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Positive results from YM BioSciences' CYT997 Phase I study for vascular disruption in tumors

YM BioSciences Inc., today announced the publication of Phase I results demonstrating that CYT997, a novel vascular disrupting agent (VDA), was well tolerated at doses that were associated with pharmacodynamic evidence of vascular disruption in tumors. The article entitled "Phase I trial of CYT997, a novel cytotoxic and vascular-disrupting agent," was published in the premier cancer journal, the British Journal of Cancer.

8 Sep 2010

Emergent BioSolutions initiates Phase I clinical trial for anthrax monoclonal antibody therapeutic

Emergent BioSolutions Inc. announced today that the Phase I clinical trial for its anthrax monoclonal antibody therapeutic has commenced with the dosing of the first subject. Emergent's fully human monoclonal antibody product candidate is being developed as a parenteral post-exposure therapeutic to treat symptoms of inhalational anthrax disease.

8 Sep 2010

OrthoAccel Technologies to host private lecture for orthodontic specialists in Brighton

OrthoAccel Technologies, Inc. has announced its plans to host a private lecture and reception for orthodontic specialists in Brighton during the British Orthodontic Conference.

8 Sep 2010

PLX4032 trial shows high degree of selectivity to achieve tumor shrinkage

Plexxikon today announced publication of key data in this week's edition of Nature demonstrating that the high degree of selectivity of PLX4032 (RG7204) enables substantial RAF/MEK/ERK pathway inhibition, which may be necessary to achieve significant tumor shrinkage and clinical response in patients with BRAF mutant melanoma.

8 Sep 2010

ImmuneRegen's Homspera with Scancell's ImmunoBody technology improves immune response for cancer

ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc. today announced that treatment with its lead compound, Homspera, in combination with a DNA vaccine utilizing Scancell's ImmunoBody technology significantly improved the immune response of the vaccine in an animal model.

8 Sep 2010

NIH announces $15 million for expansion of Pharmacogenomics Knowledge Base

To help advance research on how genes affect responses to medicines, the National Institutes of Health is spending $15 million over five years to expand a key resource, the Pharmacogenomics Knowledge Base (PharmGKB), http://www.pharmgkb.org/ .

8 Sep 2010

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

Clinical Trial News and Research

Positive results from YM BioSciences' CYT997 Phase I study for vascular disruption in tumors

Emergent BioSolutions initiates Phase I clinical trial for anthrax monoclonal antibody therapeutic

OrthoAccel Technologies to host private lecture for orthodontic specialists in Brighton

PLX4032 trial shows high degree of selectivity to achieve tumor shrinkage

ImmuneRegen's Homspera with Scancell's ImmunoBody technology improves immune response for cancer

NIH announces $15 million for expansion of Pharmacogenomics Knowledge Base

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

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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