Clinical Trial News and Research

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Hepatitis C vaccine succeeds in an early phase clinical trial

An early phase clinical trial of a hepatitis C vaccine has shown promising results, according to researchers at Oxford University. The virus causing Hepatitis C is a difficult one since it changes its appearance, making creation of a vaccine against it a challenge.

5 Jan 2012

Positive results from ProFibrix Phase II Fibrocaps clinical trial

ProFibrix B.V., a leader in the development of innovative products for hemostasis, today announced that its U.S. multicenter Phase II clinical trial with Fibrocaps in spinal, peripheral vascular and general surgery resulted in a highly statistically significant reduction in mean time to hemostasis (TTH) and incidence of hemostasis at 3, 5 and 10 minutes, as compared to active control.

5 Jan 2012

Investigational HSV vaccine shows promise against two genital herpes diseases

An investigational vaccine protected some women against infection from one of the two types of herpes simplex viruses that cause genital herpes, according to findings in the New England Journal of Medicine.

5 Jan 2012

Positive preliminary results from Alnylam's Phase I ALN-PCS trial on severe hypercholesterolemia

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today the achievement of positive preliminary results from its ongoing clinical trial of ALN-PCS, an RNAi therapeutic targeting PCSK9 for the treatment of severe hypercholesterolemia.

5 Jan 2012

Rilonacept appears safe and well-tolerated in patients with gout

A phase II clinical trial found that rilonacept, an inhibitor of the protein interleukin-1 (IL-1), significantly reduced acute gout flares that occur when initiating uric acid-lowering therapy. Results of the trial—the first placebo-controlled study investigating IL-1 targeted therapy in prevention of gout flares—show rilonacept to be generally well tolerated with no serious infections or treatment-related serious adverse events reported.

5 Jan 2012

Arrowhead receives FDA IND approval for Adipotide obesity drug

Arrowhead Research Corporation, a nanomedicine company with development programs in oncology and obesity, today announced that the Investigational New Drug Application (IND) for its first obesity drug candidate, Adipotide, was accepted by the U.S. Food and Drug Administration allowing the initiation of a clinical trial to test the safety of the compound.

5 Jan 2012

$Viamet commences VT-464 Phase 1/2 trial in castration-refractory prostate cancer$

Viamet commences VT-464 Phase 1/2 trial in castration-refractory prostate cancer

Viamet Pharmaceuticals, Inc., announced today that dosing has begun in a Phase 1/2 clinical trial of VT-464, an oral, potent and lyase-selective CYP17 inhibitor for the treatment of castration-refractory prostate cancer.

4 Jan 2012

Re-admission rates high among U.S. heart attack patients: Study

According to new research from U.S health experts, Americans who have a severe form of a heart attack are far more likely to be readmitted to the hospital than people from 16 other countries with the same kind of heart attack.

4 Jan 2012

Weight loss surgery cuts risk of heart attacks, strokes: Study

A new study shows that weight loss surgery clearly cuts the risk of heart attacks, strokes and death from cardiovascular disease. But the research also raises questions regarding which patients benefit the most from surgery.

4 Jan 2012

St. Jude Medical meets stopping rule in RESPECT clinical trial, closes patient enrollment

St. Jude Medical, Inc., a global medical device company, today announced that it has met a stopping rule in its RESPECT clinical trial - triggered by reaching the protocol-required number of primary events in the trial, defined as stroke and all-cause mortality - and is closing patient enrollment.

4 Jan 2012

One-third of NIH-funded trials remain unpublished 51 months after completion

In a study that investigates the challenges of disseminating clinical research findings in peer-reviewed biomedical journals, Yale School of Medicine researchers have found that fewer than half of a sample of trials primarily or partially funded by the National Institutes of Health (NIH) were published within 30 months of completing the clinical trial.

4 Jan 2012

Losartan may help prevent smoking-related COPD

Working with mice, scientists at Johns Hopkins have successfully used a commonly prescribed blood pressure medicine, losartan (Cozaar), to prevent almost all of the lung damage caused from two months of exposure to cigarette smoke. The treatment specifically targeted lung tissue breakdown, airway wall thickening, inflammation and lung over-expansion.

4 Jan 2012

UofL surgeons perform first transcatheter aortic-valve replacement at Jewish Hospital

Some individuals with severe aortic stenosis - also known as narrowing of the aortic valve in the heart - who are not well enough to undergo open heart surgery have a new treatment option thanks to a new procedure now available in Kentucky from University of Louisville physicians at Jewish Hospital.

4 Jan 2012

FDA issues PMA response letter to BioMimetic's Augment Bone Graft

BioMimetic Therapeutics, Inc. announced today that it received a comprehensive post-panel response letter from the FDA related to the Company's Pre-Market Approval (PMA) application for Augment Bone Graft for use as an alternative to autograft in hindfoot and ankle fusion procedures.

4 Jan 2012

Bionovo enters $5M securities purchase agreement with Socius

Bionovo, Inc., a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today announced that it has entered into a $5 million securities purchase agreement with Socius CG II, Ltd. ("Socius"), a Bermuda-based subsidiary of Socius Capital Group, LLC.

4 Jan 2012

BioLineRx commences BCM CE Mark registration trial for prevention of cardiac remodeling following AMI

BioLineRx, a biopharmaceutical development company, announced today the commencement of the PRESERVATION I clinical trial, a CE Mark registration trial of BCM (BL-1040), a novel medical device intended for the prevention of cardiac remodeling following an acute myocardial infarction (AMI).

4 Jan 2012

FDA approves Cyberonics re-designed AspireHC generator

Cyberonics, Inc. today announced that the United States Food and Drug Administration (FDA) has approved its re-designed AspireHC (High Capacity) generator, which was the subject of a voluntary product withdrawal in August 2011.

4 Jan 2012

Arena, Eisai collaborate in response to FDA's lorcaserin Complete Response Letter

Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that Arena has submitted its response to the Complete Response Letter (CRL) issued by the US Food and Drug Administration (FDA) following review of the lorcaserin New Drug Application (NDA).

4 Jan 2012

Astellas, AVEO announce results of tivozanib and sorafenib comparison trial on RCC

AVEO Pharmaceuticals, Inc. and Astellas Pharma Inc. today announced that tivozanib demonstrated superiority over sorafenib in the primary endpoint of progression-free survival (PFS) in TIVO-1, a global, randomized Phase 3 clinical trial evaluating the efficacy and safety of investigational drug tivozanib compared to sorafenib in 517 patients with advanced renal cell carcinoma.

3 Jan 2012

FDA approves Prevnar 13 pneumococcal conjugate vaccine for adults 50 and older

Prevnar 13, a pneumococcal 13-valent conjugate vaccine, was approved today by the U.S. Food and Drug Administration for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae.

31 Dec 2011

Clinical Trial News and Research

Hepatitis C vaccine succeeds in an early phase clinical trial

Positive results from ProFibrix Phase II Fibrocaps clinical trial

Investigational HSV vaccine shows promise against two genital herpes diseases

Positive preliminary results from Alnylam's Phase I ALN-PCS trial on severe hypercholesterolemia

Rilonacept appears safe and well-tolerated in patients with gout

Arrowhead receives FDA IND approval for Adipotide obesity drug

Viamet commences VT-464 Phase 1/2 trial in castration-refractory prostate cancer

Re-admission rates high among U.S. heart attack patients: Study

Weight loss surgery cuts risk of heart attacks, strokes: Study

St. Jude Medical meets stopping rule in RESPECT clinical trial, closes patient enrollment

One-third of NIH-funded trials remain unpublished 51 months after completion

Losartan may help prevent smoking-related COPD

UofL surgeons perform first transcatheter aortic-valve replacement at Jewish Hospital

FDA issues PMA response letter to BioMimetic's Augment Bone Graft

Bionovo enters $5M securities purchase agreement with Socius

BioLineRx commences BCM CE Mark registration trial for prevention of cardiac remodeling following AMI

FDA approves Cyberonics re-designed AspireHC generator

Arena, Eisai collaborate in response to FDA's lorcaserin Complete Response Letter

Astellas, AVEO announce results of tivozanib and sorafenib comparison trial on RCC

FDA approves Prevnar 13 pneumococcal conjugate vaccine for adults 50 and older

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