Clinical Trial News and Research

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Surgeons create novel matrix to control insulin dependent diabetes

Surgeons from Massachusetts General Hospital, Boston, are reporting on a whole new strategy for controlling insulin dependent diabetes without daily injections of insulin. The surgeons have bio-engineered a novel matrix that serves as a scaffold for seeding supportive stem cells as well as pancreatic islets (the cells that produce insulin in the pancreas).

7 Oct 2010

Ferring Pharmaceuticals announces publication of Phase 3 trials of LYSTEDA tablets for HMB

Ferring Pharmaceuticals Inc. today announced publication of one of its pivotal Phase 3 trials of LYSTEDA (tranexamic acid) tablets for cyclic heavy menstrual bleeding in the October issue of the peer-reviewed journal, Obstetrics & Gynecology. The six-month clinical trial demonstrated that LYSTEDA significantly reduced menstrual blood loss from baseline, and improved health-related quality-of-life parameters in women with cyclic HMB while maintaining safety and tolerability.

7 Oct 2010

New microtechnology approach may prevent pelvic autonomic nerve injury in rectal cancer surgical procedure

Surgeons in Germany have found that using microtechnology to elec-tronically stimulate and monitor pelvic autonomic nerves may help prevent problems after a surgical procedure for rectal cancer, such as bladder, urinary and fecal incontinence, and sexual function disorders, according to a study reported at the 2010 Annual Clinical Congress of the American College of Surgeons.

7 Oct 2010

Patients with muscular dystrophy mount immune response to dystophin protein prior to gene therapy: Study

A clinical trial designed to replace the genetic defect causing the most common form of muscular dystrophy has uncovered an unexpected aspect of the disease. The trial, based on therapy designed by scientists at the University of North Carolina at Chapel Hill School of Medicine, showed that some patients mount an immune response to the dystrophin protein even before they have received the gene therapy.

7 Oct 2010

BIOTRONIK's EchoCRT clinical trial design published in European Heart Journal

BIOTRONIK SE & Co. KG, a leading manufacturer of implantable cardiac devices and sponsor of clinical research to advance patient care and evidence-based medicine, announced the publication in the September 23, 2010 issue of the European Heart Journal of a peer-reviewed article that describes the rationale for the echocardiographic methods and dyssynchrony cutoff values selected for the EchoCRT study.

6 Oct 2010

Synergy reports positive results from plecanatide Phase IIa clinical trial for chronic constipation

Synergy Pharmaceuticals, Inc., a developer of new drugs to treat gastrointestinal disorders and diseases, announced today positive results in a Phase IIa clinical trial of plecanatide (SP-304) in patients with chronic constipation. Oral plecanatide given once daily, over 14 consecutive days, at doses of 0.3, 1.0, 3.0 and 9.0 mg gave improved bowel function in patients with chronic constipation.

6 Oct 2010

Adeona completes enrollment in Part 2 CopperProof-2 clinical study

Adeona Pharmaceuticals, Inc., announced completion of 100% enrollment in Part 2 of its clinical study, A Prospective, Randomized, Double Blind Trial of a Novel Oral Zinc Cysteine Preparation in Alzheimer's Disease (CopperProof-2).

6 Oct 2010

Innovacell invests 10 million Euros for clinical development

In a new round of financing, shareholders of Innsbruck's Innovacell Biotechnologie AG agreed on September 27th to make 4.3 million Euros worth of fresh capital available to the company. Financing of the current Phase IIb multi-centre study for urocell is thus totally secured," explained CEO Ekkehart Steinhuber.

6 Oct 2010

Hypertonic fluids do not improve outcomes or survival for severe traumatic brain injury: Study

Patients with a severe traumatic brain injury (and not in shock because of blood loss) who received out-of-hospital administration of hypertonic fluids (a solution with increased concentration of certain electrolytes and thought to help reduce intracranial pressure) as initial resuscitation did not experience better 6-month neurologic outcomes or survival compared to patients who received a normal saline solution, according to a study in the October 6 issue of JAMA.

6 Oct 2010

Focused Ultrasound Surgery Foundation hosts conference to discuss advancements in therapeutic medicine

The Focused Ultrasound Surgery Foundation is hosting the 2nd International Symposium on MR-guided Focused Ultrasound in Chantilly, Virginia from October 17-20. Leading researchers and clinicians from around the world will gather at the three-day scientific conference to present and discuss the latest advancements in one of the most revolutionary and promising areas of therapeutic medicine.

6 Oct 2010

Aegerion Pharmaceuticals’ MTP-I Phase III trial published in Atherosclerosis online supplement

ACR Image Metrix, a global imaging contract research organization (CRO) with expertise in imaging trial design, techniques and data extraction, is pleased to announce a Phase III trial, conducted for Aegerion Pharmaceuticals, Inc., was published as an abstract in the online supplement of Atherosclerosis and presented at the 78th European Atherosclerosis Society Congress, which took place June 20-23, 2010, in Hamburg, Germany.

6 Oct 2010

New Wipro Rapid Trials platform launched to accelerate drug development

Wipro Technologies, the global Consulting, System Integration and Outsourcing business of Wipro Limited, today announced the launch of Wipro Rapid Trials platform to accelerate drug development across the globe.

6 Oct 2010

Saneron receives grant to develop safety guidelines for transplanting HUBC cells in Alzheimer's disease

The National Institutes of Health has awarded a three-year, $2.6-million grant to the University of South Florida and Tampa-based biotechnology company Saneron-CCEL Therapeutics, Inc., to establish dosing and safety guidelines for transplanting human umbilical cord blood cells (HUBC) into animal models of Alzheimer's disease.

6 Oct 2010

Amino acid mixture increases survival in mice

When mice are given drinking water laced with a special concoction of amino acids, they live longer than your average mouse, according to a new report in the October issue of Cell Metabolism, a Cell Press publication. The key ingredients in the supplemental mixture are so-called branched-chain amino acids, which account for 3 of the 20 amino acids (specifically leucine, isoleucine, and valine) that are the building blocks of proteins.

6 Oct 2010

Lixte, NCI collaborate for clinical evaluation of LB-100 compound

Lixte Biotechnology Holdings announced today that the National Cancer Institute Experimental Therapeutics (NExT) Program Senior Advisory Committee (SAC), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), National Institutes of Health (NIH), signed a NExT Material Transfer Agreement formalizing a collaboration with Lixte Biotechnology Holdings, Inc. for clinical evaluation of LB-100, one of Lixte's lead anti-cancer compounds.

6 Oct 2010

Liquidia commences dosing in LIQ-001 Phase 1 trial for seasonal influenza

Liquidia Technologies, a privately held nanotechnology company developing particle-based vaccines and therapeutics, today announced the initiation of human dosing of its lead vaccine product candidate, LIQ-001, in a Phase 1 clinical trial. LIQ-001, the first in a pipeline of PRINT® vaccines, is being developed as a seasonal influenza vaccine for enhanced protection in the elderly and represents the company's migration from proof of concept to the clinical application of PRINT technology.

5 Oct 2010

DATATRAK receives consulting contract to provide clinical data management

DATATRAK International, Inc., a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced the award of a consulting contract with an existing global research-based biopharmaceutical client to provide clinical data management and trial design services.

5 Oct 2010

FDA grants orphan drug designation to hGH-CTP for treating growth hormone deficiency

PROLOR Biotech, Inc., a company developing next generation biobetter therapeutic proteins, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to hGH-CTP, PROLOR's longer-acting version of human growth hormone for the treatment of growth hormone deficiency.

5 Oct 2010

Supplemental brief dynamic therapy does not benefit patients with obsessive-compulsive disorder: Study

This study demonstrates that supplemental brief dynamic therapy in the treatment of patients with obsessive compulsive-disorder with concurrent major depressive disorder (who are receiving effective medication) has no significant clinical effect on both obsessive and depressive symptoms.

5 Oct 2010

RHUCIN clinical trial results published in JACI journal

Santarus, Inc., a specialty biopharmaceutical company, today announced the publication of an integrated analysis of two randomized placebo-controlled clinical trials with RHUCIN (recombinant human C1 inhibitor, or rhC1INH), in the October issue of the peer reviewed Journal of Allergy and Clinical Immunology (JACI).

5 Oct 2010

Clinical Trial News and Research

Surgeons create novel matrix to control insulin dependent diabetes

Ferring Pharmaceuticals announces publication of Phase 3 trials of LYSTEDA tablets for HMB

New microtechnology approach may prevent pelvic autonomic nerve injury in rectal cancer surgical procedure

Patients with muscular dystrophy mount immune response to dystophin protein prior to gene therapy: Study

BIOTRONIK's EchoCRT clinical trial design published in European Heart Journal

Synergy reports positive results from plecanatide Phase IIa clinical trial for chronic constipation

Adeona completes enrollment in Part 2 CopperProof-2 clinical study

Innovacell invests 10 million Euros for clinical development

Hypertonic fluids do not improve outcomes or survival for severe traumatic brain injury: Study

Focused Ultrasound Surgery Foundation hosts conference to discuss advancements in therapeutic medicine

Aegerion Pharmaceuticals’ MTP-I Phase III trial published in Atherosclerosis online supplement

New Wipro Rapid Trials platform launched to accelerate drug development

Saneron receives grant to develop safety guidelines for transplanting HUBC cells in Alzheimer's disease

Amino acid mixture increases survival in mice

Lixte, NCI collaborate for clinical evaluation of LB-100 compound

Liquidia commences dosing in LIQ-001 Phase 1 trial for seasonal influenza

DATATRAK receives consulting contract to provide clinical data management

FDA grants orphan drug designation to hGH-CTP for treating growth hormone deficiency

Supplemental brief dynamic therapy does not benefit patients with obsessive-compulsive disorder: Study

RHUCIN clinical trial results published in JACI journal

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