What is it?
Glycomics is the study and profiling of the sugars that compose a cell, including the glycosaminoglycans (GAG), which, in addition to their role in regulating blood coagulation, are involved in processes like cell growth, immune response and inflammation. Glycomics studies provide very valuable information in this respect, since they allow the receptors that take part in the interaction with each type of GAG to be determined.
What does this mean?
The degree of specialization and knowledge attained in this area allows us to consider the expansion of alternative applications, indications and action mechanisms of heparin-derived products and other glycosaminoglycans.
As a result of its effort and investment in this area, we have developed an enoxaparin biosimilar (a low-molecular-weight heparin with an antithrombotic effect). In March 2017, we successfully completed the decentralized procedure for registration of medicines in twenty-six European Union countries. Subsequently, we commenced the national phases of the registration process, which will conclude, foreseeably, with the granting of the marketing authorization by the respective competent national authorities for each individual country. We estimate that the national phase will take between three and ten months.
Where can I find information on the clinical trials that are being or have been conducted by Rovi?
It is a scientific, ethical and moral responsibility to register and publish the relevant content of clinical trials and provide public access thereto. Therefore, as a transparency measure, from 2010 ROVI holds a commitment to make a minimum data set on the clinical trials it sponsors public by registering the trials, before they begin, on a clinical trials registry recognized by the World Health Organisation.
Likewise, as a clinical trial sponsor, ROVI is obliged to publish both the positive and negative results of the clinical trials authorised. Furthermore, ROVI undertakes to share the results of advanced-phase clinical trials within a period of no longer than two years after they end.
Links where information on the clinical trials that have been or are being conducted by ROVI may be found are shown below.
Enoxaparin Programme
| Development phase | Study | Registration | Publication |
|---|---|---|---|
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I |
Study of Pharmacodynamic Equivalence of Enoxaparin Rovi to Clexane®, in Healthy Volunteers |
Bemiparin Programme
| Development phase | Study | Registration | Publication |
|---|---|---|---|
|
I |
Tissue factor pathway inhibitor and anti-FXa kinetic profiles of a new low-molecular-mass heparin, Bemiparin, at therapeutic subcutaneous doses |
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|
I |
Comparative study of the pharmacokinetic profiles of two LMWHs--bemiparin (3500 IU, anti-Xa) and tinzaparin (4500 IU, anti-Xa)--administered subcutaneously to healthy male volunteers. |
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I |
Comparative pharmacodynamic time-course of bemiparin and enoxaparin in healthy volunteers |
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| I | Pharmacodynamics assessment of Bemiparin after multiple prophylactic and single therapeutic doses in adult and elderly healthy volunteers and in subjects with varying degrees of renal impairment | https://clinicaltrials.gov/ct2/show/NCT00413088 | https://pubmed.ncbi.nlm.nih.gov/24731560/ |
|
II |
Low molecular weight heparin (bemiparin sodium) and the coagulation profile of patients with heart failure |
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| II | Prophylactic antithrombotic therapy after orthopedic surgery with bemiparin, a second-generation low molecular weight heparin | - | https://pubmed.ncbi.nlm.nih.gov/11446940/ |
| II | Treatment of chronic diabetic foot ulcers with bemiparin: a randomized, triple-blind, placebo-controlled, clinical trial | https://clinicaltrials.gov/ct2/show/NCT00399425 | https://pubmed.ncbi.nlm.nih.gov/19183313/ |
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III |
A comparative double-blind, randomised trial of a new second generation LMWH (bemiparin) and UFH in the prevention of post-operative venous thromboembolism. The Bemiparin Assessment group |
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| III | Efficacy and safety of bemiparin compared with enoxaparin in the prevention of venous thromboembolism after total knee arthroplasty: a randomized, double-blind clinical trial | - | https://pubmed.ncbi.nlm.nih.gov/12871445/ |
| III | Low-molecular-weight heparin in the acute and long-term treatment of deep vein thrombosis | - | https://pubmed.ncbi.nlm.nih.gov/12669122/ |
| III | Clinical Trial to Evaluate the Efficacy and Safety of Sodium Bemiparin for Treatment of Diabetic Foot Ulcers | https://clinicaltrials.gov/ct2/show/NCT00448903 | https://www.rovi.es/sites/default/files/Malvern.pdf |
| III | Extended prophylaxis with bemiparin for the prevention of venous thromboembolism after abdominal or pelvic surgery for cancer: the CANBESURE randomized study | https://clinicaltrials.gov/ct2/show/NCT00219973 | https://pubmed.ncbi.nlm.nih.gov/20456751/ |
| III | Comparison of Once-Daily Bemiparin with Twice-Daily Enoxaparin for Acute Deep Vein Thrombosis: A Multicenter, Open-Label, Randomized Controlled Trial | https://clinicaltrials.gov/ct2/show/NCT01880216 | https://pubmed.ncbi.nlm.nih.gov/29214507/ |
| IV | Utilisation and safety of bemiparin, a low-molecular-weight heparin, in medical patients: a prospective, uncontrolled cohort study | - | https://pubmed.ncbi.nlm.nih.gov/17532688/ |
| IV | Low-molecular-weight heparin, bemiparin, in the outpatient treatment and secondary prophylaxis of venous thromboembolism in standard clinical practice: the ESFERA Study | - | https://pubmed.ncbi.nlm.nih.gov/16700847/ |
| IV | Fixed-dose low-molecular-weight heparin, bemiparin, in the long-term treatment of venous thromboembolism in patients with transient risk factors in standard clinical practice: the FLEBUS study | - | https://pubmed.ncbi.nlm.nih.gov/16911674/ |
| IV | A prospective observational study on the effectiveness and safety of bemiparin, first dose administered 6 h after knee or hip replacement surgery | - | https://pubmed.ncbi.nlm.nih.gov/17089172/ |
| IV | Optimal dosing of bemiparin as prophylaxis against venous thromboembolism in surgery for cancer: an audit of practice | - | https://pubmed.ncbi.nlm.nih.gov/17448976/ |
| IV | Evaluation of the effectiveness and safety of bemiparin in a large population of orthopedic patients in a normal clinical practice | - | https://pubmed.ncbi.nlm.nih.gov/17895506/ |
| IV | Thromboprophylaxis with the low-molecular-weight heparin bemiparin sodium in elderly medical patients in usual clinical practice: the ANCIANOS study | - | https://pubmed.ncbi.nlm.nih.gov/20384389/ |