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Objective in Medical Technology

R788 in TASKi3 Clinical Trial Does Not Meet Efficacy Endpoints in RA Patients Who Had Previously Failed Biologic Therapies - Results Incongruent

... trial failed to meet its efficacy endpoints. The objective components (CRP and ESR)* of these ACR scores did ... conference call details below). "Our objective with R788 in RA is to position the product after ... we are pleased to see excellent results in the objective measures and in the Synovitis and Osteitis MRI ...

ISTA Pharmaceuticals Announces Positive Results for Phase 2 Study of Low-Dose Bromfenac in Dry Eye Disease

... significance in the primary endpoint of the objective sign of conjunctival staining (Lissamine Green ... also achieved statistical significance on the objective sign of corneal staining (Fluorescein test) as ... of low-dose bromfenac compared to baseline on the objective signs of conjunctival staining (Lissamine Green ...

Peregrine Pharmaceuticals Highlights Promising Early Data From Its Three Phase II Bavituximab Cancer Trials

... - 71% objective Tumor Response in Combination with Docetaxel in Advanced Breast Cancer - - 65% objective Tumor Response in Combination with Carboplatin/Paclitaxel in Advanced Lung Cancer - - 64% objective Tumor Response in Combination with ...

Horizon Therapeutics' HZT-501 Significantly Reduces Incidence of NSAID-Induced Upper Gastrointestinal Ulcers in Patients With Mild-to-Moderate Pain

... Study, or REDUCE-1 and REDUCE-2. The primary objective of these studies was to evaluate the proportion ... and weeks 8, 16 and 24. The primary efficacy objective of REDUCE-1 was to evaluate HZT-501 in reducing ... at risk for NSAID-induced ulcers. The primary objective of REDUCE-2 was to evaluate HZT-501 in reducing ...

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

... vandetanib to chemotherapy significantly improved objective response rate, which is a measurement of tumor ... presented at this year's ASCO. While the primary objective of demonstrating a statistically significant ... OS: HR 1.01, 95.08% CI 0.89-1.16; P =0.830). objective response rate and symptom control were also ...

Ongoing Landmark ROADMAP Study Demonstrates Significant Improvement in Blood Pressure Control at One Year, According to Blinded Results

... of cardiovascular disease (CVD).(1) The secondary objective of the ROADMAP trial includes incidence of ... A qualitative parameter in the secondary objective was to measure cuff blood pressure (BP). ... agents that directly block the RAS. The secondary objective is to test the hypothesis that treatment with ...

Peregrine Pharmaceuticals Completes Patient Enrollment in its Phase II Trial of Bavituximab Plus Docetaxel in Breast Cancer Patients

... undergoing treatment and follow-up. The primary objective of the multi-center, open-label Phase II study is ... evaluable patients in this cohort demonstrated an objective tumor response according to RECIST criteria. ... but not limited to, the risk that the rate of objective tumor response for the expansion stage of this ...

Peregrine Pharmaceuticals Reports Positive Preliminary Data From Phase II Bavituximab Lung Cancer Trial

... with Carboplatin + Paclitaxel Achieved an objective Tumor Response - - Patient Dosing Initiated ... non-small cell lung cancer (NSCLC) achieved an objective tumor response according to RECIST criteria, ... "We are very pleased to see these additional objective tumor responses in this difficult-to-treat cancer ...

ISTA Pharmaceuticals Announces Positive Results for Phase IIb Study of Ecabet Sodium

... sodium achieved a strong positive trend in the objective sign of Tear Film Break-Up Time (TFBUT) and a positive trend in the objective sign of quantity of tears produced (Schirmer ... no trends seen in the placebo group for either objective sign. In addition, there were no trends seen in ...

Arzerra(TM) (ofatumumab) Demonstrates High Response Rates in Patients With Fludarabine Refractory Chronic Lymphocytic Leukemia (CLL)

... primary endpoint of the study was assessment of objective response.* The overall objective response rate seen in these patient groups ... The primary endpoint of the study is objective response over a 24 week period from start of ...

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

... (370 patients) for six months. The primary objective of the study was to determine whether ... idraparinux (i.e., bioequipotency). The secondary objective of the study was occurrence of clinically ... end of six months of therapy. A final objective included the reversal of the anticoagulant effect ...

Recent Study Demonstrated VYVANSE(R) (lisdexamfetamine dimesylate) CII Provided Improvements in Behavior, Inattention, and Math Test Scores from 1.5 Hours up to 13 Hours following Administration in Children with ADHD

... dose of VYVANSE the second week. The primary objective of this study was to assess the time of onset ... as measured by both subjective (SKAMP-D) and objective (PERMP) assessments from the first time point ... of math problems that provides an objective measure of performance based on the number of ...

Genmab Announces Upcoming Ofatumumab Studies

... then every 3 months for 5 years. The primary objective of the study is to evaluate the progression ... had disease progression following at least an objective response or stable disease during a 24 week ... infusions of 2000 mg of ofatumumab.The primary objective of this study is to estimate the proportion ...

Peregrine Pharmaceuticals Reports Positive Early Results in Phase II Study of Bavituximab in Breast Cancer

... of Evaluable Patients to Date Continue to Show objective Tumor Response or Stable ... With the Stage 1 primary endpoint of six or more objective tumor responses achieved, the design of the ... of eight weeks, half of the patients had achieved objective tumor responses. Equally encouraging is that with ...

Peregrine Pharmaceuticals Doses First Patient in Phase II Trial of Bavituximab in Patients With Non-Small Cell Lung Cancer

... non-small cell lung cancer (NSCLC). The primary objective of the study is to assess the overall response ... in our Phase Ib trial achieved an objective tumor response. We look forward to learning more ... positive signs of clinical activity, achieving objective response or disease stabilization in 50% of the ...

CuraGen Announces Expansion of CR011-vcMMAE Phase II Trial in Melanoma

... - RECIST-defined objective response supports expansion of Simon 2-Stage ... Phase II trial one patient has had a confirmed objective response, as measured by RECIST criteria. As part ... efficacy of CR011-vcMMAE. We believe that this objective response confirms the initial activity observed ...

Kosan's Lead Hsp90 Inhibitor, Tanespimycin, Shows High Level of Activity in Trastuzumab Resistant/Refractory HER2-Positive Breast Cancer in a Phase 2 Trial

... HER2, a key pathway in breast cancer. The objective of the Phase 2 trial is to determine the ... incidence of 67%. -- Patients with an objective response on the Injection product maintained their objective response after crossover to the ...

ADVENTRX Presents CoFactor Data at the 2008 Annual Meeting of the American Society of Clinical Oncology (ASCO)

... (Amex: ANX ) announced today that it presented objective response rate and available safety data from the ... plus 5-FU based on investigators' assessments. objective response rate was based on the number of ... tumor response using X-rays, CT and MRI scans. objective response rate is measured by combining the number ...

BioVex Reports Positive Phase II Clinical Trial Results of OncoVEX GM-CSF in Metastatic Melanoma at the 2008 American Society of Clinical Oncology Meeting

... a year. The trial was designed to measure overall objective response, which is defined as a complete ... and agreed with the FDA was to achieve two objective responses or stable disease >2 months. Phase II ... of residual tumors. The current rate of objective response stands at 28%. Other patients have shown ...

BioVex to Report Phase II Clinical Trial Results of OncoVEX GM-CSF in Metastatic Melanoma at the 2008 American Society of Clinical Oncology Meeting

... had stage IV disease. With respect to systemic objective overall responses; three complete responses (CR), ... reported. Two further patients had post treatment objective responses and four patients had durable stable disease. All objective responses were ongoing at between four and 23 ...

Peregrine Pharmaceuticals Completes Patient Enrollment in First Stage of Bavituximab Phase II Breast Cancer Trial

... in patients with advanced breast cancer. The main objective of the safety and efficacy study is to assess the ... cancer have been enrolled initially. The primary objective of the multi-center, open-label study is to ... positive signs of clinical activity, achieving objective response or disease stabilization in 50% of the ...

BioVex Agrees SPA With the FDA for a Pivotal Study With OncoVEX(GM-CSF) in Metastatic Melanoma and Announces Presentation of Phase II Results at ASCO

... The trial was designed to measure overall objective response, which is defined as a complete response ... a highly encouraging rate of durable objective response with multiple patients with metastatic ... the Phase II study results relating to durable objective response provide a sound basis on which to ...

Peregrine Pharmaceuticals Receives Approval to Conduct a Second Phase II Trial of Bavituximab in Patients With Advanced Breast Cancer

... General of India (DCGI). The primary objective of the multi-center clinical trial is to assess ... and these same chemotherapy agents achieved objective tumor responses," said Steven W. King, president ... signs of clinical activity, achieving objective response or disease stabilization in 50% of the ...

Avicena Announces Positive Phase II Data for a Combination Trial Involving AL-08 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

... group for a futility analysis. The primary objective of the trial was selection of a treatment based ... for a futility analysis. The primary objective was treatment selection based on which drug ... historical control group. The trial's secondary objective was evaluation of futility, which showed that ...

CuraGen and TopoTarget Announce Presentation of Belinostat Clinical Trial Results at AACR-NCI-EORTC International Conference

... of 16 patients by radiologic assessment. To date, objective response has been observed in 8 ... Tumors (EOC). Primary endpoints of the study were objective response. Secondary endpoints included ... were not evaluable. Six patients remain on study. objective responses to belinostat monotherapy were ...

R7128 Receives Fast Track Designation from the FDA for the Treatment of Chronic Hepatitis C Infection

... conducted in 46 healthy volunteers. The primary objective of Part 1 is to assess the safety, tolerability ... doses under fasting conditions. The secondary objective of Part 1 is to explore the effect of food on the ... previously failed interferon therapy. The primary objective of Part 2 is to assess the safety, tolerability ...

Facet Solutions' AFRS(TM) Demonstrates Biomechanical Advantages Over Dynamic Stabilization in Independent Testing

... compared to dynamic stabilization devices. The objective of the testing was to compare the range of ... and resulted in limited range of motion. The objective of the biomechanical testing was to determine if ... stated, "The AFRS(TM) was designed with the objective of overcoming the inherent weaknesses of spinal ...

Pharmasset Commences Dosing in 28-Day Combination Study of R7128 with Pegasys(R) plus Copegus(R) for Hepatitis C

... conducted in 46 healthy volunteers. The primary objective of Part 1 is to assess the safety, tolerability ... doses under fasting conditions. The secondary objective of Part 1 is to explore the effect of food on the ... previously failed interferon therapy. The primary objective of Part 2 is to assess the safety, tolerability ...

Pharmasset Presents R7128 Phase 1 Single Ascending Dose Study in Healthy Volunteers

... doses under fasting conditions. The secondary objective of this study was to explore the effect of food ... in 46 healthy volunteers. The primary objective of Part 1 is to assess the safety, ... doses under fasting conditions. The secondary objective of Part 1 is to explore the effect of food on ...

R7128 Demonstrates Safety and Potent Antiviral Activity in HCV-Infected Patients

... in 46 healthy volunteers. The primary objective of Part 1 is to assess the safety, ... doses under fasting conditions. The secondary objective of Part 1 is to explore the effect of food on ... failed interferon therapy. The primary objective of Part 2 is to assess the safety, ...

Pharmasset Reports Positive Preliminary Antiviral Data With PSI-7851 for the Treatment of Hepatitis C

... in 30 patients chronically infected with HCV genotype 1. The primary objective was to assess the safety, tolerability, and pharmacokinetics of PSI-7851 after once-daily (QD) dosing for 3 days. The secondary objective was to assess antiviral activity by measuring the change in HCV RNA. ...

CuraGen Updates CR011-vcMMAE Data at ASCO

... The study successfully met its primary activity endpoint, with 5 objective responses (1 unconfirmed) observed in 34 evaluable patients, and median ... week schedule. Although median duration of follow-up is only 6 weeks, objective responses have thus far been observed in 3 of 11 evaluable patients ...

Results and Additional Analyses From Study Show That Corthera's Relaxin for Acute Heart Failure is the Strongest Predictor of Improved Longer-Term Outcomes Following Hospital Discharge When Compared to Other Variables

... relaxin for the treatment of AHF. In the Phase II Pre-RELAX-AHF study, the objective was proof-of-concept and dose and endpoint selection. Patients selected ... normal or elevated blood pressure. In the Phase III RELAX-AHF study, the objective is to confirm safety and efficacy. The Pre-RELAX-AHF/RELAX-AHF study was ...

Schering-Plough Highlights Hepatitis C Clinical Data Presentations at the European Association for the Study of the Liver (EASL) Annual Meeting

... Slow Responders: Final Results of the SUCCESS Study(2) The primary objective of the SUCCESS study was to evaluate the effect of extending treatment ... a reduced peginterferon dose in G2/3 patients were unknown. The primary objective of the REDD 2/3 study was to evaluate the effect of reduced treatment ...

Pharmaxis Announces Milestone in Phase III Trial for Cystic Fibrosis

... with the assistance of the European regulatory agency (EMEA) and with the objective of seeking a marketing approval for Bronchitol for treating cystic ... analysis of the various endpoints have been completed. The first objective of the trial is to demonstrate an improvement in lung function. ...

Results From Study Show Promising Efficacy and Safety Results for Corthera's Relaxin in Acute Heart Failure

... for the treatment of AHF. In the Phase II Pre-RELAX-AHF study, the objective was proof-of-concept and dose and endpoint selection. Patients selected ... normal or elevated blood pressure. In the Phase III RELAX-AHF study, the objective is to confirm safety and efficacy. The Pre-RELAX-AHF / RELAX-AHF study ...

Amicus Therapeutics Suspends Enrollment for Phase 2 Clinical Trial of AT2220 for Pompe Disease

... with the FDA and if appropriate will amend the Phase 2 protocol with the objective of restarting the trial as expeditiously as possible. Amicus ... to enroll 18 adult patients diagnosed with Pompe disease. The primary objective of the study is to evaluate the safety and tolerability of different ...

Alseres Pharmaceuticals Completes Enrollment in First Stage of the Altropane(R) POET-2 Phase III Program

... or Essential Tremor (POET-2) Phase III clinical program. The objective of the first part of the program was to acquire the set of Altropane ... "Millions of people experiencing tremor symptoms currently have no objective means to determine whether or not they have Parkinson's Disease," Ray L. ...

Algeta Completes Comprehensive Phase II Clinical Program With Alpharadin for Treating Bone Metastases in Patients With Advanced Prostate Cancer

... by i.v. injection predominantly on an outpatient basis. The primary study objective was to investigate whether there was a dose-response relationship with ... possible combination trials with docetaxel. The primary efficacy objective was met and this showed a dose-dependent effect across the three dose ...

Novel Therapeutic Approaches May Transform Treatment and Improve Patient Outcomes in Several Platelet Disorders

... (rescue) treatment of rituximab plus dexamethasone. The primary objective of the study was to compare the sustained response (platelet counts ... patient had experienced signs of clinically relevant bleeding. The primary objective of the study was the reduction of platelet transfusions by 15 to 25 ...
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(Date:7/24/2014)... Scientists at The New York Stem Cell ... to creating a viable cell replacement therapy for ... , For the first time, NYSCF scientists generated ... samples of patients with primary progressive multiple sclerosis ... induce these stem cells into becoming oligodendrocytes, the ...
(Date:7/24/2014)... 24, 2014) Scientists at The New York ... step closer to creating a viable cell replacement ... cells. , For the first time, NYSCF ... from skin samples of patients with primary progressive ... protocol to induce these stem cells into becoming ...
(Date:7/24/2014)... identified two factors that characterize sustainable university and ... highly qualified physics teachers. Specifically, one or more ... education in combination with institutional motivation and commitment ... Technology, Engineering and Math (STEM) teacher shortages are ... the way for institutions seeking to increase the ...
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(Date:7/25/2014)... reported by Wood TV 8 in the article Michigan ... nearly 500-person increase in heroin related overdose deaths in the ... and 2002, the toll increased to 728 during the 2010-2012 ... users in Michigan have turned to heroin after getting hooked ... of both substances, noting that an 80-milligram pill can cost ...
(Date:7/25/2014)... July 25, 2014 As reported by People ... Life After Jersey Shore and Getting Sober (7/15), one ... Jersey Shore, has spoken out to the public about his ... the show, The Situation admits that moving on with his ... prescription drugs, and other drugs in 2012 and even spent ...
(Date:7/25/2014)... The Little Gym of Houston will attend ... 27 at Discovery Green in downtown Houston. The ... Friendswood, Spring, The Woodlands, Sugarland-Missouri City, Kingwood, Bellaire and ... thrilled to be attending and performing at the Family ... the Sugarland-Missouri City location. “We believe in the message ...
(Date:7/25/2014)... July 25, 2014 Merrill Corporation ... technology-enabled services for the financial, legal, healthcare and ... data room business, Merrill DataSite, has been recognized ... by GrowthBusiness at the M&A Awards 2014 event. ... achievements of entrepreneurs, management teams, advisors and financiers ...
(Date:7/25/2014)... (PRWEB) July 25, 2014 Art of Facial ... services to those in Toronto who are looking for minor ... study done by the American Academy of Facial Plastic ... 2014, interest in facial plastic surgery showed a surprising increase ... rose 10 percent, while hair transplants increased by 7 percent ...
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