Clinical Trial News and Research

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Alexion's Soliris may benefit patients with thrombotic microangiopathy from uncontrolled complement activation

Researchers reported today that Soliris® (eculizumab), a first-in-class terminal complement inhibitor developed by Alexion Pharmaceuticals, Inc., may provide clinical benefits to patients with thrombotic microangiopathy (TMA) resulting from uncontrolled complement activation. TMA, the formation of blood clots in capillaries and small arteries, can lead to life-threatening damage in multiple organs including kidney failure, thrombocytopenia (abnormally low platelet count) and anemia.

15 Jun 2010

EMA COMP grants orphan medicinal product designation for Raptor's DR Cysteamine for cystinosis

Raptor Pharmaceutical Corp., announced that the European Medicines Agency's ("EMA") Committee for Orphan Medicinal Products ("COMP") has issued a positive opinion recommending orphan medicinal product designation for DR Cysteamine for the potential treatment of cystinosis.

15 Jun 2010

Inovio commences immunization in U.S. Phase I clinical trial of SynCon H5N1 influenza DNA vaccine

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that it has immunized its first subject in a U.S. Phase I clinical trial to evaluate its SynCon™ H5N1 (avian) influenza DNA vaccine, VGX-3400X.

15 Jun 2010

Pieris commences PRS-050 anti-VEGF Anticalin Phase I clinical trial for cancer

Pieris AG announced today the initiation of a Phase I clinical trial in cancer patients for its lead program, PRS-050, an anti-VEGF Anticalin. The trial is an open-label, dose-escalating evaluation of the compound's safety and tolerability in patients with solid tumors. Conducted at three sites in Germany, the trial is underway and patients from the first cohort have been dosed.

15 Jun 2010

Project ideas needed from worldwide Alzheimer Disease research community

On the 9 June 2010, 119 participants from industry, academia, and related stakeholder communities in the U.S. and Europe joined Alzforum for a Webinar, "Treating Before Symptoms—ADCS Invites Ideas for Clinical Trials in Very Early AD," presented by Alzheimer's Disease Cooperative Study (ADCS) director Paul Aisen, MD.

15 Jun 2010

ACRO unveils survey findings on decline in physician participation in clinical research

Today, the Association of Clinical Research Organizations (ACRO) unveiled findings from a groundbreaking survey exploring the decline in physician participation in clinical research across the United States and Western European markets at the 46th Drug Information Association (DIA) annual meeting. Over the past decade, the number of physicians participating in clinical research has continued to decrease in the U.S. and countries in Western Europe while participation increased at double digit rates in Asia, Latin America and Central/Eastern Europe.

15 Jun 2010

First patient treated in multicentre Phase I clinical trial of SCIB1 DNA ImmunoBody vaccine for melanoma

Scancell Holdings Plc,, the developer of therapeutic cancer vaccines, today announces the enrolment and treatment of the first patient in its multicentre Phase I clinical trial of SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma. The trial will evaluate the safety and tolerability of SCIB1 in patients with late stage melanoma.

15 Jun 2010

Xoft reports clinical benefits of isotope-free electronic radiation therapy for treatment of cancer

The clinical benefits of isotope-free electronic radiation therapy delivered directly to cancer sites with minimal exposure to surrounding healthy tissue continues to be substantiated by multiple publications, according to Xoft, Inc., developer of the Axxent Electronic Brachytherapy, eBx System. The leading provider of FDA-cleared Electronic Brachytherapy Systems, Xoft provides systems for single-dose intraoperative radiation therapy and accelerated brachytherapy applications.

15 Jun 2010

Pediatric oncologist describes current state of science in combating neuroblastoma

Pediatric oncologist John M. Maris, M.D., describes the current state of the science in combating neuroblastoma, the most common solid cancer of early childhood. In his article in the June 10, 2010 New England Journal of Medicine, "Recent Advances in Neuroblastoma," Maris reviews the field's latest research knowledge—much of it based on efforts by Maris and his colleagues at The Children's Hospital of Philadelphia.

15 Jun 2010

FDA grants HeartWare approval for IDE destination therapy study of Ventricular Assist System

HeartWare International, Inc., a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted HeartWare conditional approval to begin enrollment in an Investigational Device Exemption (IDE) destination therapy clinical study for the HeartWare® Ventricular Assist System.

15 Jun 2010

ConvaTec presents Vitala Continence Control Device Phase 2 data at 2010 WOCN/WCET joint conference

ConvaTec, a world-leading developer of innovative medical technologies for community and hospital care, today presented data supporting the safety and efficacy of Vitala™, a novel, non-intrusive pouchless ostomy device that provides temporary continence to people with a colostomy. The clinical trial data were presented at the 2010 Joint Conference of the Wound, Ostomy and Continence Nurses Society (WOCN) and World Council of Enterostomal Therapists (WCET), where the new device is being previewed to U.S. and global healthcare professionals.

15 Jun 2010

MultiCell retains CDSS to manage MCT-125 Phase IIb clinical trial for PMSF in UK

MultiCell Technologies, Inc. has retained Clinical Development & Support Services, Ltd. (CDSS) of Cheshire, England to manage its planned Phase IIb clinical trial in the United Kingdom for MCT-125, the Company's lead drug candidate for treatment of primary multiple sclerosis-related fatigue (PMSF).

14 Jun 2010

Upsher-Smith commences global USL255 Phase III clinical trial for management of epilepsy

Upsher-Smith Laboratories, Inc. today announced the initiation of a global Phase III clinical trial for USL255 (extended-release topiramate), an internally developed program for the management of epilepsy in adults, using the company's proprietary formulation technology. USL255 is designed to provide convenient once-daily dosing and reduce fluctuations in topiramate blood levels observed with currently available topiramate options.

14 Jun 2010

Calistoga Pharmaceuticals presents CAL-101 PI3K inhibitor data at European Hematology Association Congress

Calistoga Pharmaceuticals, Inc., the leader in the development of isoform-selective phosphatidylinositol 3 kinase (PI3K) inhibitors for the treatment of cancer and inflammatory diseases, today presented preclinical and clinical data on CAL-101, the Company's oral, delta selective PI3K inhibitor at the 15th Congress of the European Hematology Association in Barcelona, Spain.

14 Jun 2010

Medidata Solutions launches new RTSM solution for clinical research sponsors, sites

Medidata Solutions, a leading global provider of SaaS-based clinical development solutions, today introduced Medidata Balance™, a new randomization and trial supply management (RTSM) solution for clinical research sponsors and sites.

14 Jun 2010

Study evaluates correlation between EverOn system and detection of patient deterioration in hospitals

EarlySense, developer of the EverOn contact-free, patient supervision system for hospital and post acute care, announced today the results of a multicenter study conducted at several hospitals in the United States and Israel. The data were recently made public by Drs. Eyal Zimlichman, Martine Szyper-Kravitz, Howard Amital, and Yehuda Shoenfeld at the American Thoracic Society Conference in New Orleans in a presentation titled, Recognizing Specific Respiratory Patterns Preceding in Hospital Clinical Deterioration, a Multicenter Study.

14 Jun 2010

BioClinica eClinical Technology Suite and BIOP to be showcased at DIA Annual Meeting

BioClinica, Inc., a global provider of clinical trial management services, will exhibit at the 46th Drug Information Association Annual Meeting from June 13-17, 2010 in Washington, D.C., where it will showcase the BioClinica eClinical Technology Suite as well as introduce the BioClinica Integrated Operations Platform.

From Clario 14 Jun 2010

Endosense awards DATATRAK first two EFFICAS studies

DATATRAK International, Inc., a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced that medical technology company Endosense has awarded DATATRAK the first two studies in the EFFICAS study series. The EFFICAS studies are intended to demonstrate that the use of contact force control during cardiac ablation utilizing Endosense's TactiCath® force-sensing catheter results in superior outcomes as compared to ablations performed without a force sensor.

14 Jun 2010

Medidata Solutions introduces Grants Manager 3.0 to select correct procedure for budgeting in trial

Medidata Solutions, a leading global provider of SaaS-based clinical development solutions, today introduced Medidata Grants Manager 3.0, the newest version of its trial budgeting application in use today by many of the innovative clinical research sponsors in the life sciences industry. Now offered as a web-based solution, Grants Manager 3.0 enables users to build clinical trial grant budgets and benchmark them against Medidata's unique PICAS database of negotiated trial costs without the need to install software.

14 Jun 2010

CAMD releases first combined clinical trial data on neuro-degenerative diseases

A new database of more than 4,000 Alzheimer's disease patients who have participated in 11 industry-sponsored clinical trials will be released today by the Coalition Against Major Diseases (CAMD). This is the first database of combined clinical trials to be openly shared by pharmaceutical companies and made available to qualified researchers around the world.

14 Jun 2010

Clinical Trial News and Research

Alexion's Soliris may benefit patients with thrombotic microangiopathy from uncontrolled complement activation

EMA COMP grants orphan medicinal product designation for Raptor's DR Cysteamine for cystinosis

Inovio commences immunization in U.S. Phase I clinical trial of SynCon H5N1 influenza DNA vaccine

Pieris commences PRS-050 anti-VEGF Anticalin Phase I clinical trial for cancer

Project ideas needed from worldwide Alzheimer Disease research community

ACRO unveils survey findings on decline in physician participation in clinical research

First patient treated in multicentre Phase I clinical trial of SCIB1 DNA ImmunoBody vaccine for melanoma

Xoft reports clinical benefits of isotope-free electronic radiation therapy for treatment of cancer

Pediatric oncologist describes current state of science in combating neuroblastoma

FDA grants HeartWare approval for IDE destination therapy study of Ventricular Assist System

ConvaTec presents Vitala Continence Control Device Phase 2 data at 2010 WOCN/WCET joint conference

MultiCell retains CDSS to manage MCT-125 Phase IIb clinical trial for PMSF in UK

Upsher-Smith commences global USL255 Phase III clinical trial for management of epilepsy

Calistoga Pharmaceuticals presents CAL-101 PI3K inhibitor data at European Hematology Association Congress

Medidata Solutions launches new RTSM solution for clinical research sponsors, sites

Study evaluates correlation between EverOn system and detection of patient deterioration in hospitals

BioClinica eClinical Technology Suite and BIOP to be showcased at DIA Annual Meeting

Endosense awards DATATRAK first two EFFICAS studies

Medidata Solutions introduces Grants Manager 3.0 to select correct procedure for budgeting in trial

CAMD releases first combined clinical trial data on neuro-degenerative diseases

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