Theorem Clinical Research

Clinical Intelligence

NeuroSigma set to commence phase III trial

Tuesday, July 30, 2013 11:33 AM

NeuroSigma, a Los Angeles-based medical device company, has announced conditional approval by the FDA of its IDE application to commence a phase III trial of the Monarch eTNS System for treatment of drug resistant epilepsy. The company is planning to conduct a multi-center trial at medical institutions in the U.S., Europe and Canada.  The objective of the study is to evaluate the safety and effectiveness of the device and provide the basis for a Pre-Market Approval (PMA) application to the FDA.

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InspireMD announces first patient enrolled in MGuard trial

Tuesday, July 30, 2013 10:30 AM

InspireMD, an embolic protection stents company, has enrolled its first patient in the Master II IDE clinical trial to evaluate the safety and effectiveness of the MGuard Prime Embolic Protection Stent (EPS) in patients suffering from ST Elevation Myocardial Infarction (STEMI).

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Imprimis acquires intellectual property for drug candidate

Friday, July 26, 2013 03:11 PM

Imprimis Pharmaceuticals, which focuses on the commercialization of drug formulations utilizing the FDA drug development pathway, has acquired intellectual property for IPI-120, a novel drug formulation of both tranexamic acid, a synthetic derivative of the amino acid lysine, and an antibiotic. The company's recently-filed patent application combines tranexamic acid with an antibiotic to provide the clotting effects along with protection or treatment against infection in a transdermal, local intra-wound application or intra-cavity instillation formulation.

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Charleston Laboratories completes pre-IND meeting

Friday, July 26, 2013 03:10 PM

Charleston Laboratories, a specialty pharmaceutical company focused on the R&D of novel pain products, has announced the completion of its scheduled pre-IND meeting with the FDA for CL-H1T, a novel treatment for patients who have migraine pain and migraine induced nausea or vomiting.

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Cytokinetics provides update, revised guidance for BENEFIT-ALS

Friday, July 26, 2013 03:08 PM

Biopharmaceutical company Cytokinetics has amended the protocol for Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in amyotrophic lateral sclerosis (BENEFIT-ALS). BENEFIT-ALS is a phase IIb, multinational, double-blind, randomized, placebo-controlled clinical trial designed to evaluate the safety, tolerability and potential efficacy of tirasemtiv, a fast skeletal muscle troponin activator, in patients with ALS.

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OncoGenex completes phase II enrollment

Wednesday, July 24, 2013 12:35 PM

OncoGenex Pharmaceuticals has completed enrollment in Borealis-1, a company-sponsored, randomized, placebo-controlled phase II trial of OGX-427 in combination with first-line gemcitabine and cisplatin in patients with metastatic bladder cancer.

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UofL now enrolling patients in phase III stem cell trial

Wednesday, July 24, 2013 11:34 AM

The University of Louisville is now enrolling qualifying patients in a nationwide phase III clinical trial to study whether a patient’s own stem cells could help lessen the effects of angina.

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Astellas receives FDA approval of ASTAGRAF XL

Wednesday, July 24, 2013 10:15 AM

Astellas Pharmasaid the FDA has approved ASTAGRAF XL (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction.

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Scientists find 3D structure of key drug target for diabetes

Wednesday, July 24, 2013 09:24 AM

An international team led by scientists at The Scripps Research Institute (TSRI), an independent, nonprofit organization focused on research in the biomedical sciences, has determined and analyzed the three-dimensional atomic structure of the human glucagon receptor. The receptor, found mainly on liver and kidney cells, helps regulate glucose levels in the bloodstream and is the target of potential therapeutic agents for type 2 diabetes.

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Anti-TNF infusion therapy approved for RA patients

Friday, July 19, 2013 01:20 PM

The FDA has approved Janssen Biotech’s Simponi Aria (golimumab) infusion for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate. Simponi Aria, the only fully-human anti-tumor necrosis factor (TNF)-alpha infusible therapy, has been shown to improve signs, symptoms and physical function and inhibit the progression of structural damage.

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