Placebo News and Research

RSS

Beneficial design element in sunitinib phase III clinical trial for gastrointestinal stromal tumors

Patients benefitted from an important design element in the pivotal phase III clinical trial that led to Food and Drug Administration and worldwide regulatory approval of sunitinib for the treatment of gastrointestinal stromal tumors resistant to the only other available therapy, according to a study in Clinical Cancer Research, a journal of the American Association for Cancer Research.

2 Jun 2012

New medication proves effective in slowing the spread of metastatic prostate cancer

A new medication proved effective in slowing the spread of metastatic prostate cancer, while helping to maintain the quality of life, in patients with advanced disease. The phase 3 study was unblinded midway, allowing patients receiving the placebo to instead take the drug because of the favorable results.

2 Jun 2012

Liver metastases predicts shorter overall survival in men with mCRPC

Liver metastases predicts shorter overall survival in men with metastatic castration-refractory prostate cancer (mCRPC), according to data being presented at the 2012 American Society of Clinical Oncology Annual Meeting in Chicago.

2 Jun 2012

Zinc supplementation in young children with serious infections significantly lowers risk of treatment failure

Treating young children with suspected serious bacterial infection with zinc in addition to standard antibiotics significantly reduces the likelihood of treatment failure, according to new research published Online First in The Lancet. In 2010, worldwide, infections were responsible for nearly two-thirds of deaths in children under 5, with around two-fifths of deaths occurring within the first month of life.

1 Jun 2012

Seriously ill children administered zinc in addition to antibiotics respond better, more quickly to treatment, study shows

"In a newly released clinical study, conducted in India" and published in the Lancet on Thursday, "hundreds of seriously ill infants who received zinc -- an essential micronutrient for the immune system and human growth -- as well as antibiotics, responded better and more quickly to treatment than those who did not," IRIN reports.

1 Jun 2012

Beta-carotene safe to use during radiation therapy for prostate cancer

Despite past safety concerns, the antioxidant supplement beta-carotene, is safe to use during radiation therapy treatments for prostate cancer and does not increase the risk of prostate cancer death or metastases, according to a study in the May issue of the International Journal of Radiation Oncology•Biology•Physics, the official scientific journal of the American Society for Radiation Oncology.

1 Jun 2012

Janssen submits canagliflozin NDA with FDA for treatment of type 2 diabetes

Janssen Research & Development, LLC (Janssen), announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of canagliflozin, an investigational, oral, once-daily, selective sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of adult patients with type 2 diabetes.

1 Jun 2012

NAC reduces irritability in children with autism

Autism is a developmental disorder that affects social and communication skills. Irritability is a symptom of autism that can complicate adjustment at home and other settings, and can manifest itself in aggression, tantrums, and self-injurious behavior. These disruptive behaviors are frequently observed in children with autism, which may considerably affect their ability to function at home or in school.

1 Jun 2012

Top-line results from Genzyme’s teriflunomide Phase III trial on MS

Genzyme, a Sanofi company, announced today top-line results from the TOWER (Teriflunomide Oral in people With relapsing remitting multiplE scleRosis) trial that assessed the efficacy and safety of once-daily, oral teriflunomide in patients with relapsing forms of multiple sclerosis.

1 Jun 2012

Omeros commences planned PK substudy in Phase 3 clinical program of OMS302

Omeros Corporation today announced the initiation of the planned pharmacokinetic (PK) substudy in its Phase 3 clinical program evaluating OMS302 in patients undergoing intraocular lens replacement (ILR) surgery.

1 Jun 2012

Ketamine reduces suicidal thoughts in patients with bipolar depression

Bipolar disorder is a serious and debilitating condition where individuals experience severe swings in mood between mania and depression. The episodes of low or elevated mood can last days or months, and the risk of suicide is high. Antidepressants are commonly prescribed to treat or prevent the depressive episodes, but they are not universally effective. Many patients still continue to experience periods of depression even while being treated, and many patients must try several different types of antidepressants before finding one that works for them.

31 May 2012

Taiho to initiate TAS-102 Phase III trial in colorectal cancer

Taiho Pharmaceutical Co., Ltd. announced on May 31 that a global Phase III clinical trial (RECOURSE) for the novel combination antimetabolite TAS-102 will start in June this year.

31 May 2012

Top-line data from Flexion‘s FX005 Phase 2 trial on osteoarthritis

Flexion Therapeutics, Inc. today reported that its lead osteoarthritis drug candidate, FX005, demonstrated significant pain relief over placebo at four weeks in a Phase 2 proof-of-concept trial. Top-line data showed FX005, delivered intra-articularly to the knee, was well-tolerated and resulted in prolonged improvement in joint pain and function throughout the 12-week duration of the study.

31 May 2012

Interim data from UCLA and NeuroSigma’s eTNS Phase I trial on PTSD, MDD

Today, at the 52nd annual New Clinical Drug Evaluation Unit (NCDEU) Conference in Arizona, Ian Cook, M.D., Professor of Psychiatry at the University of California, Los Angeles (UCLA) and a Senior Medical Advisor to NeuroSigma, Inc., presented the results from the first 6-subject cohort of a 10-subject Phase I open-label clinical trial studying the effects of external trigeminal nerve stimulation (eTNS) on Post-Traumatic Stress Disorder (PTSD) and depressive symptoms in Major Depressive Disorder (MDD) as an adjunct to pharmacotherapy.

31 May 2012

Wellmune minimizes risk of URTI among marathoners

Marathoners taking Wellmune WGP, a natural immune health ingredient, for four weeks experienced an average reduction of 40% in upper respiratory tract infection symptomatic days that commonly afflict long-distance runners, according to new clinical study results presented today at the American College of Sports Medicine 59th annual meeting.

31 May 2012

Genetics can predict success of smoking cessation and need for medications

Genetics can help determine whether a person is likely to quit smoking on his or her own or need medication to improve the chances of success, according to research published in today's American Journal of Psychiatry. Researchers say the study moves health care providers a step closer to one day providing more individualized treatment plans to help patients quit smoking.

31 May 2012

Top-line results from Alnylam’s ALN-RSV01 Phase IIb trial on RSV infection

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today top-line results from a Phase IIb trial with ALN-RSV01 for the treatment of respiratory syncytial virus (RSV) infection in lung transplant patients.

31 May 2012

Topline results from Alkermes’ ALKS 37 phase 2b study on opioid-induced constipation

Alkermes plc today announced topline results from a phase 2b dose-ranging clinical study of ALKS 37 in the treatment of opioid-induced constipation. The multicenter, randomized, double-blind, placebo-controlled, repeat-dose study was designed to assess the safety, tolerability, pharmacokinetic profile and efficacy of ALKS 37 in approximately 150 patients.

31 May 2012

Exelixis commences cabozantinib phase 3 pivotal trial in mCRPC

Exelixis, Inc. today announced the initiation of COMET-1, a phase 3 pivotal trial of cabozantinib in men with metastatic castration-resistant prostate cancer.

31 May 2012

Corrected interim data from Vertex VX-809, KALYDECO combination Phase 2 study for CF

Vertex Pharmaceuticals Incorporated announced today a correction to the previously reported responder analysis, as well as additional data from, the recent interim analysis of an ongoing Phase 2 study of VX-809 and KALYDECO that showed significant improvements in lung function among adults with cystic fibrosis who have two copies of the most common mutation in the cystic fibrosis transmembrane conductance regulator gene, F508del.

30 May 2012