Probiotics are a new health "buzzword" that has people asking questions like "Should I be taking probiotics? If so, which ones?" "Are probiotic foods sufficient, or do I need a supplement?" "How do you know which brands are best or safest?"
When it comes to using probiotics effectively, some self-education is required, says Patricia Raymond, MD, board-certified gastroenterologist, author and assistant professor at Eastern Virginia Medical School.
"In the United States, probiotics are either food additives, or 'dietary supplements,'" says Dr. Raymond. "Because they are considered supplements and not drugs, they are not heavily regulated by the FDA, so you need to do some research to determine which ones will work for you."
Dr. Raymond offers her tips for choosing a probiotic:
- Assess your health needs: There is a very large variety of strains of probiotics available
and some are better suited to assist with certain problems than others. "If you're someone who simply suffers from occasional constipation, then a probiotic yogurt may do the trick," advises Dr. Raymond. "However, if you suffer from chronic, serious conditions, a supplement may be more appropriate, as more serious conditions require a probiotic dosage of at least 1 billion live micro-organisms in order to have an effect." Foods cannot sustain a number of micro-organisms that high.
- Look for scientific research. As more U.S. physicians are starting to accept probiotics as a legitimate therapy, more studies are being done with them. "For example, Saccharomyces boulardii, a yeast-based probiotic strain commonly sold under the brand name Florastor, has been shown in studies to provide significant benefits in managing even severe illnesses such as C. diff-associated disease, Crohn's disease and Ulcerative Colitis," says Dr. Raymond. Talk to your doctor to find out about the available science that supports the use of probiotics.
- Consider your lifestyle. The form in which a probiotics is packaged may be integral in how successfully you take it. "If you are a frequent traveler looking to combat issues like traveler's diarrhea, a probiotic that needs refrigeration may not be appropriate for you," suggests Dr. Raymond. "Instead, look for a freeze-dried product that can be stored and transported at room temperature."
- Read the labels: Do not take a probiotic that does not list the strain and number of live micro-organisms on the package. Also avoid products that do not have an expiration date.
florastories/
суббота, 31 декабря 2011 г.
суббота, 24 декабря 2011 г.
Abbott Launches Humira (Adalimumab) For Crohn's Disease
Abbott launches HUMIRA® (adalimumab) as a treatment for severe, active Crohn's disease. Adalimumab is the first fully-human tumour necrosis factor antagonist (anti-TNF) to receive a licence for Crohn's disease, a chronic inflammatory disease of the gastrointestinal tract that impairs the lives of up to 60,000 people in the UK1 and causes 70-80% of patients to require major surgery within their lifetime.2
"Currently, there is no cure for Crohn's disease, which reinforces the need for effective treatment options that will help maintain control of the disease. Adalimumab represents an important advance in managing this serious and debilitating condition," said Professor Ghosh, Gastroenterologist from Hammersmith Hospital, London.
Clinical trials of adalimumab showed that:
-- Adalimumab demonstrated response from as early as week one3
-- Three times as many patients who continued on adalimumab maintained clinical remission*at one year compared with placebo4
-- 29% of patients on adalimumab in clinical remission at one year were able to discontinue use of corticosteroids compared with only 6% on placebo.4
Adalimumab is the second anti-TNF licenced for Crohn's disease but the first to offer adult patients the convenience of self-injection at home.
"The unpredictability of Crohn's disease makes it difficult to lead a normal life as the disease can flare-up at any time. We welcome the approval of adalimumab as a new treatment option which will assist patient independence and improve quality of life for Crohn's disease patients" said Richard Driscoll, Director of the National Association for Colitis and Crohn's Disease (NACC).
How adalimumab works
Adalimumab is a fully human monoclonal antibody that works by specifically blocking the activity of TNF, which is a key component of the inflammatory process associated with Crohn's disease. Fully human monoclonal antibodies are essentially indistinguishable from antibodies found in the body and represent the latest advance in the evolution of monoclonal antibodies.
Clinical trials
The EMEA's decision is based on the results of three-randomised, double-blind, placebo-controlled, multi-centre trials of adalimumab. In each trial, clinical remission was measured by a Crohn's Disease Activity Index (CDAI) score of less than 150. CDAI is a weighted composite score of eight clinical factors that evaluate patient wellness, including daily number of liquid or very soft stools, severity of abdominal pain, levels of general wellness and other measures.
CLASSIC I (Clinical assessment of Adalimumab Safety and efficacy Studied as an Induction therapy in Crohn's disease)3 was a study of 299 patients with moderate to severe Crohn's disease who were new to anti-TNF therapy. Results showed that adalimumab demonstrated response from week 1 and resulted in a greater percentage of patients achieving clinical remission at four weeks compared to placebo.
CHARM (Crohn???s trial of the fully Human antibody Adalimumab for Remission Maintenance) 4 was a 56-week trial that enrolled 854 patients with moderate to severely active Crohn's disease. The 499 patients who demonstrated clinical response (CDAI decrease of greater than or equal to 70 points from baseline) to adalimumab during a four-week, open-label induction phase were randomized to receive either adalimumab or placebo. Three times as many patients who continued on adalimumab maintained clinical remission at one year compared to placebo.
GAIN (Gauging Adalimumab effectiveness in Infliximab Non-Responders)5 evaluated the efficacy of adalimumab in 325 patients with moderate to severely active Crohn's disease who had previously lost response or were unable to tolerate infliximab. Adalimumab induced significantly higher rates of clinical remission compared to placebo.
More about Crohn's disease
Typically diagnosed before the age of 40, 6 Crohn's disease can have a devastating impact on the day-to-day life of patients, many of whom are young and active. Five years after developing Crohn's, 15-20% of people are disabled to some degree by their disease.7 Common symptoms include diarrhoea, abdominal pain, weight loss, fever, and in some cases, rectal bleeding. Many patients develop complications such as intestinal obstruction, fistulas (ulcers that form tunnels to surrounding tissues), and malnutrition.
Adalimumab licensed indications8
Crohn's disease
Adalimumab is indicated for treatment of severe, active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
For induction treatment, adalimumab should be given in combination with cortiocosteroids. Adalimumab can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate.
The recommended adalimumab induction dose regimen for adult patients with severe Crohn's disease is usually 80 mg at week 0 followed by 40 mg at week 2.
In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), 80 mg at week 2, can be used with the awareness that the risk for adverse events is higher during induction. After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection.
Rheumatoid arthritis
Adalimumab in combination with methotrexate, is indicated for:
-- the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
-- the treatment of severe, active and progressive RA in adults not previously treated with methotrexate.
Psoriatic arthritis
Article Type Normal Article Headline Article Article Type 2 Normal What Is? Insert for Today 14 June 1Adalimumab is indicated for the treatment of active and progressive psoriatic arthritis (PsA) in adults when the response to previous disease-modifying anti?rheumatic drug therapy has been inadequate.
Ankylosing spondylitis
Adalimumab is indicated for the treatment of adults with severe active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy.
For RA, PsA and AS, adalimumab is usually administered as 40mg every other week as a single dose via subcutaneous injection.
Please refer to the Summary of Product Characteristics for full information on adalimumab including contraindications, special warnings and precautions and side effect information.8
To date, adalimumab has been approved across indications in 67 countries, and more than 180,000 people worldwide are currently being treated with adalimumab. Clinical trials are currently under way evaluating the potential of adalimumab in other immune-mediated diseases.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, device and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
abbott
References
1 The National Association for Colitis and Crohn's Disease (UK) IBD Basics Accessed 04 April 2007 nacc/content/ibd.asp
2 Carter M et al. Guidelines for the management of inflammatory bowel disease in
adults. Gut. 2004; 53: 1-16
3 Hanauer SB, et al. Human anti-tumour necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC 1 trial. Gastroenterology 2006; 130:323-333
4 Colombel JF, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology 2007;132:52-65
5 Sandborn, Rutgeerts et al. Adalimumab Induction Therapy for Crohn Disease Previously Treated with Infliximab: A Randomized Trial. nnals of internal Medicine 2007;146 (12)
6 Crohn's disease NHS Direct Online Health Encyclopedia Accessed 22 May 2006
nhsdirect.nhs
7 Binder V, et al. Prognosis in Crohn's disease--based on results from a regional patient group from the county of Copenhagen. Gut 1985 Feb;26(2):146-50
8 Electronics Medicines Compendium Humira (adalimumab) Summary of Product characteristics emc.medicinesbr>
View drug information on Humira.
"Currently, there is no cure for Crohn's disease, which reinforces the need for effective treatment options that will help maintain control of the disease. Adalimumab represents an important advance in managing this serious and debilitating condition," said Professor Ghosh, Gastroenterologist from Hammersmith Hospital, London.
Clinical trials of adalimumab showed that:
-- Adalimumab demonstrated response from as early as week one3
-- Three times as many patients who continued on adalimumab maintained clinical remission*at one year compared with placebo4
-- 29% of patients on adalimumab in clinical remission at one year were able to discontinue use of corticosteroids compared with only 6% on placebo.4
Adalimumab is the second anti-TNF licenced for Crohn's disease but the first to offer adult patients the convenience of self-injection at home.
"The unpredictability of Crohn's disease makes it difficult to lead a normal life as the disease can flare-up at any time. We welcome the approval of adalimumab as a new treatment option which will assist patient independence and improve quality of life for Crohn's disease patients" said Richard Driscoll, Director of the National Association for Colitis and Crohn's Disease (NACC).
How adalimumab works
Adalimumab is a fully human monoclonal antibody that works by specifically blocking the activity of TNF, which is a key component of the inflammatory process associated with Crohn's disease. Fully human monoclonal antibodies are essentially indistinguishable from antibodies found in the body and represent the latest advance in the evolution of monoclonal antibodies.
Clinical trials
The EMEA's decision is based on the results of three-randomised, double-blind, placebo-controlled, multi-centre trials of adalimumab. In each trial, clinical remission was measured by a Crohn's Disease Activity Index (CDAI) score of less than 150. CDAI is a weighted composite score of eight clinical factors that evaluate patient wellness, including daily number of liquid or very soft stools, severity of abdominal pain, levels of general wellness and other measures.
CLASSIC I (Clinical assessment of Adalimumab Safety and efficacy Studied as an Induction therapy in Crohn's disease)3 was a study of 299 patients with moderate to severe Crohn's disease who were new to anti-TNF therapy. Results showed that adalimumab demonstrated response from week 1 and resulted in a greater percentage of patients achieving clinical remission at four weeks compared to placebo.
CHARM (Crohn???s trial of the fully Human antibody Adalimumab for Remission Maintenance) 4 was a 56-week trial that enrolled 854 patients with moderate to severely active Crohn's disease. The 499 patients who demonstrated clinical response (CDAI decrease of greater than or equal to 70 points from baseline) to adalimumab during a four-week, open-label induction phase were randomized to receive either adalimumab or placebo. Three times as many patients who continued on adalimumab maintained clinical remission at one year compared to placebo.
GAIN (Gauging Adalimumab effectiveness in Infliximab Non-Responders)5 evaluated the efficacy of adalimumab in 325 patients with moderate to severely active Crohn's disease who had previously lost response or were unable to tolerate infliximab. Adalimumab induced significantly higher rates of clinical remission compared to placebo.
More about Crohn's disease
Typically diagnosed before the age of 40, 6 Crohn's disease can have a devastating impact on the day-to-day life of patients, many of whom are young and active. Five years after developing Crohn's, 15-20% of people are disabled to some degree by their disease.7 Common symptoms include diarrhoea, abdominal pain, weight loss, fever, and in some cases, rectal bleeding. Many patients develop complications such as intestinal obstruction, fistulas (ulcers that form tunnels to surrounding tissues), and malnutrition.
Adalimumab licensed indications8
Crohn's disease
Adalimumab is indicated for treatment of severe, active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
For induction treatment, adalimumab should be given in combination with cortiocosteroids. Adalimumab can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate.
The recommended adalimumab induction dose regimen for adult patients with severe Crohn's disease is usually 80 mg at week 0 followed by 40 mg at week 2.
In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), 80 mg at week 2, can be used with the awareness that the risk for adverse events is higher during induction. After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection.
Rheumatoid arthritis
Adalimumab in combination with methotrexate, is indicated for:
-- the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
-- the treatment of severe, active and progressive RA in adults not previously treated with methotrexate.
Psoriatic arthritis
Article Type Normal Article Headline Article Article Type 2 Normal What Is? Insert for Today 14 June 1Adalimumab is indicated for the treatment of active and progressive psoriatic arthritis (PsA) in adults when the response to previous disease-modifying anti?rheumatic drug therapy has been inadequate.
Ankylosing spondylitis
Adalimumab is indicated for the treatment of adults with severe active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy.
For RA, PsA and AS, adalimumab is usually administered as 40mg every other week as a single dose via subcutaneous injection.
Please refer to the Summary of Product Characteristics for full information on adalimumab including contraindications, special warnings and precautions and side effect information.8
To date, adalimumab has been approved across indications in 67 countries, and more than 180,000 people worldwide are currently being treated with adalimumab. Clinical trials are currently under way evaluating the potential of adalimumab in other immune-mediated diseases.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, device and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
abbott
References
1 The National Association for Colitis and Crohn's Disease (UK) IBD Basics Accessed 04 April 2007 nacc/content/ibd.asp
2 Carter M et al. Guidelines for the management of inflammatory bowel disease in
adults. Gut. 2004; 53: 1-16
3 Hanauer SB, et al. Human anti-tumour necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC 1 trial. Gastroenterology 2006; 130:323-333
4 Colombel JF, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology 2007;132:52-65
5 Sandborn, Rutgeerts et al. Adalimumab Induction Therapy for Crohn Disease Previously Treated with Infliximab: A Randomized Trial. nnals of internal Medicine 2007;146 (12)
6 Crohn's disease NHS Direct Online Health Encyclopedia Accessed 22 May 2006
nhsdirect.nhs
7 Binder V, et al. Prognosis in Crohn's disease--based on results from a regional patient group from the county of Copenhagen. Gut 1985 Feb;26(2):146-50
8 Electronics Medicines Compendium Humira (adalimumab) Summary of Product characteristics emc.medicinesbr>
View drug information on Humira.
суббота, 17 декабря 2011 г.
Peppermint Earns Respect In Mainstream Medicine
University of Adelaide researchers have shown for the first time how peppermint helps to relieve Irritable Bowel Syndrome, which affects up to 20% of the population.
In a paper published this week in the international journal Pain, researchers from the University's Nerve-Gut Research Laboratory explain how peppermint activates an "anti-pain" channel in the colon, soothing inflammatory pain in the gastrointestinal tract.
Dr Stuart Brierley says while peppermint has been commonly prescribed by naturopaths for many years, there has been no clinical evidence until now to demonstrate why it is so effective in relieving pain.
"Our research shows that peppermint acts through a specific anti-pain channel called TRPM8 to reduce pain sensing fibres, particularly those activated by mustard and chilli. This is potentially the first step in determining a new type of mainstream clinical treatment for Irritable Bowel Syndrome (IBS)," he says.
IBS is a gastrointestinal disorder, causing abdominal pain, bloating, diarrhoea and/or constipation. It affects about 20% of Australians and costs millions of dollars each year in lost productivity, work absenteeism and health care.
"This is a debilitating condition and affects many people on a daily basis, particularly women who are twice as likely to experience Irritable Bowel Syndrome," Dr Brierley says.
"Some people find their symptoms appear after consuming fatty and spicy foods, coffee and alcohol, but it is more complex than that. There appears to be a definite link between IBS and a former bout of gastroenteritis, which leaves nerve pain fibres in a heightened state, altering mechanisms in the gut wall and resulting in ongoing pain."
Dr Brierley says the recent floods in Queensland and Victoria could result in a spike of gastroenteritis cases in Australia due to the contamination of some water supplies in affected regions.
He said case studies in Europe and Canada showed that many people who contracted gastroenteritis from contaminated water supplies went on to experience IBS symptoms that persisted for at least eight years.
There is no cure for IBS and it often comes and goes over a person's lifetime.
Apart from gastroenteritis and food intolerance, IBS can be brought on by food poisoning, stress, a reaction to antibiotics, and in some cases is genetic.
Dr Brierley is one of 25 researchers who work at the University of Adelaide's Nerve-Gut Research Laboratory, hoping to find cures and treatments for a range of intestinal diseases.
Source:
University of Adelaide
In a paper published this week in the international journal Pain, researchers from the University's Nerve-Gut Research Laboratory explain how peppermint activates an "anti-pain" channel in the colon, soothing inflammatory pain in the gastrointestinal tract.
Dr Stuart Brierley says while peppermint has been commonly prescribed by naturopaths for many years, there has been no clinical evidence until now to demonstrate why it is so effective in relieving pain.
"Our research shows that peppermint acts through a specific anti-pain channel called TRPM8 to reduce pain sensing fibres, particularly those activated by mustard and chilli. This is potentially the first step in determining a new type of mainstream clinical treatment for Irritable Bowel Syndrome (IBS)," he says.
IBS is a gastrointestinal disorder, causing abdominal pain, bloating, diarrhoea and/or constipation. It affects about 20% of Australians and costs millions of dollars each year in lost productivity, work absenteeism and health care.
"This is a debilitating condition and affects many people on a daily basis, particularly women who are twice as likely to experience Irritable Bowel Syndrome," Dr Brierley says.
"Some people find their symptoms appear after consuming fatty and spicy foods, coffee and alcohol, but it is more complex than that. There appears to be a definite link between IBS and a former bout of gastroenteritis, which leaves nerve pain fibres in a heightened state, altering mechanisms in the gut wall and resulting in ongoing pain."
Dr Brierley says the recent floods in Queensland and Victoria could result in a spike of gastroenteritis cases in Australia due to the contamination of some water supplies in affected regions.
He said case studies in Europe and Canada showed that many people who contracted gastroenteritis from contaminated water supplies went on to experience IBS symptoms that persisted for at least eight years.
There is no cure for IBS and it often comes and goes over a person's lifetime.
Apart from gastroenteritis and food intolerance, IBS can be brought on by food poisoning, stress, a reaction to antibiotics, and in some cases is genetic.
Dr Brierley is one of 25 researchers who work at the University of Adelaide's Nerve-Gut Research Laboratory, hoping to find cures and treatments for a range of intestinal diseases.
Source:
University of Adelaide
суббота, 10 декабря 2011 г.
National Heritage Insurance Company Revises PillCam(R) SB Guidelines For California Medicare Patients
Given Imaging Ltd. (NASDAQ: GIVN) today announced that the National Heritage Insurance Company (NHIC), California's Medicare Part B carrier, has revised its existing coverage policy for small bowel capsule endoscopy so that patients will no longer be required to undergo an upper endoscopy (EGD) prior to PillCam SB. NHIC serves approximately 3 million Medicare beneficiaries in California.
NIHC's revised policy states that PillCam SB is now considered an appropriate diagnostic following a negative colonoscopy to evaluate patients with suspected, but undiagnosed Crohn's disease. Further policy revisions include the use of PillCam SB in the diagnosis of iron deficiency anemia (IDA). These amendments now coincide with policy changes made in 2006 by NHIC of New England which services an additional 1 million Medicare beneficiaries in Massachusetts, Maine, New Hampshire and Vermont.
"Medicare administrators around the country continue to recognize the ability to effectively detect and diagnose diseases of the small intestine using capsule endoscopy," said Dr. C. Gregory Albers, medical director of gastrointestinal diagnostic services the H.H. Chao Comprehensive Digestive Disease Center at the University of California, Irvine Medical Center. "We expect that this procedure will benefit more patients by eliminating the need for a prior upper endoscopy."
The updated guidelines are effective immediately. Physicians reporting claims for reimbursement of capsule endoscopy of the small bowel should use CPT code 91110. For more information visit www.medicarenhic
About Given Imaging Ltd.
Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company's technology platform is the PillCam® Platform, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient, a sensor array, data recorder and RAPID® software. Given Imaging has three commercially available capsules: the PillCam SB video capsule to visualize the entire small intestine which is currently marketed in the United States and in more than 60 other countries; the PillCam ESO video capsule to visualize the esophagus; and the Agile™ patency capsule to determine the free passage of the PillCam capsule in the GI tract. The PillCam COLON video capsule to visualize the colon has been cleared for marketing in the European Union, and multi-center clinical trials are underway in Europe and the U.S. A capsule to visualize the stomach is under development. More than 500,000 patients worldwide have benefited from the PillCam capsule endoscopy procedure. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel; it has direct sales and marketing operations in the United States, Germany and France, and local offices in Japan, Spain and Australia. For more information, visit www.givenimaging.
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, projections about our business and our future revenues, expenses and profitability. Forward-looking statements may be, but are not necessarily, identified by the use of forward-looking terminology such as "may," "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual events, results, performance, circumstances or achievements of the Company to be materially different from any future events, results, performance, circumstances or achievements expressed or implied by such forward-looking statements. Factors that could cause actual events, results, performance, circumstances or achievements to differ from such forward-looking statements include, but are not limited to, the following: (1) satisfactory results of clinical trials with PillCam Colon (2) our ability to receive regulatory clearance or approval to market our products or changes in regulatory environment, (3) our success in implementing our sales, marketing and manufacturing plans, (4) protection and validity of patents and other intellectual property rights, (5) the impact of currency exchange rates, (6) the effect of competition by other companies, (7) the outcome of future litigation, including patent litigation with Olympus Corporation, (8) the reimbursement policies for our product from healthcare payors, (9) quarterly variations in operating results, (10) the possibility of armed conflict or civil or military unrest in Israel, and (11) other risks and factors disclosed in our filings with the U.S. Securities and Exchange Commission, including, but not limited to, risks and factors identified under such headings as "Risk Factors," "Cautionary Language Regarding Forward-Looking Statements" and "Operating Results and Financial Review and Prospects" in the Company's Annual Report on Form 20-F for the year ended December 31, 2005. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except for the Company's ongoing obligations to disclose material information under the applicable securities laws, it undertakes no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.
NIHC's revised policy states that PillCam SB is now considered an appropriate diagnostic following a negative colonoscopy to evaluate patients with suspected, but undiagnosed Crohn's disease. Further policy revisions include the use of PillCam SB in the diagnosis of iron deficiency anemia (IDA). These amendments now coincide with policy changes made in 2006 by NHIC of New England which services an additional 1 million Medicare beneficiaries in Massachusetts, Maine, New Hampshire and Vermont.
"Medicare administrators around the country continue to recognize the ability to effectively detect and diagnose diseases of the small intestine using capsule endoscopy," said Dr. C. Gregory Albers, medical director of gastrointestinal diagnostic services the H.H. Chao Comprehensive Digestive Disease Center at the University of California, Irvine Medical Center. "We expect that this procedure will benefit more patients by eliminating the need for a prior upper endoscopy."
The updated guidelines are effective immediately. Physicians reporting claims for reimbursement of capsule endoscopy of the small bowel should use CPT code 91110. For more information visit www.medicarenhic
About Given Imaging Ltd.
Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company's technology platform is the PillCam® Platform, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient, a sensor array, data recorder and RAPID® software. Given Imaging has three commercially available capsules: the PillCam SB video capsule to visualize the entire small intestine which is currently marketed in the United States and in more than 60 other countries; the PillCam ESO video capsule to visualize the esophagus; and the Agile™ patency capsule to determine the free passage of the PillCam capsule in the GI tract. The PillCam COLON video capsule to visualize the colon has been cleared for marketing in the European Union, and multi-center clinical trials are underway in Europe and the U.S. A capsule to visualize the stomach is under development. More than 500,000 patients worldwide have benefited from the PillCam capsule endoscopy procedure. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel; it has direct sales and marketing operations in the United States, Germany and France, and local offices in Japan, Spain and Australia. For more information, visit www.givenimaging.
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, projections about our business and our future revenues, expenses and profitability. Forward-looking statements may be, but are not necessarily, identified by the use of forward-looking terminology such as "may," "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual events, results, performance, circumstances or achievements of the Company to be materially different from any future events, results, performance, circumstances or achievements expressed or implied by such forward-looking statements. Factors that could cause actual events, results, performance, circumstances or achievements to differ from such forward-looking statements include, but are not limited to, the following: (1) satisfactory results of clinical trials with PillCam Colon (2) our ability to receive regulatory clearance or approval to market our products or changes in regulatory environment, (3) our success in implementing our sales, marketing and manufacturing plans, (4) protection and validity of patents and other intellectual property rights, (5) the impact of currency exchange rates, (6) the effect of competition by other companies, (7) the outcome of future litigation, including patent litigation with Olympus Corporation, (8) the reimbursement policies for our product from healthcare payors, (9) quarterly variations in operating results, (10) the possibility of armed conflict or civil or military unrest in Israel, and (11) other risks and factors disclosed in our filings with the U.S. Securities and Exchange Commission, including, but not limited to, risks and factors identified under such headings as "Risk Factors," "Cautionary Language Regarding Forward-Looking Statements" and "Operating Results and Financial Review and Prospects" in the Company's Annual Report on Form 20-F for the year ended December 31, 2005. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except for the Company's ongoing obligations to disclose material information under the applicable securities laws, it undertakes no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.
суббота, 3 декабря 2011 г.
Researchers Wake Up Viruses Inside Tumors To Image And Then Destroy Cancers
Researchers have found a way to activate Epstein-Barr viruses inside tumors as a way to identify patients whose infection can then be manipulated to destroy their tumors. They say this strategy could offer a novel way of treating many cancers associated with Epstein-Barr, including at least four different types of lymphoma and nasopharyngeal and gastric cancers.
In the March 1 issue of Clinical Cancer Research, a team of radiologists and oncologists from Johns Hopkins Medical Institutions describe how they used two agents already on the market - one of which is the multiple myeloma drug Velcade - to light up tumor viruses on a gamma camera. The technique is the first in the new field of in vivo molecular-genetic imaging that doesn't require transfecting tumors with a "reporter" gene, the scientists say.
"The beauty of this is that you don't have to introduce any reporter genes into the tumor because they are already there," says radiologist Martin G. Pomper, M.D., Ph.D. "This is the only example we know of where it is possible to image activated endogenous gene expression without having to transfect cells."
A variety of blood and solid cancers are more likely to occur in people who have been infected with the Epstein-Barr virus (EBV), but not everyone with these cancers has such infections. For those who do, researchers, such as Hopkins oncologist and co-author Richard F. Ambinder, M.D., Ph.D., have been working on ways to activate the reproductive, or "lytic" cycle, within the virus to make it replicate within the tumor cell. When enough viral particles are produced, the tumor will burst, releasing the virus. In animal experiments, this experimental therapy, called lytic induction therapy, results in tumor death.
As the first step in this study, researchers screened a wide variety of drugs to see if any of them could reawaken the virus. They were fortunate in that one of the genes that is expressed upon viral lytic induction is EBV's thymidine kinase (EBV-TK), an enzyme that helps the virus begin to reproduce. This kinase is of interest because researchers know its "sister" kinase, the one produced by the herpes simplex virus, can be imaged by an injected radiolabeled chemical (FIAU), which can then be imaged using a gamma camera.
"To perform molecular-genetic imaging, we have always had to infect cells with active herpes simplex virus so that they can replicate, express TK, and only then could we use the FIAU tracer to make the cells light up," Pomper says. "So we were hoping to find a way to turn latent Epstein-Barr virus on in these cancers, and use the thymidine kinase it then produces to enable us to see the virus-associated tumors with radiolabeled FIAU."
The researchers screened 2,700 agents until they hit upon Velcade, a targeted chemotherapy drug already approved for use in multiple myeloma. "We were both surprised and lucky," he says. "Velcade is a proteasome inhibitor, but it also induces the lytic cycle thereby activating the TK in the Epstein-Barr virus. Once the TK is activated, we can image the tumors."
To test their findings, the researchers used mice carrying human Burkitt's lymphoma, a cancer often associated with Epstein-Barr viral infection. Tumors glowed in mice given Velcade followed by an injection of FIAU, but not in mice that weren't given Velcade. Mice whose Burkitt's lymphoma did not contain Epstein-Barr virus also did not respond to either Velcade or FIAU, according to researchers.
"Velcade woke up the virus in the tumors, which increased viral load by 12-fold, all the while cranking out TK," Pomper says. "An injection of FIAU made it easy to image the tumors with virus in them."
The method is highly sensitive, he says: as few as five percent of the cells within the tumor mass needed to be induced into the lytic cycle in order to be detected.
Not only can FIAU light up the tumors, it can also potentially kill them, Pomper says. For imaging purposes, FIAU can carry a radionuclide that emits a low energy gamma photon, but it can also be engineered to carry therapeutic radionuclides, which are lethal to cells in which TK is activated.
Results of this study suggests that this strategy could be applied to other viruses associated with tumors, and that other drugs may potentially be used to activate these viruses, Pomper says. "Velcade is only one of an array of new, as well as older agents, that can induce lytic infection, and a particular agent could be tailored for use in a specific patient through imaging," he says.
The study was funded by the National Cancer Institute.
The mission of the American Association for Cancer Research is to prevent and cure cancer. Founded in 1907, AACR is the world's oldest and largest professional organization dedicated to advancing cancer research. The membership includes more than 24,000 basic, translational, and clinical researchers; health care professionals; and cancer survivors and advocates in the United States and more than 70 other countries. AACR marshals the full spectrum of expertise from the cancer community to accelerate progress in the prevention, diagnosis and treatment of cancer through high-quality scientific and educational programs. It funds innovative, meritorious research grants. The AACR Annual Meeting attracts more than 17,000 participants who share the latest discoveries and developments in the field. Special Conferences throughout the year present novel data across a wide variety of topics in cancer research, treatment, and patient care. AACR publishes five major peer-reviewed journals: Cancer Research; Clinical Cancer Research; Molecular Cancer Therapeutics; Molecular Cancer Research; and Cancer Epidemiology, Biomarkers & Prevention. Its most recent publication, CR, is a magazine for cancer survivors, patient advocates, their families, physicians, and scientists. It provides a forum for sharing essential, evidence-based information and perspectives on progress in cancer research, survivorship, and advocacy.
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View drug information on Velcade.
In the March 1 issue of Clinical Cancer Research, a team of radiologists and oncologists from Johns Hopkins Medical Institutions describe how they used two agents already on the market - one of which is the multiple myeloma drug Velcade - to light up tumor viruses on a gamma camera. The technique is the first in the new field of in vivo molecular-genetic imaging that doesn't require transfecting tumors with a "reporter" gene, the scientists say.
"The beauty of this is that you don't have to introduce any reporter genes into the tumor because they are already there," says radiologist Martin G. Pomper, M.D., Ph.D. "This is the only example we know of where it is possible to image activated endogenous gene expression without having to transfect cells."
A variety of blood and solid cancers are more likely to occur in people who have been infected with the Epstein-Barr virus (EBV), but not everyone with these cancers has such infections. For those who do, researchers, such as Hopkins oncologist and co-author Richard F. Ambinder, M.D., Ph.D., have been working on ways to activate the reproductive, or "lytic" cycle, within the virus to make it replicate within the tumor cell. When enough viral particles are produced, the tumor will burst, releasing the virus. In animal experiments, this experimental therapy, called lytic induction therapy, results in tumor death.
As the first step in this study, researchers screened a wide variety of drugs to see if any of them could reawaken the virus. They were fortunate in that one of the genes that is expressed upon viral lytic induction is EBV's thymidine kinase (EBV-TK), an enzyme that helps the virus begin to reproduce. This kinase is of interest because researchers know its "sister" kinase, the one produced by the herpes simplex virus, can be imaged by an injected radiolabeled chemical (FIAU), which can then be imaged using a gamma camera.
"To perform molecular-genetic imaging, we have always had to infect cells with active herpes simplex virus so that they can replicate, express TK, and only then could we use the FIAU tracer to make the cells light up," Pomper says. "So we were hoping to find a way to turn latent Epstein-Barr virus on in these cancers, and use the thymidine kinase it then produces to enable us to see the virus-associated tumors with radiolabeled FIAU."
The researchers screened 2,700 agents until they hit upon Velcade, a targeted chemotherapy drug already approved for use in multiple myeloma. "We were both surprised and lucky," he says. "Velcade is a proteasome inhibitor, but it also induces the lytic cycle thereby activating the TK in the Epstein-Barr virus. Once the TK is activated, we can image the tumors."
To test their findings, the researchers used mice carrying human Burkitt's lymphoma, a cancer often associated with Epstein-Barr viral infection. Tumors glowed in mice given Velcade followed by an injection of FIAU, but not in mice that weren't given Velcade. Mice whose Burkitt's lymphoma did not contain Epstein-Barr virus also did not respond to either Velcade or FIAU, according to researchers.
"Velcade woke up the virus in the tumors, which increased viral load by 12-fold, all the while cranking out TK," Pomper says. "An injection of FIAU made it easy to image the tumors with virus in them."
The method is highly sensitive, he says: as few as five percent of the cells within the tumor mass needed to be induced into the lytic cycle in order to be detected.
Not only can FIAU light up the tumors, it can also potentially kill them, Pomper says. For imaging purposes, FIAU can carry a radionuclide that emits a low energy gamma photon, but it can also be engineered to carry therapeutic radionuclides, which are lethal to cells in which TK is activated.
Results of this study suggests that this strategy could be applied to other viruses associated with tumors, and that other drugs may potentially be used to activate these viruses, Pomper says. "Velcade is only one of an array of new, as well as older agents, that can induce lytic infection, and a particular agent could be tailored for use in a specific patient through imaging," he says.
The study was funded by the National Cancer Institute.
The mission of the American Association for Cancer Research is to prevent and cure cancer. Founded in 1907, AACR is the world's oldest and largest professional organization dedicated to advancing cancer research. The membership includes more than 24,000 basic, translational, and clinical researchers; health care professionals; and cancer survivors and advocates in the United States and more than 70 other countries. AACR marshals the full spectrum of expertise from the cancer community to accelerate progress in the prevention, diagnosis and treatment of cancer through high-quality scientific and educational programs. It funds innovative, meritorious research grants. The AACR Annual Meeting attracts more than 17,000 participants who share the latest discoveries and developments in the field. Special Conferences throughout the year present novel data across a wide variety of topics in cancer research, treatment, and patient care. AACR publishes five major peer-reviewed journals: Cancer Research; Clinical Cancer Research; Molecular Cancer Therapeutics; Molecular Cancer Research; and Cancer Epidemiology, Biomarkers & Prevention. Its most recent publication, CR, is a magazine for cancer survivors, patient advocates, their families, physicians, and scientists. It provides a forum for sharing essential, evidence-based information and perspectives on progress in cancer research, survivorship, and advocacy.
aacr
View drug information on Velcade.
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