Theorem Clinical Research

Clinical Intelligence

OncoGenex’s Spruce trial open for enrollment

Tuesday, August 6, 2013 10:30 AM

OncoGenex Pharmaceuticals has initiated the Spruce clinical trial, an investigator-sponsored, randomized, double-blind, placebo-controlled phase II trial evaluating OGX-427, a heat shock protein 27 (Hsp27) inhibitor, in patients with previously untreated advanced non-squamous non-small cell lung cancer (NSCLC).

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Spanish Myeloma Group study a treatment milestone

Monday, August 5, 2013 12:09 PM

Early treatment of asymptomatic myeloma, which has a high risk of developing into active multiple myeloma, can significantly improve the course of the disease, delay progression and increase patient survival. These were the conclusions of a clinical trial carried out by the Spanish Myeloma Group (GEM-PETHEMA), which unites specialists from more than 80 Spanish hospitals, published in the August issue of The New England Journal of Medicine.

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The CenterWatch Monthly, August 2013

Friday, August 2, 2013 10:36 AM

Will end-to-end outsourcing take hold?

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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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October 27

NIH’s I-Corps boot camp aims to transform researchers into better businesspeople before they launch products

Covance, Frenova form partnership to share patient databases, find effective treatments for renal disease

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CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

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Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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