Augusto B. Leguía regresó de Europa a fines del siglo XIX durante una crisis de gobierno en Perú. En 1919 fue elegido Presidente con el apoyo de la oposición y los sectores populares emergentes, aunque muchos no tenían derecho a voto. Rompió con el consenso que dio estabilidad a la República aristocrática desde el último golpe militar. Las elecciones de 1919 mostraron un ambiente calmado pero con irregularidades e impugnaciones que llevaron a que la Corte Suprema anulara votos, haciendo que Legu
Rio Info 2010 - Seminário de Tecnologia - Integração de coisas - Edmo Lopes -...Rio Info
O documento fornece um resumo histórico das principais invenções e avanços tecnológicos que levaram à era digital atual. Também discute os desafios das empresas em atrair e reter talentos em um mundo cada vez mais conectado e remoto, com mudanças nas relações de trabalho e nas expectativas dos funcionários. Por fim, destaca os desafios dos líderes em lidar com times globalizados e a necessidade de adaptação constante às novas tecnologias e modelos organizacionais.
Este documento presenta un resumen de la tesis doctoral de Jesús María Izaguirre Ronda titulada "Una antropología trascendental para la educación. La acción educativa según el pensamiento de Leonardo Polo". El autor analiza la propuesta antropológica de Leonardo Polo y cómo esta puede servir como fundamento para la acción educativa. La tesis busca ordenar las ideas principales de la antropología trascendental de Polo y mostrar su vinculación con la labor educativa. El objetivo final es contribuir a superar la desorient
Introduction to Microsoft Azure. Covers the change to a cloud development paradigm. Motivations for the change, Pricing structures, and an exercise in IT portfolio evaluation.
The document provides an overview of an investment bank's performance in 2011. It discusses near record financial results including revenue of $26.3 billion and earnings of $6.8 billion. It highlights the bank's leadership positions in various markets including #1 in global investment banking fees for the third consecutive year. The document also outlines strategic initiatives for 2011 including expanding the international footprint and completing an acquisition. It discusses positioning for regulatory changes and maintaining expense discipline to enable continued investment.
Google je symbolem doby, která bývá označována jako informační. Jeho jméno je pravděpodobně odvozeno od čísla "googol", jehož velikost je 1 x 10100 (můžeme je zapsat jako jedničku se 100 nulami). Pokud přijmeme předpoklad, že prostřednictvím Google jsou nám k dispozici googoly informací a že platí heslo, čím více informací, tím lépe, pak by se mohlo zdát, že se nacházíme v obzvlášť krásném období lidské historie. Na první pohled však tomu tak není – naše doba se potýká s množstvím vážných problémů, přičemž některé z nich jsou přímo spojené s informatizací společnosti. Namátkou můžeme jmenovat fragmentalizaci a utilitarizaci lidského poznání, informační rozdělení, informační úzkost či paradoxní úpadek sociálního života, který jde ruku v ruce s rozvojem tzv. sociálních sítí. Tyto problémy mají pravděpodobně překvapivě jednoduché vysvětlení, které nás napadne, když si uvědomíme, co to informace vlastně jsou. Zamyslíme-li se nad tím, jaké vlastnosti musí mít sdělení, abychom je mohli považovat za informaci, snadno zjistíme, že ne vše, co je nám prostřednictvím Google k dispozici, jsou informace, ale spíše jejich opaky či karikatury. Proto člověk tváří v tvář Google není v situaci, kdy by si byl vždy jistý, jaké jednání je správné. Problémové otázky vyvolávají nutnost etické reflexe, kterou se zabývá tzv. informační etika. V přednášce bude poukázáno na některé etické problémy, ke kterým může dojít při vyhledávání, správě a šíření informací a budou naznačeny obecné zásady, které je třeba dodržet, aby bylo možné lidské informační chování hodnotit jako správné.
Augusto B. Leguía regresó de Europa a fines del siglo XIX durante una crisis de gobierno en Perú. En 1919 fue elegido Presidente con el apoyo de la oposición y los sectores populares emergentes, aunque muchos no tenían derecho a voto. Rompió con el consenso que dio estabilidad a la República aristocrática desde el último golpe militar. Las elecciones de 1919 mostraron un ambiente calmado pero con irregularidades e impugnaciones que llevaron a que la Corte Suprema anulara votos, haciendo que Legu
Rio Info 2010 - Seminário de Tecnologia - Integração de coisas - Edmo Lopes -...Rio Info
O documento fornece um resumo histórico das principais invenções e avanços tecnológicos que levaram à era digital atual. Também discute os desafios das empresas em atrair e reter talentos em um mundo cada vez mais conectado e remoto, com mudanças nas relações de trabalho e nas expectativas dos funcionários. Por fim, destaca os desafios dos líderes em lidar com times globalizados e a necessidade de adaptação constante às novas tecnologias e modelos organizacionais.
Este documento presenta un resumen de la tesis doctoral de Jesús María Izaguirre Ronda titulada "Una antropología trascendental para la educación. La acción educativa según el pensamiento de Leonardo Polo". El autor analiza la propuesta antropológica de Leonardo Polo y cómo esta puede servir como fundamento para la acción educativa. La tesis busca ordenar las ideas principales de la antropología trascendental de Polo y mostrar su vinculación con la labor educativa. El objetivo final es contribuir a superar la desorient
Introduction to Microsoft Azure. Covers the change to a cloud development paradigm. Motivations for the change, Pricing structures, and an exercise in IT portfolio evaluation.
The document provides an overview of an investment bank's performance in 2011. It discusses near record financial results including revenue of $26.3 billion and earnings of $6.8 billion. It highlights the bank's leadership positions in various markets including #1 in global investment banking fees for the third consecutive year. The document also outlines strategic initiatives for 2011 including expanding the international footprint and completing an acquisition. It discusses positioning for regulatory changes and maintaining expense discipline to enable continued investment.
Google je symbolem doby, která bývá označována jako informační. Jeho jméno je pravděpodobně odvozeno od čísla "googol", jehož velikost je 1 x 10100 (můžeme je zapsat jako jedničku se 100 nulami). Pokud přijmeme předpoklad, že prostřednictvím Google jsou nám k dispozici googoly informací a že platí heslo, čím více informací, tím lépe, pak by se mohlo zdát, že se nacházíme v obzvlášť krásném období lidské historie. Na první pohled však tomu tak není – naše doba se potýká s množstvím vážných problémů, přičemž některé z nich jsou přímo spojené s informatizací společnosti. Namátkou můžeme jmenovat fragmentalizaci a utilitarizaci lidského poznání, informační rozdělení, informační úzkost či paradoxní úpadek sociálního života, který jde ruku v ruce s rozvojem tzv. sociálních sítí. Tyto problémy mají pravděpodobně překvapivě jednoduché vysvětlení, které nás napadne, když si uvědomíme, co to informace vlastně jsou. Zamyslíme-li se nad tím, jaké vlastnosti musí mít sdělení, abychom je mohli považovat za informaci, snadno zjistíme, že ne vše, co je nám prostřednictvím Google k dispozici, jsou informace, ale spíše jejich opaky či karikatury. Proto člověk tváří v tvář Google není v situaci, kdy by si byl vždy jistý, jaké jednání je správné. Problémové otázky vyvolávají nutnost etické reflexe, kterou se zabývá tzv. informační etika. V přednášce bude poukázáno na některé etické problémy, ke kterým může dojít při vyhledávání, správě a šíření informací a budou naznačeny obecné zásady, které je třeba dodržet, aby bylo možné lidské informační chování hodnotit jako správné.
El documento resume los servicios y planes de compensación de una compañía llamada Red21network, la cual ofrece servicios de telecomunicaciones. La compañía opera en Venezuela y busca expandirse a nivel nacional e internacional. Ofrece diferentes niveles de afiliación que permiten ganar bonos e ingresos por la adquisición de clientes y distribuidores.
This document provides information about an upcoming educational program hosted by the Capital Chapter of the International Facility Management Association (CCIFMA). The June 8th program will cover facilities continuity and how to plan responses, mitigate risks, and recover from disruptions. The document also lists CCIFMA partners and upcoming events. It encourages members to get involved in education, emerging leader, and community service teams.
This document summarizes the production process for Oyster Bay Sauvignon Blanc wine from grape to bottle. It details the varietals used, vineyards and locations of production and bottling facilities. The key steps covered are grape maturity and harvest, juice treatment including fermentation, post-ferment processes like blending and fining, transfer from production to bottling facility, finishing treatments prior to bottling like stabilization and filtration, and the bottling process.
The document describes Axemia, a company that develops custom software solutions tailored to customers' specific needs and requirements. It highlights Axemia's focus on developing innovative, organized, and collaborative software using a unique and focused approach. Key aspects of Axemia's methodology are gathering requirements, creating prototypes, developing applications through an iterative process, integration and user acceptance testing, and providing support after deployment. The document provides examples of software solutions Axemia has developed for companies including a event management organization, a bank for loan request management, the Belgian postal service, and an insurance company.
El documento expresa tristeza por los valores que se han perdido en la sociedad actual como el respeto a las autoridades y la confianza en los adultos. Plantea preocupación por el miedo en los niños, jóvenes y ancianos, y critica que se valore más el tener que el ser, los autos caros que las amistades y las pantallas que las conversaciones. Concluye expresando el deseo de recuperar valores como la honestidad, la rectitud y la confianza para construir un mundo mejor.
This deck from 2001 outlines opportunities to improve customer experience and cross-sell capabilities within the SwissairGroup by selling Swissotel Hotels stay with a Swissair flight.
This was done with a team at the Rotterdam School of Management
O documento descreve os diferentes tipos de erupções vulcânicas, como lavas ácidas ou básicas, e as formas de cones vulcânicos. Também distingue vulcões ativos, adormecidos e extintos com base em sua frequência e nível de atividade.
El documento describe la historia de los principales procesadores de Intel desde el 8086 en 1978 hasta el Pentium MMX en 1997. Comenzó con el 8086 de 16 bits usado en el primer PC de IBM y continuó con versiones posteriores como el 8088, 80286, 386, 486 y Pentium, cada uno con mejoras como mayor velocidad, tamaño de bus y funciones integradas.
Trabajo5 christian bejarano-victor-gutiérrezcrisbeme
Este documento describe el uso del escritorio remoto en Windows, incluyendo sus opciones, pruebas de funcionamiento en diferentes versiones de Windows como Windows 8 e Windows Vista, herramientas de software como LogMeIn y TeamViewer, restricción de usuarios autorizados y consideraciones de seguridad como la autenticación de nivel de red y el cambio de puerto predeterminado. El documento también incluye una bibliografía de recursos adicionales sobre escritorio remoto.
El documento habla sobre correos electrónicos y navegadores web. Explica las ventajas e inconvenientes del correo electrónico y las características de varios navegadores populares como Google Chrome, Mozilla Firefox y Safari. También compara diferentes motores de búsqueda como Google, Yahoo y Lycos. Finalmente, analiza las ventajas y desventajas de las redes sociales y el uso del chat.
The document summarizes the results of a clinical trial that found the drug Somatuline prolonged progression-free survival in patients with metastatic gastroenteropancreatic neuroendocrine tumors. The trial involved 204 patients across 14 countries and found that after 96 weeks, 65.1% of patients taking Somatuline had not seen disease progression compared to 33.0% of placebo patients. This represented a 53% reduced risk of progression or death. The results were published in the New England Journal of Medicine.
This document provides an overview of Allon Therapeutics Inc., a biopharmaceutical company developing novel neuroprotective peptides. Their lead product, davunetide, has demonstrated human proof of concept in Phase 2 trials for Alzheimer's disease and is currently in an international Phase 2/3 pivotal trial for Progressive Supranuclear Palsy. Allon has a portfolio of neuroprotective peptides targeting various conditions and is pursuing orphan drug approval and commercialization while advancing their second generation products.
This presentation by Zogenix discusses their development of ZX008, a low dose fenfluramine, for the treatment of seizures associated with Dravet syndrome and Lennox Gastaut Syndrome. Zogenix recently announced positive top-line results from their Phase 3 study of ZX008 in Dravet syndrome, showing a significant reduction in convulsive seizure frequency compared to placebo. They plan to submit an NDA for ZX008 in Dravet syndrome in 2018 based on results from their ongoing global Phase 3 program. Zogenix is also targeting initiation of a Phase 3 trial of ZX008 in Lennox Gastaut Syndrome in Q4 2017.
This case study describes a 7-year-old Thai boy who presented with a rash, fever, and seizures. He was initially diagnosed with epilepsy and treated with phenytoin, cef-3, and azithromycin. His condition worsened with the development of Steven Johnson Syndrome. Testing found he was positive for phenytoin on an ELISPOT test. The document discusses SJS pathogenesis, definitions, investigations including the ALDEN algorithm and ELISPOT test, and management of the patient's condition.
Opexa Therapeutics August 2015 OPXA Corporate PresentationOpexaTherapeutics
Opexa Therapeutics presented information on their precision immunotherapy platform and key programs. Their lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has shown signs of stabilizing disease progression. Tcelna works by reducing myelin reactive T-cells that damage the myelin sheath. Opexa has an option agreement with Merck Serono for the development and commercialization of Tcelna in multiple sclerosis. Additionally, Opexa is developing OPX-212 for neuromyelitis optica, an orphan indication with no approved therapies.
This document discusses potential alternatives to the thorough QT study (TQT study) that is currently required by regulatory agencies to assess the potential for drugs to cause abnormal heart rhythms. Specifically, it summarizes:
1) A study that tested using pharmacokinetic/pharmacodynamic modeling of ECG data from first-in-human trials to detect QT effects as an alternative to the TQT study.
2) Issues that still need to be addressed for this alternative approach to be widely accepted, including demonstrating assay sensitivity without an active control.
3) Separate efforts to develop nonclinical assays to directly assess a drug's potential to cause abnormal heart rhythms, with the goal of moving proarrhyth
- Neogenix Oncology announced that members of its scientific staff will present preclinical studies of NEO-101, a monoclonal antibody being developed to treat pancreatic and colorectal cancers, at the AACR annual meeting in April 2011.
- Radient Pharmaceuticals announced preliminary results from a clinical study showing its cancer diagnostic test, Onko-Sure, had a statistical advantage over CEA in detecting early-stage colorectal cancer.
- Cephalon Inc made an offer to acquire the remaining 72.48% stake in ChemGenex Pharmaceuticals it does not already own for approximately $140 million Australian dollars in cash.
This document outlines a Phase III clinical trial protocol to compare the efficacy and safety of a novel calcium channel blocker drug called Cardex to the drug Nifedipine in treating patients with stage 1 hypertension. The proposed randomized controlled trial would involve 600 patients across 15 centers in India. Patients would be randomly assigned to receive either Cardex or Nifedipine and their blood pressure and platelet aggregation would be measured at regular intervals over 18 months to assess the comparative efficacy, safety and pharmacokinetics of the two drugs. The protocol provides details on the study objectives, design, procedures, statistical analysis and ethical approval process.
Effetti a lungo termine dell'associazione a dose fissa di latanoprost e timol...Merqurio
This prospective study observed 2339 patients with glaucoma or ocular hypertension who were switched to latanoprost/timolol fixed combination therapy for at least 18 months. The primary reasons for switching were inadequate intraocular pressure (IOP) reduction and desire for once-daily dosing. IOP was effectively reduced and maintained over 24 months. Optic disc and visual field assessments showed stability. Physicians rated the fixed combination as effective, well-tolerated, and that patients were compliant with the treatment regimen.
This document discusses the presentation, testing, and management of pituitary adenomas and hypothalamic syndromes. It provides guidance on testing a 66-year-old man with a confirmed pituitary adenoma discovered on MRI after presenting with stroke symptoms. Testing strategies and their limitations are reviewed. Factors affecting decisions around intervention and appropriate follow-up strategies are also discussed, drawing on literature to support recommendations. Long-term management of patients with prolactinomas on dopamine agonists is explored, including monitoring, treatment withdrawal, and surveillance of side effects.
El documento resume los servicios y planes de compensación de una compañía llamada Red21network, la cual ofrece servicios de telecomunicaciones. La compañía opera en Venezuela y busca expandirse a nivel nacional e internacional. Ofrece diferentes niveles de afiliación que permiten ganar bonos e ingresos por la adquisición de clientes y distribuidores.
This document provides information about an upcoming educational program hosted by the Capital Chapter of the International Facility Management Association (CCIFMA). The June 8th program will cover facilities continuity and how to plan responses, mitigate risks, and recover from disruptions. The document also lists CCIFMA partners and upcoming events. It encourages members to get involved in education, emerging leader, and community service teams.
This document summarizes the production process for Oyster Bay Sauvignon Blanc wine from grape to bottle. It details the varietals used, vineyards and locations of production and bottling facilities. The key steps covered are grape maturity and harvest, juice treatment including fermentation, post-ferment processes like blending and fining, transfer from production to bottling facility, finishing treatments prior to bottling like stabilization and filtration, and the bottling process.
The document describes Axemia, a company that develops custom software solutions tailored to customers' specific needs and requirements. It highlights Axemia's focus on developing innovative, organized, and collaborative software using a unique and focused approach. Key aspects of Axemia's methodology are gathering requirements, creating prototypes, developing applications through an iterative process, integration and user acceptance testing, and providing support after deployment. The document provides examples of software solutions Axemia has developed for companies including a event management organization, a bank for loan request management, the Belgian postal service, and an insurance company.
El documento expresa tristeza por los valores que se han perdido en la sociedad actual como el respeto a las autoridades y la confianza en los adultos. Plantea preocupación por el miedo en los niños, jóvenes y ancianos, y critica que se valore más el tener que el ser, los autos caros que las amistades y las pantallas que las conversaciones. Concluye expresando el deseo de recuperar valores como la honestidad, la rectitud y la confianza para construir un mundo mejor.
This deck from 2001 outlines opportunities to improve customer experience and cross-sell capabilities within the SwissairGroup by selling Swissotel Hotels stay with a Swissair flight.
This was done with a team at the Rotterdam School of Management
O documento descreve os diferentes tipos de erupções vulcânicas, como lavas ácidas ou básicas, e as formas de cones vulcânicos. Também distingue vulcões ativos, adormecidos e extintos com base em sua frequência e nível de atividade.
El documento describe la historia de los principales procesadores de Intel desde el 8086 en 1978 hasta el Pentium MMX en 1997. Comenzó con el 8086 de 16 bits usado en el primer PC de IBM y continuó con versiones posteriores como el 8088, 80286, 386, 486 y Pentium, cada uno con mejoras como mayor velocidad, tamaño de bus y funciones integradas.
Trabajo5 christian bejarano-victor-gutiérrezcrisbeme
Este documento describe el uso del escritorio remoto en Windows, incluyendo sus opciones, pruebas de funcionamiento en diferentes versiones de Windows como Windows 8 e Windows Vista, herramientas de software como LogMeIn y TeamViewer, restricción de usuarios autorizados y consideraciones de seguridad como la autenticación de nivel de red y el cambio de puerto predeterminado. El documento también incluye una bibliografía de recursos adicionales sobre escritorio remoto.
El documento habla sobre correos electrónicos y navegadores web. Explica las ventajas e inconvenientes del correo electrónico y las características de varios navegadores populares como Google Chrome, Mozilla Firefox y Safari. También compara diferentes motores de búsqueda como Google, Yahoo y Lycos. Finalmente, analiza las ventajas y desventajas de las redes sociales y el uso del chat.
The document summarizes the results of a clinical trial that found the drug Somatuline prolonged progression-free survival in patients with metastatic gastroenteropancreatic neuroendocrine tumors. The trial involved 204 patients across 14 countries and found that after 96 weeks, 65.1% of patients taking Somatuline had not seen disease progression compared to 33.0% of placebo patients. This represented a 53% reduced risk of progression or death. The results were published in the New England Journal of Medicine.
This document provides an overview of Allon Therapeutics Inc., a biopharmaceutical company developing novel neuroprotective peptides. Their lead product, davunetide, has demonstrated human proof of concept in Phase 2 trials for Alzheimer's disease and is currently in an international Phase 2/3 pivotal trial for Progressive Supranuclear Palsy. Allon has a portfolio of neuroprotective peptides targeting various conditions and is pursuing orphan drug approval and commercialization while advancing their second generation products.
This presentation by Zogenix discusses their development of ZX008, a low dose fenfluramine, for the treatment of seizures associated with Dravet syndrome and Lennox Gastaut Syndrome. Zogenix recently announced positive top-line results from their Phase 3 study of ZX008 in Dravet syndrome, showing a significant reduction in convulsive seizure frequency compared to placebo. They plan to submit an NDA for ZX008 in Dravet syndrome in 2018 based on results from their ongoing global Phase 3 program. Zogenix is also targeting initiation of a Phase 3 trial of ZX008 in Lennox Gastaut Syndrome in Q4 2017.
This case study describes a 7-year-old Thai boy who presented with a rash, fever, and seizures. He was initially diagnosed with epilepsy and treated with phenytoin, cef-3, and azithromycin. His condition worsened with the development of Steven Johnson Syndrome. Testing found he was positive for phenytoin on an ELISPOT test. The document discusses SJS pathogenesis, definitions, investigations including the ALDEN algorithm and ELISPOT test, and management of the patient's condition.
Opexa Therapeutics August 2015 OPXA Corporate PresentationOpexaTherapeutics
Opexa Therapeutics presented information on their precision immunotherapy platform and key programs. Their lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has shown signs of stabilizing disease progression. Tcelna works by reducing myelin reactive T-cells that damage the myelin sheath. Opexa has an option agreement with Merck Serono for the development and commercialization of Tcelna in multiple sclerosis. Additionally, Opexa is developing OPX-212 for neuromyelitis optica, an orphan indication with no approved therapies.
This document discusses potential alternatives to the thorough QT study (TQT study) that is currently required by regulatory agencies to assess the potential for drugs to cause abnormal heart rhythms. Specifically, it summarizes:
1) A study that tested using pharmacokinetic/pharmacodynamic modeling of ECG data from first-in-human trials to detect QT effects as an alternative to the TQT study.
2) Issues that still need to be addressed for this alternative approach to be widely accepted, including demonstrating assay sensitivity without an active control.
3) Separate efforts to develop nonclinical assays to directly assess a drug's potential to cause abnormal heart rhythms, with the goal of moving proarrhyth
- Neogenix Oncology announced that members of its scientific staff will present preclinical studies of NEO-101, a monoclonal antibody being developed to treat pancreatic and colorectal cancers, at the AACR annual meeting in April 2011.
- Radient Pharmaceuticals announced preliminary results from a clinical study showing its cancer diagnostic test, Onko-Sure, had a statistical advantage over CEA in detecting early-stage colorectal cancer.
- Cephalon Inc made an offer to acquire the remaining 72.48% stake in ChemGenex Pharmaceuticals it does not already own for approximately $140 million Australian dollars in cash.
This document outlines a Phase III clinical trial protocol to compare the efficacy and safety of a novel calcium channel blocker drug called Cardex to the drug Nifedipine in treating patients with stage 1 hypertension. The proposed randomized controlled trial would involve 600 patients across 15 centers in India. Patients would be randomly assigned to receive either Cardex or Nifedipine and their blood pressure and platelet aggregation would be measured at regular intervals over 18 months to assess the comparative efficacy, safety and pharmacokinetics of the two drugs. The protocol provides details on the study objectives, design, procedures, statistical analysis and ethical approval process.
Effetti a lungo termine dell'associazione a dose fissa di latanoprost e timol...Merqurio
This prospective study observed 2339 patients with glaucoma or ocular hypertension who were switched to latanoprost/timolol fixed combination therapy for at least 18 months. The primary reasons for switching were inadequate intraocular pressure (IOP) reduction and desire for once-daily dosing. IOP was effectively reduced and maintained over 24 months. Optic disc and visual field assessments showed stability. Physicians rated the fixed combination as effective, well-tolerated, and that patients were compliant with the treatment regimen.
This document discusses the presentation, testing, and management of pituitary adenomas and hypothalamic syndromes. It provides guidance on testing a 66-year-old man with a confirmed pituitary adenoma discovered on MRI after presenting with stroke symptoms. Testing strategies and their limitations are reviewed. Factors affecting decisions around intervention and appropriate follow-up strategies are also discussed, drawing on literature to support recommendations. Long-term management of patients with prolactinomas on dopamine agonists is explored, including monitoring, treatment withdrawal, and surveillance of side effects.
Comparison of latanoprost, bimatoprost and travoprostAvaleks-Kiev
This study compared the 24-hour intraocular pressure (IOP) lowering effects of latanoprost, travoprost, and bimatoprost in 45 patients with exfoliation syndrome and ocular hypertension over 3 months. All 3 drugs significantly lowered IOP from baseline at all time points measured. At 1 week, travoprost lowered IOP more than latanoprost and bimatoprost. By 3 months, bimatoprost lowered IOP more than travoprost, while travoprost produced the lowest mean 24-hour IOP range, significantly lower than latanoprost and bimatoprost. The study suggests travoprost may provide better 24-hour I
International Journal of Clinical Pharmacology & Toxicology (IJCPT) ISSN:2167-910X is an Open Access journal, which aims to develop coherent means to modify drug therapy, with respect to the patient's genotype, and to ensure maximum efficiency with minimal contrary effects.
International Journal of Clinical Pharmacology & Toxicology (IJCPT) ISSN:2167-910X is an Open Access journal and a peer-reviewed journal. Clinical Pharmacology & Toxicology is the all-encompassing and becoming an increasingly important discipline for the identification of disease targets and drug designing with their toxicological effects and means to eradicate diseases.
Opexa Therapeutics is developing personalized T-cell immunotherapies for autoimmune diseases. Their lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has shown signs of stabilizing disease progression in previous trials. Opexa has an option agreement with Merck Serono for the development and commercialization of Tcelna in multiple sclerosis. Recent milestones include completing enrollment in the Tcelna Phase 2b trial for SPMS and receiving a $3 million payment from Merck Serono. Opexa is also developing OPX-212 for neuromyelitis optica and expects to file an IND by the end of 2015.
Opexa Therapeutics provides a summary of its precision immunotherapy platform and clinical programs. Key points include:
- Tcelna in development for multiple sclerosis, with a Phase 2b trial ongoing in secondary progressive MS. Topline data expected in 2016.
- Pipeline expansion includes OPX-212 for neuromyelitis optica, with IND submission planned for mid-2015.
- Clinical trials show Tcelna reduces myelin reactive T-cells and improved outcomes for relapsing remitting MS patients versus placebo in Phase 2b trials.
- Agreement with Merck Serono provides potential for commercial partnership if Phase 3 is initiated for multiple sclerosis indications.
The document summarizes an expert's assessment of 15 studies on the efficacy of the BICOM bioresonance method. The expert assessed the studies using an 8-level evidence classification scheme from the American Heart Association. 4 studies were rated as level 1 evidence, 1 as level 1-2, 1 as level 2, 1 as level 3, 4-5 as level 4-5, and 4 as level 5. The expert concluded that the totality of studies provided scientifically proven evidence for the efficacy of the BICOM bioresonance therapy.
Effect of Dapagliflozin on Cardiovascular Risk Factors.pptxVenkataSurya12
Dapagliflozin is a SGLT2 inhibitor that was evaluated in a clinical trial involving 4,744 patients with heart failure to determine its effect on cardiovascular risk factors. The trial found that dapagliflozin was safer for patients and resulted in fewer adverse reactions compared to a placebo. It significantly reduced the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular events or renal death. Based on these results, dapagliflozin was approved under the brand name Forxiga for the treatment of heart failure and chronic kidney disease.
Cyclo Therapeutics: (OTCQB: CTDH) is a clinical-stage biotechnology company that develops cyclodextrin-based products for the treatment of disease. The Company’s Trappsol® Cyclo™, an orphan drug designated product in the United States and Europe, is used to treat Niemann-Pick Disease Type C (NPC), a rare and fatal genetic disease, on a compassionate use basis as well as in three ongoing formal clinical trials. The Company’s Scientific Advisory Board endorsed Alzheimer’s Disease (AD) as the company’s next drug development indication. The Company was authorized by the FDA to use Trappsol® Cyclo™ for a late-onset AD patient under a Compassionate Use Program which began intravenous dosing in May 2018. Learn more at CTDHinfo.com.
Similar to Overview of TC-5619 Clinical Development (20)
NUMBER SYSTEM (संख्या पद्धति)|Classification of Numbers|YRS4learning
Hi Students,
In this video, I have explained the types of numbers we have in our #numbersystem.
Natural numbers
Whole numbers
Integers
Even numbers
Odd numbers
Prime numbers
Composite numbers
Co-prime numbers
Rational numbers
Irrational numbers
Real numbers
Imaginary numbers
You can also watch my videos for the follwing topics:-
Exercise 1.1 (Q. 1 (i) (ii)) Rational Numbers Chapter 1|Class 8 Maths | NCERT| CBSE
https://youtu.be/zUttADoiANw
Rational Numbers Chapter 1 |NCERT Class 8th Math
https://youtu.be/Y6AEXvw-mcE
Algebraic Identities For Class 8th & 9th | Part 2 | Identities class VIII & IX | YRS4learning
https://youtu.be/gP1Rm5UG_JI
Algebraic Identities For Class 8th & 9th | Part 2 | Identities class VIII & IX | YRS4learning
https://youtu.be/gP1Rm5UG_JI
Basic Concepts of Number System (संख्या पद्धति)|Classification of Numbers| YRS4learning
https://youtu.be/YAjaiEcmnzE
Coordinate geometry class 10|Coordinate Geometry | Class 10 Chapter 7 |
https://youtu.be/JQoa1cltWRQ
Divisibility Rules for 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 | YRS4Learning
https://youtu.be/Z_au2kZl0JI
How to download NCERT Books 1st to 12th Class Free Download from Google |NCERT| YRS4learning
https://youtu.be/n6-hZ3tYMh0
CORONA को हराना है || अनुशासन, स्वच्छता और दवाई के साथ!!Sukhwinder Kumar
कोविद-19 संक्रमण को रोकने की दिशा में -- 3 आवश्यक कदम
1. अपने हाथों को नियमित रूप से साबुन से धोएं या उन्हें सैनिटाइज़र से साफ़ करें ||
2. सही तरीके से मास्क पहनें||
3. सामाजिक दूरी है जरूरी||
आयुर्वेद से कोरोना को ठीक किया जा सकता है | रोग - प्रतिरोधक क्षमता को बढ़ाकर!!
1. सबसे पहले अपने दैनिक भोजन में हल्दी, जीरा, धनिया और लहसुन को शामिल करें|
2. काडा में तुलसी, काली मिर्च, दालचीनी, अदरक और मुनक्का जैसी सामग्री डालें ||
3. दिन में दो बार काडा लें ||
4. तिल के तेल या नारियल तेल या सरसों के तेल या घी के साथ अपने नथुने को रोजाना नम करें ||
5. हर रोज दूध में हल्दी डालकर नियमित रूप से सेवन करें ||
6. अपने दिन की शुरुआत योग और प्राणायाम से करें ||
7. स्टीम इनहेलेशन (STEAM INHALATION) आपको COVID-19 का मुकाबला करने में मदद करता है||
आओ हम खुद को बचाएं और इस विश्व को
CORONAVIRUS
से बचाएं…
ऑक्सीजन का स्तर 94 से नीचे आ जाए !! तो प्रोनिंग प्रक्रिया अपनाकर बढ़ा सकते है...Sukhwinder Kumar
ऑक्सीजनेशन में इस प्रक्रिया को 80 प्रतिशत तक सफल माना जा रहा है।
"Proning" प्रोनिंग की यह पोजीशन सांस लेने में आराम और ऑक्सीकरण में सुधार करने के लिए Medically approved है। इसमें मरीज को पेट के बल लिटाया जाता है। यह प्रक्रिया 30 मिनट से दो घंटे की होती है। इसे करने से फेफड़ों में ब्लड सकुर्लेशन (blood circulation) बेहतर होता है जिससे ऑक्सीजन फेफड़ों में आसानी से पहुंचती है और फेफड़े अच्छे से काम करने लगते हैं।
May 1st “International Labour Day”
Observed as a day to celebrate the efforts of laborers and the working class.
ANTARRASHTRIYA SHRAMIK DIWAS OR KAMGAR DIN
In 1889, the Marxist International Socialist Congress adopted a resolution for a great international demonstration in which they demanded that the workers should not be made to work for more than 8 hours a day. After this, it became an annual event and May 1 was celebrated as Labour Day.
In the year 1923, May 1st was first celebrated as LABOUR DAY In INDIA.
Prompt, complete, accurate and self-explanatory visual presentation of the concepts of various types of numbers and number line. A brief description of numbers with diagrammatic representation so that students can understand. How these numbers can be represented on the number line.
This project was developed for a competitive intelligence company by mining data from the various information sources e.g. Company (News, Investor Section, SEC filings, Annual Reports, Presentations etc), Universities/Medical Schools/Organizations, Medical Affairs Companies, Non- Profit Medical Agency, Government Agencies, Drug Delivery Companies, Contract Manufacturing Organizations, Contract Research Organizations, Consultancies and Financial Institutions. The complete information available there complied into a single MS word document, listed in MS Excel and then by using MS publisher it was converted into the report which finally converted into PDF.
The branch of mathematics which deals with location of objects in 2-D (dimensional) plane is called coordinate geometry. Need to present your work in most impressive & informative manner i.e. through Power Point Presentation call us at skype Id: kumar_sukh79 or mail us: clintech2011@gmail.com for using my service.
This document summarizes research on multiple sclerosis (MS). MS is a chronic disease that attacks the central nervous system. While the exact cause is unknown, it is believed to involve genetic and environmental factors. The most common form is relapsing-remitting MS, where neurological symptoms flare up and then decrease. Several drugs are used to treat MS and reduce relapse rates, but many have side effects. Ongoing research aims to better understand MS and develop safer, more effective treatments.
Discover the cutting-edge telemetry solution implemented for Alan Wake 2 by Remedy Entertainment in collaboration with AWS. This comprehensive presentation dives into our objectives, detailing how we utilized advanced analytics to drive gameplay improvements and player engagement.
Key highlights include:
Primary Goals: Implementing gameplay and technical telemetry to capture detailed player behavior and game performance data, fostering data-driven decision-making.
Tech Stack: Leveraging AWS services such as EKS for hosting, WAF for security, Karpenter for instance optimization, S3 for data storage, and OpenTelemetry Collector for data collection. EventBridge and Lambda were used for data compression, while Glue ETL and Athena facilitated data transformation and preparation.
Data Utilization: Transforming raw data into actionable insights with technologies like Glue ETL (PySpark scripts), Glue Crawler, and Athena, culminating in detailed visualizations with Tableau.
Achievements: Successfully managing 700 million to 1 billion events per month at a cost-effective rate, with significant savings compared to commercial solutions. This approach has enabled simplified scaling and substantial improvements in game design, reducing player churn through targeted adjustments.
Community Engagement: Enhanced ability to engage with player communities by leveraging precise data insights, despite having a small community management team.
This presentation is an invaluable resource for professionals in game development, data analytics, and cloud computing, offering insights into how telemetry and analytics can revolutionize player experience and game performance optimization.
PyData London 2024: Mistakes were made (Dr. Rebecca Bilbro)Rebecca Bilbro
To honor ten years of PyData London, join Dr. Rebecca Bilbro as she takes us back in time to reflect on a little over ten years working as a data scientist. One of the many renegade PhDs who joined the fledgling field of data science of the 2010's, Rebecca will share lessons learned the hard way, often from watching data science projects go sideways and learning to fix broken things. Through the lens of these canon events, she'll identify some of the anti-patterns and red flags she's learned to steer around.
2. Page 2 www.clinInsight.com
SEC Filli gs Status
Amount
Amount
Targacept entered into collaborative research and license agreement with AstraZeneca AB.
Notice served by Targacept under agreement offering AstraZeneca the right to license its
product candidate TC-5619 for specified conditions characterized by cognitive impairment.
DECEMBER 2005
Targacept started focusing on Cognitive disorders.JANUARY 2006
OCTOBER 2007
ASTRAZENECA AB
Amount $ 2,000,000 As Revenue
TARGACEPT Inc.
In accordance with a mutually acceptable development plan, Targacept agreed to develop
TC-5619 independently through the completion of Phase I and Phase II proof of concept
clinical trial.
Amendment to cognitive disorders agreement with AstraZeneca ABAPRIL 2010
ASTRAZENECA AB
$ 11,000,000 Deferred Revenue
TARGACEPT Inc.
ASTRAZENECA AB
Amount $ 2,000,000 Deferred Revenue
TARGACEPT Inc.
Targacept recognized all payment amounting $11,000,000 from AstraZeneca as Revenue.JUNE 2011
ASTRAZENECA AB
$ 11,000,000 Deferred Revenue
TARGACEPT Inc.
ASTRAZENECA AB
Amount $ 2,000,000 Deferred Revenue
TARGACEPT Inc.
Under the agreement, AstraZeneca had an option for an exclusive license to TC-5619 for various cog-
nitive disorders. In late April 2011, the Company received notice from AstraZeneca that it had deter-
mined not to exercise its license option.
Precli ical i for aio
urement and Treatment Research
to Improve Cognition in Schizo-
phrenia, or MATRICS initiative of
46 cognitive neuroscientists and
neuro pharmacologists have indi-
cated alpha7 NNR and cognitive
functions are closely associated
and compounds that selectively
target the alpha7 NNR may have
application in the treatment of
conditions such as schizophrenia,
cognitive impairment and in-
flammation.
TC-5619 is a compound that
selectively act on the alpha7
NNR, being developed for the
treatment of conditions charac-
terized by cognitive impairment
such as Schizophrenia, Alzhei-
mer's disease etc. A number of
published studies and a survey
conducted in connection with
National Institute of Mental
Health initiative known as Meas-
CLINICAL
DEVELOPMENT
3. Page 3 www.clinInsight.com
Mechanism of Action Modulation of activity of the alpha7 NNR
Selective Target alpha7 NNR
Therapeutic Area of
Focus
Schizophrenia, cognitive impairment or
inflammation
Target Indication (s) Conditions characterized by cognitive im-
pairment such as Schizophrenia, Alzhei-
mer's disease etc.
Route of Administra-
tion
Oral
TC- 19 JOURNEY SO FAR...
JULY 2007
APRIL 2011
SINGLE RISING DOSE STUDY
SEQUENTIAL MULTIPLE ASCENDING DOSE STUDY
MULTIPLE RISING DOSE STUDY
SCHIZOPHRENIA
ATTENTION DEFICIT HYPERACTIVE DISORDER
SCHIZOPHRENIA
ALZHEIMER’S DISEASE
ATTENTION DEFICIT HYPERACTIVE DISORDER
PHASE I
PHASE II
TC-5619
4. Page 4
August 8, 2008
Targacept, Inc
FORM 10-Q, For the quarterly period ended June 30, 2007
(Pg 14)
…TC-5619. TC-5619 is a preclinical product candidate that modulates the a7 NNR for which we are currently
conducting a Phase I single rising dose clinical trial. We believe compounds that selectively target the a7 NNR may
have application in the treatment of conditions such as schizophrenia, cognitive impairment and inflammation…
(Pg 15)
…We also announced in July 2007 our initiation of a Phase I clinical trial of TC-5619. The trial is a double blind,
placebo controlled study with single escalating doses administered orally to healthy volunteers. The trial, which is
being conducted in France, is designed to evaluate the safety and tolerability of TC-5619 and to assess its
pharmacokinetic profile…
ASSIGNED TREATMENT: In a single rising dose trial, each subject in a dose group receives a single
dose of the agent being evaluated, with subjects in each subsequent dose group receiving a pre-determined
higher dosage than subjects in the preceding dose group .
May 8, 2008
Targacept, Inc
FORM 10-Q, For the quarterly period ended March 31, 2008
(pg17)
… We have completed a Phase 1 single rising dose clinical trial of TC-5619 and plan to initiate a Phase 1 multiple
rising dose clinical trial of TC-5619 in the third quarter of 2008…
STUDY TITLE: Phase 1 multiple rising dose clinical trial of TC-5619 in healthy volunteers
STUDY ID: TC-238-CLP-002
PHASE: I
INITIATION:
JULY 2008
COMPLETION:
MAY 2008 ACCRUAL: NA
INDICATION: Schizophre ia, Cog iive I pair e t or
I la aioPATIENT SEGMENT: Healthy
STATUS: COMPLETED
OBJECTIVES: To evaluate the safety and tolerability of TC-5619. To assess the
pharmacokinetic profile of TC-5619.
ASSIGNED TREATMENT: In a multiple rising dose clinical trial, each subject in a dose
group receives a dosage of the agent being evaluated multiple times, with subjects in each
subsequent dose group receiving a pre-determined higher dosage than subjects in the preceding dose
group.
STUDY TITLE: Double blind, placebo controlled, Phase I study of TC-5619 with single escalating doses
administered orally to healthy volunteers
STUDY ID: NA
PHASE: I
INITIATION:
JULY 2007
COMPLETION:
MAY 2008 ACCRUAL: NA
INDICATION: Schizophrenia, Cognitive Impairment or
InflammationPATIENT SEGMENT: Healthy
STATUS: COMPLETED
OBJECTIVES: To evaluate the safety and tolerability of TC-5619. To assess the pharmacokinetic profile of
TC-5619.
SINGLE
RISING DOSE
STUDY
MULTIPLE
RISING
DOSE STUDY
November 6, 2008
Targacept, Inc
Form 8-K
…Completed dosing in a Phase 1 multiple
rising dose clinical trial of TC-5619, a
highly-selective alpha7 NNR-targeted
product candidate planned for develop-
ment for cognitive dysfunction in schizo-
phrenia and potentially one or more oth-
er conditions characterized by cognitive
impairment…
LOCATION: FRANCE
LOCATION:
UNITED STATES
www.clinInsight.com
5. RESULTS: In the trial, the results on the Groton Maze Learning task met the pre-defined success criteria (adjusted p-value = 0.054), as well as at two of the trial’s
three measurement dates (at 4 weeks, unadjusted p-value = 0.018; and at 12 weeks, unadjusted p-value = 0.041), and were favorable for tobacco users as compared to
non-tobacco users and for subjects at study sites in the United States as compared to subjects at study sites in India. There was no activity in non-tobacco users. Estimates
of the prevalence of smoking amongst schizophrenia patients vary, with one study indicating as high as 80%. Each of the p-values noted above was derived after data log
transformation, a commonly utilized technique where the data does not follow a normal distribution. In addition, positive signals were observed in the trial on several sec-
ondary efficacy outcome measures, including Scale for Assessment of Negative Symptoms, an investigator assessment of improvement on the negative symptoms of schizo-
phrenia, Clinical Global Impression – Global Improvement, an investigator assessment of overall response, and Subject Global Impression – Cognition scale, a patient self-
assessment of cognitive change. Other secondary outcome measures of the trial, including a composite measure of the CogState Schizophrenia Battery, did not demon-
strate a drug effect in the dataset that included all subjects.
TC-5619 exhibited a favorable tolerability profile in the trial. There were two serious adverse events in the trial, one in
the placebo dose group and one in the TC-5619 dose group. Both were considered by the applicable investigator as not drug related.
PRIMARY OUTCOME:
Measure of the trial is change from baseline on the Groton Maze Learning item of
the Cog State Schizophrenia Test Battery, a computerized battery of neuropsychi-
atric tests that assess specific cognitive domains, on each of three measurement
dates as compared to placebo.
Page 5
STUDY TITLE: Two-Part, Sequential Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and
Pharmacokinetics of TC-5619-238 in Elderly Subjects With and Without Alzheimer's Disease.
STUDY ID: TC-5619-238-CLP-003, NCT01254448
PHASE: I
INITIATION:
SEP-2010
COMPLETION:
MAR-2011 ACCRUAL: 38
INDICATION: Alzheimer’s Disease
PATIENT
SEGMENT:
Elderly Subjects
With and Without
Alzheimer's Disease
STATUS: COMPLETED
OBJECTIVE: To examine the safety, tolerability and pharmacokinetics of TC-5619 in elderly
subjects with and without Alzheimer's disease
November 6, 2009
Targacept, Inc
FORM 10-Q, For the quarterly period ended September 30, 2009
(pg17)
... We have completed a Phase 1 single rising dose clinical trial and a Phase 1
multiple rising dose clinical trial of TC-5619 in healthy volunteers. We expect to
initiate a Phase 2 clinical proof of concept trial of TC-5619 in cognitive dysfunction
in schizophrenia in the fourth quarter of 2009. Following completion of the
planned Phase 2 trial, AstraZeneca has the right to license TC-5619 on terms
specified in our agreement.
May 10, 2010
Targacept, Inc
FORM 10-Q, For the quarterly period ended March 31,
2010
(pg17-18)
…As part of the expanded TC-5619 development program, the
Company has agreed to conduct a Phase 2 clinical proof of con-
cept trial in adults with ADHD in addition to its ongoing Phase 2
clinical proof of concept trial in cognitive dysfunction in schizo-
phrenia, or CDS.
(pg20)
TC-5619. TC-5619 is a novel small molecule that modulates the
activity of the a7 NNR. We initiated a Phase 2 clinical trial of
TC-5619 in cognitive dysfunction in schizophrenia, or CDS,
in the fourth quarter of 2009 pursuant to a development
plan that we agreed upon with AstraZeneca.
(pg21)
Under our 2005 agreement with AstraZeneca:
...we are responsible for conducting and funding the ongoing
Phase 2 clinical trial of TC-5619 in CDS, the planned Phase 2 clini-
cal trial of TC-5619 in adults with ADHD and planned specified
clinical and non-clinical studies to support the potential advance-
ment of TC-5619 into Phase 2 clinical development for Alzheimer’s
disease, and AstraZeneca is responsible for conducting and fund-
ing other specified non-clinical studies to support the potential
advancement of TC-5619 into Phase 2 clinical development for
Alzheimer’s disease...
STUDY ID: TC-5619-238-CRD-001, PRO-05619-CRD-001 ,
NCT01003379
STATUS: COMPLETED
INDICATION: Schizophrenia
COMPLETION:
JAN-2011
INITIATION:
MAY-2010
PHASE: II
LOCATION:
UNITED STATES(7),
INDIA (12)
ACCRUAL:
200 (Planned)
184 (Actual)
STUDY TITLE:
A Double-Blind, Randomized, Placebo-
Controlled, Multicenter, Fixed Dose Study to Assess Efficacy, Safety, and
Tolerability of TC-5619 as Augmentation Therapy to Improve Cognition
in Outpatients With Cognitive Dysfunction in Schizophrenia.
PATIENT SEGMENT:
Outpatients With Cognitive Dys-
function
TRIAL DESIGN & TREATMENT ASSIGNMENT :
Double Blind, Placebo Controlled, Randomized, Parallel Group
Study
Subjects are were randomly assigned to receive either TC-5619 or
placebo, together with continued treatment with the atypical anti-
psychotic, for 12 weeks. As planned, approximately half of the
subjects were users of tobacco products. Subjects who received
TC-5619 received a 1mg daily dose for the first four weeks, a 5mg
daily dose for the next four weeks and a 25mg daily dose for the
last four weeks.
INCLUSION CRITERIA:
Subjects meeting DSM-IV criteria for schizophrenia, with stable psychotic symptoms and taking a stable dose of an approved medication from the drug
class known as atypical anti-psychotics (either quetiapine, marketed as Seroquel, or risperidone, marketed as Risperdal)
www.clinInsight.com
6. May 10, 2010
Targacept, Inc
FORM 10-Q, For the quarterly period ended March 31,
2010
(pg17-18)
…As part of the expanded TC-5619 development program, the
Company has agreed to conduct a Phase 2 clinical proof of concept
trial in adults with ADHD in addition to its ongoing Phase 2 clinical
proof of concept trial in cognitive dysfunction in schizophrenia, or
CDS…
(pg20)
... As part of an April 2010 amendment to our 2005 agreement with
AstraZeneca, we have also agreed to conduct a Phase 2 clinical
proof of concept trial of TC-5619 in adults with ADHD and we and
AstraZeneca have each agreed to conduct specified studies to
support the potential advancement of TC-5619 into Phase 2 clinical
development for Alzheimer’s disease…
(pg21)
Under our 2005 agreement with AstraZeneca:
...we are responsible for conducting and funding the ongoing Phase
2 clinical trial of TC-5619 in CDS, the planned Phase 2 clinical trial of
TC-5619 in adults with ADHD...
STUDY DESIGN & TREATMENT:
Double blind, placebo controlled, forced titration, multi-center,
12-week study
Adult subjects are randomly assigned to one of two cohorts, TC-
5619 or placebo, and dosed over a 12-week period. Subjects in the
TC-5619 cohort receive 1mg doses of TC-5619 for the first four
weeks, 5mg doses of TC-5619 for the next four weeks and 25mg
doses of TC-5619 for the last four weeks.
RESULTS: TC-5619 did not meet the primary outcome
measure of the trial, but showed encouraging signals on
some of the trial’s efficacy measures in the subpopulation of
subjects with ADHDi.
August 9, 2011
Targacept, Inc.
FORM 10-Q, For the quarterly period ended June 30, 2011
...Preparations for a planned Phase 2b clinical trial of TC-5619 as a
treatment for negative symptoms and cognitive dysfunction in schizo-
phrenia, as well as potential additional development in either or both
of Alzheimer’s disease and ADHD, are ongoing...
PRIMARY OUTCOME MEASURE: Change from
baseline on the inattention subscale of the Conners’ Adult
ADHD Rating Scale—Investigator-Rated, or CAARS-INV, after
four weeks of treatment with TC-5619 as compared to
placebo.
May 9, 2011
Targacept, Inc
FORM 10-Q, For the quarterly period ended March 31,
2011
(pg16)
...The Company has completed two Phase 2 clinical proof of concept
trials, one in cognitive dysfunction in schizophrenia and one in adults
with ADHD...
STUDY TITLE: A Double-blind, Randomized, Placebo-controlled, Multicenter, Fixed Dose Titration Study to Assess Efficacy, Safety,
and Tolerability of TC-5619 in Adults With Attention Deficit/Hyperactivity Disorder (ADHD)
STUDY ID: TC-5619-238-CRD-002, PRO-05619-CRD-002, NCT01124708
ACCRUAL: 135
INDICATION: Attention Deficit Hyperactivity Disorder (ADHD) PATIENT SEGMENT: Non-tobacco-using adults with ADHD
PHASE: II
INITIATION:
MAY 2010
COMPLETION:
FEBRUARY 2011
STATUS: COMPLETED
LOCATION: UNITED STATES
STUDY ID: TC-5619-238-CRD-003, NCT01488929
LOCATION: UNITED STATES, HUNGARY, ROMANIA, RUSSIAN
FEDERATION, SERBIA, UKRAINE
PRIMARY OUTCOME MEASURE: Change from baseline on the Scale for the Assessment of Negative Symptoms, or SANS, at the end of
the treatment period with TC-5619 as compared to placebo.
INDICATION: Schizophrenia PATIENT SEGMENT: Negative Symptoms and Cognition in Outpatients With Schizophrenia
ACCRUAL: 450 (Planned); 603 (Actual)
PHASE: II
INITIATION:
DECEMBER 2011
COMPLETION:
NOVEMBER 2013
STATUS: COMPLETED
STUDY TITLE: A Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study to Assess Efficacy, Safety, and Tolerability of
TC-5619 as Augmentation Therapy to Improve Negative Symptoms and Cognition in Outpatients With Schizophrenia
STUDY DESIGN & TREATMENT:
Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study
The trial design provided for a four-week screening period, followed by a 24-week treatment period during which subjects received either one of two
daily doses of TC-5619 (5mg or 50mg) or placebo together with continued treatment with an atypical antipsychotic.
Page 6 www.clinInsight.com
7. Page 7
INDICATION: Attention Deficit/Hyperactivity Disorder (ADHD)
STUDY ID: TC-5619-238-CRD-004, NCT01472991
STATUS: COMPLETED COMPLETION: JULY 2012INITIATION: NOVEMBER 2011 LOCATION: UNITED STATES
ACCRUAL: 152 (Planned), 250 (Actual)
STUDY TITLE:
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Fixed Dose Study
to Assess Efficacy, Safety, and Tolerability of TC-5619 in Adults with Inattentive
-Predominant Attention Deficit/Hyperactivity Disorder (ADHD)
PATIENT SEGMENT: Adults with Inattentive-Predominant ADHD
March 14, 2014
Targacept, Inc.
FORM 10-K, For the fiscal year ended December 31,
2013
(pg 3)
TC-5619 and TC-6987
TC-5619 and TC-6987 are novel small molecules highly
selective for the a7 NNR. The a7 NNR has been shown to
play a role in a variety of biological pathways associated
with various diseases and disorders. We previously con-
ducted clinical studies of TC-5619 as a potential treatment
for schizophrenia, Alzheimer’s disease and attention deficit
hyperactivity disorder and exploratory studies of TC-6987
as a treatment for inflammatory disorders. We do not have
plans to pursue additional development of these com-
pounds in these therapeutic areas.
PRIMARY OUTCOME MEASURE: Change from
baseline on the inattention subscale of the Conners’ Adult
ADHD Rating Scale—Investigator-Rated, or CAARS-INV,
after four weeks of treatment with TC-5619 as compared to
placebo.
STUDY DESIGN A 3-arm, fixed dose, double blind, placebo controlled, parallel
group, multi-center, 12-week study
STUDY TREATMENT: Subjects in the trial were randomly assigned to receive a daily
dose of 5mg TC-5619, 25mg TC-5619 or placebo.
RESULTS: TC-5619 did not meet the primary outcome measure of the trial, but showed encouraging signals on some of the trial’s
efficacy measures in the subpopulation of subjects with ADHDi.
March 15, 2013
Targacept, Inc.
FORM 10-K, For the fiscal year ended December 31,
2012
(pg 3)
TC-5619
TC-5619 is a novel small molecule that modulates the activity
of the a7 NNR. We are currently conducting a Phase 2b
clinical trial of TC-5619 as a treatment for negative
symptoms and cognitive dysfunction in schizophrenia. We are
also currently evaluating potential additional Phase 2 clinical
development of TC-5619 as a treatment for Alzheimer’s
disease.
PHASE II (ALZHEIMER’S DISEASE)
STATUS: COMPLETED
www.clinInsight.com
PHASE: II
RESULTS :
TC-5619 did not meet the primary outcome measure and did not demonstrate improvement on the key secondary measures.
8. ClinInsight, a complete business and competitive Intelligence service
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