Clinical Trial News and Research

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'Real world' guidelines may effectively prevent cardiovascular disease in women

Practical medical advice that works in the "real world" may more effectively prevent cardiovascular disease in women than recommendations based only on findings in clinical research settings, according to the 2011 update to the American Heart Association's cardiovascular disease prevention guidelines for women.

15 Feb 2011

Oncolytics' REOLYSIN/gemcitabine combination Phase 2 pancreatic cancer trial meets primary endpoint

Oncolytics Biotech Inc. today announced preliminary results from a U.S. Phase 2 clinical trial (REO 017) using intravenous administration of REOLYSIN® in combination with gemcitabine (Gemzar®) in patients with advanced pancreatic cancer. The trial is being conducted at the Cancer Therapy & Research Center at The University of Texas Health Science Center at San Antonio (CTRC).

15 Feb 2011

Study shows lower success rate of FDA drug approval from 2003 to 2010

Biotechnology Industry Organization Industry Analysis and BioMedTracker announced results of a study today that shows the overall success rate for drugs moving through clinical trials to FDA approval from late 2003 to the end of 2010 is near one in 10. Previous reports, taken from earlier years, showed the rate of drug approvals is one in five to one in six.

15 Feb 2011

Researchers to develop automation system for sedation control in hospital ICUs

Researchers at the Georgia Institute of Technology and the Northeast Georgia Medical Center are one step closer to their goal of automating the management of sedation in hospital intensive care units. They have developed control algorithms that use clinical data to accurately determine a patient's level of sedation and can notify medical staff if there is a change in the level.

14 Feb 2011

U-Systems completes pivotal study for automated breast ultrasound cancer screening

U-Systems, the leader in automated breast ultrasound today announced the completion of a pivotal ROC Reader Study for automated breast ultrasound cancer screening. Conducted by University of Chicago, an acclaimed pioneer in women's heath research, the multi-reader, multi-case (MRMC) ROC Reader Study was carried-out to evaluate the sensitivity of somo•v™ Automated Breast Ultrasound (ABUS) together with a screening mammogram in detecting breast cancer in women with dense breast tissue.

14 Feb 2011

Chimerix announces completion of $45 million Series F financing

Chimerix, Inc., a pharmaceutical company developing orally-available broad spectrum antiviral therapeutics, today announced the completion of a $45 million Series F financing. New Leaf Venture Partners led the round, with participation by new investors Pappas Ventures and Morningside Group, as well as existing investors Canaan Partners, Sanderling Ventures, Alta Partners, Asset Management Company and Frazier Healthcare Ventures.

14 Feb 2011

GW plays key role in NIH's Management of Myelomeningocele Study

Researchers at The George Washington University Medical Center played a key role in a National Institutes of Health (NIH) study of a surgical procedure to repair a common birth defect of the spine, which if undertaken while a baby is still in the uterus, greatly reduces the need to divert, or shunt, fluid away from the brain. The study was published online in the New England Journal of Medicine on February 9, 2011.

14 Feb 2011

PROLOR reports positive DSMB review of long-acting human growth hormone clinical trial

PROLOR Biotech, Inc., a company developing next generation biobetter therapeutic proteins, today reported that patient enrollment and dosing in the Phase II trial of its long-acting version of human growth hormone (hGH-CTP) are proceeding according to plan, with study completion targeted for mid-year 2011.

14 Feb 2011

Positive clinical data of AVEO's tivozanib featured at 2011 ASCO Genitourinary Cancers Symposium

AVEO Pharmaceuticals, Inc. today announced that previously reported positive clinical data evaluating tivozanib, its lead product candidate designed to optimally block the VEGF pathway by inhibiting all three VEGF receptors, in patients with renal cell carcinoma (RCC) will be featured in several poster presentations at the American Society of Clinical Oncology (ASCO) 2011 Genitourinary Cancers Symposium being held February 17-19, 2011 at the Orlando World Center Marriott in Orlando, Fla.

14 Feb 2011

Independent Safety Monitoring Board recommends Vical's Allovectin-7 Phase 3 trial to continue as per protocol

Vical Incorporated today announced that an independent Safety Monitoring Board (SMB) for the company's Phase 3 trial of Allovectin-7® in patients with metastatic melanoma has completed the trial's fifth scheduled safety analysis and recommended that the trial continue per the protocol.

14 Feb 2011

New clinical trial to test surgery specifically for Type 2 diabetes

A new clinical trial at NewYork-Presbyterian Hospital/Weill Cornell Medical Center is among the first to test surgery specifically for Type 2 diabetes. The aim of the study is to understand whether surgery can control diabetes, as well or even better than the best medical treatment available today. This is the first study of its kind open to patients who are overweight or mildly obese.

14 Feb 2011

The Lancet publishes CHAMPION trial results against heart failure

The CHAMPION clinical trial was published online today in The Lancet. CHAMPION demonstrated a 30% reduction in the primary efficacy endpoint of heart failure hospitalization rates at 6 months, and a 39% reduction in heart failure hospitalization rates at 15 months for heart failure patients whose treatment was guided by pulmonary artery pressures obtained through a miniature, wireless sensor, compared to control patients receiving standard heart failure treatment.

14 Feb 2011

U.S. FDA clears QMS Everolimus Immunoassay to prevent rejection in kidney transplants

The U.S. Food and Drug Administration today announced that it has cleared a test to help manage potential organ rejection in kidney transplant patients. The test, called QMS Everolimus Immunoassay, monitors the blood level of everolimus, a drug that helps prevent rejection in kidney transplants.

14 Feb 2011

FDA grants Inhibitex Fast Track Designation for INX-189 in treatment of chronic hepatitis C viral infection

Inhibitex, Inc. today reported that the U.S. Food and Drug Administration ("FDA") has designated the investigation of INX-08189, a potent guanosine nucleotide polymerase inhibitor for the treatment of chronic hepatitis C viral infection, as a Fast Track development program.

11 Feb 2011

New trial tests surgery for Type 2 diabetes

11 Feb 2011

Athersys' MultiStem cell therapy provides multiple benefits in preclinical models of ischemic stroke

Medical researchers from The University of Texas Health Science Center at Houston (UTHealth) presented new research results at the American Heart Association International Stroke Conference that demonstrated how MultiStem-, a novel stem cell therapy being developed by Athersys, Inc. provided multiple benefits when administered in preclinical models of ischemic stroke.

11 Feb 2011

Promedior initiates Phase 1b clinical study of PRM-151 in patients with IPF

Promedior, Inc., a clinical stage biotechnology company developing novel therapies to treat fibrotic and inflammatory diseases, announced today that it has initiated a Phase 1b clinical study of PRM-151 to explore the safety, tolerability, pharmacokinetics, and phamacodynamics of PRM-151 in the treatment of patients with idiopathic pulmonary fibrosis.

11 Feb 2011

Preladenant may offer new supplemental treatment for Parkinson's disease: Study

Preladenant, a non-dopaminergic medication, reduces off time in patients with Parkinson's disease receiving standard dopamine therapy, an international study led by the University of South Florida found.

11 Feb 2011

Neuralstem updates progress of ongoing clinical trial of spinal cord stem cells in treatment of ALS

Neuralstem, Inc. updated the progress of its ongoing Phase I human clinical trial of the company's spinal cord stem cells in the treatment of ALS (amyotrophic lateral sclerosis, or Lou Gehrig's disease) at Emory University in Atlanta, Georgia.

11 Feb 2011

New model of dementia care reduces emergency department visits, hospitalizations

An innovative model of dementia care developed by researchers at the Indiana University School of Medicine and the Regenstrief Institute significantly reduces emergency department visits and hospitalizations, and encourages use of medications that are not harmful to older brains. The result is improved health for older adults and their family caregivers and lower healthcare costs, according to a paper evaluating the model in real world use.

10 Feb 2011

Clinical Trial News and Research

'Real world' guidelines may effectively prevent cardiovascular disease in women

Oncolytics' REOLYSIN/gemcitabine combination Phase 2 pancreatic cancer trial meets primary endpoint

Study shows lower success rate of FDA drug approval from 2003 to 2010

Researchers to develop automation system for sedation control in hospital ICUs

U-Systems completes pivotal study for automated breast ultrasound cancer screening

Chimerix announces completion of $45 million Series F financing

GW plays key role in NIH's Management of Myelomeningocele Study

PROLOR reports positive DSMB review of long-acting human growth hormone clinical trial

Positive clinical data of AVEO's tivozanib featured at 2011 ASCO Genitourinary Cancers Symposium

Independent Safety Monitoring Board recommends Vical's Allovectin-7 Phase 3 trial to continue as per protocol

New clinical trial to test surgery specifically for Type 2 diabetes

The Lancet publishes CHAMPION trial results against heart failure

U.S. FDA clears QMS Everolimus Immunoassay to prevent rejection in kidney transplants

FDA grants Inhibitex Fast Track Designation for INX-189 in treatment of chronic hepatitis C viral infection

New trial tests surgery for Type 2 diabetes

Athersys' MultiStem cell therapy provides multiple benefits in preclinical models of ischemic stroke

Promedior initiates Phase 1b clinical study of PRM-151 in patients with IPF

Preladenant may offer new supplemental treatment for Parkinson's disease: Study

Neuralstem updates progress of ongoing clinical trial of spinal cord stem cells in treatment of ALS

New model of dementia care reduces emergency department visits, hospitalizations

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