Clinical Intelligence

Boston Scientific enrolls first patients in NECTAR-HF trial

Friday, September 30, 2011 11:11 AM

Boston Scientific has enrolled the first patients in its NECTAR-HF (neural cardiac therapy for heart failure) clinical trial.  NECTAR-HF is a prospective, randomized, international clinical feasibility study designed to assess preliminary safety and efficacy of chronic vagal nerve stimulation in heart failure patients.  The study will evaluate 96 patients with vagal nerve stimulator implants at multiple centers in Europe.

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APERION, Children’s Oncology Group collaborate in neuroblastoma study

Friday, September 30, 2011 10:32 AM

APEIRON Biologics and the Children's Oncology Group have reported a collaboration on conducting a clinical phase II study in neuroblastoma patients. Neuroblastoma, a cancer of the nervous system, can be one of the most difficult to treat childhood cancers with about 650 to 750 children diagnosed each year in the U.S. and the E.U.

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YM BioSciences enrolls first patients in phase II CYT387 trial

Wednesday, September 28, 2011 12:42 PM

YM BioSciences has enrolled the first patients in its multi-center phase II trial of CYT387 administered twice-daily (BID) for the treatment of myelofibrosis. The trial will further evaluate the safety and tolerability of YM's JAK1/JAK2 inhibitor, as well as its  efficacy in reducing spleen size, improving constitutional symptoms and  reducing transfusion dependence in patients with myelofibrosis.

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FDA approves REMICADER for pediatric UC

Tuesday, September 27, 2011 12:02 PM

FDA has approved Janssen Biotech’s REMICADER (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy.  This marks the 16th approval of REMICADER in the U.S. and the seventh for the anti-tumor necrosis factor (TNF)-alpha in the treatment of inflammatory bowel disease (IBD) spanning adult and pediatric Crohn's disease and adult and pediatric UC.  It is estimated that 1.4 million Americans have IBD with the number evenly split between UC and Crohn's disease.  An estimated 150,000 children under age 17 are living with symptoms of IBD.

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Bayer’s phase III prostate cancer trial meets primary endpoint

Tuesday, September 27, 2011 11:39 AM

Bayer HealthCare Pharmaceuticals has reported that the investigational drug radium-223 chloride showed positive data in the phase III ALSYMPCA (ALpharadin in SYMptomatic prostate cancer) trial. The study met its primary endpoint by significantly improving overall survival by 44% in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases. All of the main secondary efficacy endpoints analyzed to date were met, including delay in skeletal-related events (SREs).

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Beaumont Health System launches national breast cancer study

Tuesday, September 27, 2011 11:23 AM

Beaumont Health System has launched national research of accelerated whole breast radiation treatment for women with early-stage breast cancer. The study, RTOG 1005, was developed by the Radiation Therapy Oncology Group, a cancer therapy research cooperative group funded by the National Cancer Institute at the National Institutes of Health, part of the U.S. Department of Health and Human Services.

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Elevation Pharmaceuticals’ COPD trial shows positive results

Tuesday, September 27, 2011 10:59 AM

Elevation Pharmaceuticals, a biopharmaceutical company focused on the development of new aerosol therapies for patients with respiratory diseases, has reported positive results from a phase IIa study of EP-101 in patients with moderate to severe chronic obstructive pulmonary disease (COPD). The results demonstrated a statistically significant and well-tolerated improvement in lung function over the 24-hour time period post dosing for EP-101 versus placebo. EP-101 is a proprietary inhalation solution formulation of glycopyrrolate, a long-acting muscarinic antagonist (LAMA), delivered by an optimized, Investigational eFlowR Nebulizer System (PARI Pharma GmbH).

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FDA approves Soliris

Friday, September 23, 2011 11:36 AM

The FDA has approved Soliris to treat patients with atypical Hemolytic Uremic Syndrome, a rare and chronic blood disease that can lead to kidney (renal) failure and is also associated with increased risk of death and stroke.

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TheraVasc successfully completes phase I diabetes trial

Tuesday, September 20, 2011 12:09 PM

TheraVasc has successfully completed a phase I clinical trial of a drug, TV1001, to diabetic patients. The trial included 12 diabetic patients who each received a single dose of two different oral formulations of TV1001, an enteric coated and a non-enteric coated capsule, to determine safety and blood levels of the drug.  Based on prior studies conducted in animals, the circulating blood levels in all patients were in the range believed to be therapeutic.

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Novartis' canakinumab to potentially treat childhood arthritis

Monday, September 19, 2011 12:48 PM

Novartis has presented late-stage data showing that canakinumab, recently rejected by US regulators for gout, shows potential as a treatment for patients with the most serious form of childhood arthritis, according to PharmaTimes.

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