Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of a New Ultra Low Molecular Weight Heparin (RO-14) Administered Subcutaneously Increasing Single-doses to Healthy Male Volunteers

Clinical trial to evaluate the tolerability and pharmacokinetics of a new ultra low molecular weight heparin (RO-14) administered subcutaneously increasing single-doses to healthy male volunteers

Start Date01 Dec 2007

Sponsor / Collaborator

Rovi Pharmaceuticals Laboratories, Inc

100 Clinical Results associated with RO-14

100 Translational Medicine associated with RO-14

100 Patents (Medical) associated with RO-14

Literatures (Medical) associated with RO-14

01 Jan 2022·Journal of Contemporary BrachytherapyQ4 · MEDICINE

Advantages of TRUS-based delineation for high-dose-rate prostate brachytherapy planning

Q4 · MEDICINE

ArticleOA

Author: Carignan, Damien ; Vigneault, Eric ; Poulin, Eric ; Martin, Andre-Guy ; Foster, William ; Lacroix, Frederic ; Lavoie-Gagnon, Heloise ; Archambault, Louis ; Pilote, Laurie

PURPOSETo evaluate the variability of prostate contours delineated on computed tomography (CT) and transrectal ultrasound (TRUS).MATERIAL AND METHODSA TRUS-based high-dose-rate (HDR) brachytherapy procedure was introduced in 2016 in our center. The first thirty patients were additionally imaged with CT immediately after the treatment. In 2018, four different radiation oncologists (ROs: 1, 2, 3, 4) contoured the prostate on both modalities. A volume comparison was performed between CT and TRUS imaging. Using prostate gold fiducial makers, a rigid registration between CT and TRUS was done in 20 of the 30 patients studied. Jaccard index (JI) was computed to evaluate the inter-observer volume delineation agreement.RESULTSThe ratio of TRUS/CT volumes was 0.82 (95% CI: 0.79-0.87%). The mean JI was 87% for CT and 92% for TRUS, when comparing all four ROs; CT and TRUS JIs were significantly different (p < 0.001). The mean JI for the prostate on CT was significantly more consistent (p < 0.001) when comparing RO1, 2, and 3 together (RO1-2, RO1-3, and RO2-3; mean = 89%) than when comparing RO4 (newest to clinical practice) to others (RO1-4, RO2-4, and RO3-4; mean = 85%). For TRUS planning, the mean JI was not significantly different (p > 0.05) when comparing all ROs.CONCLUSIONSThe inter-observer and intra-observer variability were statistically significantly smaller on TRUS compared to CT-based planning, despite varying ROs clinical experiences. The superior soft tissue contrast offered by TRUS obviates the effect of the ROs experience on prostate contour volumes and enables more reproducible prostate delineation.

01 Jan 2014·Drug Discoveries & Therapeutics

Pharmacological effects and clinical applications of ultra low molecular weight heparins

Review

Author: Juzheng Sheng ; Zhang Liu ; Shengli Ji ; Fengshan Wang

Heparin, one of the common anticoagulants, is clinically used to prevent and treat venous thromboembolism (VTE). Though it has been the drug of choice for many advanced medical and surgical procedures with a long history, the adverse events, such as bleeding, heparin-induced thrombocytopenia (HIT), allergic reactions, follow. Therefore, low molecular weight heparins (LMWHs) and ultra low molecular weight heparins (ULMWHs), with lower molecular weights, higher anti-FXa activity, longer half-life times and lower incidence of adverse events than unfractionated heparin (UFH), were researched and developed. Fondaparinux, a chemically synthesized ULMWH of pentasaccharide, has the same antithrombin III (AT-III)-binding sequence as found in UFH and LMWH. In addition, AVE5026 and RO-14, another two ULMWHs, are obtained by selective chemical depolymerization. In this paper, we review the preparation process, pharmacological effects and clinical applications of fondaparinux, AVE5026 and RO-14.

01 Jan 2012·Journal of Postgraduate MedicineQ4 · MEDICINE

Oral and parenteral anticoagulants

Q4 · MEDICINE

ReviewOA

Author: Aditya, S

Well-documented drawbacks of traditional anticoagulants have lead to the quest for an ideal anticoagulant resulting in a surge of novel anticoagulant molecules. These newer agents directly target specific steps in coagulation cascade and include newer low molecular weight heparins (adomiparin), ultra low molecular weight heparins (semuloparin, RO-14), inhibitors of activated factor II (dabigatran, AZD0837), X (rivaroxaban, apixaban, edoxaban, betrixaban), IX (REG1,2), XI (antisense oligonucleotides, BMS 262084, clavatadine A), VII/tissue factor (tifacogin, PCI 274836, and BMS 593214), V (recomodulin, solulin), VIII (TB402), dual thrombin/factor X inhibitors (EP21709, tanogitran), and newer vitamin K antagonists (tecarfarin). Direct thrombin inhibitors and Factor X inhibitors are the most clinically advanced. This article discusses the recent advances in the development of novel targets of anticoagulants. Medline, EMBASE, cochrane database, medscape, SCOPUS, and clinicaltrials.gov were searched using terms "anticoagulants", "blood coagulation inhibitors", "anticoagulants and venous thromboembolism", "anticoagulants and atrial fibrillation", and "'antithrombins." Journal articles published from 2007 to 2012 discussing pharmacology and/or clinical trials were screened.

100 Deals associated with RO-14

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Indication	Highest Phase	Country/Location	Organization	Date
Thromboembolism	Phase 1	ES	Laboratorios Farmaceúticos Rovi SA	31 Dec 2007
Venous Thrombosis	Phase 1	ES	Laboratorios Farmaceúticos Rovi SA	31 Dec 2007
Thrombosis	Phase 1	ES	Rovi Corp.	-

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