Clinical Trial News and Research

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Tolerx publishes follow-up data from study of otelixizumab therapy for new onset T1DM patients

Tolerx, Inc., today announced the publication in Diabetologia, the journal of the European Association for the Study of Diabetes, of the four-year follow-up clinical data from new onset type 1 diabetes (T1DM) patients (age 12-39) who received a single short course of therapy with otelixizumab (ChAglyCD3).

16 Mar 2010

Patient enrollment in Spinal Restoration' Phase III study of Biostat System now underway

Spinal Restoration, Inc. announced today that patient enrollment in the company’s Phase III study of the Biostat System for the treatment of discogenic chronic low back pain is now underway. The study, which will be conducted at 15 U.S. clinical sites, is one of only a few multi-center, randomized, blinded, placebo-controlled trials of a nonsurgical treatment for discogenic low back pain ever to be conducted.

16 Mar 2010

Hybrid revascularization procedure is safe and feasible for left main coronary artery stenosis

The left main coronary artery provides most of the blood to the heart, and current guidelines call for patients with blockages in this artery to undergo bypass surgery.

16 Mar 2010

PERSEUS clinical program demonstrates positive results of TAXUS Element Paclitaxel-Eluting Stent System

Boston Scientific Corporation today announced 12-month results from its PERSEUS clinical program that demonstrated positive safety and efficacy outcomes in workhorse lesions for the platinum chromium TAXUS® Element™ Paclitaxel-Eluting Stent System compared to the TAXUS® Express2™ Paclitaxel-Eluting Stent System.

16 Mar 2010

Minimal improvements made in survival rates of AYA population with cancer

Despite cancer survival rates increasing dramatically for children and older adults in the last 20 years, there has been minimal improvement in the survival rates in the Adolescent and Young Adult (AYA) population, an age range defined as 15 – 29 years by the presenters.

16 Mar 2010

Stage IV colorectal cancer: Therapy that improves overall survival over IFL/bevacizumab will earn 60% patient share

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a therapy that would improve median overall survival over IFL (bolus 5-fluorouracil, generics/leucovorin, generics/irinotecan*) plus bevacizumab (Roche/Genentech/Chugai's Avastin), would earn a 60 percent patient share in stage IV colorectal cancer, according to surveyed U.S. oncologists. In Europe, such an agent would earn a 50 percent patient share, according to surveyed European oncologists.

16 Mar 2010

Study suggests coffee can reduce chronic inflammation and raise ‘good' cholesterol

Multitudes of people worldwide begin each day with a cup of steaming hot coffee. Although it is sometimes referred to as "the devil's brew," coffee contains several nutrients (eg, calcium) as well as hundreds of potentially biologically active compounds (eg, polyphenols) that may promote health.

16 Mar 2010

Obesity limits body's ability to fight infections

Obesity may limit the body's ability to develop immunity to influenza viruses, particularly secondary infections, by inhibiting the immune system's ability to "remember" how it fought off previous similar bouts of illness, according to new research from the University of North Carolina at Chapel Hill.

16 Mar 2010

Nuvo Research commences enrollment in WF10 Phase 2 clinical trial for allergic rhinitis

Nuvo Research Inc., a Canadian drug development company focused on the research and development of drug products that are delivered to and through the skin using its topical and transdermal drug delivery technologies, and on the development of its immune modulating drug candidate WF10, today announced that it has enrolled the first patient in its European Phase 2 clinical trial evaluating WF10 as a treatment for allergic rhinitis.

16 Mar 2010

Medtronic announces positive STOP AF clinical trial data at 59th American College of Cardiology session

Medtronic, Inc. today announced data from the STOP AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) clinical trial during late-breaking sessions at the 59th Annual Scientific Session of the American College of Cardiology in Atlanta. The data showed superiority over anti-arrhythmic drugs, with 69.9 percent of patients with paroxysmal atrial fibrillation (PAF) treated with the Arctic Front® Cardiac CryoAblation Catheter System remaining free of atrial fibrillation (AF) one year after cryoablation, compared to 7.3 percent on drug therapy.

15 Mar 2010

Progenics Pharmaceuticals to advance oral methylnaltrexone for OIC into late stage clinical development

Progenics Pharmaceuticals, Inc. today announced that it plans to advance oral methylnaltrexone for the treatment of opioid-induced constipation (OIC) into late stage clinical development and will commence a phase 2b/3 clinical trial of a methylnaltrexone tablet in chronic-pain patients in the second half of 2010. Progenics also announced data from a clinical trial of this methylnaltrexone tablet.

15 Mar 2010

MicuRx Pharmaceuticals files IND for MRX-I antibiotic drug candidate with Chinese SFDA

MicuRx Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing next-generation antibiotics, today announced that it has filed an Investigational New Drug (IND) application with the State Food and Drug Administration (SFDA) in China for MRX-I, its first development-stage antibiotic drug candidate. MRX-I, an orally-administered oxazolidinone, targets multi-drug resistant Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE).

15 Mar 2010

Hemispherx Biopharma reports net loss of $13,438,000 for fiscal year 2009

Hemispherx Biopharma, Inc., announced its financial results for the fiscal year ended December 31, 2009. The net loss for the year (including non-cash charges) was approximately $13,438,000 or $0.12 per share as compared to a net loss of $12,219,000 or $0.16 per share in 2008.

15 Mar 2010

Positive results from second phase of ABSORB clinical trial on BVS technology

Abbott today announced positive 30-day results from the first 101 patients enrolled in the second phase of the ABSORB trial. Patients treated with Abbott's bioresorbable vascular scaffold (BVS), under clinical investigation in Europe, demonstrated no cases of blood clots (thrombosis), no need for repeat procedures (ischemia-driven target lesion revascularization) and a very low rate of major adverse cardiac events (MACE(1) rate of 2.0 percent) at 30 days.

15 Mar 2010

Alnylam Pharmaceuticals presents data on RNAi therapeutic targeting PCSK9 for hypercholesterolemia

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today the presentation of new pre-clinical data from its hypercholesterolemia program, performed in collaboration with scientists at the University of Texas Southwestern Medical Center at Dallas. The data were presented at the PCSK9 Conference: From Gene to Therapeutics held in Nantes, France from March 11-13, 2010.

15 Mar 2010

GTx reacquires full rights to Ostarine

GTx, Inc. today provided a company update and reported financial results for the fourth quarter and full year 2009.

15 Mar 2010

Reducing collateral damage to excised tissue: Surgeons study device using radiofrequency energy

Every year more than 100,000 women in the United States undergo a lumpectomy, a conservative procedure to remove cancerous tumors while preserving the breast. The surgeon's goal is to attain a tumor-free, or negative, surgical margin the first time they operate. Current surgical tools may cause heat damage to the tissue samples needed for examination by a pathologist in order to identify the presence of cancerous cells on the edges of tumors.

15 Mar 2010

NDA for BYDUREON: FDA issues complete response letter

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the New Drug Application for BYDUREON™ (exenatide for extended-release injectable suspension).

15 Mar 2010

FDA Neurological Devices Panel recommends approval of DBS Therapy for epilepsy

The U.S. Food and Drug Administration Neurological Devices Panel today voted seven to five to recommend approval with conditions of Deep Brain Stimulation (DBS) Therapy for Epilepsy from Medtronic, Inc. as adjunctive treatment for partial-onset seizures in adults with medically refractory epilepsy.

15 Mar 2010

NCCN Guidelines and impact of escalating health care costs highlighted at NCCN Annual Conference

The escalating costs of cancer care combined with variations in concordance with evidence-based practice guidelines is putting the United States on a collision course for an impending collapse of its current health care system according to roundtable panelists at the NCCN 15th Annual Conference.

15 Mar 2010

Clinical Trial News and Research

Tolerx publishes follow-up data from study of otelixizumab therapy for new onset T1DM patients

Patient enrollment in Spinal Restoration' Phase III study of Biostat System now underway

Hybrid revascularization procedure is safe and feasible for left main coronary artery stenosis

PERSEUS clinical program demonstrates positive results of TAXUS Element Paclitaxel-Eluting Stent System

Minimal improvements made in survival rates of AYA population with cancer

Stage IV colorectal cancer: Therapy that improves overall survival over IFL/bevacizumab will earn 60% patient share

Study suggests coffee can reduce chronic inflammation and raise ‘good' cholesterol

Obesity limits body's ability to fight infections

Nuvo Research commences enrollment in WF10 Phase 2 clinical trial for allergic rhinitis

Medtronic announces positive STOP AF clinical trial data at 59th American College of Cardiology session

Progenics Pharmaceuticals to advance oral methylnaltrexone for OIC into late stage clinical development

MicuRx Pharmaceuticals files IND for MRX-I antibiotic drug candidate with Chinese SFDA

Hemispherx Biopharma reports net loss of $13,438,000 for fiscal year 2009

Positive results from second phase of ABSORB clinical trial on BVS technology

Alnylam Pharmaceuticals presents data on RNAi therapeutic targeting PCSK9 for hypercholesterolemia

GTx reacquires full rights to Ostarine

Reducing collateral damage to excised tissue: Surgeons study device using radiofrequency energy

NDA for BYDUREON: FDA issues complete response letter

FDA Neurological Devices Panel recommends approval of DBS Therapy for epilepsy

NCCN Guidelines and impact of escalating health care costs highlighted at NCCN Annual Conference

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