Theorem Clinical Research

Clinical Intelligence

Boehringer Ingelheim planning two global trials of Pradaxa

Tuesday, November 26, 2013 10:34 AM

Boehringer Ingelheim Pharmaceuticals plans to initiate two new global clinical trials of PRADAXA. One of the new trials, RE-DUAL PCI (Randomized Evaluation of Dual Therapy with Dabigatran v. Triple Therapy Strategy with Warfarin in Patients with NVAF that have undergone PCI with Stenting), is designed to evaluate the efficacy and safety of PRADAXA in patients with non-valvular atrial fibrillation (NVAF) who have undergone percutaneous coronary intervention (PCI), also known as angioplasty, with stent placement. The second of the new trials, RE-SPECT ESUS(TM) (Randomized Evaluation in Secondary stroke Prevention Comparing the Thrombin inhibitor dabigatran etexilate v. ASA in Embolic Stroke of Undetermined Source), is designed to evaluate the efficacy and safety of PRADAXA as a secondary stroke prevention therapy in patients who have suffered an embolic stroke of undetermined source (ESUS). Embolic strokes occur when a blood clot forms somewhere in the body and travels through the bloodstream to the brain.

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Quest Diagnostics

Novocure initiates NovoTTF Therapy trial for brain metastases from NSCLC

Tuesday, November 26, 2013 09:29 AM

Novocure, a privately-held Jersey Isle oncology company, has enrolled the first patients in the EF-21 Study, a prospective randomized clinical study of NovoTTF Therapy for patients with brain metastases from non-small cell lung carcinoma (NSCLC) cancer. NovoTTF Therapy is an anti-mitotic treatment delivered continuously throughout the day by the NovoTTF-100A System.

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Reinforced safety profile of Boehringer Ingelheim’s Pradaxa released

Tuesday, November 19, 2013 01:37 PM

Boehringer Ingelheim Pharmaceuticals has announced results from a new, long-term, combined analysis of the pivotal phase III RE-LY trial and its extension safety study RELY-ABLE. The data showed that after a median follow up of 4.6 years, with some patients followed up to 6.7 years, rates of stroke/systemic embolism and major bleeding were consistent with rates in previously reported analyses of RE-LY, one of the largest stroke prevention clinical studies ever conducted in patients with non-valvular atrial fibrillation (NVAF).

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Isis earns $5 million milestone Payment from GSK

Tuesday, November 19, 2013 12:35 PM

Isis Pharmaceuticals has earned a $5 million milestone payment from GlaxoSmithKline related to the designation of ISIS-GSK4Rx as a development candidate. ISIS-GSK4Rx is an antisense drug designed to treat an undisclosed ocular disease. 

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Lumena Pharmaceuticals receives positive opinion in the E.U. for four rare liver diseases

Tuesday, November 19, 2013 11:33 AM

Lumena Pharmaceuticals, a San Diego-based based company developing oral therapeutics for rare liver diseases, has received positive opinions for four Orphan Drug designations by the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) for LUM001. The company's lead drug candidate, LUM001, received the first positive opinion granted by the EMA for primary sclerosing cholangitis (PSC). In addition, the company received positive opinions for LUM001 in three other rare cholestatic liver diseases, including Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC) and primary biliary cirrhosis (PBC). This follows the Orphan Drug Designation in September by the FDA Office of Orphan Product Development for LUM001 in the same indications.

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Study finds children born prematurely face higher risk of retinal detachment

Wednesday, November 13, 2013 04:40 PM

Children born extremely prematurely have up to a 19 times greater risk of retinal detachment later in life than peers born at term, according to a Swedish study published this month in Ophthalmology, the journal of the American Academy of Ophthalmology. In the first large population-based, long-term investigation of the association between preterm birth and later retinal detachment, the research determined that birth before 32 weeks is associated with increased risks of retinal detachment in childhood, adolescence and young adult life. The study's findings indicate the need for ophthalmologic follow-up in children and adults born extremely and very prematurely. The U.S. has the sixth largest number of premature births, with more than 500,000 premature babies born each year.

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FDA approves Imbruvica for rare blood cancer

Wednesday, November 13, 2013 04:13 PM

The FDA has approved Imbruvica (ibrutinib) to treat patients with mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer.

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Alexion presents positive results from four trials of Soliris (eculizumab)

Tuesday, November 12, 2013 09:00 AM

Alexion Pharmaceuticals has announced that researchers presented data from  four clinical trials, all demonstrating the clinical benefits of Soliris (eculizumab) for the treatment of atypical hemolytic uremic syndrome (aHUS), a genetic, chronic, ultra-rare disease associated with vital  organ failure and premature death. Soliris is the first and only approved safe and effective treatment for pediatric and adult patients with aHUS. In two large, prospective, multinational studies, Soliri inhibited systemic complement-mediated thrombotic microangiopathy (TMA, the formation of blood clots in small blood vessels throughout the body) and improved renal function in both pediatric and adult patients with aHUS. The data were presented at Kidney Week 2013, the annual meeting of the American Society of Nephrology (ASN).

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OncoMed earns $15 million milestone payment from Bayer

Wednesday, November 6, 2013 03:44 PM

OncoMed Pharmaceuticals, a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, has earned a $15 million milestone payment from Bayer Pharma related to achieving a dose escalation milestone in the phase Ia clinical trial of OMP-54F28 (Fzd8-Fc). OMP-54F28 is an antagonist of the Wnt pathway, a key cancer stem cell pathway. 

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Soterix Medical announces phase III trial for depression

Tuesday, November 5, 2013 10:02 AM

Soterix Medical has announced a phase III trial for Major Depressive Disorder (MDD), which will compare Soterix Medical's Transcranial Direct Current Stimulation (tDCS) Limited Total Energy (LTE) technology against a fully dosed, effective antidepressant Escitalopram oxalate (Lexapro). The seminal ELECT-TDCS study, initiated by Dr. Andre Brunoni of the University of Sao Paulo, builds on prior work. This work combined tDCS with antidepressant sertraline and concluded "in MDD, the combination of tDCS and sertraline increases the efficacy of each treatment. The efficacy and safety of tDCS and sertraline did not differ."

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