announces Results of Clinical Trials with NT-201(Botulinum neurotoxin type A free from complexing proteins) at Annual Movement Disorders Society Meeting
...
In the randomized, active-controlled, double-blind studies in focal dystonia NT 201 and one other Botulinum toxin (BTXCo) have been used with a dose
ratio of 1:1. The results demonstrate equivalent efficacy between the NT 201 and BTXCo. Onset, waning, and duration of effect were comparable. These finding...
Studies Show AFRESA(R) Controls Post-Meal Sugar Levels With Less Weight Gain and Hypoglycemia Risk for Diabetes Patients
... statistically significant (p<0.0001). Finally, the AFRESA group had a statistically significant reduction in the incidence of mild/moderate (odds
ratio [OR] 0.474, confidence interval [CI] 0.271, 0.831; p=0.0091) and total hypoglycemia (OR 0.488; CI 0.278, 0.856; p=0.0124).
About Diabetes
Di...
Arena Pharmaceuticals Announces Lorcaserin Data Demonstrating Highly Significant Categorical and Absolute Weight Loss and Improvements in Secondary Endpoints Associated with Cardiovascular Risk
...lude any dose titration or run-in period. Patients were randomized in a 1:1
ratio to lorcaserin or placebo at baseline. At Week 52, 856 patients taking lorcaserin were re-randomized in a 2:1
ratio to continue lorcaserin or to switch to placebo, and 697 patients on placebo...
Medivation Announces Positive New Efficacy Data From Phase 1-2 Trial of MDV3100 in Advanced Prostate Cancer Patients
...ase 3 clinical trial of MDV3100 later this year. The primary endpoint of the trial will be overall survival.
"We believe that the benefit-risk
ratio for MDV3100 is highly favorable, and we are working diligently to initiate the Phase 3 clinical trial later this year," said David Hung, M.D., preside...
Pixantrone Produces High Rates of Complete and Partial Remissions Even Among Aggressive NHL Patients With Extensive Prior Doxorubicin Treatment or Prior Rituximab Treatment
...ration of remission compared with the four patients who achieved a CRu with standard chemotherapy (7 months vs. 3.5 months, p=0.03, HR=0.279; a hazard
ratio of less than one indicates a decreased risk of disease progression and a p-value of less than 0.05 indicates statistical significance).
An analys...
TNFerade(TM) Phase III Data Presented at ASCO
...so indicated a 25% reduction in the risk of death in the TNFerade plus standard-of-care (SOC) arm compared to the patients receiving SOC alone (Hazard
ratio = 0.75; 95% Confidence Interval [0.494 - 1.15]).
Dr. Mark Thornton, GenVec's Senior Vice President of Product Development commented on the poste...
Video: Phase III Study Data With Vandetanib (Zactima(TM)) in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Presented at American Society of Clinical Oncology
...patient lives without their cancer growing (hazard
ratio [HR] 0.79, 97.58% CI 0.70-0.90; P <0.001. Medi...statistical significance in the ZEAL study (hazard
ratio [HR] 0.86, 97.58% CI 0.69-1.06; P =0.108. Median ... efficacy to erlotinib for PFS and OS (PFS: hazard
ratio [HR] 0.98, 95.22% CI 0.87-1.10; P =0.721; OS: HR ...
New Phase 3 Study of Tapentadol Immediate Release Tablets Published in Current Medical Research and Opinion Journal
...ain following bunionectomy studied the safety and efficacy of tapentadol IR for postoperative analgesia. Patients were randomly assigned in a 4:4:4:1
ratio to receive tapentadol IR 50-mg, tapentadol IR 75-mg, oxycodone HCl IR 10-mg, or placebo every four to six hours over a 72-hour period following surger...
Lilly Advances Second Alzheimer's Disease Treatment Candidate Into Late-Stage Testing by Launching Two Global Trials
...cal trials are identical multicenter, randomized, double-blind, placebo-controlled trials. Patients enrolled in the trials will be randomized in a 1:1
ratio (500 patients in each trial arm) to receive intravenous infusions of either placebo or 400 mg of solanezumab once every four weeks. Patients who are t...
Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS)
...placebo.
While the studies were not powered to demonstrate an effect on overall survival, a pre-specified exploratory endpoint, the pooled hazard
ratio (pirfenidone: placebo) was 0.77 (p=0.326).
ADDITIONAL EXPLORATORY EFFICACY RESULTS REPORTED AT ATS
The ATS presentation highlighted new effi...
New Studies on Once-Daily Extended Release Pramipexole Presented at American Academy of Neurology Annual Meeting
...Mean pramipexole extended release dosage increased from 2.63 to 2.75mg/d (a
ratio of 1:1.05) and mean pramipexole immediate release dosage from 2.74 to 2.83mg/d (a
ratio of 1:1.03); these data support a 1:1 switch from pramipexole immediate rele...
Merz Pharmaceuticals Announces Results of Three Clinical Trials With NT-201 (Botulinum Neurotoxin Type A Free From Complexing Proteins) in Movement Disorder Patients
... 64.8 U in the NT-201 group. Pre-treated subjects were randomized in a 2:1
ratio to NT-201 or placebo. Subjects were followed-up for up to 20 weeks. The Ja...onia NT-201 and one other Botulinum toxin (BoNT) have been used with a dose
ratio of 1:1. The results demonstrate equivalent efficacy between the two produc...
Pharmasset Voluntarily Halts Clinical Studies with Clevudine in Hepatitis B Infected Patients
...ASH trials was low and the severity was mild, more severe reports from other trials and post marketing surveillance led us to believe the risk benefit
ratio for clevudine was insufficient to continue development. We would like to take this opportunity to thank patients and our investigators for their parti...
Cynosure Announces Presentation of Favorable Results from Post-Marketing Studies of Smartlipo MPX
... and three months post-treatment.
At one and three months, skin treated with Smartlipo MPX had a statistically significant higher skin shrinkage
ratio than skin treated with liposuction only, Dr. DiBernardo reported. Of the nine patients who were fully evaluated, eight, or 89%, had an average of 54% ...
Schering-Plough's Investigational Oral Thrombin Receptor Antagonist Meets Primary Endpoint in a Newly Published Study
...th coronary artery disease for whom PCI was planned, and randomized to one of three oral loading doses of TRA (10mg, 20mg or 40mg) or placebo in a 3:1
ratio of active drug to placebo. The loading doses were increased in a sequential fashion based on a blinded review by a Safety Review Committee. Those pa...
Freezing Kidney Cancer: Hot Treatment Should Be New Gold Standard for Destroying Small Tumors
...or freezing) is a very effective option for patients who cannot or do not want to have surgery," noted Georgiades. Cryoablation's efficacy rate -- the
ratio of how many patients' renal cell carcinoma was destroyed completely for localized tumors by size -- is 100 percent up to 4 centimeters (about 2 inches...
Compared to Standard Therapies, Pixantrone Decreases Time to Achieve Complete Remission by 47% in Relapsed Aggressive Non-Hodgkin's Lymphoma
...major response.
However, the overall progression free survival (PFS) was significantly longer
in the pixantrone arm (4.7 months vs. 2.6 months, hazard
ratio = 0.6; p =
0.0074, pixantrone vs. standard chemotherapy). Thirty-two percent (32%) of
pixantrone patients received all 6 cycles of therapy, with 84% r...
ViroPharma Announces Discontinuation of Maribavir Phase 3 Study in Liver Transplant Patients
...tive). Following transplantation, eligible subjects were randomized to receive maribavir 100mg BID or oral ganciclovir 1,000mg TID in a 1:1 allocation
ratio for up to 14 weeks. If CMV disease, defined as symptomatic CMV infection or CMV organ disease, occurred during the study drug administration period, s...
Cell Therapeutics and IDIS Announce Agreement for a European Named Patient/Compassionate Use Program for Pixantrone
...gnificant improvement in median progression-free survival, compared with other single-agent chemotherapeutic agents (4.7 months vs. 2.6 months, hazard
ratio = 0.6; p = 0.0074, pixantrone vs. standard chemotherapy) based on an intent to treat analysis. PFS, CR/CRu and ORR were determined by an independent ...
CVS Caremark Study Finds Non-Adherent Heart Failure Patients Almost Twice as Likely to be Re-Hospitalized Within a Year
... hospitalization. Results found that 49.9 percent of patients studied were not optimally adherent to their medications and had a medication possession
ratio (MPR) of less than 0.80. Across all patients, 41% were re-hospitalized at least once within the 12-month follow-up period; however, the highest rate o...
The Leukemia & Lymphoma Society and Celator Pharmaceuticals Announce Partnership to Accelerate Development of CPX-351 for AML
... delivery vehicle in order to maintain the desired
ratio following administration. CPX-351 has been granted... to treat cancer. CombiPlex(R), the company's drug
ratio technology platform, represents a novel approach t...l deliver a synergistic benefit, locks the desired
ratio in a drug delivery vehicle that maintains the...
Study Finds DOXIL(R) Combination Therapy Delays Disease Progression for Patients With Metastatic Breast Cancer
...nts treated with the DOXIL and docetaxel
combination had a 35% risk reduction for developing disease progression
compared with docetaxel alone (hazard
ratio = 0.65; 95% confidence interval
[0.55, 0.77]; p=0.000001). There is an almost three-month improvement in
median TTP for patients treated with the comb...
Vical Pandemic Influenza Vaccines Achieve T-Cell Responses and Cross-Clade Reactivity in Humans
...fluenza virus. A dose response was apparent, as mice vaccinated with decreasing doses below a threshold level were afforded decreasing protection. The
ratio of Vaxfectin(R) adjuvant to DNA in the vaccine also affected the protective efficacy of the vaccine. In separate tests, the use of alternative PCR pri...
Continued Overall Survival Advantage Reported From Pivotal Trial of VELCADE(R) (Bortezomib) for Injection Based Therapy in Patients With Previously Untreated Multiple Myeloma
...d by Professor San-Miguel, included:
Thirty-six percent reduced risk of death in the VcMP arm, compared with the MP arm (hazard
ratio =0.644, p=0.0032; median survival not yet reached in either arm).
This OS advantage was maintained despite 43 percent of MP patients receiving...
Video: Tasigna(R) Demonstrates Rapid Response as Initial Therapy in Life-Threatening Form of Leukemia
...trial. After six months of treatment, 96% of patients had achieved CCyR(2).
In addition, 74% of patients achieved MMR, defined as Bcr-Abl/Abl
ratio < 0.1%. The percentage of patients achieving this level of response rapidly increased after one month of treatment. Adverse reactions were manageab...
Research Highlights New Approaches to Prevent Blood Clots in Several High-Risk Patient Populations Including Largest Study Ever to Examine Use of Blood-Thinning Medication in Patients With Cancer
...medications and even certain foods. For that reason, patients receiving warfarin require regular blood testing to monitor the international normalized
ratio (INR) to ensure that an adequate yet safe dose of warfarin is given.
A total of 1,146 patients with atrial fibrillation were randomized to re...
New Phase II Data Show Safety of Once-Daily Oral Factor Xa Inhibitor, DU-176b, Comparable to Warfarin in Patients With Non-Valvular Atrial Fibrillation
...istered once daily; 30mg/N=244 or 60mg/N=180 administered
twice daily), or warfarin (N=250) dose-adjusted locally to a target
International Normalized
ratio (INR) of 2.0-3.0 for 12 weeks. The INR was
determined weekly for four weeks and every two weeks thereafter.
Investigators, sponsors and study subject...
GSK Reports PROMACTA(R) (eltrombopag) Significantly Increased Platelet Counts and Reduced Bleeding in Long-Term Study of Patients With Chronic ITP
...e eight times more likely to achieve an overall response of
increased platelet counts of 50,000 to 400,000/microliters than those taking
placebo (Odds
ratio = 8.2; 99 percent CI [3.59, 18.73]; p < 0.001). In
comparison to the placebo group, significantly fewer patients treated with
PROMACTA had any blee...
More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies
... gradual dose escalation, if the clinical benefit is expected to outweigh potential risks.
Intermittent proteinuria (urine protein/creatinine
ratio >0.6 mg/mg) occurred in 18.6% of Exjade-treated patients, compared to 7.2% of deferoxamine-treated patients in Study 1, and monthly monitoring is r...
Pharmacyclics Announces Completion of Phase 1 Clinical Trial of Factor VIIa Inhibitor PCI-27483
... safety and pharmacologic effect of
PCI-27483. A single administration of PCI-27483 resulted in a linear dose
response in the International Normalized
ratio (INR), a routine laboratory
test used to assess the level of anticoagulation (blood-thinning).
"Single doses of PCI-27483 reliably and quickly...
Celator(R) Pharmaceuticals Announces Enrollment of First Patient in Phase 2 Study with CPX-351
...tarabine and daunorubicin delivered in a 5:1 molar
ratio shown in preclinical studies to represent a synergistic
ratio for use in combination chemotherapy. CPX-351 repre...er (CPX-351) Containing a Synergistic, Fixed Molar
ratio of Cytarabine (Ara-C) and Daunorubicin (DNR) in Ad...
Young Women Diagnosed with Early-Stage Breast Cancer More Likely to Die than Older Women
...ted into the analysis, women
under age 40 are 39 percent more likely to die from breast cancer than
older women. This breakdown was based on a hazards
ratio survival analysis,
which is the standard analysis for this type of study.
Dr. Margenthaler further explained that the tumors of women under 40
tende...