Schering-Plough Highlights PEGINTRON(TM) and Boceprevir Data Presentations at European Association for the Study of the Liver (EASL) Annual Meeting
... IIIb study.
Sulkowski, M. et al. Late-Breaker
parallel Session 16, Saturday, April 26,
4:45 p.m. Hall ... EPIC3 program. Poynard, T. et
al. Late-Breaker
parallel Session 16, Saturday, April 26, 4:00 p.m. Hall ... with boceprevir (SCH503034). Susser, S.
et al.
parallel Session 7, Friday April 25, 5:00 p.m., Hall 000.
...
Rigel Expects R788 Partnership After Phase 2b Clinical Trials Results
... double-blind, double-dummy, randomized, positive
and placebo controlled
parallel study of the effects of R788 on QT/QTc
intervals in healthy subjects ... 208 healthy
volunteers were divided into four dosage groups and given in a
parallel design
either placebo, a standard dose of 100mg bid of R788, a super dose ...
Rigel's R788 Phase 2a Results Published in Arthritis and Rheumatism
... placebo in a
multi- center, randomized, double blind, placebo controlled
parallel dose
study of RA patients who have failed to respond to methotrexate. ... placebo in a multi-center, randomized,
double blind, placebo controlled,
parallel dose study of R788 in patients
who have failed at least one marketed ...
Four Alzheimer's Clinical Trials Address a Variety of Treatment Targets - Amyloid, Tau, Synapse Formation
... colleagues conducted a 24-week, double-blind,
randomized, dose-ranging,
parallel design trial of MTC monotherapy in 321
people with Alzheimer's at 17 ... in mild Alzheimer's
disease: A randomized, controlled, double-blind,
parallel Group,
multi-centre, multi-country clinical trial." (Funder: Danone ...
AstraZeneca Submits an sNDA for SYMBICORT(R) for COPD Indication
... Stephen I., et al. A 12-Month Double-Blind, Double-Dummy, Randomized,
parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT(R) pMDI 2 x ... Donald P., et al. A 6-Month Double-Blind, Double-Dummy, Randomized,
parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT(R) pMDI 2 x ...
Project Zero Delay Accelerates Drug's Path to Clinical Trial
... delays while fully meeting regulatory requirements for scientific and human safety review."
The key to Zero Delay was performing most tasks in
parallel instead of sequentially, said lead author Razelle Kurzrock, M.D., professor and chair of M. D. Anderson's Department of Investigational Therapeutics. ...
R788 in TASKi3 Clinical Trial Does Not Meet Efficacy Endpoints in RA Patients Who Had Previously Failed Biologic Therapies - Results Incongruent
... --- --- ---
Trial Design
TASKi3 was a 3 month, multi-center, randomized, double blind, placebo controlled,
parallel dose clinical trial involving 219 RA patients in the U.S. who had failed to respond to at least one biologic treatment (such as TNF inhibitors). The ...
Analysis of Edoxaban Phase II Data Provides Insight Into Reduced Bleeding Events Seen in Once-Daily Dosing
... no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
(1) "Randomized,
parallel Group, Multicenter, Multinational Study Evaluating Safety of DU-176b Compared with Warfarin in Subjects with Non-Valvular Atrial Fibrillation," ...
Rigel's R788 Significantly Improves Rheumatoid Arthritis in Phase 2b Clinical Trial
... -4 -20 -16
Study Design
TASKi2 was a 6 month, multi-center, randomized, double blind, placebo controlled,
parallel dose clinical trial involving 457 RA patients in the U.S., Latin America and Europe who had failed to respond to methotrexate alone. The patients ...
Alfacell Provides Shareholder Update
... a series of animal studies on immune deficient mice to see what effect Onconase would have on human tumors grafted onto these mice. Tumorgrafts
parallel sensitivity and resistance in the clinic. The results showed Onconase has a documented synergistic effect in Cisplatin sensitive and resistant NSCLC. ...
Neurocrine Biosciences Presents Elagolix Data
... in which elagolix was evaluated over six weeks (42 days) in 60 healthy premenopausal women. The study was a double-blind, placebo-controlled study in
parallel groups in which 88% of the participants completed the treatment period. The purpose of this study was to evaluate the safety, tolerability, ...
New Study Showed Lantus(R) Plus One, Two or Three Shots of Apidra(R) Lowered Patients' Blood Sugar
... during the 69th Annual Scientific Sessions of the American Diabetes Association (ADA).
The study was a multicenter, randomized, open-label,
parallel group study in insulin naive patients. Lantus(R) was started for a 14-week run-in period, after which time patients not at goal (A1C<7%) at week ...
Encouraging First Data on New Targeted Treatment for Patients With Melanoma - the Deadliest Form of Skin Cancer
...
PLX4032 works in a highly innovative way by selectively inhibiting the cancer-causing BRAF mutation, and is being developed in
parallel with a companion diagnostic to identify mutation-positive patients. These data represent a significant development in the treatment of melanoma for ...
New Phase 3 Study of Tapentadol Immediate Release Tablets Published in Current Medical Research and Opinion Journal
... in an extended release formulation for chronic pain.
Study Design
This Phase 3, double-blind, randomized, active- and placebo-controlled,
parallel group, multi-center trial of 901 patients with moderate-to-severe pain following bunionectomy studied the safety and efficacy of tapentadol IR for ...
Oxford BioTherapeutics and GlaxoSmithKline Form Strategic Alliance to Develop Novel Cancer Therapeutic Antibodies
... metastatic and recurring forms of
cancer.
Under the alliance, GSK will develop novel antibody therapies against
selected OBT targets. In
parallel OBT will develop one of its own monoclonal
antibodies through to clinical proof of concept, at which point GSK will have
an exclusive option to ...
Essentialis Meets Primary Endpoint in Phase 2b Trial of DCCR for Treatment of Hypertriglyceridemia and is Granted Extensive Patent Coverage in the US
... for very high triglycerides and phase 2 protocols for statin combination therapy are currently being finalized with input from experts and the FDA in
parallel with partnering discussions.
About DCCR
DCCR, diazoxide choline controlled release, is an ATP-dependent potassium channel agonist with ...
Boston Scientific Welcomes Publication of HORIZONS AMI Trial Results in New England Journal of Medicine
... results from the HORIZONS AMI trial showed ischemia-driven TLR was reduced by 41 percent with DES compared to BMS (4.5% vs. 7.5%, p=0.002), with
parallel reduction in ischemia-driven target vessel revascularization (TVR) among patients treated with DES (5.8% vs. 8.7%, p=0.006). Angiographic follow-up ...
Phase 1 Trial of Whole-Parasite Malaria Vaccine to Begin
... School of Medicine's Center for Vaccine Development notes, "Development of Sanaria's vaccine candidate is based in part on the findings from
parallel studies conducted in the early 1970s by teams at the Center for Vaccine Development and the Naval Medical Research Center -- findings that were never ...
New Data for Abbott's TRILIPIX(R) (fenofibric acid) in Combination with Rosuvastatin Calcium Shows Improvement on Key Lipids for Cholesterol Management
... Design
The efficacy and safety of TRILIPIX in combination with rosuvastatin calcium was evaluated in a multicenter, randomized, double-blind,
parallel group, 12-week, Phase III study of 760 patients with mixed dyslipidemia. Patients included in the study had multiple lipid problems, with an LDL ...
Innocoll Announces Dosing of Last Patient in US Phase 3 Clinical Trial to Investigate GENTAMICIN SURGICAL IMPLANT for Prevention of Surgical Site Infections in Cardiac Surgery Patients
... President and CEO commented, "We are delighted to have completed patient enrolment in this phase 3 cardiac surgery trial, which we are running in
parallel with the second phase 3 trial in colorectal surgery. Previous meetings with FDA have indicated that no other clinical trials are necessary for NDA ...
TissueGene Announces Regulatory Allowance to Initiate Phase IIa Study of TG-C in South Korea for Osteoarthritis of the Knee
... Phase I clinical trials in the U.S. and continues to work closely with KLS in order to coordinate their regulatory efforts and efficiently conduct
parallel clinical trials for TG-C in both the U.S. and Korea.
The Phase IIa clinical trial is designed as a randomized, multi-center study in order to ...
Boston Scientific Begins Clinical Trial Enrollment for New Everolimus-Eluting Stent
... endpoint of the workhorse study is target lesion failure (TLF) at 12 months, with clinical follow-up scheduled out to five years.
Two additional
parallel studies will evaluate the PROMUS Element Stent in small vessels and long lesions. The small vessel study will examine lesions from 2.25 to 2.50 mm ...
Cardio3 BioSciences Raises EUR13.7 Million in Series B Fundraising and Grant Funding
... and Grifols, a
Spanish holding company specialising in the pharmaceutical hospital industry.
Other new investors were not disclosed.
In
parallel with this equity fund raising Cardio3 BioSciences has raised
a further EUR6.5 million in cash advances from the Walloon Region General
Directorate ...
Amicus Therapeutics Announces Positive Progress of Three Lead Clinical Programs and General Outlook for 2009
... Amicus and its partner Shire HGT plan additional discussions with the EMEA in the first half of 2009 to finalize the design of this study.
In
parallel with the Phase 3 regulatory discussions, 23 of the original 26 patients from the Phase 2 studies continue to be treated in a voluntary extension ...
Pulmo BioTech Inc. Announces Dual Listing on Frankfurt Borse
... system of the lungs, which will follow the successful completion of its Phase I trials. The company intends to carry out European Phase II trials in
parallel with similar trials in the USA and Canada. The resulting increased visibility in Europe will further raise the profile of the company.
About ...
Sosei Confirms the Safety of SD118 in Two Phase I Trials
... in membranes, cells or tissues. NeuroSolutions'
current clients include many established pharmaceutical and biotechnology
companies.
In
parallel to running its service business, the Company is also
exploiting its in-house technologies and expertise for its own internal R&D
and has a mature ...
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
... 2.4 percent for the placebo group. The infusion of avidin was well- tolerated with no allergic reactions observed.
Rando m i z e d,
parallel Group, Multicenter, Multinational Stu d y Evaluati ng Safety of D U -176b Compared With Warfarin in Subjects With Non-Valvular Atrial ...
Phase III Trial Results Show Elitek(R) (rasburicase) Significantly Reduced Plasma Uric Acid Levels versus Allopurinol in Adults with Hematologic Cancers at Risk for Tumor Lysis Syndrome
... a serious condition that can lead to renal failure if not controlled.
The primary objective of the multi-center, open-label, randomized,
parallel group comparative study was to compare the adequacy of control of PUA concentration and the safety profile in three treatment arms. Among the three ...
Enobia Initiates Infantile Enzyme Replacement Trial for Rare Bone Disease
... trial in adults. In addition, Enobia has regulatory approval to enroll several additional severely affected infants who meet study criteria in a
parallel study. There is no approved treatment for the disease. To date Winnipeg is the only approved study site for the infantile protocol.
The ...
Sosei and NeuroSolutions Present Further Data on NSL-043/SD118 at the Society for Neuroscience 38th Annual Meeting
... in membranes, cells or tissues. NeuroSolutions'
current clients include many established pharmaceutical and biotechnology
companies.
In
parallel to running its service business, the Company is also
exploiting its in-house technologies and expertise for its own internal R&D
and has a mature ...
NicOx Announces Favorable Blood Pressure Data for Naproxcinod in a Large ABPM Study
... Additional note on study design: The 111 study was a 12-week
pharmacodynamic ABPM trial (with 9 weeks of active treatment), with a
double-blind,
parallel group design, in which 118 OA patients with
controlled hypertension were enrolled at 30 clinical sites in the United
States. Eligible patients were ...
SYNTAX Data Show Comparable Safety for Complex Patients Treated with TAXUS(R) Express2(TM) Stents and Bypass Surgery
... methods (PCI or CABG). If
either the cardiologist or surgeon felt that PCI or CABG was the preferred
option, then patients were placed in one of two
parallel registries for PCI
or CABG.
The safety and effectiveness of the TAXUS Express2 Stent System has not
been established in patients with left main, ...
SCOLR Pharma Announces Completion of Patient Enrollment and Dosing for Pivotal Clinical Trial Evaluating Extended Release Ibuprofen
... Company enrolled and treated approximately 240 patients at a single
center in the United States. The randomized, placebo-controlled,
double-blind,
parallel group study was designed to evaluate the efficacy
and safety of multiple doses of ibuprofen 600mg ER in dental pain following
molar extraction. It is ...
Boston Scientific Completes Clinical Trial Enrollment for Third-Generation Drug-Eluting Stent
... study is
target lesion failure (TLF) at 12 months, and its secondary endpoint is
in-segment percent diameter stenosis at nine months.
A second
parallel study named the TAXUS PERSEUS Small Vessel study will
compare the TAXUS Element Stent to a historic control (TAXUS V de novo
bare-metal Express(R) ...
Orexigen(R) Therapeutics Presents Data on Its Proprietary Formulation of Naltrexone Sustained Release (SR) Used in Contrave(R)
... SR compared to naltrexone IR.
-- Preliminary evidence for improved tolerability with naltrexone SR
came from a trial utilizing a multiple dose,
parallel design in 60 healthy
volunteers randomized to either naltrexone SR 37.5mg / bupropion SR 270mg
or naltrexone IR 36mg / bupropion SR 270mg. Patients ...
Established Safety Profile of Spiriva Confirmed by 30 Rigorously Controlled Clinical Trials and the Landmark Trial UPLIFT
... to regulatory authorities worldwide this important
information, which is part of a very robust analysis of all our
double-blind, placebo-controlled,
parallel group trials with a duration of
at least 4 weeks. Our analysis, which includes data from the four-year
UPLIFT trial, supports the safety profile of ...
Baxter Initiates Phase III Trial for the Treatment of Alzheimer's Disease
... a potential treatment for
the disease.
The Phase III trial is a prospective, 18-month, randomized,
double-blind, placebo-controlled, two dose-arm,
parallel study in 360
subjects of both genders, ages 50 to 89 years old, with dementia of
mild-to-moderate severity. The study will determine whether ...
Queen's University Chooses Xceed's Ziplex(R) System for Translational Research
... translational research. Xceed
designed the Ziplex System with turnkey functionality and significant
advances in automation, array format, fluidics,
parallel sample processing,
and analytics to minimize complexity, user interaction, and variability
between users and sites.
About Xceed Molecular ( ...
Cerimon Pharmaceuticals Announces Positive Results from a Phase II Clinical Study of Its Diclofenac Sodium Patch for Acute Pain
... subjects treated with the diclofenac patch used fewer doses of
rescue medication (acetaminophen) as well.
The study was a randomized, double-blind,
parallel group,
placebo-controlled study, in which half of the subjects received the
topical diclofenac patch and the other half received a placebo ...
Volcano's VH(R) IVUS Technology Used in Imaging Study of GlaxoSmithKline's Novel Investigational Compound, Darapladib
... the Steering
Committee for IBIS-2.
IBIS-2 was a 52 week, 300 participant, international, multicenter,
randomized, double-blind, placebo-controlled,
parallel group trial of
darapladib in subjects with angiographically documented coronary heart
disease. The main objectives of the study were to determine the ...