Since 2004 Foodborne Illness Incidence In America Has Not Dropped, CDC
April 12, 2008
The number of cases of people with reported foodborne illnesses in the United States was dropping until 2004 - since then the numbers have not fallen, according to a report published by the CDC (Centers for Disease Control and Prevention).
The new data comes from FoodNet. FoodNet is part of the CDC’s Foodborne Diseases Active Surveillance Network - it monitors foodborne diseases and carries out epidemiologic* studies which help health offices better understand the epidemiology of foodborne disease across the nation.
* Epidemiology is the study of how often diseases occur in different groups of people and why.
The report shows that the following have not dropped significantly -
– Campylobacter
– Listeria
– Salmonella
– Shigella
– E.coli O157
– Vibrio
– Yersinia
Since 2004 the incidence of Cryptosporidium has increased.
The CDC stresses that over the long term there has been a fall in the incidence of foodborne infections. The worry is that the fall stopped in 2004.
Dr. Robert Tauxe, Deputy Director, Division of Foodborne, Bacterial and Mycotic Diseases, CDC, said “The results show that prevention efforts have been partly successful, but there has been little further progress in the most recent years. More needs to be done to make our food safer. We are constantly working to help our public health system better detect, investigate and control outbreaks and to understand how to prevent foodborne illnesses from happening in the first place. FoodNet is an important part of our food safety system and is how we measure progress.”
Faye Feldstein, Acting Director, Office of Food Defense, FDA, said “FoodNet is an important public health surveillance tool. FDA will continue to support this important endeavor and is committed to pursuing strategies to reduce all foodborne illness. FDA′s Food Protection Plan represents a major new initiative that is heavily focused on prevention linked to targeted intervention and rapid response that is taking a production to consumption approach to addressing protection of the food supply”
As a consumer, there are things you can do to protect yourself and your family from foodborne illnesses. You should follow safe food-handling recommendations; avoid consuming unpasteurized milk, raw or undercooked oysters, raw/undercooked eggs, raw/undercooked ground beef, and undercooked poultry.
“Preliminary FoodNet Data on the Incidence of Infection with Pathogens Transmitted Commonly Through Food - 10 States, United States, 2007″
Morbidity and Mortality Weekly Report April 11, 2008 / 57(14);366-370
Click here to see the report online
Written by - Christian Nordqvist
Copyright: Medical News Today
Recombinant Human Intestinal Trefoil Factor (rhITF) Oral Spray For Prophylaxis Of Chemotherapy-induced Oral Mucositis
April 8, 2008
The GI Company, Inc., a privately held developer of gastrointestinal therapeutics, announced that an abstract detailing combined results from its Phase I and Phase II clinical trials has been accepted for a poster presentation at the Multinational Association of Supportive Care in Cancer’s and the International Society of Oral Oncology’s 2008 International Symposium on Supportive Care in Cancer (MASCC / ISOO). The symposium takes place June 26-28, 2008 at the Hilton Hotel Houston, Texas.
The abstract is titled, “Recombinant human intestinal trefoil factor (rhITF) oral spray for prophylaxis of chemotherapy-induced oral mucositis.”
The GI Company’s lead Phase II clinical candidate, Intestinal Trefoil Factor (ITF), is an endogenous protein in development for the treatment of oral mucositis, a common, debilitating complication resulting from high-dose chemotherapy and / or radiotherapy. The GI Company has retained Burrill & Company to assist in the selection of a transaction partner for its clinical programs.
About Intestinal Trefoil Factor
Intestinal Trefoil Factor is an endogenous protein found primarily on mucosal surfaces throughout the gastrointestinal tract, including the mouth, esophagus and intestines, as well as in other tissues such as the eye and lungs. The protein is known to promote mucosal restitution and repair and is therefore being developed as a therapeutic. ITF mucositis therapy is designed to alleviate damage to the soft tissues of the oral cavity by providing ITF to the cells of the mouth and throat using a proprietary buccal (oral) delivery system. This therapeutic target is backed by proven biology and compelling efficacy data on ITF in numerous in vivo models of mucosal damage.
About Oral Mucositis
Oral mucositis, also called stomatitis, is a common, serious complication resulting from high-dose chemotherapy and / or radiotherapy. These cytotoxic therapies are used to kill cancer cells, but they also indiscriminately kill other fast-growing cells such as those lining the inside of the mouth and throat. Oral mucositis is an inflammation of the mucosa of the mouth which ranges from redness to severe ulcerations on the inner cheek, tongue and lips. These debilitating oral sores further diminish quality of life by preventing patients from eating, drinking, or talking for weeks at a time. These conditions can reappear after every course of treatment. In addition to extremely painful open oral sores, patients with oral mucositis typically have diminished immunity resulting from chemotherapy and / or radiotherapy and are prone to serious life-threatening opportunistic infections. Currently, there is no effective treatment approved to prevent oral mucositis or shorten its duration. This condition can affect as many as 80 percent of bone marrow / blood stem cell transplant patients and 40 percent of chemotherapy / radiotherapy patients. This market represents a $1B annual market opportunity in the U.S. alone.
About MASCC
The Multinational Association of Supportive Care in Cancer (MASCC) is an international, multidisciplinary organization with members representing over sixty (60) countries and five continents. Founded in 1990, MASCC is dedicated to research and education in all aspects of supportive care for patients with cancer, regardless of the stage of their disease. In 1998 MASCC joined forces with the International Society of Oral Oncology (ISOO), an organization that addresses the management of complications arising in oral tissues secondary to cancer and its treatment. For more information, please visit http://www.mascc.org/.
About The GI Company, Inc.
The GI Company is a clinical-stage biotechnology company highly specialized at developing drugs to treat gastrointestinal and related diseases. The company’s lead clinical candidate is Intestinal Trefoil Factor (ITF) which is being developed for the treatment of oral mucositis. The GI Company also has pre-clinical development projects in enteritis / proctitis, inflammatory bowel disease, erosive gastroesophageal reflux disease, peptic ulcer disease and gastrointestinal motility disorders, as well as clinical programs in erosive gastritis (NSAID induced), ulcerative colitis and corneal wound healing. The company is funded through a private equity financing consortium and has raised over $20M to date.
The GI Company, Inc.
FDA Approves ROTARIX(R) Rotavirus Vaccine
April 7, 2008
AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) announced that its partner, GlaxoSmithKline (GSK), has received approval from the U.S. Food and Drug Administration (FDA) for ROTARIX® for the prevention of rotavirus gastroenteritis in infants. With only two doses, ROTARIX will offer protection against the most commonly circulating rotavirus types in the U.S. and allow infants to complete the vaccination series by four months of age. The U.S. Centers for Disease Control and Prevention (CDC) currently recommends that children complete the rotavirus immunization series by six months of age. Rotavirus infects virtually every child in the United States by age five and is the leading cause of severe gastroenteritis in infants and young children worldwide. ROTARIX may help prevent many of the 55,000 - 70,000 hospitalizations by young children that result from rotavirus in the U.S. each year.
Not only does ROTARIX confer protection at an early age, but clinical trials have shown that protection is broad and sustained. ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a two-dose series in infants and children. Clinical data published on the two-dose series of ROTARIX show that protection was sustained through the first two years of life and was highly efficacious against rotavirus hospitalizations (96%) and severe rotavirus gastroenteritis (90%). In addition, ROTARIX was effective against rotavirus gastroenteritis of any severity (79%). Specifically, significant protection was demonstrated against severe rotavirus gastroenteritis during two rotavirus seasons caused by types G1 (96%), G2 (86%), G3 (94%), G4 (95%), and G9 (85%), the most commonly circulating rotavirus types in the U.S.
“We are delighted that our partner GSK has received approval of ROTARIX in the United States,” said Una S. Ryan, Ph.D., President and Chief Executive Officer of AVANT Immunotherapeutics. “With only two doses, ROTARIX will allow infants to complete the vaccination series against rotavirus earlier than ever before. We have great expectations for GSK to launch ROTARIX prior to the upcoming rotavirus season.”
AVANT licensed the technology for ROTARIX to GSK in 1997 for worldwide commercialization. The vaccine was originally developed at Cincinnati Children’s Hospital Medical Center. The FDA’s approval of ROTARIX was based on one of the largest clinical development plans undertaken by a vaccine manufacturer and includes data from nearly 75,000 infants. These clinical trials were conducted in the Americas, Europe, Asia and Africa and reflect an ethnically diverse population.
About ROTARIX
ROTARIX is an oral live-attenuated human rotavirus vaccine licensed in more than 100 countries around the world. More than 25 million doses of ROTARIX have been distributed worldwide. The vaccine was developed for the prevention of rotavirus gastroenteritis by mimicking the protective effects of natural human rotavirus infection. Naturally occurring human rotavirus infection provides significant protection against subsequent moderate to severe rotavirus gastroenteritis regardless of the infecting serotype(s). Five Phase 3 clinical trials were conducted worldwide to assess the safety and efficacy of ROTARIX in support of U.S. licensure. The clinical trials conducted in support of U.S. licensure demonstrated efficacy against rotavirus gastroenteritis of any severity due to the most common currently circulating rotavirus types in the U.S. In clinical studies, common adverse events were fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting. ROTARIX is contraindicated in certain individuals with a history of uncorrected congenital malformation of the gastrointestinal tract.
About Rotavirus
Rotavirus infects virtually every child worldwide by age five and is the leading cause of severe gastroenteritis in infants and young children in the U.S. and worldwide. Severe, dehydrating gastroenteritis can occur as young as three months of age. In the U.S. each year, 2.7 million children younger than five years of age suffer from rotavirus disease, resulting in 410,000 clinic visits and up to 272,000 emergency department visits. In addition, between 55,000 and 70,000 children are hospitalized and 20 to 60 die each year. In the U.S., the rotavirus season typically begins in the southwest during November-December and spreads to the northeast by April-May.
About GlaxoSmithKline: A Leader in Vaccines
GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and Research Triangle Park, NC, is one of the world’s leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GlaxoSmithKline Biologicals (GSK Biologicals) is a global vaccine company which has shown to be a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Biologicals has 14 manufacturing sites strategically positioned around the globe. In 2007 GSK Biologicals distributed 1.1 billion doses of vaccines to 169 countries in both developed and the developing world — an average of 3 million doses a day.
GSK Biologicals employs over 9,000 people worldwide including more than 1,600 passionate scientists engaged in research aimed at discovering innovative vaccines that contribute to the health and well-being of people of all generations around the world.
About AVANT Immunotherapeutics, Inc.
AVANT Immunotherapeutics, Inc. is a NASDAQ-listed company discovering and developing innovative vaccines and targeted immunotherapeutics for the treatment of cancer, infectious and inflammatory diseases. AVANT focuses on the use of tumor-specific targets and human monoclonal antibodies (mAbs) to precisely deliver therapeutic agents through its novel “targeted immunization” approach. AVANT also possesses innovative bacterial vector delivery technologies with unique manufacturing and preservation processes that offer the potential for a new generation of infectious disease vaccines. AVANT’s deep product pipeline consists of products in varying stages of development, with its lead candidate, CDX-110, currently undergoing evaluation in a Phase 2/3 clinical trial in newly diagnosed glioblastoma multiforme, one of the most aggressive forms of brain cancer. AVANT also has five product candidates in its development pipeline including:
-CDX-1307, a product based on its proprietary APC Targeting Technology™, which is in two Phase 1 clinical trials for patients with advanced pancreatic, bladder, breast and colon cancer;
-a complement inhibitor, TP10, in development for transplantation and other indications; and
-three candidates based on its oral, rapidly-protecting, single-dose and temperature-stable vaccine technology, including combination vaccines for travelers, the military and global health needs.
AVANT has three commercialized products, including ROTARIX for the prevention of rotavirus infection and two human food safety vaccines for reducing salmonella infection in chickens and eggs.
AVANT Immunotherapeutics, Inc.
Rotarix, An Oral Rotavirus Vaccine, Approved By The FDA
April 5, 2008
The FDA (Food and Drug Administration, USA) has approved Rotarix, an oral vaccine for the prevention of rotavirus - an infection in children and infants which causes vomiting and diarrhea (gastroenteritis).
The vaccine, which is presented in liquid form, is given in two doses to infants aged 6 and 24 weeks. It protects against gastroenteritis caused by the G1, G3, G4, and G9 strains of rotavirus.
There are approximately 2,700,000 gastroenteritis cases among US children each year, of which 55,000-70,000 need to be hospitalized. Between 20 and 60 children/babies die each year as a result of gastroenteritis annually in the USA. Health experts say that virtually every American kid will be infected with rotavirus by the age of 5 at least once if they are not vaccinated.
Jesse L. Goodman, M.D., M.P.H., Director, Center for Biologics Evaluation and Research, FDA, said “This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children.”
Studies involving over 24,000 infants showed that Rotarix is effective in preventing rotavirus-caused gastroenteritis during the first two years of a baby’s life.
The following adverse events were reported during the clinical trials - fussiness, irritability, cough, runny nose, fever, loss of appetite and vomiting.
A different rotavirus vaccine was voluntarily withdrawn by the manufacturer in 1999 because it was linked to a raised risk of intussusception, or intestinal folding, which can lead to potentially life-threatening intestinal blockage.
Intussusception can occur in non-vaccinated children spontaneously, but to help ensure that Rotarix does not raise the risk of intussusception, GlaxoSmithKline (GSK) conducted a study of more than 63,000 infants. The study compared 31,673 children who received Rotarix to 31,552 children who received a placebo - Rotarix was found not to increase a child’s risk of intussusception.
The FDA has asked the manufacturer (GSK) to conduct post-marketing safety studies involving over 40,000 infants- because during the intussusception study a higher rate of convulsions and pneumonia-related deaths were observed. However, this was not observed in other studies.
– Rotarix
Written by - Christian Nordqvist
Copyright: Medical News Today
FDA Approves New Vaccine To Prevent Gastroenteritis Caused By Rotavirus
April 4, 2008
The U.S. Food and Drug Administration announced the approval of Rotarix, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children. Rotarix is a liquid and given in a two-dose series to infants from 6 to 24 weeks of age.
Although the disease is usually self-limiting, rotavirus causes about 2.7 million cases of gastroenteritis in U.S. children each year-about 55,000 to 70,000 of those require hospitalization; and between 20 and 60 deaths are attributed to it. Without vaccination, nearly every child in the United States would likely be infected at least once with rotavirus by age 5.
There are many different strains of rotavirus. The vaccine protects against rotavirus gastroenteritis caused by the G1, G3, G4, and G9 strains.
“This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children,” said Jesse L. Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research.
During studies involving more than 24,000 infants, Rotarix was effective in preventing both severe and mild cases of rotavirus-caused gastroenteritis during the first two years of life. The most common adverse reactions reported during clinical trials were fussiness, irritability, cough, runny nose, fever, loss of appetite and vomiting.
In 1999, a different rotavirus vaccine from another manufacturer was voluntarily withdrawn from the U.S. market because of an association with an increased risk of intussusception, or intestinal folding, which can lead to potentially life-threatening intestinal blockage. Intussusception can occur in children spontaneously in the absence of vaccination, but to help ensure that Rotarix does not increase the risk of intussusception, its manufacturer conducted a study of more than 63,000 infants.
In that study, there was no increase in the risk of intussusception in those who received Rotarix (31,673 infants) compared to those who received placebo (31,552 infants). Increased rates of convulsion and pneumonia-related deaths were observed in the Rotarix recipients in the intussusception study, however these events were not observed in other studies conducted by the manufacturer. Although the FDA has concluded that the available data do not establish that these events are related to the vaccine, the agency has requested the manufacturer to conduct post-marketing safety studies involving more than 40,000 infants to provide additional safety information.
Rotarix is manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium.
http://www.fda.gov
SAGES/ACS Fundamentals Of Laparoscopic Surgery (FLS) Program Receives Landmark Grant From Covidien
April 4, 2008
The Fundamentals of Laparoscopic Surgery (FLS), a joint educational program from the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the American College of Surgeons (ACS), has received a $1.8 million grant from Covidien, a leading manufacturer of medical devices and supplies, to launch The Covidien Educational Fund. Covidien will be supporting surgical residency and fellowship training by providing an opportunity for surgeons-in-training to utilize the FLS program to study and to certify their basic skills in laparoscopy before going into clinical practice. The Covidien Educational Fund will allow the FLS program to be provided to over 250 surgical residency programs in the United States and Canada, reaching thousands of surgeons-in-training.
“We are proud to extend our partnership with SAGES and ACS by supporting the Fundamentals of Laparoscopy Surgery program,” said Scott Flora, President, Surgical Devices, Covidien. “This Covidien grant will allow thousands of physicians in training to be certified in laparoscopic skills which will ultimately lead to new innovative surgical procedures and better patient outcomes,” added Flora.
The FLS program, developed by SAGES and now jointly supported by the ACS, is a comprehensive and validated educational module designed to teach the physiology, fundamental knowledge and technical skills required in basic laparoscopy that allows practice in a safe environment without putting patients at risk. FLS consists of two multi-media CD-ROMs (soon to be web-based), a hands-on skills training component and an assessment tool. Upon completion of the didactic and manual skills training portion of the course, participants take a proctored, two-part exam that covers cognitive knowledge, clinical judgment and technical skills.
Recognizing the importance of improving surgeon’s technical skills and enhancing patient safety, as well as the need for on-site training and testing, Covidien provided a generous, multi-year gift to the FLS program which will bring no-cost training and testing in FLS directly to general surgery residency programs for the next three academic years. It will also cover MIS/HPB/colorectal fellowships for one academic year.
In implementing the Covidien Educational Fund, SAGES and ACS will provide access to the didactic content, an FLS Trainer Box with manual skills training accessories, plus test vouchers and access to regional or on-site FLS-proctored testing. Visit http://www.flsprogram.org for more information, or call 310-437-0544, ext. 130.
About Covidien Ltd.
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in four segments: Medical Devices, Imaging Solutions, Pharmaceutical Products and Medical Supplies. With 2007 revenue of nearly $9 billion, Covidien has more than 43,000 employees worldwide in 57 countries, and its products are sold in over 130 countries. Please visit http://www.covidien.com to learn more about our business.
About the Society of American Gastrointestinal and Endoscopic Surgeons
The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) was founded in 1981 to foster, promote, support and encourage academic, clinical and research achievement in gastrointestinal Endoscopic surgery. The Society has grown from fewer than 50 original members to almost 6,000 from every U.S. state and over 80 countries. SAGES provides signature guidelines for training, standards of practice and granting of privileges which promote patient safety and the best clinical outcomes. Visit http://www.sages.org for more information.
About the American College of Surgeons (ACS)
Founded in 1913, the College is dedicated to improving the care of the surgical patient and to safeguarding standards of care in an optimal and ethical practice environment. The ACS has more than 64,000 Fellows and is the premier educational resource for surgeons and offers numerous activities for continuous professional development including Clinical Congress, CD-ROMs, Web casts, and e-learning modules. Visit http://www.facs.org for more information.
About the Fundamentals of Laparoscopic Surgery (FLS) Program
Developed by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) the Fundamentals of Laparoscopic Surgery program (FLS) includes cognitive and hands-on skills training components, and a validated assessment focusing on the physiology, fundamental knowledge, and technical skills required in basic laparoscopic surgery.
Fundamentals of Laparoscopic Surgery
Mayo Clinic Identifies Infection Risks For Patients With Inflammatory Bowel Disease
April 3, 2008
A new Mayo Clinic study finds that patients who are 50 or older and take multiple immunosuppressive medications for inflammatory bowel disease have a higher risk for developing infections. The study is published in this month’s issue of Gastroenterology.
More than 1 million Americans are believed to have ulcerative colitis or Crohn’s disease, the most common forms of inflammatory bowel disease. These conditions inflame the lining of the digestive tract and cause severe bouts of watery diarrhea and abdominal pain. The cause of these conditions is not known, but the most common theory is that the immune system of patients with inflammatory bowel disease reacts abnormally to bacteria in the gut.
“Patients with inflammatory bowel disease are often treated with a combination of immunosuppressive medications to help relieve symptoms,” says Edward Loftus, M.D. a Mayo Clinic gastroenterologist and an author of this study. “Since these medications compromise immune reactions in the body, patients can develop what are called opportunistic infections, or infections from common organisms that would not affect individuals with healthy immune systems.”
Dr. Loftus and a team of Mayo Clinic researchers set out to identify and quantify the risk factors that are associated with opportunistic infections in inflammatory bowel disease patients. They studied the medical records of 300 patients with inflammatory bowel disease. One hundred of these patients had contracted opportunistic infections and 200 patients had no history of these infections. The team found that patients who were age 50 or older were three times more likely to have infections than younger patients. Additionally, patients on one immunosuppressive medication were three times more likely to develop opportunistic infections than those on none. Patients on two or three different immunosuppressive medications were 14 times more likely to develop opportunistic infections than those on none.
“This study shows that patients with inflammatory bowel disease who are on immunosuppressive medications should have a low threshold for seeking medical attention at any sign of infection, such as cough or fever,” says Dr. Loftus. “For the medical community, this is another example of the need to be cognizant of the potential risks of combination immunosuppressive therapies.”
Other members of the Mayo Clinic research team included Murat Toruner, M.D.; W. Scott Harmsen; Alan Zinsmeister, Ph.D.; Robert Orenstein, D.O.; William Sandborn, M.D.; Jean-Frederic Colombel, M.D.; and Laurence Egan, M.D.
Each year, physicians at Mayo Clinic’s campuses in Arizona, Florida and Minnesota treat thousands of patients who have digestive diseases. For more information on the treatment of digestive diseases at Mayo Clinic, visit http://www.mayoclinic.org/gi.
To obtain the latest news releases from Mayo Clinic, go to http://www.mayoclinic.org/news. MayoClinic.com (http://www.mayoclinic.com) is available as a resource for your health stories.
Mayo Clinic
http://www.mayoclinic.com
Burden Of Gastroenteritis On The Island Of Ireland Estimated At Over 135 Million Euros
April 2, 2008
1st April 2008: A new safefood study - The Economic Impact of Gastroenteritis on the Island of Ireland has revealed the total burden of gastroenteritis on the economy for the island of Ireland is estimated at over €135 million per annum.
The report commissioned by safefood and carried out by Trinity College Dublin and the London School of Hygiene and Tropical Medicine was launched today at a conference in the Royal College of Physicians of Ireland.
”This report highlights the substantial economic burden of gastroenteritis on the island of Ireland. Although the costs associated with work make up a large part of the economic burden, a significant proportion falls on patients and their families. The average annual cost to individuals and their families represent about 20% of the overall burden to the economy or €24.20 per person. 40% to 50% of the economic burden is associated with the cost of missing work and 20% is associated with health system costs,” Dr Thomas Quigley, Director, Food Science, safefood commented. “This economic assessment enables us to understand the financial impact of the disease on the economy, which will help determine the measures necessary to reduce the number of cases,” Dr Quigley continued.
Professor Charles Normand, Trinity College Dublin said “Although gastroenteritis is a commonly known illness, it has hidden costs and an economic impact which is often not considered. The estimate of €135 million as the burden on the economy is conservative and in reality, the actual economic burden is likely to be even higher.”
“Gastroenteritis is a common, but generally preventable illness of the digestive system. It is usually caused by germs and symptoms include diarrhoea, vomiting, abdominal pain and nausea. The main treatment for gastroenteritis is fluid replacement and attention to hygiene to prevent the spread of the illness to others. However, medical attention should be sought if symptoms persist and for vulnerable groups such as infants. safefood advises that by implementing simple measures like proper hand washing and following the correct food safety rules for the preparation and handling of food, the incidence of gastroenteritis can be reduced,” Dr Quigley continued.
Approximately 10% of people on the island of Ireland report suffering symptoms of gastroenteritis each year. These figures are in line with estimated rates from other similar European Union studies. However, it is thought that gastroenteritis is underreported because in many cases patients can manage the illness themselves without going to their doctor. Between 20% and 40% of gastroenteritis is reported amongst children aged one to four years of age and almost 2% of children on the island of Ireland are hospitalised each year due to gastroenteritis.
A full report on the research is available on the safefood website, http://www.safefood.eu.
Epistem To Provide Preclinical Efficacy Testing Services For Exponential Biotherapies
April 1, 2008
Epistem (LSE: EHP) announced that Exponential Biotherapies, Inc. (EBI) of Virginia, USA, have contracted Epistem to provide their specialised preclinical efficacy testing services for agents likely to protect the gastrointestinal tract against radiation damage. The first compound that Epistem will assess is EBI’s lead candidate drug, EA-230, which is a small peptide immunoregulator, which has shown the potential to treat (minimise) radiation insult and could therefore be administered following a terrorist nuclear attack to reduce the level of intestinal related radiation sickness.
Epistem is a world leader in supplying assays that measure qualitatively and quantitatively the effects of radiation damage on the stem cells in the gut. Epistem’s assays show the effects of agents developed to protect the very sensitive cells of the gut. These assays were chosen by the National Institutes of Health (NIH) Medical Countermeasures against Radiological and Nuclear Threats (MCART) programme and Epistem also works with a number of pharmaceutical companies developing new drugs candidates with the potential to treat mucositis, the erosion of the lining of the mouth and gut, which is a very common side effect of radiation therapy used during cancer treatment. The assays provide quantitative and mechanism of action data to assess the efficacy of novel drug candidates, and help define optimum dose scheduling for progression to the clinical phases in this very important area of oncology supportive care.
Dr Zsolt Harsanyi, the Chairman and Chief Executive of Exponential Biotherapies, Inc. said “Epistem’s well established assays and unrivalled expertise in the field of gastrointestinal epithelial radiation toxicity are extremely valuable to us in confirming the potential of EA-230 as a therapeutic treatment for radionuclear attack”.
Dr Catherine Booth, head of Epistem’s contract research division commented: “We are looking forward to working with EBI to assess the therapeutic potential of EA-230. If it is able to improve gastrointestinal wound healing following radiation exposure it may have widespread applications in biodefence, oncology supportive care (the area for which we first developed and validated these assays), and possibly in other related intestinal wound healing situations, such as inflammatory bowel disease.”
http://www.epistem.co.uk
Ethicon Endo-Surgery Submits Application To FDA For Approval Of The Sedasys™ System The First Computer-Assisted Personalized Sedation System
March 31, 2008
Ethicon Endo-Surgery announced that the company has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the SEDASYS™ System, the first computer-assisted personalized sedation (CAPS) system.
The SEDASYS™ System is intended for use by physician/nurse teams to administer minimal to moderate propofol sedation to patients undergoing screening and diagnostic procedures for colorectal cancer (colonoscopy), and disorders of the upper gastrointestinal tract (EGD). For routine colonoscopy or EDG procedures, physicians prefer the sedative propofol (also known as DIPRIVAN®), which produces rapid onset and quick recovery for patients.i
The PMA submission includes results from a multi-center prospective, randomized, controlled trial of 1,000 patients that compared the safety and effectiveness of the SEDASYS™ System to the current standard of care for sedation in routine endoscopic procedures physician-administered benzodiazepine and opioids. The pivotal clinical trial was conducted from March 2007 to October 2007 at eight locations in the U.S.
About Ethicon Endo Surgery
Ethicon Endo-Surgery, a Johnson & Johnson company, develops and markets advanced medical devices for minimally invasive and open surgical procedures, focusing on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, gynecology and surgical oncology. More information can be found at http://www.ethiconendo.com.
DSL#08-0281 ©Ethicon Endo-Surgery, Inc. 2008
SEDASYS is a trademark of Ethicon Endo-Surgery
DIPRIVAN® is a registered trademark of the AstraZeneca group of companies.
(This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from
Johnson & Johnson’s expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of the Company’s Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.)
i American Gastroenterological Association press release March 8, 2004. “Gastroenterological Societies Reach Consensus on Recommendations for Sedation During Endoscopic Procedures”
