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Clinical trial to examine use of biomarkers to advance treatment of malignant gliomas launched

The Brain Tumor Unit at the Moores UCSD Cancer Center at the University of California, San Diego in La Jolla, is launching a clinical trial that will examine the use of biomarkers to advance the treatment of malignant gliomas, brain tumors that start in the brain or spinal cord tissue. Annually, about 17,000 Americans are diagnosed with gliomas, which are difficult to treat and often fatal.

16 Jun 2010

New cancer research centre launched in Edinburgh

Edinburgh today (Wednesday) becomes the next link in a unique chain of Cancer Research UK Centres that are being launched across the UK.

16 Jun 2010

Immunomedics initiates dosing in milatuzumab-doxorubicin conjugate Phase I/II trial for relapsed multiple myeloma

Immunomedics, Inc., a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced the dosing of the first patient in a Phase I/II clinical trial of the doxorubicin conjugate of milatuzumab for the treatment of patients with relapsed multiple myeloma.

16 Jun 2010

Biogen Idec initiates enrollment in Phase II BG-12 combination trial for relapsing-remitting multiple sclerosis

Biogen Idec today announced enrollment of the first patient in a multicenter Phase II clinical trial designed to evaluate its investigational oral therapy BG-12 (dimethyl fumarate) in combination with commonly used first-line treatments in patients with relapsing-remitting multiple sclerosis (RRMS).

15 Jun 2010

Anacor's AN3365 novel systemic antibiotic achieves proof of concept

Anacor Pharmaceuticals today announced that a Joint Research Committee, composed of both GlaxoSmithKline (GSK) and Anacor employees, has determined that AN3365, a novel systemic antibiotic derived from Anacor's boron chemistry platform, has achieved proof of concept as defined under the collaboration agreement between GSK and Anacor.

15 Jun 2010

Positive clinical trial results for Anacor Pharmaceuticals' AN2728 announced

Anacor Pharmaceuticals today announced positive clinical trial results for its lead phosphodiesterase-4 inhibitor, AN2728, a novel topical anti-inflammatory compound derived from Anacor's boron chemistry platform. These results were obtained from a multi-center, Phase 2b, randomized, double-blind, dose-ranging, bilateral trial comparing AN2728 ointment, 0.5% and 2.0%, applied once or twice daily, to vehicle in 145 patients with mild-to-moderate plaque-type psoriasis.

15 Jun 2010

BioClinica releases MCC Clinical Trial Performance Metrics reporting solution

BioClinica™, Inc.,, a global provider of clinical trial management services, is the first clinical technology provider to offer a reporting solution that incorporates the industry-standard performance metrics for clinical trials as defined by the Metrics Champion Consortium (MCC).

From Clario 15 Jun 2010

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

Clinical Trial News and Research

Clinical trial to examine use of biomarkers to advance treatment of malignant gliomas launched

New cancer research centre launched in Edinburgh

Immunomedics initiates dosing in milatuzumab-doxorubicin conjugate Phase I/II trial for relapsed multiple myeloma

Biogen Idec initiates enrollment in Phase II BG-12 combination trial for relapsing-remitting multiple sclerosis

Anacor's AN3365 novel systemic antibiotic achieves proof of concept

Positive clinical trial results for Anacor Pharmaceuticals' AN2728 announced

BioClinica releases MCC Clinical Trial Performance Metrics reporting solution

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

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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