Clinical Trial News and Research

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FDA issues draft guidance on artificial pancreas system

The U.S. Food and Drug Administration today issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat type 1 diabetes.

2 Dec 2011

Two studies uncover limitations in screening for hepatocellular carcinoma

Two studies available in the December issue of Hepatology, a journal of the American Association for the Study of Liver Diseases, have uncovered limitations in screening for primary liver cancer, also known as hepatocellular carcinoma.

2 Dec 2011

Cheaper test as effective as a more sophisticated test in guiding anti-retroviral drug treatment

A cheaper laboratory test that helps guide anti-retroviral drug treatment for people with HIV/AIDS may be just as effective as a more sophisticated test, a group of international researchers has found - a discovery that could be particularly important in rural Africa.

2 Dec 2011

Idera receives FDA notification to proceed with IMO-3100 Phase 2 clinical trial for psoriasis

Idera Pharmaceuticals, Inc. today announced the receipt of verbal notification from the Food and Drug Administration that the company may proceed with a Phase 2 clinical trial of IMO-3100 in patients with psoriasis based on a trial protocol submitted by the company in October 2011.

2 Dec 2011

ADVENTRX, FDA discuss ANX-188 development plans for treatment of sickle cell crisis

ADVENTRX Pharmaceuticals, Inc. announced today that it met with the U.S. Food and Drug Administration (FDA) to review development plans for ANX-188 (purified poloxamer 188), the Company's first-in-class treatment for sickle cell patients experiencing vaso-occlusive crisis.

1 Dec 2011

Enrollment complete in Ceregene's CERE-120 Phase 2b trial for Parkinson's

Ceregene, Inc. reported today that it has completed enrollment in its Phase 2b trial of CERE-120, a gene therapy product expressing the neurturin (NRTN) gene for the treatment of Parkinson's disease.

1 Dec 2011

Cancer researchers create catalog of possible targets for new treatments

As cancer researchers continue to identify genetic mutations driving different cancer subtypes, they are also creating a catalog of possible targets for new treatments.

1 Dec 2011

Immune system stimulant used as suppressor to treat chronic graft-versus-host disease

In a study that seems to pivot on a paradox, scientists at Dana-Farber Cancer Institute have used an immune system stimulant as an immune system suppressor to treat a common, often debilitating side effect of donor stem cell transplantation in cancer patients. The effect, in some cases, was profound.

1 Dec 2011

Statens Serum Institut, Aeras initiate new candidate TB vaccine Phase I trial

Statens Serum Institut and Aeras today announce the initiation of the first Phase I clinical trial of a new candidate TB vaccine designed to protect people latently infected with TB from developing active TB disease.

1 Dec 2011

Onconova uses BioClinica EDC, data management services to support clinical trials

BioClinica, Inc., a global provider of clinical trial management solutions, today announced that Onconova Therapeutics, Inc. has extended agreements using BioClinica Express electronic data capture (EDC) and data management services to support their clinical trials world-wide.

From Clario 1 Dec 2011

New gene therapy approach safe for patients with muscular dystrophy

Researchers at the University of North Carolina at Chapel Hill have shown that it is safe to cut and paste together different viruses in an effort to create the ultimate vehicle for gene therapy. In a phase I clinical trial, the investigators found no side effects from using a "chimeric" virus to deliver replacement genes for an essential muscle protein in patients with muscular dystrophy.

1 Dec 2011

Idera regains global rights to IMO-2055 from Merck KGaA for treatment of cancer

Idera Pharmaceuticals, Inc. today announced that it has regained global rights to IMO-2055, an agonist of Toll-like Receptor (TLR) 9, as part of an agreed-upon termination of its oncology collaboration with Merck KGaA, Darmstadt, Germany.

1 Dec 2011

ACGME approves Cedars-Sinai's neurology residency training program

The Accreditation Council for Graduate Medical Education has approved a neurology residency training program at Cedars-Sinai Medical Center. Recruitment of the first group of three residents is under way through the 2012 "match," a process in which an independent organization pairs applicants with programs to meet the preferences of each.

30 Nov 2011

Global leaders plan next steps at Harvard on World AIDS Day

Thirty years, 30 million deaths and 60 million infections after HIV appeared, medical researchers now have the tools to halt the deadly epidemic. "We have the weapons to win the war against AIDS," says Richard Marlink, M.D., Executive Director of the AIDS Initiative at the Harvard School of Public Health. "It is time to take what we have learned to turn the epidemic around and end AIDS."

30 Nov 2011

BioLineRx reports third quarter net loss of NIS 7.9 million

BioLineRx Ltd., a biopharmaceutical development company, today reported its results for the third quarter ending September 30, 2011.

29 Nov 2011

Testing of vaginal gel for HIV prevention halted after interim results showed no difference from placebo

Researchers involved with a multi-armed clinical trial designed to evaluate different antiretroviral (ARV) interventions for HIV prevention on Friday announced the arm testing a vaginal gel had been stopped because it was not working, the New York Times reports.

29 Nov 2011

Critical breakthrough in development of treatment for Duchenne Muscular Dystrophy

Academics from Royal Holloway, University of London and a team lead by scientists at the UCL Institute of Child Health (ICH), have made an important breakthrough in the development of a treatment for Duchenne Muscular Dystrophy (DMD) which in the future could help the likes of the Lloyd family who were featured on last night's X-Factor show.

29 Nov 2011

VOICE continues testing daily use of ARV Truvada among women in sub-Saharan Africa

VOICE, an HIV prevention trial that has been evaluating two antiretroviral (ARV)-based approaches for preventing the sexual transmission of HIV in women - daily use of one of two different ARV tablets or of a vaginal gel - has stopped testing the gel.

29 Nov 2011

New compound circumvents drug-efflux pumps associated with Gram-positive bacteria

It's no wonder that medicine's effort to combat bacterial infections is often described as an arms race. When new drugs are developed to combat infections, the bacterial target invariably comes up with a deterrent.

29 Nov 2011

CINJ experts available to discuss cancer-related fatigue

Between 70 and 100 percent of cancer patients receiving treatment suffer from fatigue related to their condition, according to the American Cancer Society, and up to one-half of all survivors have reported fatigue lasting months or even years after treatment. Fatigue can be one of the most distressing side effects of cancer treatment and can sometimes be overlooked by patients, caregivers and doctors.

28 Nov 2011

Clinical Trial News and Research

FDA issues draft guidance on artificial pancreas system

Two studies uncover limitations in screening for hepatocellular carcinoma

Cheaper test as effective as a more sophisticated test in guiding anti-retroviral drug treatment

Idera receives FDA notification to proceed with IMO-3100 Phase 2 clinical trial for psoriasis

ADVENTRX, FDA discuss ANX-188 development plans for treatment of sickle cell crisis

Enrollment complete in Ceregene's CERE-120 Phase 2b trial for Parkinson's

Cancer researchers create catalog of possible targets for new treatments

Immune system stimulant used as suppressor to treat chronic graft-versus-host disease

Statens Serum Institut, Aeras initiate new candidate TB vaccine Phase I trial

Onconova uses BioClinica EDC, data management services to support clinical trials

New gene therapy approach safe for patients with muscular dystrophy

Idera regains global rights to IMO-2055 from Merck KGaA for treatment of cancer

ACGME approves Cedars-Sinai's neurology residency training program

Global leaders plan next steps at Harvard on World AIDS Day

BioLineRx reports third quarter net loss of NIS 7.9 million

Testing of vaginal gel for HIV prevention halted after interim results showed no difference from placebo

Critical breakthrough in development of treatment for Duchenne Muscular Dystrophy

VOICE continues testing daily use of ARV Truvada among women in sub-Saharan Africa

New compound circumvents drug-efflux pumps associated with Gram-positive bacteria

CINJ experts available to discuss cancer-related fatigue

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