"I am a 49 year old female and am currently being treated for colon cancer, stage 4. I was initially diagnosed last year, February 2007, and have been undergoing chemotherapy ever since," said Andrea Bates of Indianapolis, Ind. My initial prognosis was not good, but now is looking very good and I am thankful for that. I currently have insurance through my husband's employer and have been receiving great care, which again, I'm grateful for.
"I recently inquired about another treatment center, Cancer Treatment Centers of America, which has a lot more available options to treat my cancer that my current hospital does not provide. I was informed that because I have an HMO, I cannot pursue treatment outside my network. If I had a PPO, insurance would most likely cover the cost of me going to the Cancer Treatment Center of America though.
"Since the insurance I have is through my husband's work, we were only given two options to choose from for insurance for the 2008 year - Advantage HMO or Anthem PPO. For obvious reasons, we had to take the Advantage HMO route because it was more than half as cheap than the Anthem PPO. Why should we have to choose in the first place and why only these two types of insurances?
"But they finally did allow me to go to another hospital to have my final major surgery, and I was grateful for this since this last surgery was the one that probably ended up saving my life. I had 65 percent of my liver removed that had cancer on it.
"I don't know if the insurance company would have eventually allowed me to go to the Cancer Treatment Center of America. They might have if I would have continued to pursue it, but I guess that's part of the problem - why should I have to justify my intentions of going somewhere else where better treatment is offered that could save my life?
"It simply is not fair that we have to choose between 'affordable' healthcare versus 'not-so-affordable' healthcare and only being given limited choices of insurance plans to choose from. These choices obviously can make a difference between life and death. I'm sick to death with increasing premiums year after year and receiving less coverage, year after year."
Read stories like this every day through Election Day at: GuaranteedHealthcare
Sponsored by the California Nurses Association/National Nurses Organizing Committee
Eighty-two percent of Americans think the U.S. healthcare system should be fundamentally changed or completely rebuilt (Commonwealth Fund, Aug. 7, 2008). America's nurses know that only single-payer, improved and expanded Medicare for all will fix our broken system and the tragedy of our devastated families. HR 676, by U.S. Rep John Conyers, is the most comprehensive, cost effective way to achieve guaranteed healthcare for all.
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суббота, 10 сентября 2011 г.
Novel Drug Boosts Platelet Production, Reversing Chronic Immune Thrombocytopenic Purpura
Attacking a platelet-depleting autoimmune disease in a whole new way, an experimental drug is helping patients with immune thrombocytopenic purpura (ITP) once again produce healthy amounts of platelets -- with no major side effects.
That's the conclusion of a new, multicenter study led by Dr. James B. Bussel, professor of pediatrics at Weill Cornell Medical College, attending pediatrician at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, and director of the Hospital's Program for Platelet Disorders.
His team's findings appear in The New England Journal of Medicine.
The new drug, a novel protein called AMG 531, successfully boosted platelet production in patents with chronic ITP, a serious autoimmune disorder that affects more than 16,000 adult Americans, and perhaps as many children, each year.
In ITP, immune system antibodies mysteriously begin to attack and destroy blood platelet cells. In some cases, the disease goes into spontaneous remission, but for many patients it remains a chronic condition. Impaired clotting leaves many patients, especially the elderly, vulnerable to serious or fatal hemorrhage.
Up till now, ITP patients have typically turned to powerful drugs such as corticosteroids or intravenous immune globulin, which work by inhibiting platelet destruction. These drug therapies can have limited success, but they also have serious side effects. For some ITP patients splenectomy (surgical removal of the spleen) is another treatment option.
AMG 531 fights ITP in a totally different way.
"Experts have long realized that ITP not only destroys platelets, it also inhibits platelet production in the marrow," explains Dr. Bussel.
In fact, prior work in the 1990s had focused on a type of recombinant thrombopoietin, called PEG-MGDF, that researchers hoped would stimulate platelet production.
The drug did have success. "However, Dr. David Kuter at Massachusetts General Hospital showed that some patients -- and even healthy volunteers -- developed antibodies to the drug, and these antibodies cross-reacted with their own natural thrombopoietin. The result was chronic low platelet counts in people who, in many cases, had never had such problems before," Dr. Bussel says.
The trick, then, was to find a platelet-stimulating agent that avoided this dangerous immune-system response.
"Luckily, Amgen, the company that has funded this research, didn't throw in the towel," Dr. Bussel says.
The company, under the guidance of the study's senior author, Dr. Janet Nichol, eventually developed AMG 531 -- a novel protein with no structural similarity to human thrombopoietin. This dissimilarity and other features mean AMG 531 is largely ignored by the immune system.
The new, two-phase trial was led by Dr. Bussel and conducted at nine centers across the United States.
In the Phase 1 part of the study, doctors first gave six groups of four ITP patients (24 total) two subcutaneous injections of AMG 531 delivered at least two weeks apart. Depending on the group they were in, patients received anywhere from 0.2 to 10 micrograms of the drug per kilogram of body weight.
In the Phase 2 part of the trial, 21 patients were randomized to receive six weekly injections of either a harmless placebo, or AMG 531 at doses of 1, 3, or 6 micrograms per kilogram of body weight.
The Phase 1 results showed the drug to be safe, with no major adverse events attributed to AMG 531 during the treatment period. Four of a total of 41 patients did show some temporary post-treatment lowering of their platelet counts, but this later resolved.
The drug's efficacy impressed the researchers.
"We were very pleased," says Dr. Bussel. Hoping to boost platelet counts to between 50,000 to 450,000 per cubic millimeter, the researchers report that seven of 12 patients given higher doses of AMG 531 (3, 6 or 10 micrograms/kilogram) fell within that range after six weeks on the therapy.
"In fact, three of these patients saw their counts rise to over 450,000 per cubic millimeter," Dr. Bussel notes.
Platelet counts increased in treated patients in a dose-dependent fashion, with mean peak counts of 163,000, 309,000 and 746,000 per cubic millimeter for doses of 3, 6 and 10 micrograms/kilogram, respectively.
"This was a relatively small trial, so more study is needed. However, the results point to a new, effective and safe way of letting people receive an injection once a week that stimulates them to increase their platelets," Dr. Bussel says.
How does AMG 531 work? According to the researchers, the drug acts much like natural thrombopoietin, stimulating the production of platelets from their earliest stages of development within the marrow, straight through to their appearance in the bloodstream.
Based on the findings, Dr. Bussel is optimistic that ITP patients everywhere will soon have a potent new weapon against the disease.
"Further clinical trials in AMG 531 are well under way," he says, "and the next step, we hope, will be to license the compound. Then, maybe, we can begin to broaden its use to other illnesses, where boosting platelets might help the many other patients with low platelets fight disease."
Co-researchers include Dr. David J. Kuter of Massachusetts General Hospital, Boston; Dr. James N. George of the University of Oklahoma Medical Center, Oklahoma City; Drs. Robert MacMillan and Jorge Nieva, of Scripps Cancer Center, La Jolla, Calif; Dr. Louis M. Aledort of Mount Sinai Medical Center, New York City; Dr. George T. Conklin of the Diagnostic Clinic of Houston; Dr. Alan E. Lichtin, of the Cleveland Clinic Foundation; Dr. Roger M. Lyons of Hematology-Oncology Associates of South Texas, San Antonio; Dr. Jeffrey S. Wasser of DeQuattro Community Cancer Center, Manchester, Conn; Dr. Israel Wiznitzer of the Broward General Medical Center, Fort Lauderdale, Fla; and Reggie Kelly and Dr. Chien-Feng Chen, of Amgen, Thousand Oaks, Calif.
NewYork-Presbyterian Hospital
425 East 61st St., Fl. 7
New York, NY 10021
United States
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That's the conclusion of a new, multicenter study led by Dr. James B. Bussel, professor of pediatrics at Weill Cornell Medical College, attending pediatrician at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, and director of the Hospital's Program for Platelet Disorders.
His team's findings appear in The New England Journal of Medicine.
The new drug, a novel protein called AMG 531, successfully boosted platelet production in patents with chronic ITP, a serious autoimmune disorder that affects more than 16,000 adult Americans, and perhaps as many children, each year.
In ITP, immune system antibodies mysteriously begin to attack and destroy blood platelet cells. In some cases, the disease goes into spontaneous remission, but for many patients it remains a chronic condition. Impaired clotting leaves many patients, especially the elderly, vulnerable to serious or fatal hemorrhage.
Up till now, ITP patients have typically turned to powerful drugs such as corticosteroids or intravenous immune globulin, which work by inhibiting platelet destruction. These drug therapies can have limited success, but they also have serious side effects. For some ITP patients splenectomy (surgical removal of the spleen) is another treatment option.
AMG 531 fights ITP in a totally different way.
"Experts have long realized that ITP not only destroys platelets, it also inhibits platelet production in the marrow," explains Dr. Bussel.
In fact, prior work in the 1990s had focused on a type of recombinant thrombopoietin, called PEG-MGDF, that researchers hoped would stimulate platelet production.
The drug did have success. "However, Dr. David Kuter at Massachusetts General Hospital showed that some patients -- and even healthy volunteers -- developed antibodies to the drug, and these antibodies cross-reacted with their own natural thrombopoietin. The result was chronic low platelet counts in people who, in many cases, had never had such problems before," Dr. Bussel says.
The trick, then, was to find a platelet-stimulating agent that avoided this dangerous immune-system response.
"Luckily, Amgen, the company that has funded this research, didn't throw in the towel," Dr. Bussel says.
The company, under the guidance of the study's senior author, Dr. Janet Nichol, eventually developed AMG 531 -- a novel protein with no structural similarity to human thrombopoietin. This dissimilarity and other features mean AMG 531 is largely ignored by the immune system.
The new, two-phase trial was led by Dr. Bussel and conducted at nine centers across the United States.
In the Phase 1 part of the study, doctors first gave six groups of four ITP patients (24 total) two subcutaneous injections of AMG 531 delivered at least two weeks apart. Depending on the group they were in, patients received anywhere from 0.2 to 10 micrograms of the drug per kilogram of body weight.
In the Phase 2 part of the trial, 21 patients were randomized to receive six weekly injections of either a harmless placebo, or AMG 531 at doses of 1, 3, or 6 micrograms per kilogram of body weight.
The Phase 1 results showed the drug to be safe, with no major adverse events attributed to AMG 531 during the treatment period. Four of a total of 41 patients did show some temporary post-treatment lowering of their platelet counts, but this later resolved.
The drug's efficacy impressed the researchers.
"We were very pleased," says Dr. Bussel. Hoping to boost platelet counts to between 50,000 to 450,000 per cubic millimeter, the researchers report that seven of 12 patients given higher doses of AMG 531 (3, 6 or 10 micrograms/kilogram) fell within that range after six weeks on the therapy.
"In fact, three of these patients saw their counts rise to over 450,000 per cubic millimeter," Dr. Bussel notes.
Platelet counts increased in treated patients in a dose-dependent fashion, with mean peak counts of 163,000, 309,000 and 746,000 per cubic millimeter for doses of 3, 6 and 10 micrograms/kilogram, respectively.
"This was a relatively small trial, so more study is needed. However, the results point to a new, effective and safe way of letting people receive an injection once a week that stimulates them to increase their platelets," Dr. Bussel says.
How does AMG 531 work? According to the researchers, the drug acts much like natural thrombopoietin, stimulating the production of platelets from their earliest stages of development within the marrow, straight through to their appearance in the bloodstream.
Based on the findings, Dr. Bussel is optimistic that ITP patients everywhere will soon have a potent new weapon against the disease.
"Further clinical trials in AMG 531 are well under way," he says, "and the next step, we hope, will be to license the compound. Then, maybe, we can begin to broaden its use to other illnesses, where boosting platelets might help the many other patients with low platelets fight disease."
Co-researchers include Dr. David J. Kuter of Massachusetts General Hospital, Boston; Dr. James N. George of the University of Oklahoma Medical Center, Oklahoma City; Drs. Robert MacMillan and Jorge Nieva, of Scripps Cancer Center, La Jolla, Calif; Dr. Louis M. Aledort of Mount Sinai Medical Center, New York City; Dr. George T. Conklin of the Diagnostic Clinic of Houston; Dr. Alan E. Lichtin, of the Cleveland Clinic Foundation; Dr. Roger M. Lyons of Hematology-Oncology Associates of South Texas, San Antonio; Dr. Jeffrey S. Wasser of DeQuattro Community Cancer Center, Manchester, Conn; Dr. Israel Wiznitzer of the Broward General Medical Center, Fort Lauderdale, Fla; and Reggie Kelly and Dr. Chien-Feng Chen, of Amgen, Thousand Oaks, Calif.
NewYork-Presbyterian Hospital
425 East 61st St., Fl. 7
New York, NY 10021
United States
nyp
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Families Of Sudden Unexplained Death Victims Should Receive Comprehensive Cardiogenetic Testing
Relatives of a young person who dies suddenly should always be referred for cardiological and genetic examination in order to identify if they too are at risk of sudden death, a scientist told the annual conference of the European Society of Human Genetics. Dr. Christian van der Werf, a research fellow at the Department of Cardiogenetics, Academic Medical Centre, Amsterdam, The Netherlands said that, although his team's research showed that inherited heart disease was present in over 30% of the families of sudden unexplained death (SUD) victims, the majority of such relatives were currently not being referred for examination.
When an individual aged 1-50 years dies suddenly, autopsy reveals an inheritable heart disease in the majority of the victims. But in approximately 20% autopsy does not reveal the cause of death. "We thought that cardiological and genetic examination of surviving first degree relatives of these SUD patients might reveal an inherited heart disease", said Dr. van der Werf.
In the largest such study to date, the team looked at the outcome of first degree relative screening in 127 families who had suffered an SUD and where either there had been no autopsy (53.8%), or the autopsy did not reveal a cause of death. The average age at death of the SUD victims was only 29.8 years old.
The initial examination of the relatives consisted of taking personal and family medical history and a resting ECG. A second cardiac autopsy of the SUD victim was undertaken if tissue had been stored and was available. Additional cardiological examinations of the relatives were performed where necessary. Genetic analysis of the associated candidate gene(s) was performed in material obtained from the deceased person or in those relatives who showed clinical abnormalities.
The researchers found inherited heart disease in 36, or 32% of the families. These results meant that doctors were able to treat affected relatives and try to prevent their succumbing to sudden cardiac death. "The scale of heart disease that we found in such families underlines the necessity for general practitioners to refer first degree relatives of SUD victims to a specialised cardiogenetics department as soon as possible", said Dr. van der Werf. "Currently we estimate that only 10% of SUD families are being examined for inherited heart conditions.
The study is the second report from the registry of families who attended the Amsterdam centre's cardiogenetics department because of unexplained sudden death of a relative aged 1-50 years. The scientists intend to continue to report the yield of family screening in an increasing number of families.
"At present we are conducting a study to stimulate general practitioners and other involved physicians to request autopsy and DNA-storage for SUD patients and to refer relatives to a cardiogenetics department after a case of sudden death at young age. We hope this will lead to identification of more families at risk of sudden cardiac death, in which preventive measures then can be taken" said Dr. van der Werf.
"Relatives of young sudden death victims are often referred to cardiologists for cardiological examination. We believe relatives should instead be referred to cardiogenetics departments, where clinical geneticists, cardiologists and psychosocial workers cooperate. These professionals specialise in inherited heart diseases and their clinical and psychosocial implications, and can provide a better quality of care. Additionally, cardiologists should receive more education in inherited heart diseases. By taking these measures we can save lives and avoid further distress for families who have already suffered enough," he said.
Source:
Mary Rice
European Society of Human Genetics
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When an individual aged 1-50 years dies suddenly, autopsy reveals an inheritable heart disease in the majority of the victims. But in approximately 20% autopsy does not reveal the cause of death. "We thought that cardiological and genetic examination of surviving first degree relatives of these SUD patients might reveal an inherited heart disease", said Dr. van der Werf.
In the largest such study to date, the team looked at the outcome of first degree relative screening in 127 families who had suffered an SUD and where either there had been no autopsy (53.8%), or the autopsy did not reveal a cause of death. The average age at death of the SUD victims was only 29.8 years old.
The initial examination of the relatives consisted of taking personal and family medical history and a resting ECG. A second cardiac autopsy of the SUD victim was undertaken if tissue had been stored and was available. Additional cardiological examinations of the relatives were performed where necessary. Genetic analysis of the associated candidate gene(s) was performed in material obtained from the deceased person or in those relatives who showed clinical abnormalities.
The researchers found inherited heart disease in 36, or 32% of the families. These results meant that doctors were able to treat affected relatives and try to prevent their succumbing to sudden cardiac death. "The scale of heart disease that we found in such families underlines the necessity for general practitioners to refer first degree relatives of SUD victims to a specialised cardiogenetics department as soon as possible", said Dr. van der Werf. "Currently we estimate that only 10% of SUD families are being examined for inherited heart conditions.
The study is the second report from the registry of families who attended the Amsterdam centre's cardiogenetics department because of unexplained sudden death of a relative aged 1-50 years. The scientists intend to continue to report the yield of family screening in an increasing number of families.
"At present we are conducting a study to stimulate general practitioners and other involved physicians to request autopsy and DNA-storage for SUD patients and to refer relatives to a cardiogenetics department after a case of sudden death at young age. We hope this will lead to identification of more families at risk of sudden cardiac death, in which preventive measures then can be taken" said Dr. van der Werf.
"Relatives of young sudden death victims are often referred to cardiologists for cardiological examination. We believe relatives should instead be referred to cardiogenetics departments, where clinical geneticists, cardiologists and psychosocial workers cooperate. These professionals specialise in inherited heart diseases and their clinical and psychosocial implications, and can provide a better quality of care. Additionally, cardiologists should receive more education in inherited heart diseases. By taking these measures we can save lives and avoid further distress for families who have already suffered enough," he said.
Source:
Mary Rice
European Society of Human Genetics
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Policy Recommendations For Improving Medication Adherence
A diverse group of health care and consumer organizations released five policy recommendations this week that are designed to promote better medication adherence and improved health outcomes for patients.
The group, which includes the American College of Cardiology, GlaxoSmithKline, the National Association of Chain Drug Stores, the National Consumers League and the Pharmaceutical Research and Manufacturers of America, focused their recommendations on the areas of quality improvement, care coordination, health information technology, patient/provider education and engagement, and health services research.
Although some of the recommendations have been the subject of discussion during the ongoing health care reform debate, and in fact have been reflected in some of the proposals under consideration, the recommendations are being released with an eye toward an ongoing and consistent commitment to improving health care - and health outcomes - in America.
According to a 2005 study published in the New England Journal of Medicine, an estimated one-third to one-half of all patients in the United States do not take their medications as prescribed. The impact of this non-adherence is costly in terms of both quality of care and medical expenses. In fact, recent research including work by the New England Healthcare Institute (NEHI) and a 2004 study published in Medical Care suggested that costs resulting from non-adherence may be as high as $300 billion annually.
"Not only is poor medication adherence costly, but it also can be dangerous," said Sally Greenberg, Executive Director of National Consumers League. "Because patients don't take their medications for a variety of reasons, including side effects, misconceptions or fears about the medication, trouble with dosing, and costs such as co-pays, we need to employ a multitude of strategies to improve adherence. Our efforts are focused on identifying key opportunities to reduce barriers that keep patients from adhering to their medications."
The five recommendations were constructed, refined and finalized following a July conference with more than 40 medication adherence experts, including providers, patients, health plans, employers, and researchers. The dialogue was informed by research by the RAND Corporation, which conducted a review of the literature on medication adherence to provide an evidence-base for the discussions, and by Avalere Health, which described lessons learned from here-and-now programs to improve medication adherence.
Walid Gellad, M.D., the lead RAND researcher on this review noted that, "Poor medication adherence is an enormous public health problem. Finding solutions to this problem should be part of health reform discussions now and in the future."
Each of the recommendations is supported by specific action items to help guide its implementation. To see the full recommendations, please click here.
Quality Improvement - National quality improvement strategies should explicitly recognize medication adherence and appropriate medication use as critical components to improve health care quality and clinical outcomes.
Care Coordination - Proposals aimed at improving care coordination must recognize the important role that medications play in treating and managing illnesses.
Health Information Technology - Health information technology must improve the flow of timely and complete information between patients and providers, and enable providers and payers to identify and address gaps in patients' medication use.
Patient/Provider Education and Engagement - Strategies to improve medication adherence must fully engage patients, and patient-centered care must involve strategies to help them better understand their conditions and treatments. These efforts also must support providers in effectively communicating the importance of following treatment plans, and in providing medication support services to patients and caregivers.
Health Services Research - There is a need for additional research on medication adherence, including a focus on the effectiveness of a wider range of interventions to improve adherence, as well as an analysis of the diverse factors, behaviors, costs and consequences related to poor adherence.
"Medical adherence is a problem that should unite all providers, elected officials, pharmacists, insurers and pharmaceutical companies," said Jack Lewin, CEO of the American College of Cardiology. "Fifty percent of patients with heart disease are not taking their potentially life-saving medications, but it is our hope that recommendations like these will go a long way toward addressing this serious problem."
Source:
Tom Murphy
Chandler Chicco Agency
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The group, which includes the American College of Cardiology, GlaxoSmithKline, the National Association of Chain Drug Stores, the National Consumers League and the Pharmaceutical Research and Manufacturers of America, focused their recommendations on the areas of quality improvement, care coordination, health information technology, patient/provider education and engagement, and health services research.
Although some of the recommendations have been the subject of discussion during the ongoing health care reform debate, and in fact have been reflected in some of the proposals under consideration, the recommendations are being released with an eye toward an ongoing and consistent commitment to improving health care - and health outcomes - in America.
According to a 2005 study published in the New England Journal of Medicine, an estimated one-third to one-half of all patients in the United States do not take their medications as prescribed. The impact of this non-adherence is costly in terms of both quality of care and medical expenses. In fact, recent research including work by the New England Healthcare Institute (NEHI) and a 2004 study published in Medical Care suggested that costs resulting from non-adherence may be as high as $300 billion annually.
"Not only is poor medication adherence costly, but it also can be dangerous," said Sally Greenberg, Executive Director of National Consumers League. "Because patients don't take their medications for a variety of reasons, including side effects, misconceptions or fears about the medication, trouble with dosing, and costs such as co-pays, we need to employ a multitude of strategies to improve adherence. Our efforts are focused on identifying key opportunities to reduce barriers that keep patients from adhering to their medications."
The five recommendations were constructed, refined and finalized following a July conference with more than 40 medication adherence experts, including providers, patients, health plans, employers, and researchers. The dialogue was informed by research by the RAND Corporation, which conducted a review of the literature on medication adherence to provide an evidence-base for the discussions, and by Avalere Health, which described lessons learned from here-and-now programs to improve medication adherence.
Walid Gellad, M.D., the lead RAND researcher on this review noted that, "Poor medication adherence is an enormous public health problem. Finding solutions to this problem should be part of health reform discussions now and in the future."
Each of the recommendations is supported by specific action items to help guide its implementation. To see the full recommendations, please click here.
Quality Improvement - National quality improvement strategies should explicitly recognize medication adherence and appropriate medication use as critical components to improve health care quality and clinical outcomes.
Care Coordination - Proposals aimed at improving care coordination must recognize the important role that medications play in treating and managing illnesses.
Health Information Technology - Health information technology must improve the flow of timely and complete information between patients and providers, and enable providers and payers to identify and address gaps in patients' medication use.
Patient/Provider Education and Engagement - Strategies to improve medication adherence must fully engage patients, and patient-centered care must involve strategies to help them better understand their conditions and treatments. These efforts also must support providers in effectively communicating the importance of following treatment plans, and in providing medication support services to patients and caregivers.
Health Services Research - There is a need for additional research on medication adherence, including a focus on the effectiveness of a wider range of interventions to improve adherence, as well as an analysis of the diverse factors, behaviors, costs and consequences related to poor adherence.
"Medical adherence is a problem that should unite all providers, elected officials, pharmacists, insurers and pharmaceutical companies," said Jack Lewin, CEO of the American College of Cardiology. "Fifty percent of patients with heart disease are not taking their potentially life-saving medications, but it is our hope that recommendations like these will go a long way toward addressing this serious problem."
Source:
Tom Murphy
Chandler Chicco Agency
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Vical Begins Phase 1 Trial Of DNA Vaccine Against H5N1 Pandemic Influenza
Vical Incorporated
(Nasdaq: VICL) announced the enrollment of the first subject in its
Phase 1 trial of the company's Vaxfectin(TM)-formulated plasmid DNA (pDNA)
pandemic influenza vaccine. The double-blind, placebo-controlled trial will
evaluate safety, tolerability and immune responses in up to 60 healthy
volunteers age 18 to 45 at two U.S. clinical sites.
"We have designed a promising pandemic influenza vaccine and
demonstrated its effectiveness against a highly lethal H5N1 challenge in
ferrets, the best available animal model," said Vijay B. Samant, Vical's
President and Chief Executive Officer, "and we have now begun testing in
humans. The currently stockpiled pandemic influenza vaccines primarily
generate antibody responses against a specific strain, and have a limited
shelf life because they cannot be stored frozen. Our pDNA vaccine is
designed to provide T-cell and antibody immune responses for broad
cross-strain protection, and if frozen, would offer improved storage and
deployment. This trial is also important because it marks the first time in
humans for our Vaxfectin(TM) adjuvant, which has potential applications
with both pDNA vaccines and conventional protein-based vaccines."
Vical's vaccine contains three individual DNA plasmids encoding
consensus sequences of two highly-conserved influenza virus proteins --
nucleoprotein (NP) and ion channel protein (M2) -- plus a hemagglutinin
(HA) surface protein from the H5N1 influenza virus strain,
A/Vietnam/1203/04. The combination is designed to elicit both T-cell and
antibody immune responses against emerging strains of influenza virus that
have the potential to cause a pandemic. A monovalent pDNA vaccine encoding
only the H5 protein will also be tested. Both vaccines are formulated with
the company's Vaxfectin(TM) adjuvant, which has demonstrated effectiveness
with a variety of pDNA vaccines in multiple animal models. It has also
demonstrated dose-sparing and immune-enhancing ability with a conventional
seasonal influenza vaccine in animals.
Pandemic Influenza Vaccine Background
Vical's pandemic influenza program goal is to design a vaccine that can
be developed and manufactured quickly and safely without handling the
infectious organism, provide cross-strain protection, and be stockpiled
longer and in less restrictive conditions than conventional vaccines. Vical
systematically tested prototype vaccines using a range of viral antigens to
determine the optimum combination of conserved and variable targets. The
company then systematically tested different formulations for maximum
efficacy at the lowest possible dose. Initial virus challenge studies at
Vical with Vaxfectin(TM)-formulated vaccines encoding NP, M2 and HA
demonstrated significant protection in mice against H1N1 and H3N2 strains
of human influenza. Subsequent studies at St. Jude Children's Research
Hospital demonstrated complete protection with a single dose of the
trivalent vaccine against a lethal challenge in ferrets with the highly
pathogenic A/Vietnam/1203/04 (H5N1) influenza virus strain. Funding for the
preclinical development was provided under a previously-announced grant
from the National Institutes of Health.
"We are excited to advance our pandemic influenza DNA vaccine program
into initial human testing," said Larry R. Smith, Ph.D., Vical's Vice
President of Vaccine Research, "and to conduct our first human tests with
the novel Vaxfectin(TM) adjuvant, which was designed for pDNA vaccines but
also has demonstrated significant dose-sparing and immune-enhancing results
with the sanofi pasteur trivalent inactivated influenza vaccine in
animals."
About Vical
Vical researches and develops biopharmaceutical products based on its
patented DNA delivery technologies for the prevention and treatment of
serious or life-threatening diseases. Potential applications of the
company's DNA delivery technology include DNA vaccines for infectious
diseases or cancer, in which the expressed protein is an immunogen; cancer
immunotherapeutics, in which the expressed protein is an immune system
stimulant; and cardiovascular therapies, in which the expressed protein is
an angiogenic growth factor. The company is developing certain infectious
disease vaccines and cancer therapeutics internally. In addition, the
company collaborates with major pharmaceutical companies and biotechnology
companies that give it access to complementary technologies or greater
resources. These strategic partnerships provide the company with mutually
beneficial opportunities to expand its product pipeline and address
significant unmet medical needs. Additional information on Vical is
available at vical.
This press release contains forward-looking statements subject to risks
and uncertainties that could cause actual results to differ materially from
those projected, including: whether results in mouse and ferret studies
will be predictive of results in human studies; whether Vical or others
will continue development of the pandemic influenza DNA vaccine candidate;
whether H5N1 or other strains of avian influenza will emerge as pandemic
threats; whether the company's DNA vaccine candidate will be effective in
protecting humans against H5N1 or other strains of avian influenza; whether
development of an avian influenza vaccine would lead to development of a
seasonal influenza vaccine; whether the influenza vaccine or any other
product candidates will be shown to be safe and effective; the timing,
nature and cost of clinical trials; whether Vical or its collaborative
partners will seek or gain approval to market the influenza vaccine or any
other product candidates; whether Vical or its collaborative partners will
succeed in marketing the influenza vaccine or any other product candidates;
and additional risks set forth in the company's filings with the Securities
and Exchange Commission. These forward-looking statements represent the
company's judgment as of the date of this release. The company disclaims,
however, any intent or obligation to update these forward-looking
statements.
Vical Incorporated
vical
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(Nasdaq: VICL) announced the enrollment of the first subject in its
Phase 1 trial of the company's Vaxfectin(TM)-formulated plasmid DNA (pDNA)
pandemic influenza vaccine. The double-blind, placebo-controlled trial will
evaluate safety, tolerability and immune responses in up to 60 healthy
volunteers age 18 to 45 at two U.S. clinical sites.
"We have designed a promising pandemic influenza vaccine and
demonstrated its effectiveness against a highly lethal H5N1 challenge in
ferrets, the best available animal model," said Vijay B. Samant, Vical's
President and Chief Executive Officer, "and we have now begun testing in
humans. The currently stockpiled pandemic influenza vaccines primarily
generate antibody responses against a specific strain, and have a limited
shelf life because they cannot be stored frozen. Our pDNA vaccine is
designed to provide T-cell and antibody immune responses for broad
cross-strain protection, and if frozen, would offer improved storage and
deployment. This trial is also important because it marks the first time in
humans for our Vaxfectin(TM) adjuvant, which has potential applications
with both pDNA vaccines and conventional protein-based vaccines."
Vical's vaccine contains three individual DNA plasmids encoding
consensus sequences of two highly-conserved influenza virus proteins --
nucleoprotein (NP) and ion channel protein (M2) -- plus a hemagglutinin
(HA) surface protein from the H5N1 influenza virus strain,
A/Vietnam/1203/04. The combination is designed to elicit both T-cell and
antibody immune responses against emerging strains of influenza virus that
have the potential to cause a pandemic. A monovalent pDNA vaccine encoding
only the H5 protein will also be tested. Both vaccines are formulated with
the company's Vaxfectin(TM) adjuvant, which has demonstrated effectiveness
with a variety of pDNA vaccines in multiple animal models. It has also
demonstrated dose-sparing and immune-enhancing ability with a conventional
seasonal influenza vaccine in animals.
Pandemic Influenza Vaccine Background
Vical's pandemic influenza program goal is to design a vaccine that can
be developed and manufactured quickly and safely without handling the
infectious organism, provide cross-strain protection, and be stockpiled
longer and in less restrictive conditions than conventional vaccines. Vical
systematically tested prototype vaccines using a range of viral antigens to
determine the optimum combination of conserved and variable targets. The
company then systematically tested different formulations for maximum
efficacy at the lowest possible dose. Initial virus challenge studies at
Vical with Vaxfectin(TM)-formulated vaccines encoding NP, M2 and HA
demonstrated significant protection in mice against H1N1 and H3N2 strains
of human influenza. Subsequent studies at St. Jude Children's Research
Hospital demonstrated complete protection with a single dose of the
trivalent vaccine against a lethal challenge in ferrets with the highly
pathogenic A/Vietnam/1203/04 (H5N1) influenza virus strain. Funding for the
preclinical development was provided under a previously-announced grant
from the National Institutes of Health.
"We are excited to advance our pandemic influenza DNA vaccine program
into initial human testing," said Larry R. Smith, Ph.D., Vical's Vice
President of Vaccine Research, "and to conduct our first human tests with
the novel Vaxfectin(TM) adjuvant, which was designed for pDNA vaccines but
also has demonstrated significant dose-sparing and immune-enhancing results
with the sanofi pasteur trivalent inactivated influenza vaccine in
animals."
About Vical
Vical researches and develops biopharmaceutical products based on its
patented DNA delivery technologies for the prevention and treatment of
serious or life-threatening diseases. Potential applications of the
company's DNA delivery technology include DNA vaccines for infectious
diseases or cancer, in which the expressed protein is an immunogen; cancer
immunotherapeutics, in which the expressed protein is an immune system
stimulant; and cardiovascular therapies, in which the expressed protein is
an angiogenic growth factor. The company is developing certain infectious
disease vaccines and cancer therapeutics internally. In addition, the
company collaborates with major pharmaceutical companies and biotechnology
companies that give it access to complementary technologies or greater
resources. These strategic partnerships provide the company with mutually
beneficial opportunities to expand its product pipeline and address
significant unmet medical needs. Additional information on Vical is
available at vical.
This press release contains forward-looking statements subject to risks
and uncertainties that could cause actual results to differ materially from
those projected, including: whether results in mouse and ferret studies
will be predictive of results in human studies; whether Vical or others
will continue development of the pandemic influenza DNA vaccine candidate;
whether H5N1 or other strains of avian influenza will emerge as pandemic
threats; whether the company's DNA vaccine candidate will be effective in
protecting humans against H5N1 or other strains of avian influenza; whether
development of an avian influenza vaccine would lead to development of a
seasonal influenza vaccine; whether the influenza vaccine or any other
product candidates will be shown to be safe and effective; the timing,
nature and cost of clinical trials; whether Vical or its collaborative
partners will seek or gain approval to market the influenza vaccine or any
other product candidates; whether Vical or its collaborative partners will
succeed in marketing the influenza vaccine or any other product candidates;
and additional risks set forth in the company's filings with the Securities
and Exchange Commission. These forward-looking statements represent the
company's judgment as of the date of this release. The company disclaims,
however, any intent or obligation to update these forward-looking
statements.
Vical Incorporated
vical
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Toward A Less Expensive Version Of The Anti-flu Drug Tamiflu
Scientists have developed an alternative method for producing the active ingredient in Tamiflu®, the mainstay for fighting H1N1 and other forms of influenza. The new process could expand availability of the drug by reducing its cost, which now retails for as about $8 per dose. Their study is in ACS' Organic Letters, a bi-weekly journal.
Anqi Chen, Christina Chai and colleagues note that the global pandemic of H1N1 has resulted in millions of infected cases worldwide and nearly 10,000 deaths to date. Tamiflu®, also known as oseltamivir phosphate, remains the most widely used antiviral drug for the prevention and treatment of H1N1 infections as well as bird flu and seasonal influenzas. But growing demand for the drug has put pressure on the supply of shikimic acid, the raw material now used in making the drug. "As a result, chemists worldwide including ourselves have explored the possibility of using other alternative raw materials for the synthesis of the drug" said Chen and Chai, who led the research.
The scientists describe a new process for making the drug that does not use shikimic acid. They found that D-ribose, a naturally-occurring sugar produced by fermentation in large scales, potentially provides an inexpensive and abundant source of starting material for making the drug. D-ribose costs only about one-sixth as much as shikimic acid. In lab studies, the scientists demonstrated the potential use of D-ribose as an alternative source for the synthesis of Tamiflu®.
ARTICLE: "Efficient Formal Synthesis of Oseltamivir Phosphate (Tamiflu) with Inexpensive D-Ribose as the Starting Material" pubs.acs/doi/full/10.1021/ol9024716
Source: Michael Bernstein
American Chemical Society
View drug information on Tamiflu capsule.
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Anqi Chen, Christina Chai and colleagues note that the global pandemic of H1N1 has resulted in millions of infected cases worldwide and nearly 10,000 deaths to date. Tamiflu®, also known as oseltamivir phosphate, remains the most widely used antiviral drug for the prevention and treatment of H1N1 infections as well as bird flu and seasonal influenzas. But growing demand for the drug has put pressure on the supply of shikimic acid, the raw material now used in making the drug. "As a result, chemists worldwide including ourselves have explored the possibility of using other alternative raw materials for the synthesis of the drug" said Chen and Chai, who led the research.
The scientists describe a new process for making the drug that does not use shikimic acid. They found that D-ribose, a naturally-occurring sugar produced by fermentation in large scales, potentially provides an inexpensive and abundant source of starting material for making the drug. D-ribose costs only about one-sixth as much as shikimic acid. In lab studies, the scientists demonstrated the potential use of D-ribose as an alternative source for the synthesis of Tamiflu®.
ARTICLE: "Efficient Formal Synthesis of Oseltamivir Phosphate (Tamiflu) with Inexpensive D-Ribose as the Starting Material" pubs.acs/doi/full/10.1021/ol9024716
Source: Michael Bernstein
American Chemical Society
View drug information on Tamiflu capsule.
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New Health Reform Law Will Benefit All Residents Of Illinois
A group of Illinoisans were briefed yesterday about how the historic new health care law, the Patient Protection and Affordable Care Act, will make health care more affordable and accessible, and make their communities and the nation as a whole stronger and healthier.
Ron Pollack, Executive Director of the consumer health organization Families USA, joined other speakers here in outlining the vast and growing problems in our health care system that led to passage of the reform law, and how the law addresses those problems.
"Our recent history tells the tale," Pollack said. "Every year, millions of people are denied health coverage by insurance companies due to pre-existing conditions. Every year, health insurance premiums have climbed far faster than wages, making health coverage unaffordable. Every year, seniors struggle with the costs of prescription drugs, and unemployed workers have lost health coverage and been unable to afford COBRA coverage."
The new law will halt and reverse these trends, Pollack said. "Under the new law, the 2.5 million non-elderly people in Illinois who were at risk of health coverage denial because they were diagnosed with a serious health condition will have guaranteed access to coverage, regardless of their gender or health status," he said.
"With the new law, 1,163,000 uninsured Illinoisans will gain health coverage. Diseases will be caught at an earlier and more treatable stage, and these Illinoisans will live longer, more productive lives," Pollack said.
"Under the new law, our senior citizens will be able to continue to buy their prescription drugs under Medicare without the crushing burden of paying 100 percent of the price when they reach the $2,700 annual threshold, and Illinois seniors who have reached that threshold will see checks arriving this week to help cover their drug bills.
"With the new law, we won't see premiums rising five times faster than wages in Illinois, as they did from 2000 to 2009, and employers will be able to afford quality plans and be able to hire and keep good workers.
"Under the new law, young adults will be able to stay on their parents' health plans until they are 26, ensuring that they have uninterrupted access to preventive care as they finish advanced schooling and get settled in their own businesses or careers.
"These are great improvements for Illinoisans, and these improvements will make a huge difference in their health and pocketbooks," Pollack said.
Source
Families USA
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Ron Pollack, Executive Director of the consumer health organization Families USA, joined other speakers here in outlining the vast and growing problems in our health care system that led to passage of the reform law, and how the law addresses those problems.
"Our recent history tells the tale," Pollack said. "Every year, millions of people are denied health coverage by insurance companies due to pre-existing conditions. Every year, health insurance premiums have climbed far faster than wages, making health coverage unaffordable. Every year, seniors struggle with the costs of prescription drugs, and unemployed workers have lost health coverage and been unable to afford COBRA coverage."
The new law will halt and reverse these trends, Pollack said. "Under the new law, the 2.5 million non-elderly people in Illinois who were at risk of health coverage denial because they were diagnosed with a serious health condition will have guaranteed access to coverage, regardless of their gender or health status," he said.
"With the new law, 1,163,000 uninsured Illinoisans will gain health coverage. Diseases will be caught at an earlier and more treatable stage, and these Illinoisans will live longer, more productive lives," Pollack said.
"Under the new law, our senior citizens will be able to continue to buy their prescription drugs under Medicare without the crushing burden of paying 100 percent of the price when they reach the $2,700 annual threshold, and Illinois seniors who have reached that threshold will see checks arriving this week to help cover their drug bills.
"With the new law, we won't see premiums rising five times faster than wages in Illinois, as they did from 2000 to 2009, and employers will be able to afford quality plans and be able to hire and keep good workers.
"Under the new law, young adults will be able to stay on their parents' health plans until they are 26, ensuring that they have uninterrupted access to preventive care as they finish advanced schooling and get settled in their own businesses or careers.
"These are great improvements for Illinoisans, and these improvements will make a huge difference in their health and pocketbooks," Pollack said.
Source
Families USA
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