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Octapharma announces new study of IVIG in chronic inflammatory demyelinating polyradiculoneuropathy

Octapharma AG today announced the imminent start of the biggest ever study of an intravenous immunoglobulin preparation (IVIG) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

8 Sep 2010

Switching to nevirapine drug from PI based regimen reduces viremia in children: Study

HIV infected children in South Africa who were exposed to the drug nevirapine at birth (used to help prevent mother to child HIV transmission) and then received a protease inhibitor (PI) for viral suppression achieved lower rates of viremia (virus in the blood stream) if they were switched to nevirapine, compared to children who continued on the PI-based regimen, according to a study in the September 8 issue of JAMA.

8 Sep 2010

Penn receives $12M NIH grant to study pharmacogenetics of nicotine addiction treatment

A variety of smoking cessation treatments are currently available for the more than 18 million adult Americans try to quit smoking each year, but success rates vary widely. Despite the importance of quitting smoking, more personalized approaches to smoking cessation treatment are needed to help smokers pick the right method that will work best for them. A major new personalized medicine clinical trial, led by addiction researchers at the University of Pennsylvania, will study how a smokers' genetic make-up influences their quitting success.

8 Sep 2010

Quintiles new lab in Japan achieves CAP accreditation

Quintiles today announced that its new lab in Tokyo, Japan has received accreditation from the College of American Pathologists (CAP), joining the largest network of fully harmonized, CAP-accredited central labs in the world.

7 Sep 2010

Tikcro reports $3.2 million net loss for second-quarter 2010

Tikcro Technologies Ltd. today reported results for the second quarter and six months ended June 30, 2010.

7 Sep 2010

AtheroMed initiates enrollment in Phoenix Atherectomy catheter trial for PAD

AtheroMed, Inc. announced today the start of enrollment in the EASE study to evaluate the safety and effectiveness of the Phoenix Atherectomy™ catheter, a minimally invasive device for the treatment of peripheral arterial disease (PAD) in the legs. EASE - Endovascular Atherectomy Safety and Effectiveness - is an FDA-approved Investigational Device Exemption (IDE) clinical trial that will enroll 90 patients at up to 20 clinical sites.

7 Sep 2010

Rexahn submits Phase IIb protocol to FDA for study of Serdaxin for major depressive disorder

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced that it has submitted a Phase IIb protocol to the U.S. Food and Drug Administration (FDA) for the clinical study of Serdaxin for the treatment of major depressive disorder (MDD).

7 Sep 2010

CytRx commences PROACT Phase 2 clinical trial of bafetinib for advanced prostate cancer

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced initiation of the PROstate Advanced Cancer Treatment (PROACT) Phase 2 proof-of-concept clinical trial to evaluate the efficacy and safety of bafetinib in patients with advanced prostate cancer.

7 Sep 2010

Promedior initiates PRM-151 Phase 2a clinical study in prevention of scarring post glaucoma filtration surgery

Promedior, Inc., a clinical stage biotechnology company developing novel therapies to treat fibrotic and inflammatory diseases, announced today that it has initiated a Phase 2a clinical study of PRM-151 to evaluate the efficacy, safety, and tolerability of PRM-151 in preventing post-surgical scarring in glaucoma patients following glaucoma filtration surgery. There currently are no approved drugs for preventing post-surgical scarring in glaucoma, and there are no approved anti-fibrotic drug therapies in the U.S. or Europe for any fibrotic disease.

7 Sep 2010

Positive immune responses elicited from Scancell's DNA vaccine in combination with ImmuneRegen's Homspera

Scancell Holdings Plc, the developer of therapeutic cancer vaccines, announces that a treatment utilising a DNA vaccine based on its ImmunoBody® technology, in combination with ImmuneRegen BioSciences, Inc.®'s lead compound, Homspera®, has significantly improved the immune response of the vaccine in an animal model. Follow-up studies are currently being performed to optimize the effects of Homspera in enhancing the next generation of Scancell's cancer vaccines.

7 Sep 2010

Idenix Pharmaceuticals receives clinical hold order from FDA for IDX184, IDX320 programs

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the company received verbal notice on Friday, September 3, 2010 from the U.S. Food and Drug Administration (FDA) that the IDX184 and IDX320 programs have been placed on clinical hold.

7 Sep 2010

TenX Biopharma recommences enrollment in suspended Phase III trial for cutaneous T-cell lymphoma

TenX Biopharma, Inc. announced today that it has re-initiated enrollment in the pivotal Phase III clinical trial assessing zanolimumab treatment for cutaneous T-cell lymphoma (CTCL) patients (ClinicalTrials.gov identifier: NCT00127881). The trial enrollment was suspended in October 2008 while Genmab was seeking a out-license agreement to further develop the compound. TenX Biopharma acquired global rights to zanolimumab in February, 2010 from Genmab.

7 Sep 2010

GI Dynamics announces data on EndoBarrier therapy for type 2 diabetes, obesity

GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, today announced data with the EndoBarrier Gastrointestinal Liner at 12 months showing significant weight loss and cardiovascular and metabolic improvements in obese patients.

7 Sep 2010

An overview on low-carbohydrate diets

Headlines make news, but don't read too much into current headlines about a recent study titled "Low-Carbohydrate Diets and All-Cause and Cause-Specific Mortality," published in the September 7, 2010, issue of Annals of Internal Medicine. Although the headlines may say the study suggests that long-term adherence to a low-carb diet based heavily on animal protein may reduce lifespan, Dr. Funga, who was the lead author of the study, says that her research "is not representative of popular low-carb eating plans

7 Sep 2010

Survey reveals lack of public awareness about radiotherapy's importance in treating cancer

Only one in ten people know that radiotherapy helps cure forty per cent of cancer patients according to new figures published by Cancer Research UK today.

7 Sep 2010

Challenges Chief Medical Officers face in clinical trial operations

“One of the major issues that Chief Medical Officers (CMO) encounter in their day to day practice is the variety of countries that they deal with and the different regulatory issues that they need to solve.”

4 Sep 2010

AVAC calls for economic and political support for CAPRISA 004 microbicide trial's critical follow-up studies

AVAC today issues a call to action to donors, policy-makers, researchers and advocates to ensure that critical follow-up studies to the landmark CAPRISA 004 microbicide trial receive the economic and political support needed to move forward as quickly as possible. The call comes as a group of microbicide and public health experts have agreed upon a plan for further studies, which are expected to cost $100 million over three years, of which only $58 million has been committed.

4 Sep 2010

FDA approves IDE study to evaluate HeartWare 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 approved an IDE (Investigational Device Exemption) Supplement that allows HeartWare to enroll a second allotment of 54 patients in its "ADVANCE" bridge-to-transplant clinical trial under a Continued Access Protocol (CAP).

4 Sep 2010

TNS therapy improves depression: Study

Major depression is a common and disabling brain condition marked not only by the presence of depressed mood but also by its effects on sleep, energy, decision-making, memory and thoughts of death or of suicide.

3 Sep 2010

Researchers develop gLQ Model to determine optimal dose level, treatment schedules for high-dose radiation therapies

There is yet no straightforward way to determine the optimal dose level and treatment schedules for high-dose radiation therapies such as stereotactic radiation therapy, used to treat brain and lung cancer, or for high-dose brachytherapy for prostate and other cancers.Radiation oncologists at the Ohio State University Comprehensive Cancer Center-Arthur G. James Cancer Hospital and Richard J. Solove Research Institute may have solved the problem by developing a new mathematical model that encompasses all dose levels.

3 Sep 2010

Clinical Trial News and Research

Octapharma announces new study of IVIG in chronic inflammatory demyelinating polyradiculoneuropathy

Switching to nevirapine drug from PI based regimen reduces viremia in children: Study

Penn receives $12M NIH grant to study pharmacogenetics of nicotine addiction treatment

Quintiles new lab in Japan achieves CAP accreditation

Tikcro reports $3.2 million net loss for second-quarter 2010

AtheroMed initiates enrollment in Phoenix Atherectomy catheter trial for PAD

Rexahn submits Phase IIb protocol to FDA for study of Serdaxin for major depressive disorder

CytRx commences PROACT Phase 2 clinical trial of bafetinib for advanced prostate cancer

Promedior initiates PRM-151 Phase 2a clinical study in prevention of scarring post glaucoma filtration surgery

Positive immune responses elicited from Scancell's DNA vaccine in combination with ImmuneRegen's Homspera

Idenix Pharmaceuticals receives clinical hold order from FDA for IDX184, IDX320 programs

TenX Biopharma recommences enrollment in suspended Phase III trial for cutaneous T-cell lymphoma

GI Dynamics announces data on EndoBarrier therapy for type 2 diabetes, obesity

An overview on low-carbohydrate diets

Survey reveals lack of public awareness about radiotherapy's importance in treating cancer

Challenges Chief Medical Officers face in clinical trial operations

AVAC calls for economic and political support for CAPRISA 004 microbicide trial's critical follow-up studies

FDA approves IDE study to evaluate HeartWare Ventricular Assist System

TNS therapy improves depression: Study

Researchers develop gLQ Model to determine optimal dose level, treatment schedules for high-dose radiation therapies

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