Trials in Medical Technology

Sanofi Pasteur Submits Supplemental Application for A(H1N1) Pandemic Vaccine to U.S. FDA

... A(H1N1) 2009 monovalent vaccine through clinical trials in the U.S., which began August 6. The planned clinical trials will consist of approximately 2,000 subjects and ... on the influenza A(H1N1) 2009 vaccine clinical trials is available at www.clinicaltrials.gov . ...

Isis Reports Strong Financial Results and Highlights for Second Quarter of 2009

... with type 2 diabetes Begin clinical trials on at least one additional drug in 2009; clinical trials already initiated on three drugs this year ... payment from Alnylam for initiation of clinical trials on ALN-VSP. Isis earned $1.4 million of ...

NOVAVAX Achieves Pandemic H1N1 Influenza Production Milestone

... VLP vaccine and is currently in Phase II trials with a VLP based seasonal flu vaccine candidate. ... progress of its preclinical studies and clinical trials and other research and development activities; ... if the data from preclinical studies or clinical trials is positive, the product may not prove to be safe ...

Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patients Compared to Zometa(R)

... infusion every four weeks. In clinical trials thus far to test new medications for bone ... down bone). With more than 19,000 patients in trials across indications worldwide, the denosumab ... been enrolled in the denosumab oncology clinical trials testing the drug for bone loss and destruction ...

Access Pharmaceuticals Provides Update on ProLindac Clinical Development Program

... Access believes that three ProLindac combination trials will start shortly upon regulatory approvals of ... leaders in Korea, and hope to get the combination trials started in Korea as soon as reasonably possible." ... the clinical data from all three planned clinical trials in the Far East to further development in North ...

European Division of Global Top 20 Pharmaceutical Company Awards Phase III Trial to DATATRAK

... on global eClinical solutions for the clinical trials industry, today announced that a European ... solutions and related services for the clinical trials industry. The Company delivers a complete ... supported hundreds of international clinical trials involving thousands of clinical research sites ...

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

... events were as expected from the earlier TASKi trials and appear to be manageable. Rigel will ... partner, the timing and success of clinical trials and the commercialization of product candidates, ... the risk that acceptable results in early trials may not be repeated in later trials, and Rigel's ...

Lupus Research Institute Highly Encouraged by Benlysta(TM) Trial Results

... BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in people with lupus. ... approach--huge international concurrent trials which represent a large investment in systemic ... assists in recruiting patients to participate in trials to bring safe and effective treatments to market ...

Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Erythematosus

... in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic ... multi-center Phase 3 superiority trials - BLISS-52 and BLISS-76 - to evaluate the ... North America and Europe. The design of the two trials is similar, but the duration of therapy in the ...

BioCryst Pharmaceuticals Reports Positive Results of Shionogi & Co. Sponsored Phase 3 Studies of i.v. Peramivir for Influenza

... drugs discovered in-house in late-stage clinical trials for influenza and lymphoma. In addition, the ... program; that ongoing peramivir clinical trials or our peramivir program in general may not be ... required number of subjects in planned clinical trials of our product candidates and that such ...

Velos, Inc. Releases Software to Support Cancer Centers With New Workflow and Content for NCI Clinical Trials Reporting Program

... the U.S. National Cancer Institute (NCI) Clinical trials Reporting Program, (CTRP). Velos has proactively ... studies to the NCI database. Changes to existing trials will also be posted and it is expected that by ... process to more effectively focus resources on trials judged most likely to facilitate advances in ...

Results From Drug Trials and New Risk Factors Announced at International Alzheimer's Conference

... from ICAD 2009 include: DHA Drug trials Results from two large studies using ... studies -- and other recent Alzheimer's therapy trials -- raise the possibility that treatments must be ... Recruiting Strategies for Alzheimer's Clinical trials Several studies at ICAD 2009 ...

Results From Trials of DHA in Alzheimer's Disease and Age-Related Cognitive Decline

... ) One of the trials was conducted by the Alzheimer's Disease ... studies - and other recent Alzheimer's therapy trials - raise the possibility that treatments for ... Alzheimer's and mild cognitive impairment therapy trials - concerns a possible interaction between certain ...

Denosumab Demonstrates Superiority Over Zometa(R) in Pivotal Phase 3 Head-to-Head Trial in Breast Cancer Patients With Bone Metastases

... weeks as per the labeled use. In clinical trials testing new medications for bone metastases, ... down bone). With more than 19,000 patients in trials across indications worldwide, the denosumab ... been enrolled in the denosumab oncology clinical trials testing the drug for bone loss and destruction ...

Why Do African-Americans Fare Worse With Cancer? Access and Economics Are Only Part of the Story

... Southwest Oncology Group's database of clinical trials finds, for the first time, that African-American ... The study analyzed records from 35 clinical trials - going back as far as 1974 - that had been ... similar way that people are treated on clinical trials that these differences are even detectable," he ...

Leading Experts Endorse Bioheart's Muscle Stem Cell MyoCell Therapy

... forward to complete the final phase of clinical trials (MARVEL) to advance muscle stem cell (myoblast) ... this is what's so exciting about the myoblast trials that Bioheart has proposed. We are very ... Rotterdam discussed the history of the Bioheart trials in Europe to date and added that "the myoblast ...

New Review on PROSTVAC(TM) Published by Key Investigators From NCI

... Quote from the article: "Preliminary clinical trials have indicated negligible toxicity, and Phase II trials have suggested a survival benefit after treatment ... BN ImmunoTherapeutics. In clinical trials to date PROSTVAC(TM) and related PSA ...

ThromboGenics' Microplasmin Phase III Program Progressing According to Schedule

... lead product microplasmin, which is in Phase III trials for the treatment of vitreomacular adhesion, is ... randomized, placebo controlled, double-masked trials which will evaluate 125micro g of microplasmin ... patients with focal vitreomacular adhesion. The trials will enrol a total of approximately 320 patients ...

GeoVax Labs, Inc. Announces Results of 2009 Annual Shareholders Meeting

... company currently conducting Phase 2a clinical trials for an AIDS vaccine in the U.S., excellent safety ... of plans to begin human therapeutic [treatment] trials in the U.S., stable corporate financial ... conduct a critically important Phase 2 AIDS Human trials in the U.S. and Peru. That Phase 2a trial is ...

Cytel Signs Cooperative Research And Development Agreement With FDA Center for Devices and Radiological Health (CDRH)

... Adaptive trials leader and CDRH regulators join to create ... to use innovative Bayesian designs for clinical trials involving device products. The Bayesian approach ... for designing and analyzing Bayesian clinical trials are not available in any validated, commercially ...

DIA Annual Meeting Attendees Invited to Participate in Electronic Data Capture (EDC) Clinical Trial Survey

... have invited site staff involved in clinical trials to participate in this global and ... in seven years to a report on EDC use in clinical trials published in July 2001. At that time, it was ... EDC. Within that group, 44 percent of clinical trials used EDC. The majority of patient data ...

Families of Spinal Muscular Atrophy Announces Latest Developments on Three SMA Drug Discovery Programs

... essential step in the path towards human clinical trials of the drug candidate." Motor Neuron ... (IND) application to the FDA to begin clinical trials in SMA Type I. It is the intent of CSC to gain approval to begin FDA-approved clinical trials for the use of these cells in development of a ...

VIA Pharmaceuticals Meets With FDA to Discuss Next Steps For VIA-2291 and Phase 3 Outcome Trial in Cardiovascular Disease

... data from the VIA-2291 Phase 2 CEA and ACS trials with the FDA and received guidance including ... our ability to successfully complete our clinical trials of VIA-2291 on expected timetables and the ... and implementing cardiovascular clinical trials using histological examinations, measurement of ...

FDA Advisory Committee Votes in Favor of Zyprexa for Two Adolescent Indications

... examined findings from two pivotal clinical trials of Zyprexa in adolescents with schizophrenia or ... weight at baseline. Although no clinical trials comparing adolescents to adults were conducted, data from the adolescent trials were compared to those from the adult trials. The ...

DOR BioPharma Receives EMEA Agreement on the Design of its Confirmatory Phase 3 Clinical Trial of orBec(R) in GI GVHD

... placebo-controlled Phase 2 and 3 clinical trials support orBec(R)'s ability to provide clinically ... and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, ... due to difficulties or delays in clinical trials or due to lack of progress or positive results ...

Meta-Analysis of Clinical Data Showed No Increased Risk of Cardiovascular Events Associated With Exenatide Use: Data Presented at ADA 2009

... of 12 completed, randomized, controlled clinical trials of 12-52 weeks, the unadjusted rate at which ... new data; safety and technical issues; clinical trials not confirming previous results; pre-clinical trials not predicting future results; label expansion ...

Merz Pharmaceuticals Announces Results of Clinical Trials with NT-201(Botulinum neurotoxin type A free from complexing proteins) at Annual Movement Disorders Society Meeting

... from two randomized, active-controlled clinical trials in patients with blepharospasm and cervical ... on the pooled data from 2 pivotal clinical trials in blepharospasm and cervical dystonia (343 NT ... patients). For the safety analyses, 6 clinical trials (blepharospasm, cervical dystonia, and upper limb ...

Boehringer Ingelheim Unveils Diabetes Pipeline

... being studied in five pivotal Phase III clinical trials including more than 4,000 patients. These trials are fully recruited and underway globally and in ... of glucose in the kidney.(4) Phase IIb clinical trials for this innovative approach to diabetes ...

Arena Pharmaceuticals Announces Lorcaserin Data Demonstrating Highly Significant Categorical and Absolute Weight Loss and Improvements in Secondary Endpoints Associated with Cardiovascular Risk

... and Obesity Management), the first of two pivotal trials evaluating the safety and efficacy of lorcaserin ... Management), the integrated data set from the two trials will be more than sufficiently large to meet this ... exclusion criteria for entry into these trials and there is no monitoring by an independent ...

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

... II trial in advanced lung cancer and two Phase II trials in advanced breast cancer. Recently-reported ... parameters. The Phase II bavituximab cancer trials have a Simon two-stage design, where an initial ... if pre-specified criteria are met. All three trials surpassed the criteria for expanding enrollment ...

CuraGen Updates CR011-vcMMAE Data at ASCO

... data presentations from its ongoing clinical trials of CR011-vcMMAE, an antibody-drug conjugate that ... effect. CR011-vcMMAE is currently in two Phase II trials assessing the safety and efficacy in the ... to advance CR011-vcMMAE through Phase II clinical trials for melanoma and metastatic breast cancer, to ...

Researchers Present Safety and Efficacy Results of 429 Patients Treated With Radiofrequency Ablation for Pre-Cancerous Barrett's Esophagus

... setting demonstrates comparable outcomes as trials conducted in predominantly tertiary academic ... clinical setting comport with those from reported trials conducted as predominantly academic tertiary ... for comparable results as seen in prospective trials from tertiary referral centers." About ...

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

... Week (DDW) meeting from two pivotal Phase 3 trials evaluating its lead compound HZT-501, which ... were two randomized, double-blind, controlled trials that enrolled more than 1500 patients with ... patients at risk for NSAID-induced ulcers. The trials were conducted via a Special Protocol Assessment ...

Shire Presented Results of a New Database Analysis on Lialda(R) (Mesalamine) and Other 5-ASAs for Ulcerative Colitis at Digestive Disease Week

... intolerance syndrome (3% of patients in clinical trials with mesalamine or sulfasalazine) that may be ... events in the double-blind, placebo-controlled trials were mild or moderate in severity. In clinical trials (N=535), the most common treatment-related ...

Neurobiological Technologies' Partner, Celtic Pharma, Announces Results of XERECEPT(R) Phase 3 Clinical Program

... NTI has not reviewed the data from the clinical trials or the preclinical studies and cannot ... risks relating to the results of the clinical trials for XERECEPT(R) and the ability of Celtic Pharma ... (ancrod), which was studied in Phase 3 clinical trials as a potential new drug to treat acute ischemic ...

Proteolix Presents Phase 1b/2 Clinical Data for Carfilzomib in Advanced Solid Tumor Patients at the 2009 ASCO Annual Meeting

... UCLA . Data from the Phase 1b/2 clinical trials of relapsed solid tumor patients were presented ... 65 patients in the Phase 1b and Phase 2 clinical trials have received 154.5 cycles of carfilzomib. ... treatment with bortezomib. Both Phase 2 clinical trials are being conducted by Proteolix in collaboration ...

Perceptive Informatics Enhances Investigator Application of New RECIST Version in Imaging-Based Oncology Trials

... trials." "Today, the majority of clinical trials evaluating cancer treatments for objective ... the National Cancer Institute of Canada Clinical trials Group. RECIST 1.1, published in January 2009, is ... consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. ...

Catalyst Pharmaceutical Partners Announces Top-Line Results of CPP-109 Phase II Trial for Cocaine Addiction

... given the positive results of three prior human trials and numerous animal studies; however, we are not ... appropriate path for conducting future clinical trials evaluating CPP-109 for the treatment of cocaine ... our ability to successfully complete the clinical trials required for us to file a new drug application ...

CuraGen to Present CR011-vcMMAE Data at ASCO

... data presentations from its ongoing clinical trials of CR011-vcMMAE, an antibody-drug conjugate that ... CR011-vcMMAE is currently in two Phase II trials assessing the safety and efficacy in the ... to advance CR011-vcMMAE through Phase II clinical trials for melanoma and metastatic breast cancer, to ...

PAREXEL Reaches Milestone in Management of Oncology Trials Over Last Five Years Involving 175,000 Patients Worldwide

... a milestone in managing oncology-based clinical trials over the last five years, which have involved ... To meet industry demand for conducting cancer trials across a broad range of indications, PAREXEL ... consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. ...