Jugla Medical Center - Läti (Lisatud 19.
september 2003)
DNA
Diagnostics Laboratory, University College Galway - Iirimaa. (Lisatud 10.
september 2003)
PR euroCHEM Ltd. - Iirimaa (Lisatud 10.
september 2003)
Clinical Trials End-Point Ltd. (CTEP) - Iirimaa
(Lisatud 10. september 2003)
Jugla Medical Center, Riga - Läti
(Lisatud 10. september 2003)
Laboratory of Immunology of the Institute of
Biotechnology - Leedu (Lisatud 10. september 2003)
The Clinical Pharmacology Research
Unit, The Cardiology Institute, Assaf-Harofeh Medical Center - Iisrael
(Lisatud 10. september 2003)
Dr. Kopatch - Iisrael
(Lisatud 10. september 2003)
Partnerid Tšehhi Vabariigist
(Lisatud 10. september 2003)
Partnerid Sloveenia Vabariigist
(Lisatud 10. september 2003)
(Lisatud 19. september 2003)
Activity Code Areas addressed applicable instruments
lsh-2003-2.1.1-2
Molecular basis of exercise ipeffect on the metabolic syndrome noE
And insulin resistance
Natural dolichol like substances as modifier to exercise effects on progress of the Non Alcoholic Fatty Liver Diseases associated with metabolic syndrome
CONTRIBUTORS
Jugla Medical Center, Riga, Latvia
Medical & Pharmaceutical firm "BF- esse" Ltd, Riga, Latvia
Latvian Center of Infectology, Riga, Latvia
Juris Rubens, Dr. med.
Telphone + 371-7-521480
elita@internet.lv
Ejaz-ul-haq, Dr
Fax: +371-7-521397
Address: Jugla Medical Center,
2 Jugla Str., Riga, Latvia, LV-1024
Victor Roschin , Prof., Dr. State Academy of forestry engineering named after
S.M.Kirov, Saint Petersburg, Russian Federation
Yury Marakhouski, Prof., Dr. Med Department of Gatroenterology and Nutrition
Byelorussion Medical Academy of post Gradution Education,Republic of Belarus
Maris Daugaviatis, Prof., Dr Joint Stock Association "Biolat", Riga , Latvia
Objectives of Proposal Research
The main objective of this study is to assessment the promotional effects of the natural dolichol derivatives at different exercise interventions on the development progress of liver disorders and its complications on the general wellbeing of people with NAFLD associated with metabolic syndrome.
Types of studies
Prospective randomised controlled trials (RCT) fulfilling the inclusion
criteria..
Types of participants
All the studies will include adult participants, above 18 years old, who are
diagnosed with NAFLD. The acceptable diagnosis criteria will include those
described by: the American Association for the Study of Liver Diseases Studies
performed on participants with impaired glucose tolerance (IGT) will not be
included in the analysis.
Types of intervention
Studies that combine exercise and medication as an intervention will be
included in the separate analysis of the effect of medication and the effect of
exercise, which we intend to measure. It is common for exercise interventions to
be prescribed along with diet interventions. Based on the assumption that the
effects of diet and medication are additive to the effects of exercise, the
analysis will include the following subcategories:
Types of outcome measures
MAIN OUTCOME MEASURES
ADDITIONAL OUTCOME MEASURES
TIMING OF OUTCOME ASSESSMENT
Outcomes such as morbidity and mortality and the NAFLD progress will be assessed in
long-term studies ( > 1 year). Outcomes such as changes in metabolic syndrome parameters (levels of fasting insulin, glucose, blood pressure, and BMI), body weight and VO2 max will be assessed in long-term, medium term and short term ( < 6 weeks) studies.
Experimental part
Animal
Objectives
The main objective of this study is to assessment the
promotional effects of the natural dolichol derivatives at different exercise
interventions on the development progress of liver disorders in experimental
chronic liver disorder(steatisis/fibrosis) at animals (rat CD36/FAT-deficient
SHR/N, rats BN.SHR4 congenic strain and CD36(-/-) mice)
Types of studies
Prospective case control..
Types of intervention
Exercise can be defined as a form of physical activity by training animal in select dose regulating exercise, which is performed on a repeated basis for an extended period of time (exercise training). Physical activity comprises any body movement produced by skeletal muscle which results in a substantial increase in energy expenditure and dolichol utilisation to phosphorylation / glycosilation. Studies will be as the combine exercise and medication as an intervention and will be included in the separate analysis of the effect of medication and the effect of exercise, which we intend to measure. It is common for exercise interventions to be prescribed along with diet interventions. Based on the assumption that the effects of diet and medication are additive to the effects of exercise, the experimental will planed with specific standard diet regimes and include the following subcategories:
Types of outcome measures
MAIN OUTCOME MEASURES
ADDITIONAL OUTCOME MEASURES
TIMING OF OUTCOME ASSESSMENT
Outcomes such as NAFLD progress will be assessed in 6-8 weeks
(Lisatud: 10. september 2003)
The DNA Diagnostics Laboratory, UCG, has ongoing research activities in the following areas:
1) Development of tests using nucleic acid technologies (conventional and real-time formats) for food-borne, clinical and veterinary pathogens.
2) Investigation of the molecular basis of virulence, pathogenesis and antibiotic resistance in food-borne pathogens.
3) Molecular epidemiology of food-borne pathogens.
4) Investigation of the molecular genetics of male infertility and activated protein C resistance in pregnancy using conventional, real-time and micrarray-based technologies.
5) For further information on the activies of the research group, its track record and publication list, see www.nuigalway.ie/ndc/ Specifically with regard to opportunities in the current FP6 call, in 'Food Safety and Quality' T4, T22 and T23 are of interest.
For the 'Health' programme, 'development of genetic tests allowing for harmonization, validation and standardization' would be of interest.
Majella Maher
Team Leader
DNA Diagnostics Laboratory
TheNational Diagnostics Centre
NUI Galway
Tel. +353-91-512350
E-mail:
(Lisatud 10. september 2003)
PR euroCHEM is a small company specialising in providing chemical synthesis, and operates in the international market. The company is in existence for 5 years and performs contract synthesis of low volume/high value products for the chemical industry. Over the past 5 years, the company has carried out organic synthesis for multinational corporations in the UK, Europe and the US. The company also performs R&D for chemical companies to develop chemical production processes. The company has has state of the art production and analytical facilities and special expertise in the synthesis of natural products, pharmaceutical ingredients and intermediates and narcotics.
The company would be interested in partnering with suitable FP6 consortia, where it could provide organic synthesis services or be a partner for R&D activities.
Rabih-Gabriel Jaouhari (DSc)
General Manager
PR euroCHEM Ltd.
Ballyvolane Business Park, Unit C
Spring Lane, Ballyvolane
Cork, IRELAND
Tel.. 353 (0)21 4 212 146
Fax. 353 (0)21 4 212 151
Mobile: 353 (0)86 3684264
e-mail:
(Lisatud 10. september 2003)
CTEP, a Dublin-based international Contract Research Organisation, facilitates both the principle investigator and the trial sponsor to achieve accelerated completion of clinical trials. Deploying its novel proprietary internet technology, CTEP enables client companies to obtain earlier insights from trials, and to benefit from significant cost savings which accrue.
Recognising the need to make the clinical trial cycle shorter, CTEP has built their service in collaboration with clinical investigators, combining their specific on-site needs with those of the trial sponsor.
Investigators require a simpler process that will reduce administration, speed-up recruitment, resolve queries contemporaneously and eliminate the paper overload. Designed and created with the clinical research team, the CTEP internet-based electronic trial product, called SteelThread©, achieves this goal.
As a potential partner or subcontractor for an FP6 project, CTEP are specialists in clinical trial management. They can provide electronic data capture, data management and other contract research outsourcing services (for example, study design, regulatory applications, training and helpdesk). They facilitate the clinical research team, project team managers and clinical research associates to proactively manage studies, improving patient recruitment and study milestones. The types of project undertaken to date have included the following:
* Undertook 5000 patient data management project for a large company.
* Currently managing a 200 patient GP study, sponsored by the Irish Dept. of
Health.
* Currently shortlisted by a number of leading Pharma companies.
* Set-up electronic CRF for Site Management Organisation and Sponsor.
* Product customisation for a leading Oncology research centre.
CTEP can offer a project consortium the following range of services:
* Design and help manage small or large trials (strategic input)
* Undertake Post Marketing, Health Outcome, Quality of Life and
Pre-registration studies
* Undertake Project Management and Data Management
* Support / Helpdesk / Training
* Produce Reports e.g. Study Tracking, Safety Archive and Store Data
The company has a special interest and expertise in the areas of HIV and cancer.
Stephen Dorman or Tomįs O'Mahoney
Clinical Trial EndPoint (CTEP) Ltd.
8 Hanover Quay, Dublin 2, Ireland.
Phone: -353-1-673 1340,
E-mail:
(Lisatud 10. september 2003)
FULL TITLE:
Dolichol like natural derivative substances as a potential immuno modulator to liver diseasesCONTRIBUTORS
Jugla Medical Center, Riga, Latvia
Medical & Pharmaceutical firm "BF- esse" Ltd, Riga, Latvia
Latvian Center of Infectology, Riga, Latvia
Juris Rubens,Dr. med.
Telphone + 371-7-521480
elita@internet.lv
Ejaz-ul-haq, Dr
Fax: +371-7-521397
Address: Jugla Medical Center, 2 Jugla Str., Riga, Latvia, LV-1024
Victor Roschin, Prof., Dr.
State Academy of forestry engineering named after S.M.Kirov,
Saint Petersburg, Russian Federation
Yury Marakhouski, Prof., Dr.
Med Department of Gatroenterology and Nutrition Byelorussion Medical Academy of
post Gradution Education
Republic of Belarus
Maris Daugaviatis, Prof., Dr
Joint Stock Association "Biolat"
Riga, Latvia
PRESENT STATUS OF RESEARCH
BRIEF DESCRIPTION OF RESEARCH
We have developed the orignal semi-synthetic drug FITESTEN whose main active ingredient is the product of dolichol like substances as polyprenols (natural long-chain isoprenoid alcohols having common structure H-[-CH2-C(CH3)=CH-CH2-]n-OH where n=8-18 is a number of isoprene units). The prepration was found to possess much more wide and powerful physiological action as compared from description in literature for polyprenols.For example, We are the first to demonstrate immuno moudulation activity of exogenous polyprenols in additonal antiviral, anti-inflamatory and antioxidant effects of such substances. FITESTEN is our first preparation which is registered , approved and recommended in 1996 by Latvian Pharmacology Committee (Reg. No 950002) as a drug for treatment of sevral gastrointestinal diseases.
We developed the unique technology for the manufacture of FITESTEN and its active ingredients-polyprenols. The process includes chemical phosphorylation of starting material, isolation of the product and injection dosage form preparation. The technology is ecologically safe and has practically no waste products. The starting material (polyprenols) is the component obtained at present from needles of conifers , this source of the raw material is practically limitless in our country. Now we work on improving the FITESTEN manufacture and creating new orignal drugs from polyprenols.
LEGAL ASPECTS
FITESTEN,s deravatives manufacture is realised via "know
how" technology ,application of polyprenol as immuno modulator drug is patented
in Latvia (Republic of Latvia) patents no LV 11277from 20.02.1997.
"Product having an Hepatoprotective effectivity" (Republic of Latvia)
LV patents no LV 10925 from 20.06 1996 "Substance with immunomodulatory effect
United States patents. Patent no 5,731,357
Date of patent: May 24,1998
"Active immunomodulatory substance"*
Euroasian patents No 001115, From July 7 2000
"Method for diagnosing aggravation or remission of acquired immunodefficiency
and autoimmune diseases"
SPECIAL FACILITIES
At present, Polyprenols can be manufactured upto 10000 dosage /year ,but in need the manufacturing can be extended.In last case supplementary facilities would be useful.
SCIENTIFIC PAPER
Evaluation of the oral polyprenols efficacy at chronic liver diseases to
regarding the improvement of disease activity and cholestasis
Rubens Y.P , Marakhouvski Y.Kh , Medical Clinic BF-ESSE, Riga, Latvia,
Department of Gastroenterology and Nutrition, Medical Academy Postgraduation
Education , Minsk, Belarus
10th United European Gatroenterology week "UEGW 2002"
Geneva, Switzerland, 19-23 Oct 2002
Polyprenols Significance as the potential Hepatoprotective Compound
Marakhouvski Y.K, Rubens Y.P, Department of Gastroenterology and Nutrition
Byelorussian Medical Academy Postgradution Education, Medical firm
"BF-ESSE.Riga, Latvia
Baltic States Congress on Hepatology, Oct 3-5, 2002, Riga, Latvia
FUTURE RESEARCH DIRECTION
POTENTIAL APPLICATION
We plan:
We intend also to continue our investigation in the field of creating orignal polyprenyl containing compounds with planned physiological activity and to develop on this base a series of new effective and safe drugs possessing wide scope of therapeutic action
With Respect,
Dr. Ejaz-ul-haq
(Lisatud 10. september 2003)
Laboratory of Immunology of the Institute of Biotechnology (Vilnius,
Lithuania) would be interested to join research projects within this thematic
area:
1.1.1. Life Sciences, Genomics and Biotechnology for Health;
1.2.3. Development of new in vitro tests to replace animal
experimentation;
1.2.3-2: Non-animal test methods for chemicals, medicines, biologicals and
biomaterials: a prospective analysis (SSA).
Our laboratory has long-year experience in development and validation of in vitro bioassays using cell lines. Several in vitro bioassays for human recombinant cytokines have been established in our laboratory, including those for human interferons, TNF-alpha, G-CSF, IL-2, IL-3. Some of these bioassays were validated and introduced into pharmaceutical industry. We have close contacts with a biopharmaceutical company Sicor Biotech UAB (Vilnius, Lithuania), collaboration agreement with Micromun (Greifswald, Germany). Our current research project supported by Sicor Biotech and Lithuanian State Science and Study Foundation is aimed to develop an in vitro bioassay for human erythropoietin. Our laboratory has participated in a recent multicenter colaborative study on new International Standards for Human Interferon organised by NIBSC (results published in: Meager et al, J Imm Meth, 2001).
Relevant publications:
H.K. Sebeka, B.Starkuviene, O.V.Trepsiene, A. A.Pauliukonis, V.A.Bumelis. Comparative effects of stabilizing additives on the rates of heat inactivation of recombinat human interferon-a2b in solution. Antiviral Res. 2001, 50: 117-127.
A.Zvirbliene, O.V.Trepsiene, M.Mauricas. PDGF induces proliferation of myeloid leukemia G-NFS-60 cells, In: EFIS 2000. 14 European Immunology Meeting. Monduzzi Editore, Bologna, Italy, 2001, p. 447-453.
A.Žvirblienė, O-V.Trepšienė
, M.Mauricas. Expression of a functional PDGF beta receptor by myeloid leukemia G-NFS-60 cells. Acta Medica Lituanica, 2000 suppl.5: 70-74Meager A, Gaines Das R, Zoon K, Mire-Sluis A. Establishment of new and replacement World Health Organization International Biological Standards for human interferon alpha and omega. J Immunol Methods. 2001; 257(1-2): 17-33.
Team:
Dr. Aurelija Zvirbliene, Senior scientist, Head of the Laboratory of
Immunology;
Dr. Ona Trepsiene, Scientist,
Laura Shamonskyte, PhD Student,
Loreta Jasiuleviciute, Assistant.
Contact person: Dr. Aurelija Zvirbliene,
azvirb@ibt.lt
Institute of Biotechnology, EU Centre of Excellence www.ibt.lt
The Institute of Biotechnology is a State Research Institute, leader in molecular biology, genetic engineering and cytokine research in Lithuania. It was founded in 1975. The Institute comprises 8 laboratories, 105 employees: 42 scientists, 23 assistants and students, 40 technicians, engineers, administrative personnel. The main research areas are: restriction-modification enzymes and recombinant biomedical proteins. Currently 12 international RTD projects are financed by: European Comission (6), Howard Hughes Medical School (3), NATO (1), Volkswagen Stiftung (l), Wellcome Trust (1). Since 2002, the Institute is EU Centre of Excellence (project BIOCEL, QL-AM-2001-00575).
The Laboratory of Immunology has excellent basic infrastructure for tissue culture, molecular biology, immunochemical and immunofluorescence analysis. The Laboratory has good contacts with clinical laboratories and hospitals in Lithuania, biotechnological companies Fermentas and Sicor Biotech (Lithuania), collaborates with partners from Sweden, Latvia, Germany, Canada. The Laboratory has participated in several international projects supported by EuroHep, INCO-Copernicus, BMBF (Bundesministerium fur Bildung und Forschung, Germany). Currently the Laboratory is supported by research grants from the Lithuanian Science and Study Foundation and Framework 5 programme QLK4-1999-01446. The main research areas are: cytokine research, development of new monoclonal antibodies, epigenetic studies of complex diseases, studies on immune response mechanisms in chronic inflammation, immunogenicity studies of new recombinant vaccines.
(Lisatud 10. september 2003)
Partners especially sought for pre-clinical and genomic aspects for a project being organized for submission in Call 2, LifeSciHealth, LSH-2003-2.1.0-1: EICOSANOIDS AND NITRIC OXIDE: MEDIATORS OF CARIOVASCULAR, CEREBRAL AND NEOPLASTIC DISEASES.
Please contact Dr. Cotter directly or send an email to ISERD.
1.
AbsractBACKGROUND: Cardiogenic shock continues to be the major cause of mortality for patients suffering acute myocardial infarction (AMI). Although recent studies testing the effect of early revascularization have shown improvement in outcome, almost half of patients suffering from this complication do not survive their hospital course. Nitric oxide (NO) has been implicated in the pathogenesis of myocardial stunning during experimental ischemia and reperfusion, and likely is one of the key factors contributing to generalized myocardial and vascular dysfunction in the setting of cardiogenic shock. During ischemia and reperfusion inducible NOS (iNOS or NOS-II) causes the synthesis of excess NO. This results in production of peroxynitrites that have a deleterious effect on cell function and contribute to myocyte injury. By virtue of its vasodilatory effect, excess NO also inhibits the vasopressor response that would be generated in response to a hypoperfused, low output state that exists in the setting of cardiogenic shock. Excess NO also suppresses glucose metabolism. Recently, infusion of L-monomethy-arginine (L-NMMA), a nonselective inhibitor of nitric oxide synthase (NOS), and a similar agent L-NAME, have shown promise in improving blood pressure, urine output and survival in 2 small studies of patients with cardiogenic shock.
STUDY AIMS The central hypothesis of the pilot study is that treatment with the nonselective NOS inhibitor L-NMMA will improve blood pressure and systemic perfusion as indicated by lactate levels compared to placebo in patients with acute myocardial infarction complicated by cardiogenic shock. A secondary hypothesis is that that treatment with the NOS inhibitor L-NMMA will improve left ventricular (LV) function at 24 and 72 hours.
The primary objectives are: 1) to evaluate the efficacy of L-NMMA in improving mean arterial pressure (MAP) at 2 hours in patients with acute myocardial infarction complicated by cardiogenic shock who have persistent shock despite an open infarct-related artery 2) to determine the safety of therapy with L-NMMA administered revascularization in the treatment of critically ill patients with a control in-hospital mortality of close to 60%; Secondary objectives include the effects of L-NMMA on 1) MAP at 6, 12, 24 and 72 hours, 2) serum lactate at 24 and 72 hours, 3) change in plasma creatinine at 24 and 72 hours, 4) urine output 24 and 72 hours, 5) LV function, systolic and diastolic function and regional wall motion at 6, 12, 24 and 72 hours, 6) need for vasopressors at 24, 48 and 72 hours, 7) time needed for ventilatory support, 8) time needed for IABP support, 9) mortality at 30 days and 6 months, and 10) NYHA Class IV CHF at 30 days and 6 months.
STUDY DESIGN The study is the pilot phase of a double-blind, prospective, randomized, multicentre trial of treatment with L-NMMA to reduce death in patients with acute myocardial infarction complicated by cardiogenic shock who have had patency of the infarct-related artery established by percutaneous coronary intervention (PCI) and who remain in cardiogenic shock between 1 and 12 hours after the PCI procedure. The main aim of this pilot phase is to assess the efficacy of L-NMMA administered to patients with cardiogenic shock complicating acute MI who have had PCI resulting in patency of the infarct-related artery and who remain in shock between 1 and 12 hours post-procedure, in improving mean arterial pressure (MAP) at 2 hours. The primary endpoint is change in MAP at 2 hours. Secondary end-points include change in MAP at 6, 12, 24 and 72 hours, change in serum lactate and urine output at 24 and 72 hours, LV function at 6, 12, 24 and 72 hours, duration of required intra-aortic balloon pump support and mechanical ventilation, safety of L-NMMA and death and NYHA Class IV heart failure at 30 days and 6 months. The sample size will be 30 patients, or 15 patients per treatment arm. This sample will have 85% power to detect a difference in the change in MAP between the 2 groups of 20 mm Hg.
Contact:
Gad Cotter MD
The Clinical Pharmacology Research Unit
The Cardiology Institute
Assaf-Harofeh Medical Center
70300, Zerifin, ISRAEL
Tel: +972-8-9779340/1, Fax: +972-8-9779779
The Sackler Faculty of Medicine, Tel-Aviv University
E-mail: cotterg@hotmail.com
(Lisatud 10. september 2003)
Project Proposal: Genetically modified Dendritic cells for new vaccine development
A partner search for a project which could fit into one of these topics in
Call 2, LifeSciHealth,
LSH-2003-1.2.4-1;
LSH-2003-1.2.4-2;
LSH-2003-1.2.4-6;
LSH-2003-1.2.4-7
So far, there is a core group of France and Israel--additional countries are
welcome or perhaps, you know of a group organizing around one of these topics to
which this small group could join. Please contact Dr. Kopatch directly
Summary of project objectives: short
Keywords: Immunotherapy, vaccine, Dendritic Cells, monocytes,
genetically-modified DCs, transfection, nonviral vectors, antigen-encoding cDNA
The purpose of this project is to initiate a basic study, exploring the possibility of delivering DNA into primary monocytes and DCs by nonviral gene delivery. The project will be set up as collaboration between the Dr. Jean-Paul Behr and his staff (Polyplus transfection, Illkirch, France), and the laboratory of Dr. Steffen Jung at the Department of Immunology at the Weizmann Institute. As a gene delivery vector, we will employ linear polyethylenimin (PEI),6,7 which was developed by Dr. Behr and is among the most efficient and popular compounds for delivery of DNA into animal cells, also for primary cell cultures.8,9,10 Dr. Jung is interested in the development and function of DCs, 11,12,13 as well as in applicative aspects of these cells, and his lab will host the project.
As a first stage, we will work on protocols that allow efficient gene transfer into freshly isolated monocytes and BM-derived murine DCs. We will try to resolve some of the problems that set limit so far for the use of non-viral vectors in these cells.
At the second stage of the project, and if considerable transfection efficiencies will be achieved in vitro, we will investigate the immuno-potential of the transfected cells with respect to GFP in vivo, upon adoptive transfer into recipient mice. The proposed project combines the group of Jean-Paul Behr, a world-leading group in the field of non-viral gene therapy, to the research team of Dr. Steffen Jung and will lead to a mechanistic study of gene delivery into DCs/monocytes, employing immunological tools. While the proposed project is of a fundamental nature, it is expected to have applicative implications for the development of DCs-based vaccines.
The project will be carried out by Dr. Kopatz who had recently returned from a postdoctoral training in the laboratory of Dr. Jean-Paul Behr. Dr. Kopatz had studied some mechanistic aspects of transfection17 and her joining to the research team of Steffen Jung will ensure efficient technology transfer between the labs.
Contact:
Dr. Idit Kopatch
Iditko@hotmail.com
(Lisatud 10. september 2003)
Potentsiaalseid partnereid on 26, põhjalikum informatsioon ja ülevaade vt lisatud failist (rtf)
Book of Abstracts
for Poster Offering Cooperation (EuroMicroDay 2003) (rtf)
Book II of Abstracts for Poster
Offering Cooperation (rtf)