XEPOL Immonogobulina Intravenosa Medicamento Para SPP Publicado en el 2006

Effect of intravenous immunoglobulin in patients with post-polio syndrome — an uncontrolled pilot study.
Kaponides G, Gonzalez H, Olsson T, Borg K.
Department of Public Health Sciences, Division of Rehabilitation Medicine, Stockholm, Sweden. georgios.kaponides@ds.se
Abstract
OBJECTIVE: To analyse changes in muscle strength, physical performance and quality of life during intravenous immunoglobulin (IVIg) treatment in patients with post-polio syndrome. DESIGN: Open clinical trial.Patients: A total of 14 patients (6 women, 8 men; mean age 57 years, range 43-67 years) were included in the study. INTERVENTION: Treatment with 90 g IVIg (30 g daily for 3 days). Main outcome: Muscle strength, measured with dynamic dynamometry, muscle function, by means of performing the 6-minute walk test, and quality of life, analysed by means of the SF-36 questionnaire, were performed before and after treatment. RESULTS: For quality of life there was a statistically significant improvement for all but one of the 8 multi-item scales of SF-36 when comparing data before and after treatment with IVIg. The multi-item scale most improved was Vitality. There was no significant increase in muscle strength and physical performance. CONCLUSION: Data indicate that IVIg may have a clinically relevant effect, with an improvement in quality of life. The effect may be due to a decrease in an inflammatory process in the central nervous system, which earlier has been reported in patients with past-polio syndrome after IVIg treatment. Since a possible placebo effect cannot be ruled out, a randomized controlled study is needed.
PMID: 16546773 [PubMed – indexed for MEDLINE]

Eur J Neurol. 2007 Jan;14(1):60-5.
Post-polio syndrome patients treated with intravenous immunoglobulin: a double-blinded randomized controlled pilot study.
Farbu E, Rekand T, Vik-Mo E, Lygren H, Gilhus NE, Aarli JA.
Department of Neurology, Haukeland University Hospital, Bergen, Norway. elfa@sir.no
Abstract
Post-polio syndrome (PPS) is characterized by new muscle weakness, atrophy, fatigue and pain developing several years after the acute polio. Some studies suggest an ongoing inflammation in the spinal cord in these patients. From this perspective, intravenous immunoglobulin (IvIg) could be a therapeutic option. We performed a double-blinded randomized controlled pilot study with 20 patients to investigate the possible clinical effects of IvIg in PPS. Twenty patients were randomized to either IvIg 2 g/kg body weight or placebo. Primary endpoints were changes in pain, fatigue and muscle strength 3 months after treatment. Surrogate endpoints were changes in cerebrospinal fluid (CSF) cytokine levels. Secondary endpoints were pain, fatigue and isometric muscle strength after 6 months. Patients receiving IvIg reported a significant improvement in pain during the first 3 months, but no change was noted for subjective fatigue and muscle strength. CSF levels of tumour necrosis factor-alpha (TNF-alpha) were increased compared with patients with non-inflammatory neurological disorders. In conclusion, in this small pilot study no effect was seen with IvIg treatment on muscle strength and fatigue, however IvIg treated PPS patients reported significantly less pain 3 months after treatment. TNF-alpha was increased in the CSF from PPS patients. The results are promising, but not conclusive because of the low number of patients studied.
PMID: 17222115 [PubMed – indexed for MEDLINE]
Xepol® (XP-28)
The first medical treatment of Post-Polio Syndrome

Xepol is the first pharmaceutical product to address the unmet medical need of patients suffering from Post-Polio Syndrome (PPS). Even though new infections from the poliovirus ceased in developed countries more than 30 years ago, many patients are now struggling with renewed complications from the disease. While rarely fatal, the neurological and muscular symptoms of PPS are lifelong and debilitating. There is no medical treatment besides physiotherapy and assistive devices. Approximately 30-40% of survivors of paralytic polio develop severe PPS. There are around 300,000 PPS patients in major Western markets.
Product background

The concept behind Xepol was first developed by Dr Henrik Gonzalez and Professor Kristian Borg, both scientists at the Karolinska Institute (Sweden), and is backed by strong evidence suggesting an underlying neuroinflammatory pathology. Xepol is an injectable biological product which is administered once every 9 – 12 months and down regulates the inflammatory process in the nervous system of PPS patients. It was acquired by Pharmalink as an original concept backed by preliminary positive clinical observations.
Xepol is protected by patents in major markets. In addition, market exclusivity was achieved by a US Orphan Drug Designation granted in 2006.
Given the prevalence of PPS, there is the potential to achieve orphan drug designation in all major markets.
Development status

Following positive preliminary clinical studies, Pharmalink sponsored a Phase III of Xepol in PPS. The trial clearly met one of its two primary endpoints, relating to muscle strength, and results were published in the Lancet. In a follow-on study trial, still double-blinded, a defined subset of patients met both original endpoints showing a reduction of inflammatory cytokines in the cerebrospinal fluid and a significant reduction of symptoms of PPS while also showing that Xepol is safe and well tolerated with few or no side-effects. Significant results were also shown in endpoints such as pain, walking ability and SF-36 scores.
A confirmatory Phase III study will be a further step in the development of Xepol, creating a basis for regulatory applications in the US, Europe and other potential markets. Pharmalink has prepared plans for the Phase III trial to be conducted in the US.
Pharmalink is actively seeking a partner to bring Xepol onto the market.Lancet Neurol. 2006 Jun;5(6):493-500.
Intravenous immunoglobulin for post-polio syndrome: a randomised controlled trial.
Gonzalez H, Sunnerhagen KS, Sjöberg I, Kaponides G, Olsson T, Borg K.
Division of Rehabilitation Medicine, Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden. henrik.gonzales@telia.com
Abstract
BACKGROUND: Survivors of poliomyelitis often develop increased or new symptoms decades after the acute infection, known as post-polio syndrome. Production of proinflammatory cytokines within the CNS indicates an underlying inflammatory process, accessible for immunomodulatory treatment. We did a multicentre, randomised, double-blind, placebo-controlled study of intravenous immunoglobulin in post-polio syndrome. METHODS: 142 patients at four university clinics were randomly assigned infusion of either 90 g in total of intravenous immunoglobulin (n=73) or placebo (n=69) during 3 consecutive days, repeated after 3 months. Seven patients were withdrawn from the study. Thus, 135 patients were assessed per protocol. Primary endpoints were muscle strength in a selected study muscle and quality of life as measured with the SF-36 questionnaire (SF-36 PCS). Secondary endpoints were 6-minute walk test (6MWT), timed up and go (TUG), muscle strength in muscles not chosen as the study muscle, physical activity scale of the elderly (PASE), visual analogue scale (VAS) for pain, multidimensional fatigue inventory (MFI-20), balance, and sleep quality. Outcome tests were done immediately before the first infusion and 3 months after the second infusion. This study is registered with , number NCT00160082. FINDINGS: Compared with baseline, median muscle strength differed by 8.3% between patients receiving intravenous immunoglobulin and placebo, in favour of the treatment group (p=0.029). SF-36 PCS did not differ significantly between the groups after treatment (p=0.321). Differences in the subscale vitality score (p=0.042) and PASE (p=0.018) favoured the active treatment group. MFI-20, TUG, muscle strength in the muscles not chosen as the study muscle, 6MWT, balance, and sleep quality did not differ between groups. For the whole study population there was no significant change in pain, as determined by VAS. Nevertheless, patients who reported pain at the study start improved in the intervention group but not in the placebo group (p=0.037). Intravenous immunoglobulin was well tolerated. INTERPRETATION: Intravenous immunoglobulin could be a supportive treatment option for subgroups of patients with post-polio syndrome. Further studies on responding subgroups, long-term effects, and dosing schedules are needed.
PMID: 16713921 [PubMed – indexed for MEDLINE]
Publication Types, MeSH Terms, Substances, Secondary Source ID
LinkOut – more resourcesEfficacy and Safety of Xepol (Human Immunoglobulin) in Subjects With Post-Polio Syndrome (PPS)
This study has been completed.
First Received: September 9, 2005 Last Updated: April 2, 2007 History of Changes
Sponsor:
Pharmalink AB
Information provided by:
Pharmalink AB
ClinicalTrials.gov Identifier:
NCT00160082
Purpose
The primary objective was to assess the effect of Xepol compared to placebo on physical health and on muscle strength in subjects with post-polio syndrome.The secondary objective was to assess the effect of Xepol compared to placebo on functional balance, activity patterns, pain, fatigue, sleep, vitality, muscular strength, pulmonary capacity, walking ability, balance and safety.

Condition
Intervention
Post Polio Syndrome, PPS
Drug: Xepol

Study Type:
Interventional
Study Design:
Allocation: Randomized
Control: Placebo Control
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title:
Efficacy and Safety of Xepol (Human Immunoglobulin) in Subjects With Post-Polio Syndrome (PPS): A Randomized, Two-Arm, Parallel, Double-Blind, Multi-Centre, Placebo Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Fatigue Polio and Post-Polio Syndrome
Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources

Further study details as provided by Pharmalink AB:

Primary Outcome Measures:
Primary endpoints:
Physical health was quantified using the SF-36 questionnaire scales summarized into the composite Physical Component Summary (PCS) measure.
Muscular strength was measured using a dynamometer or anelectronic grip force sensor (GRIPPIT) depending on the musclechosen.

Secondary Outcome Measures:
Secondary endpoints:
Functional balance was assessed by using the Timed “Up and Go” (TUG) test.
Activity pattern was assessed by the Physical Activity Scale of the Elderly (PASE).
Pain was assessed by a Visual Analogue Scale and by a pain drawing.
Fatigue was assessed using the Multidimensional Fatigue Inventory (MFI-20) questionnaire.
Vitality was assessed using the vitality subscale (VT) of SF-36 questionnaire.
Sleep was assessed using the Sleep quality scale.
Muscular strength measured by a dynamometer and an electronic grip force sensor (GRIPPIT) for those muscles not included as the primary endpoint.
Walking ability was assessed by a 6 minutes walking test.
Pulmonary capacity (vital capacity, FEV1, FEV %) was measured by a standard spirometer method.
Balance was assessed as postural sway velocity and the subject’s ability to voluntarily sway to various locations in space (NeuroCom Balance Master) or balance assessed by static and dynamic posturography (Chattecx® balance system)
Adverse events
Vital signs (blood pressure and heart rate)
Physical examination
Laboratory tests

Estimated Enrollment:
124
Study Start Date:
January 2001
Estimated Study Completion Date:
May 2003
Detailed Description:
Study Rationale:
In an earlier open and non-controlled study in 10 patients with PPS, Xepol was given during three days. The patients showed improvements in muscular strength and co-ordination and a decrease in pain. The aim of this study was to investigate if these findings can be confirmed in a larger, double-blind, randomised and placebo controlled study.
There are no simple clinical findings and specific laboratory changes that can be used to indicate the severity and progress of PPS. Different self-reporting questionnaires and objective measures of disability have often been used in clinical studies including SF-36 questionnaire, muscle strength measurement and walking test. The primary and secondary variables in this study were based on the clinical experience and literature reviewed.
Eligibility

Ages Eligible for Study:
18 Years to 75 Years
Accepts Healthy Volunteers:
No
Criteria
Inclusion Criteria:
Male or female subjects ≥18 to ≤75 years of age.

Post-polio syndrome according to Halstead and Gawne:
History of polio virus infection
Restitution or improvement regarding motor function and disabilities after initial infection
Confirmed polio by EMG
Subjectively increased muscular weakness after a period of at least 15 years functional stability
No other explanation but post-polio syndrome to the symptoms
Confirmed polio by EMG in the lower extremities in at least two of the following major muscle groups; musculi quadriceps, gastrocnemicus and tibialis anterior. (Two affected muscle groups in the same extremity were accepted).
Subjectively increased muscular difficulties or pain after a period of at least 15 years functional stability.
A muscle that had deteriorated within the last five years, and had 20-75 % of the muscle strength compared to age matched normal population when measured by a dynamometer or an electronic grip force sensor (GRIPPIT).
Stable weight (defined as weight change <7 kg) during the last five years.
Body Mass Index (BMI) £ 29 kg/m2.
Subjects capable to understand given information and had signed the Informed Consent Form after full discussion of the research nature of the treatment and its risks and benefits.

Exclusion Criteria:
Known or suspected intolerance to trial product or related products (e.g. sorbitol, glucose and fructose).
Selective IgA deficiency.
Inability to walk with walking aids.
Any active malignancy, history of active malignancy or treatment for malignancy during the last three years.
Disabling pain from extremities or skeletal system due to previous fracture(s), arthritis or other reasons not related to PPS.
Subjects who received or who within 12 weeks prior to enrolment received any immunosuppressive/ systemic corticosteroid treatment (topical corticosteroids excluded).
Treatment with intravenous human immunoglobulin for the Post-polio syndrome within six months prior to the first screening visit.
Participation in any other study during this study and the receipt of any investigational drug within three months prior to the screening visit.
Pregnancy or lactation or females of childbearing potential taking inadequate measures to prevent pregnancy.
Hepatitis or HIV disease.
Increased liver enzymes (ASAT, ALAT, γGT) above twice the upper normal value.
Creatine kinase >10 mkat/l.
Any disease or treatment that according to the discretion of the Investigator could pose a medical threat to the subject in combination with study drug, i.e. clinical manifested severe cardiovascular disease or severe arteriosclerosis or severe psychiatric disorder or other treatment that affected the immunological system such as prednisone and methotrexate.
Any disease or condition that according to the discretion of the Investigator would obstruct the subject from performing the tests in the protocol (e.g. fill in the questionnaires).
Conditions associated with a risk of poor protocol compliance (e.g. known drug or alcohol abuse).
Previous participation in the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00160082

Locations
Sweden
Danderyd Hospital
Danderyd, Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden
Huddinge University Hospital
Stockholm, Sweden, SE-141 86
Uppsala Academic Hospital
Uppsala, Sweden
Sponsors and Collaborators
Pharmalink AB
Investigators
Principal Investigator:
Kristian Borg, MD, Prof
Department of Rehabilitation Medicine;Huddinge University Hospital; Stockholm, Sweden
More Information

Inmunoterapias y vacunas para los no tradicionales Indicaciones Informe – Tabla de contenidos

Autor: Sannes Lucy J., PhD, MBA
CAPÍTULO 1

INTRODUCCIÓN
1.1. El Sistema Inmune
1.2. Objeto del informe
CAPÍTULO 2

ENFERMEDAD DE ALZHEIMER
2.1. Enfermedad de Alzheimer Fisiopatología, Epidemiología, y los tratamientos actuales
2.2. ¿Por qué vacunas o inmunoterapias para el tratamiento de la enfermedad de Alzheimer?
2.3. Empresas que desarrollan o inmunoterapias Vacunas para la Enfermedad de Alzheimer
AFFITOPE AFFiRiS ‘AD01 y AD02 AFFITOPE
Gammagard Baxter
Novartis y la biotecnología Cytos de CAD106
Eli Lilly LY2062430
Genentech y AC Immune anti-Abeta
GSK933776A de GlaxoSmithKline
Inmunoterapia JANSSEN de Alzheimer (parte de Johnson &
Johnson) y bapineuzumab de Pfizer
Merck & Co. ‘s V950
Octagam de Octapharma
PF-4360365 de Pfizer
Roche y MorphoSys "RG1450
2.4. Las consideraciones comerciales: inmunoterapias para la enfermedad de Alzheimer
CAPÍTULO 3

ADICCIÓN
3.1. Fisiopatología, Epidemiología y Tratamiento actual
Adicción a la cocaína
Adicción a la nicotina (para dejar de fumar)
3.2. ¿Por qué inmunoterapias para el apego?
3.3. Empresas que desarrollan inmunoterapias para adicción a la cocaína o
Para dejar de fumar
Adicción a la cocaína
Celtic Pharma TA-CD
Adicción a la nicotina (para dejar de fumar)
Celtic Pharma TA-NIC
NicVAX Nabi Biopharmaceuticals ‘
Novartis y la biotecnología Cytos de NIC002
3.4. Las consideraciones comerciales: inmunoterapias para adicción a la cocaína o para dejar de fumar
CAPÍTULO 4

NEUROLOGÍA otras indicaciones de MONOCLONALES
ANTICUERPOS e inmunoterapias
4.1. Fisiopatología, Epidemiología y Tratamiento actual
La neuropatía motora multifocal Dolor Síndrome Post-Polio Otras indicaciones potenciales Neurología

4.2. ¿Por qué inmunoterapias para el tratamiento del dolor?
4.3. Empresas que desarrollan o Marketing inmunoterapias para otras indicaciones neurológicas
Alexion Pharmaceuticals Soliris (eculizumab)
Array BioPharma Arry-797
Globulina Inmune de Baxter
Inmunoglobulina Behring CSL
GlaxoSmithKline 249320 (GSK249320)
Tanezumab de Pfizer
Xepol PharmaLink de (XP-28)
Gamunex Biotherapeutics Talecris
4.4. Las consideraciones comerciales: inmunoterapias para otras indicaciones neurológicas
CAPÍTULO 5

ENFERMEDADES CARDIOVASCULARES incluyendo trombosis
5.1. Fisiopatología, Epidemiología y Tratamiento actual
Angina
La aterosclerosis
Dislipidemia (colesterol y otros lípidos)
Hipertensión
Tromboembolismo venoso
Toxicidad por digoxina
5.2. ¿Por qué inmunoterapias para una selección de las enfermedades cardiovasculares?
5.3. Empresas que desarrollan inmunoterapias para las enfermedades cardiovasculares
ALX Ablynx ‘y ALX-0081-0681
DigiFab BTG
La angiotensina BTG vacuna terapéutica
Centocor Ortho Biotech y ReoPro Eli Lilly (abciximab)
La biotecnología Cytos de CYT006-AngQb
Genentech y BioInvent Internacional de Lucha contra el oxLDL (BI-204)
Digibind de GlaxoSmithKline
Roche y la de Genmab RG1512
ThromboGenics y BioInvent Internacional de la TB-402
5.4. Las consideraciones comerciales: inmunoterapias para las enfermedades cardiovasculares
CAPÍTULO 6

Hematología / TRASTORNOS DE LA SANGRE

6.1. Fisiopatología, Epidemiología y Tratamiento actual
Idiopática (inmune) Púrpura Trombocitopénica (PTI)
La hemoglobinuria paroxística nocturna (HPN)
La incompatibilidad Rh y enfermedad hemolítica del recién nacido (HDN)
6.2. ¿Por qué inmunoterapias para hematología seleccionada / Trastornos de la Sangre?
6.3. Empresas que desarrollan o Marketing de inmunoterapias
Hematología y Enfermedades de Sangre
Amgen Nplate (romiplostim)
Globulina Inmune Los preparativos para la idiopática (inmune)
Púrpura trombocitopénica (ITP)
Rho (D) y preparaciones de inmunoglobulinas Rhesus LFB Anti-D
Anticuerpo monoclonal
6.4. Las consideraciones comerciales: inmunoterapias para hematología / Trastornos de la Sangre
CAPÍTULO 7

OFTALMOLOGÍA
7.1. Fisiopatología, Epidemiología y Tratamiento actual

Relacionada con la Edad Degeneración Macular (AMD)
Retinopatía diabética y edema macular diabético
Oclusión venosa retiniana
La uveítis
7.2. ¿Por qué la base terapias de anticuerpos-para una selección de las enfermedades oftalmológicas?
7.3. Empresas que desarrollan terapias-base de anticuerpos para las enfermedades oftalmológicas
ESBATech ESBA105
Genentech y Novartis Lucentis (ranibizumab)
Lpath iSONEP (sonepcizumab)
7.4. Las consideraciones comerciales: En base a terapias-de anticuerpos para las enfermedades oftalmológicas
CAPÍTULO 8

OSTEOPOROSIS Y OTROS TRASTORNOS DEL METABOLISMO ÓSEO
8.1. Fisiopatología, Epidemiología y Tratamiento actual
8.2. ¿Por qué anticuerpos para una selección de Metabolismo Enfermedades Óseas?
8.3. Empresas que desarrollan anticuerpos para la osteoporosis y otros trastornos del metabolismo óseo

ALX Ablynx ‘-0141
Amgen Prolia (denosumab)
Amgen y UCB Pharma Ab esclerostina
8.4. Negocios Consideraciones: Los anticuerpos para la osteoporosis y otros trastornos del metabolismo óseo
CAPÍTULO 9

DIABETES TIPO 2

9.1. Fisiopatología, Epidemiología y Tratamiento actual
9.2. ¿Por qué Anticuerpos Monoclonales para la diabetes tipo 2?
9.3. Empresas que desarrollan anticuerpos monoclonales para la diabetes tipo 2

Amgen AMG 477
La biotecnología Cytos de CYT013-IL1bQb
Novartis Ilaris (canakinumab)
XOMA Xoma de 052
9.4. Las consideraciones comerciales: Anticuerpos Monoclonales para la diabetes tipo 2
CAPÍTULO 10

OTRAS APLICACIONES DE ANTICUERPOS Y

Inmunoterapias
10,1. Empresas que desarrollan anticuerpos, a base de anticuerpos Drogas y Medicamentos Anti-inflamatorios para otras indicaciones 153

Fármacos para el seleccionado Otras indicaciones
Amgen AMG 745
AstraZeneca y CytoFab BTG
CroFab BTG y ViperaTAb
ESBATech ESBA105
FG-3019 de FibroGen
Genzyme GC1008
GlaxoSmithKline 656933 (Sb656933)
Novartis Ilaris (canakinumab)
Globulina Inmune preparativos para otras indicaciones
10,2. Las consideraciones comerciales: Anticuerpos e inmunoterapias para otras indicaciones
CAPÍTULO 11

ENTREVISTAS DE EXPERTOS 165
11,1. Steven Glazer, MD; Vicepresidente Senior de Desarrollo Internacional BioInvent
11,2. Beate (Josi) Holz, MD, responsable médico de Josefin-&-Lotta Allan Eva, Oficial Jefe de Negocios; Ablynx
11,3. David Y. Liu, PhD, Vicepresidente de Investigación y William Hodder, Vicepresidente de Desarrollo de Negocios; FibroGen
11,4. Pakola Steve, MD; Director General de Salud; ThromboGenics
11,5. Andrea Pfeifer, PhD, director general; AC Immune
11,6. Roger Sabbadini, PhD, fundador, vicepresidente principal oficial científico; Lpath
11,7. Walter Schmidt, PhD, director general; AFFiRiS

J Clin Immunol. 2010 Apr 28. [Epub ahead of print]
Immunoglobulin Responsive Chronic Pain.
Goebel A.
Pain Research Institute, 3rd Floor, Clinical Sciences Centre, Liverpool University, Lower Lane, Liverpool, L9 7AL, UK, andreasgoebel@rocketmail.com.
Abstract
INTRODUCTION: Over the last 15 years, clinical and experimental data have emerged that suggest that peripheral and central, glial-mediated neuroimmune activation is both necessary and sufficient to sustain chronic pain. Immune modulation appears to be, therefore, a possible new therapeutic option.

MATERIALS AND METHODS: The Medline database and international trial registry databases were searched using the keywords "intravenous immunoglobulin" or "IVIG," "pain" or "chronic pain," "neuropathic pain," "CRPS," "complex regional pain syndrome" or "fibromyalgia." RESULTS: Evidence from RCTs suggest that IVIG is effective to reduce pain in complex regional pain syndrome (low-dose IVIG) and post-polio syndrome (high-dose IVIG), and open trials have suggested efficacy in additional pain conditions.

CONCLUSION: IVIG therapy may emerge as a novel treatment modality for refractory cases. However, before this drug can be confidently used by clinicians, important questions need to be answered concerning optimal treatment doses, duration of treatment, and its effect on function and quality of life.
PMID: 20424897 [PubMed – as supplied by publisher]
LinkOut – more resources

Clasificación Internacional de Enfermedades Codifico al Síndrome de Post Polio con el Código G14 Síndrome Postpolio Incluye : Síndrome postpoliomielítico Excluyéndolo del código B91Secuelas de poliomielitis

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