The Arthritis Foundation supports health care reform, which provides universal and affordable health care for the 46 million Americans living with arthritis.
American families, both insured and uninsured, are struggling with rising health care costs - and the number of uninsured is rising. Due to the nature of chronic disease, people with arthritis struggle to pay for physician visits and for the increasing costs of multiple medications and other care that is necessary to properly manage their disease.
"Arthritis is the nation's most common cause of disability, though many people are not aware that it is a very serious, painful and life-altering disease," said Amy Melnick, chief public policy officer for the Arthritis Foundation. "The burden of medical debt excessively falls on patients with chronic diseases, and studies show that out-of-pocket costs are rising faster for arthritis than for many other chronic conditions."
In 2007, 28 percent of working-age adults with chronic conditions such as arthritis reported that their families had trouble paying medical bills. Of those, one in four went without needed care, half delayed needed care and 56 percent failed to get prescription medications, because of cost concerns. Prescription costs are hitting harder than ever due to reduced coverage, pre-existing conditions and higher co-pays. These unmet needs put people with arthritis at greater risk for complications and permanent disability.
The Arthritis Foundation applauds the current proposals in Congress for the many provisions that would benefit all Americans, and particularly those affected by a chronic disease or disability, like arthritis. The provisions included for affordability; preventive services; the prohibitions of discrimination based on health status; the elimination of the annual or lifetime limits on coverage; requiring coverage of dependents up to 26 years of age; and the strategy to develop national quality and efficiency standards mirror the principles of the Arthritis Foundation and will greatly improve the American health care system. We support these goals and principles as outlined in the current proposed legislation.
"In our nation, the costs for individual health insurance premiums have risen nearly eight times faster than average incomes. With 45 million uninsured citizens, it is now more important than ever to find ways to make health care affordable and ensure greater access to care for all," said Melnick.
Indeed, unwieldy medical bills contributed to 62 percent of all bankruptcies in 2007, according to a recent study (PDF) published in the American Journal of Medicine, and to half of all home foreclosures as revealed in a similar 2008 Harvard study.
The Arthritis Foundation wants health care reform this year that will improve the lives of people with arthritis and other chronic diseases. We strongly believe that legislative action is necessary to guarantee quality, affordable, essential health care for all Americans.
For more information about the Arthritis Foundation's position on health care reform and to learn what you can do to help yourself and others, visit arthritis/access-to-health care.
Source
Arthritis Foundation
суббота, 7 мая 2011 г.
пятница, 6 мая 2011 г.
Tanezumab Alleviates Osteoarthritis Pain So Well That Some Patients Overuse Their Diseased Joints
After halting studies on tanezumab, a drug that is extremely good at relieving pain and improving function in patients with moderate to severe osteoarthritis, a small phase II clinical trial has reported just a few slight side effects, and considerable improvement in the condition of patients. Details of the 16-week trial have been published in the New England Journal of Medicine. Previous longer-lasting trials have revealed that tanezumab may speed up the progression of osteoarthritis - the trial was subsequently suspended until the FDA (Food and Drug Administration) could check trial data and decide on its safety. Researchers believe this occurred because the drug worked too well - some patients may have overused their joints because the pain had gone, and damaged them more.
NSAIDs (non-steroidal anti-inflammatory inhibitors) are commonly used to treat osteoarthritis symptoms, however when used long term they can lead to serious problems, such as heart attacks, strokes, gastrointestinal bleeding, kidney dysfunction and ulcers. Examples of such medications include, aspirin, naproxen, ibuprofen and COX-2 inhibitors such as Celebrex and Vioxx.
Nancy E. Lane, professor of internal medicine and director of the UC Davis Center for Healthy Aging, principal investigator and co-author, said:
The need to find new drugs to treat osteoarthritis is critical. We really don't have anything that slows its course, and most people with severe disease end up dependent on narcotic analgesics while waiting to have a joint replaced.
How does Tanezumab reduce pain?
Nerve growth factor is a small protein, it is vital for the maintenance, growth and survival of sympathetic and sensory neurons.
In patients with osteoarthritis whose tissues are inflamed, growth factor levels tend to be much higher than normal.
Tanezumab, a humanized monoclonal antibody, binds and inhibits nerve growth factor.
Animal experiments showed that when growth factor is inhibited, the signs of pain are reduced.
Consequently, scientists developed a new drug to block nerve growth factor.
Co-author, Thomas Schnitzer, a rheumatologist and professor of physical medicine and rehabilitation, said:
The bottom line is this is a very effective drug for relieving pain. Unfortunately, it appears some people go on to have their osteoarthritis progress more quickly. The long-term safety of tanezumab needs to be better understood.
In a Phase II trial, a new compound (drug) is tried out on hundreds of patients. The aim is to check for efficacy and safety - how well it works and how safe it is to use. Before entering the market, the compound will then be tried out in a Phase III study with some thousands of patients - the compound is compared to the best medication that is being used at that time for the targeted disease/condition.
Some Phase III trials were in progress when reports came in of a small number of patients developing accelerated osteoarthritis in the shoulders and hips. Pfizer, the creators of tanezumab were asked by the FDA to suspend the ongoing clinical trials in June 2010.
Lane said:
I believe that the apparent worsening of certain patients' condition may be due to the fact that tanezumab works so well. People feel so much better that they become more active, putting increased stress on their already badly diseased joints.
Lane added that appropriate tanezumab candidates will have to be identified carefully, so that they can use the medication safely and appropriately.
Lane said:
Giving tanezumab to people with the most severe disease is probably not a wise choice. Increasing the activity level of a patient who already needs a joint replaced may not be in their best interest.
In this latest study, 450 osteoarthritis patients who had knee pain after/during walking were given varying dosages of either tanezumab or a placebo. They were given one injection on the first day and another after eight weeks.
They were asked to rate their pain and physical functioning on a scale of 1 to 100.
The researchers found that:
Over 16 weeks, walking knee pain went down from baseline by up to 62% among the tanezumab patients
Over 16 weeks, walking knee pain went down from baseline by up to 22% among the placebo patients
The tanezumab patients experienced more relief from stiffness than the placebo patients
The tanezumab patients experienced better physical function than the placebo patients
Overall, the tanezunab patients found it easier to live with the degenerative joint disease
Lane said:
The effects of tanezumab were remarkable. People on the drug went from having very limited activity to practically being on the dance floor. No medication available today has such dramatic results.
55% of those on a placebo reported experiencing side effects, compared to 68% on the tanezumab. The researchers also report that those on higher tanezumab dosages were more likely to experience side effects. The most common side effects, which were temporary and deemed "minor", were:
Headache - 9%
Cold-like symptoms - 7%
Paresthesias - 7% (tingling, itchiness, numbness or hypersensitivity)
Doctors found that some patients had diminished tendon reflexes when they tapped their knees or ankles with a medical hammer
Approximately 20 million people in the USA are affected with osteoarthritis, the authors inform. When the cartilage in the joints breaks down and eventually withers away, the patient experiences the hallmark symptoms of pain in the hips, spine, feet, hands and knees. At first, the sufferers usually only feel pain upon movement; in some severe cases, however, the pain is persistent, even while resting.
Lane added:
This is how drug development should be carried out. As with any potentially great new drug, you expect challenges, but the important thing is to carry out investigations in a responsible and open manner.
Source: UC Davis Health System
"Tanezumab for the Treatment of Pain from Osteoarthritis of the Knee"
Nancy E. Lane, M.D., Thomas J. Schnitzer, M.D., Ph.D., Charles A. Birbara, M.D., Masoud Mokhtarani, M.D., David L. Shelton, Ph.D., Mike D. Smith, Ph.D., and Mark T. Brown, M.D.
NEJM September 29, 2010 (10.1056/NEJMoa0901510)
Written by
View drug information on Vioxx.
NSAIDs (non-steroidal anti-inflammatory inhibitors) are commonly used to treat osteoarthritis symptoms, however when used long term they can lead to serious problems, such as heart attacks, strokes, gastrointestinal bleeding, kidney dysfunction and ulcers. Examples of such medications include, aspirin, naproxen, ibuprofen and COX-2 inhibitors such as Celebrex and Vioxx.
Nancy E. Lane, professor of internal medicine and director of the UC Davis Center for Healthy Aging, principal investigator and co-author, said:
The need to find new drugs to treat osteoarthritis is critical. We really don't have anything that slows its course, and most people with severe disease end up dependent on narcotic analgesics while waiting to have a joint replaced.
How does Tanezumab reduce pain?
Nerve growth factor is a small protein, it is vital for the maintenance, growth and survival of sympathetic and sensory neurons.
In patients with osteoarthritis whose tissues are inflamed, growth factor levels tend to be much higher than normal.
Tanezumab, a humanized monoclonal antibody, binds and inhibits nerve growth factor.
Animal experiments showed that when growth factor is inhibited, the signs of pain are reduced.
Consequently, scientists developed a new drug to block nerve growth factor.
Co-author, Thomas Schnitzer, a rheumatologist and professor of physical medicine and rehabilitation, said:
The bottom line is this is a very effective drug for relieving pain. Unfortunately, it appears some people go on to have their osteoarthritis progress more quickly. The long-term safety of tanezumab needs to be better understood.
In a Phase II trial, a new compound (drug) is tried out on hundreds of patients. The aim is to check for efficacy and safety - how well it works and how safe it is to use. Before entering the market, the compound will then be tried out in a Phase III study with some thousands of patients - the compound is compared to the best medication that is being used at that time for the targeted disease/condition.
Some Phase III trials were in progress when reports came in of a small number of patients developing accelerated osteoarthritis in the shoulders and hips. Pfizer, the creators of tanezumab were asked by the FDA to suspend the ongoing clinical trials in June 2010.
Lane said:
I believe that the apparent worsening of certain patients' condition may be due to the fact that tanezumab works so well. People feel so much better that they become more active, putting increased stress on their already badly diseased joints.
Lane added that appropriate tanezumab candidates will have to be identified carefully, so that they can use the medication safely and appropriately.
Lane said:
Giving tanezumab to people with the most severe disease is probably not a wise choice. Increasing the activity level of a patient who already needs a joint replaced may not be in their best interest.
In this latest study, 450 osteoarthritis patients who had knee pain after/during walking were given varying dosages of either tanezumab or a placebo. They were given one injection on the first day and another after eight weeks.
They were asked to rate their pain and physical functioning on a scale of 1 to 100.
The researchers found that:
Over 16 weeks, walking knee pain went down from baseline by up to 62% among the tanezumab patients
Over 16 weeks, walking knee pain went down from baseline by up to 22% among the placebo patients
The tanezumab patients experienced more relief from stiffness than the placebo patients
The tanezumab patients experienced better physical function than the placebo patients
Overall, the tanezunab patients found it easier to live with the degenerative joint disease
Lane said:
The effects of tanezumab were remarkable. People on the drug went from having very limited activity to practically being on the dance floor. No medication available today has such dramatic results.
55% of those on a placebo reported experiencing side effects, compared to 68% on the tanezumab. The researchers also report that those on higher tanezumab dosages were more likely to experience side effects. The most common side effects, which were temporary and deemed "minor", were:
Headache - 9%
Cold-like symptoms - 7%
Paresthesias - 7% (tingling, itchiness, numbness or hypersensitivity)
Doctors found that some patients had diminished tendon reflexes when they tapped their knees or ankles with a medical hammer
Approximately 20 million people in the USA are affected with osteoarthritis, the authors inform. When the cartilage in the joints breaks down and eventually withers away, the patient experiences the hallmark symptoms of pain in the hips, spine, feet, hands and knees. At first, the sufferers usually only feel pain upon movement; in some severe cases, however, the pain is persistent, even while resting.
Lane added:
This is how drug development should be carried out. As with any potentially great new drug, you expect challenges, but the important thing is to carry out investigations in a responsible and open manner.
Source: UC Davis Health System
"Tanezumab for the Treatment of Pain from Osteoarthritis of the Knee"
Nancy E. Lane, M.D., Thomas J. Schnitzer, M.D., Ph.D., Charles A. Birbara, M.D., Masoud Mokhtarani, M.D., David L. Shelton, Ph.D., Mike D. Smith, Ph.D., and Mark T. Brown, M.D.
NEJM September 29, 2010 (10.1056/NEJMoa0901510)
Written by
View drug information on Vioxx.
четверг, 5 мая 2011 г.
ACZ885, A New Biological Drug In Development, Shows Potential In Treating Serious Life-long Autoinflammatory Diseases
New data demonstrate that ACZ885, a human monoclonal antibody in Phase III development, achieves long-lasting clinical remission in patients with genetic autoinflammatory diseases1,2.
The results indicate that ACZ885 could develop into a major therapeutic advance in the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), a group of rare but serious life-long diseases including Muckle Wells Syndrome3.
In the Phase II study, CAPS patients treated with ACZ885 showed an improvement in symptoms within one day and all achieved complete clinical remission within seven days1. Clinical remission lasted 115 days on average1. The results were presented today at the Fifth International Congress on Familial Mediterranean Fevers and Systemic Autoinflammatory Diseases in Rome.
"The latest findings are a promising step forward for patients with rare autoinflammatory diseases," said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. "We are optimistic that ACZ885 could become an innovative treatment option for patients affected by inflammatory diseases involving IL-1??. ACZ885 reflects our commitment to developing innovative treatments that address unmet medical needs, in patients with serious but rare conditions."
ACZ885 is also being investigated in more common inflammatory diseases such as rheumatoid arthritis (RA), which affects up to 1% of the world's population4. A study in RA currently under way uses an innovative tailored approach with biomarkers to predict response to treatment. If successful, this will give suitable patients a personalized approach to treating their disease.
Unlike other agents, ACZ885 blocks solely interleukin 1?? (IL-1??), one form of interleukin-1 protein that causes the body to 'attack' itself in autoinflammatory diseases such as CAPS. Patients affected by CAPS have symptoms such as fever, fatigue, skin rash, painful joints and muscles, and severe headache. They can also suffer from more severe complications like hearing loss and amyloidosis, a group of diseases in which some organs accumulate high deposits of proteins causing kidney failure and leading to dialysis or transplantation3.
The study results presented in Rome involved 20 patients with CAPS aged between six and 50 years, who received an injection of ACZ885 every two months dosed at 150 mg for adults or two mg per kilo body-weight for children1,2. ACZ885 was well-tolerated in the study, with only mild skin reactions at the injection site. The most common adverse events were upper respiratory tract infections2.
"Traditional drugs for autoinflammatory diseases, which work by suppressing the immune system as a whole, are not always effective, while newer therapies control the disease better but are short-acting," said Professor Philip Hawkins of the National Amyloidosis Centre at the Royal Free and University College Medical School, London. "The data for ACZ885 are exciting for the medical community as symptoms disappeared within a few days of treatment and the response was sustained, so patients may only need to be treated every second month."
The potential of ACZ885 is reflected in its broad development program. In addition to the Phase III study program in CAPS and the Phase II study in rheumatoid arthritis, a Phase II study is also ongoing in another condition called Systemic Onset Juvenile Idiopathic Arthritis (SJIA).
Orphan drug status has already been granted to ACZ885 in the European Union and US for treating CAPS, and in the EU for SJIA. Orphan drugs are those designed to treat serious or life-threatening diseases affecting less than 200,000 people (in the US)5 or less than five out of 10,000 people (in the EU)6.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "in development", "potential", "can", being investigated", "could", "promising", "optimistic", "commitment", "will", "may", or similar expressions, or by express or implied discussions regarding potential marketing approvals for ACZ885 or regarding potential future revenues from ACZ885. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with ACZ885 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that ACZ885 will be approved for sale in any market. Nor can there be any guarantee that ACZ885 will achieve any levels of revenue in the future. In particular, management's expectations regarding ACZ885 could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
Novartis AG provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on growth areas in healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group's continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,200 full-time associates and operate in over 140 countries around the world. For more information, please visit novartis.
References
1. Lachmann H.J. et al. Treatment of cryopyrin associated periodic fever syndrome with a fully human anti-IL-beta monoclonal antibody (ACZ885): results from a subcutaneous administration study, oral presentation at FMFSAID, April 8 2008, Rome, Italy.
2. Kuemmerle-Deschner J.B. et al, Long lasting response to ACZ885 in patients with Muckle-Wells Syndrome, oral presentation at FMFSAID, April 8 2008, Rome, Italy.
3. capscommunity/index.html, Last access March 17, orpha/consor/cgi-bin/index.php, Last access March 17
4. Data Monitor Report, 2007.
5. fda/orphan, Last access March 17, 2008
6. ec.europa.eu/health/ph_threats/non_com/rare_6_en.htm, Last access March 17, 2008
novartis
The results indicate that ACZ885 could develop into a major therapeutic advance in the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), a group of rare but serious life-long diseases including Muckle Wells Syndrome3.
In the Phase II study, CAPS patients treated with ACZ885 showed an improvement in symptoms within one day and all achieved complete clinical remission within seven days1. Clinical remission lasted 115 days on average1. The results were presented today at the Fifth International Congress on Familial Mediterranean Fevers and Systemic Autoinflammatory Diseases in Rome.
"The latest findings are a promising step forward for patients with rare autoinflammatory diseases," said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. "We are optimistic that ACZ885 could become an innovative treatment option for patients affected by inflammatory diseases involving IL-1??. ACZ885 reflects our commitment to developing innovative treatments that address unmet medical needs, in patients with serious but rare conditions."
ACZ885 is also being investigated in more common inflammatory diseases such as rheumatoid arthritis (RA), which affects up to 1% of the world's population4. A study in RA currently under way uses an innovative tailored approach with biomarkers to predict response to treatment. If successful, this will give suitable patients a personalized approach to treating their disease.
Unlike other agents, ACZ885 blocks solely interleukin 1?? (IL-1??), one form of interleukin-1 protein that causes the body to 'attack' itself in autoinflammatory diseases such as CAPS. Patients affected by CAPS have symptoms such as fever, fatigue, skin rash, painful joints and muscles, and severe headache. They can also suffer from more severe complications like hearing loss and amyloidosis, a group of diseases in which some organs accumulate high deposits of proteins causing kidney failure and leading to dialysis or transplantation3.
The study results presented in Rome involved 20 patients with CAPS aged between six and 50 years, who received an injection of ACZ885 every two months dosed at 150 mg for adults or two mg per kilo body-weight for children1,2. ACZ885 was well-tolerated in the study, with only mild skin reactions at the injection site. The most common adverse events were upper respiratory tract infections2.
"Traditional drugs for autoinflammatory diseases, which work by suppressing the immune system as a whole, are not always effective, while newer therapies control the disease better but are short-acting," said Professor Philip Hawkins of the National Amyloidosis Centre at the Royal Free and University College Medical School, London. "The data for ACZ885 are exciting for the medical community as symptoms disappeared within a few days of treatment and the response was sustained, so patients may only need to be treated every second month."
The potential of ACZ885 is reflected in its broad development program. In addition to the Phase III study program in CAPS and the Phase II study in rheumatoid arthritis, a Phase II study is also ongoing in another condition called Systemic Onset Juvenile Idiopathic Arthritis (SJIA).
Orphan drug status has already been granted to ACZ885 in the European Union and US for treating CAPS, and in the EU for SJIA. Orphan drugs are those designed to treat serious or life-threatening diseases affecting less than 200,000 people (in the US)5 or less than five out of 10,000 people (in the EU)6.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "in development", "potential", "can", being investigated", "could", "promising", "optimistic", "commitment", "will", "may", or similar expressions, or by express or implied discussions regarding potential marketing approvals for ACZ885 or regarding potential future revenues from ACZ885. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with ACZ885 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that ACZ885 will be approved for sale in any market. Nor can there be any guarantee that ACZ885 will achieve any levels of revenue in the future. In particular, management's expectations regarding ACZ885 could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
Novartis AG provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on growth areas in healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group's continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,200 full-time associates and operate in over 140 countries around the world. For more information, please visit novartis.
References
1. Lachmann H.J. et al. Treatment of cryopyrin associated periodic fever syndrome with a fully human anti-IL-beta monoclonal antibody (ACZ885): results from a subcutaneous administration study, oral presentation at FMFSAID, April 8 2008, Rome, Italy.
2. Kuemmerle-Deschner J.B. et al, Long lasting response to ACZ885 in patients with Muckle-Wells Syndrome, oral presentation at FMFSAID, April 8 2008, Rome, Italy.
3. capscommunity/index.html, Last access March 17, orpha/consor/cgi-bin/index.php, Last access March 17
4. Data Monitor Report, 2007.
5. fda/orphan, Last access March 17, 2008
6. ec.europa.eu/health/ph_threats/non_com/rare_6_en.htm, Last access March 17, 2008
novartis
среда, 4 мая 2011 г.
Recent Study Shows Significant Improvement In Knee Function And Joint Mobility Following Use Of InflameAway(TM)-Celadrin(R)
Imagenetix, Inc. (OTC
Bulletin Board: IAGX), announced today that a new clinical study was
presented at the 4th annual "Natural Supplements: An Evidence-Based Update"
medical conference, hosted by Scripps Center for Integrative Medicine, has
demonstrated that Celadrin(R) can significantly improve knee function and
help relieve the painful symptoms of osteoarthritis. Findings were released
by Imagenetix (imagenetix), an innovator in scientifically tested,
natural-based bioceutical products and maker of Inflame Away(TM)-Celadrin.
The new study -- the fourth clinical study performed on the efficacy of
Celadrin during the past six years -- was conducted and presented by Jay
Udani, M.D., at the Scripps Center for Integrative Medicine conference. Dr.
Udani is a Medical Director of Medicus Research, Medical Director of the
Integrative Medicine Program at Northridge Hospital and Assistant Clinical
Professor at the UCLA/Geffen School of Medicine. The study was awarded
first place in the "Original Clinical Research Category" competition.
The study reported that after eight weeks of taking Inflame
Away-Celadrin capsules, average walking ability increased 45 percent, and
participants claimed a 35 percent decrease in knee discomfort. These
improvements were statistically significantly better than the results seen
in the placebo group, and no negative side effects were found throughout
the entire study.
"This study demonstrates that after two weeks of taking Celadrin
orally, subjects showed significant enhancement of their functional ability
with progressive improvement continuing through the end of the 8 week
study," said Dr. Udani.
The randomized, double-blind, placebo-controlled study, titled "Oral
Cetylated Fatty Acids (Celadrin) for the Improvement of Functional Ability
and Pain in Patients with Moderate Knee Osteoarthritis," evaluated 93
participants over a period of 60 days. Subjects, ranging from 40 to 86
years of age, were evaluated before Celadrin was administered and again
after two, four and eight weeks. During each evaluation, participants were
asked to walk for six minutes to measure how far they could travel with
their knee discomfort.
The participants who consumed Celadrin were able to walk an average
distance of 1183 feet when they started the study. After only two weeks of
taking Celadrin capsules, the average walking distance increased
significantly by about 19 percent, or approximately 232 feet. The
participants continued to improve throughout the study period and after
eight weeks of taking Celadrin capsules; the participants walked an average
distance of 1720 feet -- 45 percent more than when they had started only
two months before.
Non-prescription Inflame Away-Celadrin is available in two forms: a
softgel and a topical cream application.
"Dr. Udani's study further supports the efficacy of Celadrin," said
Robert Hesslink Jr., Sc.D., Director of Research and Development at
Imagenetix. "Our studies conducted in the past have shown that Celadrin can
be used to not only aid in osteoarthritis pain for aging individuals, but
also to alleviate everyday joint discomfort for anyone who is physically
active."
A study on the efficacy of Celadrin-based cream on patients with
osteoarthritis, published in the Journal of Rheumatology in 2004, states
that patients reported a significant relief in joint pain after only 30
minutes of application of the Inflame Away cream formula -- benefits which
continued to improve over time with daily use of the product.
"We are pleased with the results of this award winning study," said
William Spencer, CEO of Imagenetix. "It validates Celadrin's significantly
superior and proven joint health benefits compared to our competitors'
glucosamine, chondroitin, MSM, SAMe, and other natural based joint health
products. Collectively these products represent a market that exceeds $2
billion. Celadrin has once again clinically demonstrated that it works many
times faster and is significantly more effective than
glocosamine/chondroitin combined or any other natural joint health products
on the market today."
About Imagenetix, Inc.
Based in San Diego, Calif., Imagenetix (OTC Bulletin Board: IAGX) is an
innovator of scientifically tested, natural-based, proprietary bioceutical
products developed to enhance human health on a global basis. Imagenetix
develops, formulates and private-labels proprietary over-the-counter
topical creams, skincare products and nutritional supplements to be
marketed globally through multiple channels of distribution. In addition,
the company develops patentable compounds for entering into licensing
agreements with pharmaceutical partners. Imagenetix is the creator of
Inflame Away(TM)- Celadrin(R), which has been clinically tested to relieve
osteoarthritis pain and significantly improve joint health. For more
information, please visit imagenetix.
This document contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of
the Securities Exchange Act of 1934, as amended. Such statements are
subject to risks and uncertainties that could cause actual results to vary
materially from those projected in the forward-looking statements. The
company may experience significant fluctuations in future operating results
due to a number of economic, competitive, and other factors, including,
among other things, the size and timing of customer contracts, new or
increased competition, changes in market demand, and seasonality of
purchases of the company's products and services. These factors and others
could cause operating results to vary significantly from those in prior
periods and those projected in forward-looking statements. Additional
information with respect to these and other factors, which could materially
affect the company and its operations, are included in certain forms the
company has filed and will periodically file with the Securities Exchange
Commission.
Imagenetix, Inc.
imagenetix
Bulletin Board: IAGX), announced today that a new clinical study was
presented at the 4th annual "Natural Supplements: An Evidence-Based Update"
medical conference, hosted by Scripps Center for Integrative Medicine, has
demonstrated that Celadrin(R) can significantly improve knee function and
help relieve the painful symptoms of osteoarthritis. Findings were released
by Imagenetix (imagenetix), an innovator in scientifically tested,
natural-based bioceutical products and maker of Inflame Away(TM)-Celadrin.
The new study -- the fourth clinical study performed on the efficacy of
Celadrin during the past six years -- was conducted and presented by Jay
Udani, M.D., at the Scripps Center for Integrative Medicine conference. Dr.
Udani is a Medical Director of Medicus Research, Medical Director of the
Integrative Medicine Program at Northridge Hospital and Assistant Clinical
Professor at the UCLA/Geffen School of Medicine. The study was awarded
first place in the "Original Clinical Research Category" competition.
The study reported that after eight weeks of taking Inflame
Away-Celadrin capsules, average walking ability increased 45 percent, and
participants claimed a 35 percent decrease in knee discomfort. These
improvements were statistically significantly better than the results seen
in the placebo group, and no negative side effects were found throughout
the entire study.
"This study demonstrates that after two weeks of taking Celadrin
orally, subjects showed significant enhancement of their functional ability
with progressive improvement continuing through the end of the 8 week
study," said Dr. Udani.
The randomized, double-blind, placebo-controlled study, titled "Oral
Cetylated Fatty Acids (Celadrin) for the Improvement of Functional Ability
and Pain in Patients with Moderate Knee Osteoarthritis," evaluated 93
participants over a period of 60 days. Subjects, ranging from 40 to 86
years of age, were evaluated before Celadrin was administered and again
after two, four and eight weeks. During each evaluation, participants were
asked to walk for six minutes to measure how far they could travel with
their knee discomfort.
The participants who consumed Celadrin were able to walk an average
distance of 1183 feet when they started the study. After only two weeks of
taking Celadrin capsules, the average walking distance increased
significantly by about 19 percent, or approximately 232 feet. The
participants continued to improve throughout the study period and after
eight weeks of taking Celadrin capsules; the participants walked an average
distance of 1720 feet -- 45 percent more than when they had started only
two months before.
Non-prescription Inflame Away-Celadrin is available in two forms: a
softgel and a topical cream application.
"Dr. Udani's study further supports the efficacy of Celadrin," said
Robert Hesslink Jr., Sc.D., Director of Research and Development at
Imagenetix. "Our studies conducted in the past have shown that Celadrin can
be used to not only aid in osteoarthritis pain for aging individuals, but
also to alleviate everyday joint discomfort for anyone who is physically
active."
A study on the efficacy of Celadrin-based cream on patients with
osteoarthritis, published in the Journal of Rheumatology in 2004, states
that patients reported a significant relief in joint pain after only 30
minutes of application of the Inflame Away cream formula -- benefits which
continued to improve over time with daily use of the product.
"We are pleased with the results of this award winning study," said
William Spencer, CEO of Imagenetix. "It validates Celadrin's significantly
superior and proven joint health benefits compared to our competitors'
glucosamine, chondroitin, MSM, SAMe, and other natural based joint health
products. Collectively these products represent a market that exceeds $2
billion. Celadrin has once again clinically demonstrated that it works many
times faster and is significantly more effective than
glocosamine/chondroitin combined or any other natural joint health products
on the market today."
About Imagenetix, Inc.
Based in San Diego, Calif., Imagenetix (OTC Bulletin Board: IAGX) is an
innovator of scientifically tested, natural-based, proprietary bioceutical
products developed to enhance human health on a global basis. Imagenetix
develops, formulates and private-labels proprietary over-the-counter
topical creams, skincare products and nutritional supplements to be
marketed globally through multiple channels of distribution. In addition,
the company develops patentable compounds for entering into licensing
agreements with pharmaceutical partners. Imagenetix is the creator of
Inflame Away(TM)- Celadrin(R), which has been clinically tested to relieve
osteoarthritis pain and significantly improve joint health. For more
information, please visit imagenetix.
This document contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of
the Securities Exchange Act of 1934, as amended. Such statements are
subject to risks and uncertainties that could cause actual results to vary
materially from those projected in the forward-looking statements. The
company may experience significant fluctuations in future operating results
due to a number of economic, competitive, and other factors, including,
among other things, the size and timing of customer contracts, new or
increased competition, changes in market demand, and seasonality of
purchases of the company's products and services. These factors and others
could cause operating results to vary significantly from those in prior
periods and those projected in forward-looking statements. Additional
information with respect to these and other factors, which could materially
affect the company and its operations, are included in certain forms the
company has filed and will periodically file with the Securities Exchange
Commission.
Imagenetix, Inc.
imagenetix
вторник, 3 мая 2011 г.
TreatmentTrends®: Gout Study Highlights Differences In Clinical Management Of Gout Between Primary Care Physicians And Rheumatologists
BioTrends Research Group, Inc. is pleased to announce the recent publication of a syndicated report, TreatmentTrends®: Gout. This biannual report provides a comprehensive market overview of current and future treatment trends in gout based on a primary research study fielded among 60 primary care physicians (PCPs) and 123 rheumatologists in the U.S. The report focuses on chronic and acute therapies, perceived strengths and weaknesses of chronic therapies, barriers to broader usage, promotional activity, thought leaders in the field and the anticipated impact of a newly approved agent for chronic refractory gout -- Savient Pharmaceuticals' Krystexxa.
Although half of surveyed respondents indicated that they are relatively satisfied with current gout therapies, significant barriers to effective treatment still exist. These include the toxicity and dosing limitations associated with currently available agents, the incidence of acute gout flare attacks and resultant acute care visits, the difficulty in treating patients with renal insufficiency and the extent of switching and discontinuation among users of uric acid lowering (UAL) therapies.
The report also uncovered major differences in treatment approaches between PCPs and rheumatologists including differences in gout classification, the use of serum uric acid levels to guide treatment and the use of various medications to control uric acid levels and prevent and/or treat acute flares. Both PCPs and rheumatologists have favorable impressions of Takeda's Uloric (febuxostat) for most attributes compared to allopurinol, although reimbursement and out of pocket cost to patients continue to be barriers for Uloric uptake.
Krystexxa (pegloticase) was approved in September 2010 by the FDA for the treatment of chronic gout in patients who are refractory to conventional therapy. As many as three-fourths of surveyed rheumatologists indicated they would be likely to prescribe Krystexxa within the first 12 months of commercial availability. The agent's rapid onset of action, ability to resolve tophi and potency in lowering uric acid levels were cited as its most important advantages with varying degrees of uptake by physician specialty and severity of disease.
Source: BioTrends Research Group, Inc
View drug information on Krystexxa; Uloric.
Although half of surveyed respondents indicated that they are relatively satisfied with current gout therapies, significant barriers to effective treatment still exist. These include the toxicity and dosing limitations associated with currently available agents, the incidence of acute gout flare attacks and resultant acute care visits, the difficulty in treating patients with renal insufficiency and the extent of switching and discontinuation among users of uric acid lowering (UAL) therapies.
The report also uncovered major differences in treatment approaches between PCPs and rheumatologists including differences in gout classification, the use of serum uric acid levels to guide treatment and the use of various medications to control uric acid levels and prevent and/or treat acute flares. Both PCPs and rheumatologists have favorable impressions of Takeda's Uloric (febuxostat) for most attributes compared to allopurinol, although reimbursement and out of pocket cost to patients continue to be barriers for Uloric uptake.
Krystexxa (pegloticase) was approved in September 2010 by the FDA for the treatment of chronic gout in patients who are refractory to conventional therapy. As many as three-fourths of surveyed rheumatologists indicated they would be likely to prescribe Krystexxa within the first 12 months of commercial availability. The agent's rapid onset of action, ability to resolve tophi and potency in lowering uric acid levels were cited as its most important advantages with varying degrees of uptake by physician specialty and severity of disease.
Source: BioTrends Research Group, Inc
View drug information on Krystexxa; Uloric.
понедельник, 2 мая 2011 г.
Chondroitin, Popular Supplement For Joint Pain, Shows No Benefit
Chondroitin, a dietary supplement used to treat osteoarthritis, is ineffective, a new meta-analysis -- a study of published research -- finds (Review, p. 580).
The authors selected 20 trials comparing chondroitin to placebo or no treatment and found that chondroitin had little effect on knee or hip pain caused by arthritis.
Although few adverse side effects were reported, the authors conclude that chondroitin use should "be discouraged."
In an accompanying editorial, a writer notes that the market in the United States for chondroitin and glucosamine (usually sold together in the U.S.) tops $1 billion/year (Editorial, p. 611), and writes that despite these findings, "chondroitin sulfate should not be considered dangerous. If patients say that they benefit from chondroitin, I see no harm in encouraging them to continue taking it as long as they perceive a benefit."
(The article and editorial are published online, annals/. They will be available in the May 1, 2007, print edition of Annals of Internal Medicine.)
Note: Annals of Internal Medicine is published by the American College of Physicians.
Tip sheet Annals of Internal Medicine, April 17, 2007
Contact: Susan Anderson
American College of Physicians
The authors selected 20 trials comparing chondroitin to placebo or no treatment and found that chondroitin had little effect on knee or hip pain caused by arthritis.
Although few adverse side effects were reported, the authors conclude that chondroitin use should "be discouraged."
In an accompanying editorial, a writer notes that the market in the United States for chondroitin and glucosamine (usually sold together in the U.S.) tops $1 billion/year (Editorial, p. 611), and writes that despite these findings, "chondroitin sulfate should not be considered dangerous. If patients say that they benefit from chondroitin, I see no harm in encouraging them to continue taking it as long as they perceive a benefit."
(The article and editorial are published online, annals/. They will be available in the May 1, 2007, print edition of Annals of Internal Medicine.)
Note: Annals of Internal Medicine is published by the American College of Physicians.
Tip sheet Annals of Internal Medicine, April 17, 2007
Contact: Susan Anderson
American College of Physicians
воскресенье, 1 мая 2011 г.
Discovery Of Pain-Causing Compounds Leads To Development Of New Non-Addictive Painkillers
A substance similar to capsaicin, which gives chili peppers their heat, is generated at the site of pain in the human body. Scientists at The University of Texas Health Science Center at San Antonio have discovered how to block these capsaicin-like molecules and created a new class of non-addictive painkillers.
The findings were published April 26 in the Journal of Clinical Investigation. The senior investigator was Kenneth Hargreaves, D.D.S., Ph.D., professor and chair of the Department of Endodontics in the Dental School at the UT Health Science Center. Amol M. Patwardhan, M.B.B.S., Ph.D., a graduate of the Health Science Center's Department of Pharmacology who worked under Dr. Hargreaves' supervision, is the lead author.
"Nearly everyone will experience persistent pain at some point in their lifetime," Dr. Hargreaves said. "Our findings are truly exciting because they will offer physicians, dentists and patients more options in prescription pain medications. In addition, they may help circumvent the problem of addiction and dependency to pain medications, and will have the potential to benefit millions of people who suffer from chronic pain every day."
A 'complex epidemic'
Pain has been called a "complex epidemic" in the United States. Nearly 50 million Americans live with chronic pain caused by disease or injury. Few physicians or dentists specialize in the field of pain medicine. With pain medication options largely limited to opioids (such as morphine) and aspirin-like drugs, some patients become addicted or dependent upon these drugs, or suffer side effects such as kidney or liver damage.
Researchers at the UT Health Science Center found a new family of fatty acids, produced by the body itself, that play an important role in the biology of pain.
"Capsaicin is an ingredient in hot chili peppers and causes pain by activating a receptor called transient potential vanilloid 1 (TRPV1). We started out seeking the answer to the question "Why is TRPV1 consistently activated in the body upon injury or painful heat? We wanted to know how skin cells talk to pain neurons," Dr. Hargreaves said. "What we found was much more surprising and exciting. We have discovered a family of endogenous capsaicin-like molecules that are naturally released during injury, and now we understand how to block these mechanisms with a new class of non-addictive therapies."
The hot chili pepper effect
Researchers used flaps of skin from laboratory mice that were heated in a water bath at temperatures greater than 43 degrees Celsius. The degree of heat used was significant because the human body normally begins to feel discomfort and pain at 43 degrees Celsius and higher, Dr. Hargreaves noted.
TRPV1 resides on the membranes of pain- and heat-sensing neurons. When a person eats a hot chili pepper, for example, he immediately feels a burning sensation because the capsaicin, the primary ingredient in the chili pepper, has activated the TRPV1 protein in the pain neurons. In high concentrations, capsaicin can also cause a burning effect on other sensitive areas of the skin.
The fluid from the heated skin was then applied to sensory neurons cultured from two sets of laboratory mice, including one set of animals in which a gene was deleted or "knocked out." Neurons from the wild type (non-altered) mice were sensitive to capsaicin, the main ingredient in chili peppers. The neurons of the knockout mice, in which the TRPV1 gene was deleted, were not sensitive to capsaicin and were used as the control.
"We found that in the skin flaps heated at greater than 43 degrees Celsius, the cells' pain neurons showed tremendous activity in the wild type, but not in neurons from mice that lacked TRPV1," Dr. Hargreaves said. He indicated that this novel phenomenon was taking place because the cells, in response to the heat, began to create their own natural endogenous capsaicins, which they later identified as a series of compounds or fatty acids called oxidized linoleic acid metabolites (OLAMs).
Linoleic acid is one of the most abundant fatty acids in the human body. Under conditions such as inflammation, low blood pressure and some other illnesses, linoleic acid is rapidly oxidized to form biologically active metabolites. However, little else is understood about these substances. The metabolites that were consistently seen in increased amounts in the mouse skin biopsies exposed to heat temperatures greater than 43 degrees Celsius are called 9- and 13-HODE (hydroxyoctadecadienoic acid).
'Major breakthrough'
"This is a major breakthrough in understanding the mechanisms of pain and how to more effectively treat it," Dr. Hargreaves said. "These data demonstrate, for the first time, that OLAMs constitute a new family of naturally occurring capsaicin-like agents, and may explain the role of these substances in many pain conditions. This hypothesis suggests that agents blocking either the production or action of these substances could lead to new therapies and pharmacological interventions for various inflammatory diseases and pain disorders such as arthritis, fibromyalgia and others, including pain associated with cancer."
The research has led Dr. Hargreaves' team to develop two new classes of analgesics using drugs that either block the synthesis of OLAMs or antibodies that inactivate them. These drugs could eventually come in the form of a topical agent, or a pill or liquid that could be ingested, or in the form of an injection. Both approaches have the potential to block pain at its source, unlike opioid narcotics that travel to the brain and affect the central nervous system.
Co-authors of the study with Drs. Hargreaves and Patwardhan from the UT Health Science Center San Antonio are: Armen N. Akopian, Ph.D., assistant professor of endodontics; Anibal Diogenes, D.D.S., Ph.D., assistant professor of endodontics; Susan Weintraub, Ph.D., professor of biochemistry; Nikita Ruparel, D.D.S., Ph.D., a graduate student in the Department of Cellular and Structural Biology, and Charis Uhlson, a research associate at the University of Colorado Health Sciences Center. Robert Murphy, Ph.D., professor of pharmacology at the University of Colorado Health Sciences Center, is also a co-author.
Source:
University of Texas Health Science Center at San Antonio
The findings were published April 26 in the Journal of Clinical Investigation. The senior investigator was Kenneth Hargreaves, D.D.S., Ph.D., professor and chair of the Department of Endodontics in the Dental School at the UT Health Science Center. Amol M. Patwardhan, M.B.B.S., Ph.D., a graduate of the Health Science Center's Department of Pharmacology who worked under Dr. Hargreaves' supervision, is the lead author.
"Nearly everyone will experience persistent pain at some point in their lifetime," Dr. Hargreaves said. "Our findings are truly exciting because they will offer physicians, dentists and patients more options in prescription pain medications. In addition, they may help circumvent the problem of addiction and dependency to pain medications, and will have the potential to benefit millions of people who suffer from chronic pain every day."
A 'complex epidemic'
Pain has been called a "complex epidemic" in the United States. Nearly 50 million Americans live with chronic pain caused by disease or injury. Few physicians or dentists specialize in the field of pain medicine. With pain medication options largely limited to opioids (such as morphine) and aspirin-like drugs, some patients become addicted or dependent upon these drugs, or suffer side effects such as kidney or liver damage.
Researchers at the UT Health Science Center found a new family of fatty acids, produced by the body itself, that play an important role in the biology of pain.
"Capsaicin is an ingredient in hot chili peppers and causes pain by activating a receptor called transient potential vanilloid 1 (TRPV1). We started out seeking the answer to the question "Why is TRPV1 consistently activated in the body upon injury or painful heat? We wanted to know how skin cells talk to pain neurons," Dr. Hargreaves said. "What we found was much more surprising and exciting. We have discovered a family of endogenous capsaicin-like molecules that are naturally released during injury, and now we understand how to block these mechanisms with a new class of non-addictive therapies."
The hot chili pepper effect
Researchers used flaps of skin from laboratory mice that were heated in a water bath at temperatures greater than 43 degrees Celsius. The degree of heat used was significant because the human body normally begins to feel discomfort and pain at 43 degrees Celsius and higher, Dr. Hargreaves noted.
TRPV1 resides on the membranes of pain- and heat-sensing neurons. When a person eats a hot chili pepper, for example, he immediately feels a burning sensation because the capsaicin, the primary ingredient in the chili pepper, has activated the TRPV1 protein in the pain neurons. In high concentrations, capsaicin can also cause a burning effect on other sensitive areas of the skin.
The fluid from the heated skin was then applied to sensory neurons cultured from two sets of laboratory mice, including one set of animals in which a gene was deleted or "knocked out." Neurons from the wild type (non-altered) mice were sensitive to capsaicin, the main ingredient in chili peppers. The neurons of the knockout mice, in which the TRPV1 gene was deleted, were not sensitive to capsaicin and were used as the control.
"We found that in the skin flaps heated at greater than 43 degrees Celsius, the cells' pain neurons showed tremendous activity in the wild type, but not in neurons from mice that lacked TRPV1," Dr. Hargreaves said. He indicated that this novel phenomenon was taking place because the cells, in response to the heat, began to create their own natural endogenous capsaicins, which they later identified as a series of compounds or fatty acids called oxidized linoleic acid metabolites (OLAMs).
Linoleic acid is one of the most abundant fatty acids in the human body. Under conditions such as inflammation, low blood pressure and some other illnesses, linoleic acid is rapidly oxidized to form biologically active metabolites. However, little else is understood about these substances. The metabolites that were consistently seen in increased amounts in the mouse skin biopsies exposed to heat temperatures greater than 43 degrees Celsius are called 9- and 13-HODE (hydroxyoctadecadienoic acid).
'Major breakthrough'
"This is a major breakthrough in understanding the mechanisms of pain and how to more effectively treat it," Dr. Hargreaves said. "These data demonstrate, for the first time, that OLAMs constitute a new family of naturally occurring capsaicin-like agents, and may explain the role of these substances in many pain conditions. This hypothesis suggests that agents blocking either the production or action of these substances could lead to new therapies and pharmacological interventions for various inflammatory diseases and pain disorders such as arthritis, fibromyalgia and others, including pain associated with cancer."
The research has led Dr. Hargreaves' team to develop two new classes of analgesics using drugs that either block the synthesis of OLAMs or antibodies that inactivate them. These drugs could eventually come in the form of a topical agent, or a pill or liquid that could be ingested, or in the form of an injection. Both approaches have the potential to block pain at its source, unlike opioid narcotics that travel to the brain and affect the central nervous system.
Co-authors of the study with Drs. Hargreaves and Patwardhan from the UT Health Science Center San Antonio are: Armen N. Akopian, Ph.D., assistant professor of endodontics; Anibal Diogenes, D.D.S., Ph.D., assistant professor of endodontics; Susan Weintraub, Ph.D., professor of biochemistry; Nikita Ruparel, D.D.S., Ph.D., a graduate student in the Department of Cellular and Structural Biology, and Charis Uhlson, a research associate at the University of Colorado Health Sciences Center. Robert Murphy, Ph.D., professor of pharmacology at the University of Colorado Health Sciences Center, is also a co-author.
Source:
University of Texas Health Science Center at San Antonio
Подписаться на:
Сообщения (Atom)