GE Healthcare Announces Phase I Results With Amyloid Imaging Agent GE-067
GE Healthcare, a unit of the General Electric Company (NYSE:GE), announced positive results from a Phase I clinical trial of GE-067, a [18F]-labeled PET diagnostic imaging agent being developed by the company to assist in the detection of brain beta-amyloid. The results, presented today at the International Conference on Alzheimer's Disease, Chicago, USA by the Principal Investigator, Professor Rik Vandenberghe, of the University of Leuven, Belgium, show significantly greater brain uptake of GE-067 in Alzheimer's Disease patients compared with healthy volunteers1. The two hour half-life of the [18F] labeled ligand offers the potential for greater clinical accessibility compared with the research compound [11C] PIB.
Currently, post-mortem diagnosis of Alzheimer's disease (AD) is the "gold standard" of disease confirmation, which offers no possibilities to patients and... their carers while they are alive. A key focus of AD research is to identify in vivo imaging agents that could potentially assist in the diagnosis of the disease while the patient is alive. The ability to demonstrate whether a patient does or does not have amyloid pathology might not only be used to support a clinician's diagnosis, but could in the future be used to aid treatment decisions if any of the amyloid targeted therapies now in development are successfully approved. [11C] PIB is now the most recognised and widely used research tool for imaging amyloid. A recent study2 from the Pittsburgh group of Klunk and Mathis has demonstrated that the in-vivo image seen with a PIB PET scan mirrors the distribution and intensity of amyloid pathology identified at subsequent autopsy. However, the [11C] labeled form of PIB has a short half-life (20-minutes) which hampers its potential as a routine clinical diagnostic agent. GE Healthcare has pioneered the synthesis of a PIB derivative labeled with [18F] in order to help overcome this significant barrier to potential clinical use. The [18F] form of the ligand, with a much longer half-life of 110 minutes, may offer greater clinical utility and wider accessibility to hospitals.
The Phase I study (presented using the chemical number [18F] AH1100690) consisted of 22 subjects who were injected with the agent GE-067. Initially 6 healthy volunteers had whole body scans to determine the radiation dose. A further 8 healthy and 8 probable AD) subjects had cranial scans with significant amounts of uptake being observed in the probable AD brains compared to the healthy volunteers. These initial results suggest that GE-067 could be used to detect amyloid pathology in vivo and potentially contribute towards future diagnostic and treatment algorithms, subject to performance of confirmatory studies.
Don Black, Head of R&D, Medical Diagnostics at GE Healthcare said: "We were excited to see the results from this Phase I study with GE-067 and as a result have initiated a larger study with manufacturing and scanning centres across Europe. We also plan to extend our studies to the United States of America."
Commenting on the results, Rik Vandenberghe, Principal Investigator of the trial and Professor of Neurology at the University of Leuven, Belgium said "The results of this Phase I trial are a very encouraging step forward in our quest to develop a clinically useful diagnostic imaging agent to assist in the early diagnosis of Alzheimer's Disease and directly demonstrate in vivo the presence of abnormal quantities of beta amyloid in an individual's brain. With latest estimates of the incidence of Alzheimer's Disease predicted to quadruple to 106 million by 20503 and with the potential development of amyloid - lowering therapies, there is a critical need for an effective diagnostic product to directly and reliably demonstrate the presence of amyloid deposits as early as possible during the course of the disease and ultimately improve the lives of patients and caregivers."
The PIB series of compounds are licensed by GE Healthcare from The University of Pittsburgh. In 2008, the inventors of PIB, William E. Klunk, MD, PhD, and Chester A. Mathis, PhD, from the University of Pittsburgh, were awarded the prestigious American Academy of Neurology Potamkin Prize for their significant contribution to the imaging of amyloid.
About Alzheimer Disease
Alzheimer's disease is the most common cause of dementia and a leading cause of death worldwide. Latest estimates put the global prevalence at 26.6 million and forecast that by 2050 the prevalence will quadruple, to leave 1 in 85 people worldwide living with the disease3.
References:
1. Phase I study of the 18F-labelled benzothiazole derivative [18F]AH110690 as a biomarker of AD-related brain amyloidosis Rik Vandenberghe1 et al,. Poster Presentation, International Conference on Alzheimer's Disease 2008.
2. Post-mortem correlates of in vivo PIB-PET amyloid imaging in a typical case of Alzheimer's disease Ikonomovic, M.D. et al. Brain 2008 Jun; 131(Pt 6):1630-45.
3. Forecasting the global burden of Alzheimer's disease. R. Brookmeyer, et al. Alzheimer's and Dementia 2007 ,Volume 3 ,Issue 3 ,Pages 186 - 191
About GE Healthcare
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.
GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries.
GE Healthcare
Read More..
Currently, post-mortem diagnosis of Alzheimer's disease (AD) is the "gold standard" of disease confirmation, which offers no possibilities to patients and... their carers while they are alive. A key focus of AD research is to identify in vivo imaging agents that could potentially assist in the diagnosis of the disease while the patient is alive. The ability to demonstrate whether a patient does or does not have amyloid pathology might not only be used to support a clinician's diagnosis, but could in the future be used to aid treatment decisions if any of the amyloid targeted therapies now in development are successfully approved. [11C] PIB is now the most recognised and widely used research tool for imaging amyloid. A recent study2 from the Pittsburgh group of Klunk and Mathis has demonstrated that the in-vivo image seen with a PIB PET scan mirrors the distribution and intensity of amyloid pathology identified at subsequent autopsy. However, the [11C] labeled form of PIB has a short half-life (20-minutes) which hampers its potential as a routine clinical diagnostic agent. GE Healthcare has pioneered the synthesis of a PIB derivative labeled with [18F] in order to help overcome this significant barrier to potential clinical use. The [18F] form of the ligand, with a much longer half-life of 110 minutes, may offer greater clinical utility and wider accessibility to hospitals.
The Phase I study (presented using the chemical number [18F] AH1100690) consisted of 22 subjects who were injected with the agent GE-067. Initially 6 healthy volunteers had whole body scans to determine the radiation dose. A further 8 healthy and 8 probable AD) subjects had cranial scans with significant amounts of uptake being observed in the probable AD brains compared to the healthy volunteers. These initial results suggest that GE-067 could be used to detect amyloid pathology in vivo and potentially contribute towards future diagnostic and treatment algorithms, subject to performance of confirmatory studies.
Don Black, Head of R&D, Medical Diagnostics at GE Healthcare said: "We were excited to see the results from this Phase I study with GE-067 and as a result have initiated a larger study with manufacturing and scanning centres across Europe. We also plan to extend our studies to the United States of America."
Commenting on the results, Rik Vandenberghe, Principal Investigator of the trial and Professor of Neurology at the University of Leuven, Belgium said "The results of this Phase I trial are a very encouraging step forward in our quest to develop a clinically useful diagnostic imaging agent to assist in the early diagnosis of Alzheimer's Disease and directly demonstrate in vivo the presence of abnormal quantities of beta amyloid in an individual's brain. With latest estimates of the incidence of Alzheimer's Disease predicted to quadruple to 106 million by 20503 and with the potential development of amyloid - lowering therapies, there is a critical need for an effective diagnostic product to directly and reliably demonstrate the presence of amyloid deposits as early as possible during the course of the disease and ultimately improve the lives of patients and caregivers."
The PIB series of compounds are licensed by GE Healthcare from The University of Pittsburgh. In 2008, the inventors of PIB, William E. Klunk, MD, PhD, and Chester A. Mathis, PhD, from the University of Pittsburgh, were awarded the prestigious American Academy of Neurology Potamkin Prize for their significant contribution to the imaging of amyloid.
About Alzheimer Disease
Alzheimer's disease is the most common cause of dementia and a leading cause of death worldwide. Latest estimates put the global prevalence at 26.6 million and forecast that by 2050 the prevalence will quadruple, to leave 1 in 85 people worldwide living with the disease3.
References:
1. Phase I study of the 18F-labelled benzothiazole derivative [18F]AH110690 as a biomarker of AD-related brain amyloidosis Rik Vandenberghe1 et al,. Poster Presentation, International Conference on Alzheimer's Disease 2008.
2. Post-mortem correlates of in vivo PIB-PET amyloid imaging in a typical case of Alzheimer's disease Ikonomovic, M.D. et al. Brain 2008 Jun; 131(Pt 6):1630-45.
3. Forecasting the global burden of Alzheimer's disease. R. Brookmeyer, et al. Alzheimer's and Dementia 2007 ,Volume 3 ,Issue 3 ,Pages 186 - 191
About GE Healthcare
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.
GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries.
GE Healthcare
Anavex Presents Neuroprotective Effects Of Anavex 1-41 At The International Conference On Alzheimer's Disease 2008
ANAVEX Life Sciences Corp. (OTCBB: AVXL), a biopharmaceutical company engaged in the discovery and development of novel therapeutics to treat Central Nervous System (CNS) diseases and cancer, presented data from the company's novel compound, ANAVEX 1-41, targeting Alzheimer's disease, at the International Conference on Alzheimer's Disease (ICAD) 2008, Chicago, USA, July 26 to 31, 2008. The compound has a synergistic neuroprotective and anti-apoptotic effect in Alzheimer's disease in animal models using amyloid (beta) 25-35 peptide.
"We are pleased by our continued progress in the development of ANAVEX 1-41, and are excited to be presenting data regarding its potent neuroprotective and... anti-apoptotic properties at such low doses at ICAD," said Dr. Vamvakides, Chief Scientific Officer of ANAVEX. "Based on our pre-clinical studies to date, we continue to believe that ANAVEX 1-41 may offer disease-modifying options that reverse memory and learning deficits and protect nerve cells from death."
The Anavex Life Sciences presentation is entitled: "Neuroprotective effects of activators/agonists of the sigma-1 chaperone protein against amyloid toxicity in a mouse mode". The authors are: Tanguy Maurice (1), Vanessa Villard (1), Johann Meaner (1), Emetine Keller (1), Fanny Malaria (1), Alexandre Vamvakides (2) 1. Inserm U. 710, EPHE, Univ. Montpellier II, Montpellier, France 2. Anavex Life Sciences, Pallini, Greece.
Neuroprotection was attained in the ANAVEX 1-41 compound at very low doses (0,1mg/kg) in mice. At the same doses there was synergy between Sigma-1 receptors and Muscarinic receptors, amplifying the anti-amnesic potential effects, as well as the anti-apoptotic and the anti-oxidative stress potential.
Neuroprotection is the most important component necessary to attain long-term benefits in neurodegenerative diseases. In Alzheimer's disease, neuroprotection is about shielding the neuronal cells in the brain from degeneration or death. Therefore, ANAVEX's potent neuroprotective compound may offer disease-modifying treatment and not merely symptomatic relief from Alzheimer's disease. Moreover, the compound does not target pathologoanatomic hallmarks, such as amyloid-plaques, whose role has turned out to be controversial, since approaches to inhibit them have failed to provide compelling benefit.
Anavex's approach is based on the exploitation of the multiple modulation properties of Sigma-1 receptors, which are as of yet unexploited by the existing drugs in the market. Sigma-1 receptors are proteins that regulate the activity of other different proteins (like IP3 receptors or ER stress sensors) and also of sodium and calcium channels. Moreover, through their modulatory role, Sigma-1 receptors are able to regulate cellular apoptotic processes.
Unlike the challenge of pro-amyloid and anti-amyloid theories of AD, Anavex Life Sciences' SIGMACEPTOR(TM) Discovery Platform sigma-1 activator molecules target neuronal intracellular structures with the goal of preventing neurodegenerative action of disturbed biochemical pathways and channels.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (http://www.anavex.com) is an emerging biopharmaceutical company engaged in the discovery and development of novel drug targets for the treatment of cancer and neurological diseases such as Alzheimer's, epilepsy and depression. The company's proprietary SIGMACEPTOR(TM) Discovery Platform involves the rational design of drug compounds that fulfill specific criteria based on unmet market needs and new scientific advances. Selected drug candidates demonstrate high, non-exclusive affinity for sigma receptors, which are involved in the modulation of multiple cellular biochemical signaling pathways.
ANAVEX's SIGMACEPTOR(TM)-N program involves the development of novel and original drug candidates that target neurological and neurodegenerative diseases (Alzheimer's disease, epilepsy, depression, pain). The company's lead drug candidates exhibit high, non-exclusive affinity for sigma receptors with strong evidence for anti-amnesic, neuroprotective, anti-apoptotic, anti-oxidative, anti-inflammatory, anti-convulsive, anti-depressant and anxiolytic properties. The company believes that oxidative stress, not amyloid-beta, is the cause of Alzheimer's. ANAVEX 1-41 uses sigma receptors, a unique class of receptor molecules, to guard against oxidative stress and repair cells compromised by its effects. So far, through the advanced pre-clinical phase of development, the compound has performed extremely well in well-recognized animal models of Alzheimer's disease, underscoring the promise of this alternative approach to the disease.
ANAVEX SIGMACEPTOR(TM)-C program involves the development of novel and original drug candidates targeting cancer. The company's lead drug candidates exhibit high, non-exclusive affinity for sigma receptors with strong evidence for selective pro-apoptotic, anti-metastatic and low toxicity properties in various types of solid cancers such as colon, prostate, breast and lung. ANAVEX 7-1037 has already demonstrated its ability to significantly delay the growth of cancerous tumors in patient-derived xenografts during advanced pre-clinical studies.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery and development, which include, without limitation, the potential failure of development candidates to advance through preclinical studies or demonstrate safety and efficacy in clinical testing and the ability to file an IND or commence clinical studies. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
Anavex Life Sciences Corp
Read More..
"We are pleased by our continued progress in the development of ANAVEX 1-41, and are excited to be presenting data regarding its potent neuroprotective and... anti-apoptotic properties at such low doses at ICAD," said Dr. Vamvakides, Chief Scientific Officer of ANAVEX. "Based on our pre-clinical studies to date, we continue to believe that ANAVEX 1-41 may offer disease-modifying options that reverse memory and learning deficits and protect nerve cells from death."
The Anavex Life Sciences presentation is entitled: "Neuroprotective effects of activators/agonists of the sigma-1 chaperone protein against amyloid toxicity in a mouse mode". The authors are: Tanguy Maurice (1), Vanessa Villard (1), Johann Meaner (1), Emetine Keller (1), Fanny Malaria (1), Alexandre Vamvakides (2) 1. Inserm U. 710, EPHE, Univ. Montpellier II, Montpellier, France 2. Anavex Life Sciences, Pallini, Greece.
Neuroprotection was attained in the ANAVEX 1-41 compound at very low doses (0,1mg/kg) in mice. At the same doses there was synergy between Sigma-1 receptors and Muscarinic receptors, amplifying the anti-amnesic potential effects, as well as the anti-apoptotic and the anti-oxidative stress potential.
Neuroprotection is the most important component necessary to attain long-term benefits in neurodegenerative diseases. In Alzheimer's disease, neuroprotection is about shielding the neuronal cells in the brain from degeneration or death. Therefore, ANAVEX's potent neuroprotective compound may offer disease-modifying treatment and not merely symptomatic relief from Alzheimer's disease. Moreover, the compound does not target pathologoanatomic hallmarks, such as amyloid-plaques, whose role has turned out to be controversial, since approaches to inhibit them have failed to provide compelling benefit.
Anavex's approach is based on the exploitation of the multiple modulation properties of Sigma-1 receptors, which are as of yet unexploited by the existing drugs in the market. Sigma-1 receptors are proteins that regulate the activity of other different proteins (like IP3 receptors or ER stress sensors) and also of sodium and calcium channels. Moreover, through their modulatory role, Sigma-1 receptors are able to regulate cellular apoptotic processes.
Unlike the challenge of pro-amyloid and anti-amyloid theories of AD, Anavex Life Sciences' SIGMACEPTOR(TM) Discovery Platform sigma-1 activator molecules target neuronal intracellular structures with the goal of preventing neurodegenerative action of disturbed biochemical pathways and channels.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (http://www.anavex.com) is an emerging biopharmaceutical company engaged in the discovery and development of novel drug targets for the treatment of cancer and neurological diseases such as Alzheimer's, epilepsy and depression. The company's proprietary SIGMACEPTOR(TM) Discovery Platform involves the rational design of drug compounds that fulfill specific criteria based on unmet market needs and new scientific advances. Selected drug candidates demonstrate high, non-exclusive affinity for sigma receptors, which are involved in the modulation of multiple cellular biochemical signaling pathways.
ANAVEX's SIGMACEPTOR(TM)-N program involves the development of novel and original drug candidates that target neurological and neurodegenerative diseases (Alzheimer's disease, epilepsy, depression, pain). The company's lead drug candidates exhibit high, non-exclusive affinity for sigma receptors with strong evidence for anti-amnesic, neuroprotective, anti-apoptotic, anti-oxidative, anti-inflammatory, anti-convulsive, anti-depressant and anxiolytic properties. The company believes that oxidative stress, not amyloid-beta, is the cause of Alzheimer's. ANAVEX 1-41 uses sigma receptors, a unique class of receptor molecules, to guard against oxidative stress and repair cells compromised by its effects. So far, through the advanced pre-clinical phase of development, the compound has performed extremely well in well-recognized animal models of Alzheimer's disease, underscoring the promise of this alternative approach to the disease.
ANAVEX SIGMACEPTOR(TM)-C program involves the development of novel and original drug candidates targeting cancer. The company's lead drug candidates exhibit high, non-exclusive affinity for sigma receptors with strong evidence for selective pro-apoptotic, anti-metastatic and low toxicity properties in various types of solid cancers such as colon, prostate, breast and lung. ANAVEX 7-1037 has already demonstrated its ability to significantly delay the growth of cancerous tumors in patient-derived xenografts during advanced pre-clinical studies.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery and development, which include, without limitation, the potential failure of development candidates to advance through preclinical studies or demonstrate safety and efficacy in clinical testing and the ability to file an IND or commence clinical studies. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
Anavex Life Sciences Corp
First Ever Study On Alzheimer's Disease Treatment In Hispanics Presented At Major Medical Meeting
Eisai Inc. and Pfizer Inc (NYSE: PFE) announced results from a new open-label study that showed Hispanics with mild to moderate Alzheimer's disease (AD) experienced significant improvement in cognition compared to baseline after 12 weeks of treatment with ARICEPT. This is the first clinical trial looking at an AD prescription medication exclusively in Hispanics, and is important given the high risk of AD among this large population. These results are consistent with pivotal ARICEPT studies in the general population and also in studies specific to African Americans, as seen in the 2006 Treatment of Alzheimer's in African American Patients (TAAAP) study. The Evaluating ARICEPT Treatment in Hispanics (EARTH) study was presented at the 2008 Alzheimer's Association International Conference on Alzheimer's Disease and Related Disorders (ICAD).
"We know the Hispanic community is in need of increased education on the benefits of diagnosing and treating AD early," said Dr. Oscar Lopez, professor, department of neurology, University of Pittsburgh, and the first author of the... EARTH poster presented at ICAD. "This news should serve as a call to action for Hispanic families to watch for early signs of AD among their loved ones and speak with a doctor as soon as possible if symptoms are suspected."
This multi-center open-label clinical trial enrolled 106 Hispanic men and women from across the U.S. Patients were at least 50 years of age and had a diagnosis of mild to moderate AD. In order to most accurately measure the efficacy of ARICEPT in Hispanics, unique measurement tools with little language bias were specifically selected for use in the EARTH study. For instance, the Fuld Object Memory Evaluation (FOME) assessment reduces dependence on spoken English, and it has been proven effective in detecting cognitive impairment and in the diagnosis of AD in Spanish-speaking individuals. The Symbol Digit Modality Test (SDMT) is also extremely sensitive for detecting dementia and has minimal cultural bias. A third, commonly used measurement included the Mini-Mental State Examination (MMSE).
The MMSE score, which measures cognitive function, significantly improved from baseline (p<0.0001) with a treatment effect that was similar to that seen in the pivotal studies for ARICEPT. The FOME, which assesses learning and memory through common object recognition, also showed significant improvement with ARICEPT (p=0.0042) in terms of retrieval scores. The FOME storage scores did not show statistically significant improvement from baseline. The SDMT measures speed of mental processing, attention and concentration functions, and also showed significant improvement from baseline (p<0.0001). Behavioral symptoms and associated caregiver distress were assessed with the Neuropsychiatric Inventory (NPI). A numeric improvement in NPI total score was observed but did not reach statistical significance; however, the NPI Caregiver Distress scale (NPI-D) total score significantly improved (p=0.0500).
The most common adverse events greater than or equal to five percent were insomnia (9.5 percent), dizziness (7.6 percent), diarrhea (5.7 percent) and nausea (5.7 percent).
"All too often, Hispanics dismiss the symptoms of AD as signs of normal aging and wait years before consulting a doctor," said Yanira Cruz, who has a doctorate in public health and is president and CEO of the National Hispanic Council on Aging (NHCOA), a national organization dedicated to improving the quality of life for Hispanic communities. "This study reminds us of the value of treating AD to slow symptoms of the disease, and I encourage primary care physicians with Hispanic patients to start screening for signs of dementia at a younger age, potentially at 55 or 60 years."
Dr. Cruz urges more attention to diagnosis and treatment of AD among Hispanics and advises family members suspecting AD symptoms in a loved one to visit http://www.losamigosdesumemoria.com to learn more about the disease and complete an online memory screener.
The EARTH study represents Eisai and Pfizer's leadership in understanding the benefits of ARICEPT in multiple populations. The TAAAP study, published in the Journal of the National Medical Association in 2006, found that African Americans with mild to moderate AD and treated with ARICEPT experienced significant improvement in cognition and function. ARICEPT has now been studied in two underserved populations, both with higher prevalence and incidence of AD than the general population.
Alzheimer's Disease in the Hispanic Community
-- There are an estimated 200,000 Hispanics living in the U.S. with AD today, and by 2050, it is estimated that approximately 1.3 million Hispanic Americans will have the disease.
-- Due to language differences and cultural barriers, Hispanics typically wait to see a doctor until they are in a later stage of the disease -- usually three years after symptoms emerge.
-- Many Hispanics living with AD remain undiagnosed and untreated (approximately 40 percent).
-- Hispanics start showing AD symptoms nearly seven years earlier than non-Hispanics.
-- Reasons for increased AD risk in the Hispanic community include the growing senior population (age is the number one risk for disease), higher rates of diabetes and hypertension (known risk factors), and familial risk (genetics and heredity).
-- Hispanic participation in AD clinical trials remains historically low. Information About ARICEPT Treatment in Alzheimer's Disease
ARICEPT is the only AD treatment to be approved in the U.S. for mild, moderate and severe dementia of the Alzheimer's type. While there is no cure for AD, ARICEPT can help slow the progression of symptoms. Extensive data derived from clinical studies with thousands of patients have demonstrated that ARICEPT helps cognition and function.
ARICEPT is an acetylcholinesterase inhibitor and is believed to work by inhibiting the breakdown of acetylcholine, thereby increasing available levels of this chemical in the brain. There is an established association between the loss of acetylcholine, a brain chemical involved in memory and thinking, and AD.
In a progressively degenerative disease such as Alzheimer's, improvement, stabilization or a less-than-expected decline over time is considered a positive response to treatment. These types of responses have been observed in patients treated with ARICEPT in clinical trials for AD. Individual responses to treatment vary, and some patients may not respond.
ARICEPT is well tolerated, but may not be for everyone. People at risk for stomach ulcers or who take certain other medicines should tell their doctors because serious stomach problems, such as bleeding, may get worse. Some people who take ARICEPT may experience fainting. Some people may have nausea, vomiting, diarrhea, bruising, or not sleep well. Some people may have muscle cramps or loss of appetite or may feel tired. In studies these were usually mild and temporary.
About Eisai Inc.
Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care. Established in 1995 and ranked among the top-20 U.S. pharmaceutical companies (based on retail sales), Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business with fiscal year 2007 (year ended March 31, 2008) sales of approximately $3 billion, including the results of the acquisition of MGI PHARMA, Inc.
Eisai Inc. employs approximately 1,500 people at its headquarters in Woodcliff Lake, NJ, at its state-of-the-art pharmaceutical production and formulation research and development facility in Research Triangle Park, NC, and in the field. For more information about Eisai, please visit http://www.eisai.com.
About Pfizer Inc
Founded in 1849, Pfizer is the world's largest research-based pharmaceutical company. Pfizer is taking new approaches to advancing better health as it discovers, develops, manufactures and delivers quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. Pfizer also partners with healthcare providers, governments and local communities around the world to expand access to medicines and to provide better quality health care and health system support. At Pfizer, more than 85,000 colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide. For more information visit http://www.pfizer.com.
Pfizer Inc
Read More..
"We know the Hispanic community is in need of increased education on the benefits of diagnosing and treating AD early," said Dr. Oscar Lopez, professor, department of neurology, University of Pittsburgh, and the first author of the... EARTH poster presented at ICAD. "This news should serve as a call to action for Hispanic families to watch for early signs of AD among their loved ones and speak with a doctor as soon as possible if symptoms are suspected."
This multi-center open-label clinical trial enrolled 106 Hispanic men and women from across the U.S. Patients were at least 50 years of age and had a diagnosis of mild to moderate AD. In order to most accurately measure the efficacy of ARICEPT in Hispanics, unique measurement tools with little language bias were specifically selected for use in the EARTH study. For instance, the Fuld Object Memory Evaluation (FOME) assessment reduces dependence on spoken English, and it has been proven effective in detecting cognitive impairment and in the diagnosis of AD in Spanish-speaking individuals. The Symbol Digit Modality Test (SDMT) is also extremely sensitive for detecting dementia and has minimal cultural bias. A third, commonly used measurement included the Mini-Mental State Examination (MMSE).
The MMSE score, which measures cognitive function, significantly improved from baseline (p<0.0001) with a treatment effect that was similar to that seen in the pivotal studies for ARICEPT. The FOME, which assesses learning and memory through common object recognition, also showed significant improvement with ARICEPT (p=0.0042) in terms of retrieval scores. The FOME storage scores did not show statistically significant improvement from baseline. The SDMT measures speed of mental processing, attention and concentration functions, and also showed significant improvement from baseline (p<0.0001). Behavioral symptoms and associated caregiver distress were assessed with the Neuropsychiatric Inventory (NPI). A numeric improvement in NPI total score was observed but did not reach statistical significance; however, the NPI Caregiver Distress scale (NPI-D) total score significantly improved (p=0.0500).
The most common adverse events greater than or equal to five percent were insomnia (9.5 percent), dizziness (7.6 percent), diarrhea (5.7 percent) and nausea (5.7 percent).
"All too often, Hispanics dismiss the symptoms of AD as signs of normal aging and wait years before consulting a doctor," said Yanira Cruz, who has a doctorate in public health and is president and CEO of the National Hispanic Council on Aging (NHCOA), a national organization dedicated to improving the quality of life for Hispanic communities. "This study reminds us of the value of treating AD to slow symptoms of the disease, and I encourage primary care physicians with Hispanic patients to start screening for signs of dementia at a younger age, potentially at 55 or 60 years."
Dr. Cruz urges more attention to diagnosis and treatment of AD among Hispanics and advises family members suspecting AD symptoms in a loved one to visit http://www.losamigosdesumemoria.com to learn more about the disease and complete an online memory screener.
The EARTH study represents Eisai and Pfizer's leadership in understanding the benefits of ARICEPT in multiple populations. The TAAAP study, published in the Journal of the National Medical Association in 2006, found that African Americans with mild to moderate AD and treated with ARICEPT experienced significant improvement in cognition and function. ARICEPT has now been studied in two underserved populations, both with higher prevalence and incidence of AD than the general population.
Alzheimer's Disease in the Hispanic Community
-- There are an estimated 200,000 Hispanics living in the U.S. with AD today, and by 2050, it is estimated that approximately 1.3 million Hispanic Americans will have the disease.
-- Due to language differences and cultural barriers, Hispanics typically wait to see a doctor until they are in a later stage of the disease -- usually three years after symptoms emerge.
-- Many Hispanics living with AD remain undiagnosed and untreated (approximately 40 percent).
-- Hispanics start showing AD symptoms nearly seven years earlier than non-Hispanics.
-- Reasons for increased AD risk in the Hispanic community include the growing senior population (age is the number one risk for disease), higher rates of diabetes and hypertension (known risk factors), and familial risk (genetics and heredity).
-- Hispanic participation in AD clinical trials remains historically low. Information About ARICEPT Treatment in Alzheimer's Disease
ARICEPT is the only AD treatment to be approved in the U.S. for mild, moderate and severe dementia of the Alzheimer's type. While there is no cure for AD, ARICEPT can help slow the progression of symptoms. Extensive data derived from clinical studies with thousands of patients have demonstrated that ARICEPT helps cognition and function.
ARICEPT is an acetylcholinesterase inhibitor and is believed to work by inhibiting the breakdown of acetylcholine, thereby increasing available levels of this chemical in the brain. There is an established association between the loss of acetylcholine, a brain chemical involved in memory and thinking, and AD.
In a progressively degenerative disease such as Alzheimer's, improvement, stabilization or a less-than-expected decline over time is considered a positive response to treatment. These types of responses have been observed in patients treated with ARICEPT in clinical trials for AD. Individual responses to treatment vary, and some patients may not respond.
ARICEPT is well tolerated, but may not be for everyone. People at risk for stomach ulcers or who take certain other medicines should tell their doctors because serious stomach problems, such as bleeding, may get worse. Some people who take ARICEPT may experience fainting. Some people may have nausea, vomiting, diarrhea, bruising, or not sleep well. Some people may have muscle cramps or loss of appetite or may feel tired. In studies these were usually mild and temporary.
About Eisai Inc.
Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care. Established in 1995 and ranked among the top-20 U.S. pharmaceutical companies (based on retail sales), Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business with fiscal year 2007 (year ended March 31, 2008) sales of approximately $3 billion, including the results of the acquisition of MGI PHARMA, Inc.
Eisai Inc. employs approximately 1,500 people at its headquarters in Woodcliff Lake, NJ, at its state-of-the-art pharmaceutical production and formulation research and development facility in Research Triangle Park, NC, and in the field. For more information about Eisai, please visit http://www.eisai.com.
About Pfizer Inc
Founded in 1849, Pfizer is the world's largest research-based pharmaceutical company. Pfizer is taking new approaches to advancing better health as it discovers, develops, manufactures and delivers quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. Pfizer also partners with healthcare providers, governments and local communities around the world to expand access to medicines and to provide better quality health care and health system support. At Pfizer, more than 85,000 colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide. For more information visit http://www.pfizer.com.
Pfizer Inc
Langganan:
Postingan (Atom)