VGX Pharmaceuticals, a biopharmaceutical company that is developing DNA vaccines for cancer and HIV and therapeutics for other diseases, announced today the results of a Phase I single ascending dose (SAD) study that demonstrated that its lead anti-inflammatory compound, VGX-1027, was generally safe and well tolerated in humans. As a result, VGX Pharmaceuticals and VGX International, a Korean affiliate that is jointly developing VGX-1027, have commenced a multiple ascending dose (MAD) study. VGX-1027 is an orally active, small molecule compound that has shown preclinical efficacy against various inflammatory diseases including rheumatoid arthritis (RA) and Type 1 diabetes (T1D).
VGX-1027 is the first of a new class of immune modulators that inhibits the production of several pro-inflammatory cytokines responsible for the damaging effects of inflammatory diseases. Preclinical studies have shown that VGX-1027 is effective in inhibiting these cytokines in cell cultures. They have also demonstrated the product's efficacy in animal models for several diseases including RA, T1D, colitis, and uveitis. Its mechanism of action includes the inhibition of NF-kB and the early transient inhibition of P38 MAP kinase signaling pathways.
Inflammatory diseases including RA, T1D, psoriasis, and colitis represent major medical problems. In the U.S. alone, over 2.7 million people suffer from rheumatoid arthritis. An additional 1 million Americans suffer from type 1 diabetes, which is fatal if untreated.
Several blockbuster therapeutic agents, primarily biologics, dominate the multi-billion dollar RA drug market. However, these agents require parenteral (e.g. such as intravenous) delivery. There are few treatment options available for T1D patients other than insulin, which requires daily injections. VGX-1027 is being investigated as an oral therapeutic.
"VGX looks forward to the results of the MAD studies for VGX-1027. Successful completion of the MAD studies would allow initiation of two Phase II studies: one for RA patients, to be conducted by VGX Pharmaceuticals, and one for T1D patients, to be conducted by VGX International," stated Dr. J. Joseph Kim, President and Chief Executive Officer.
About VGX International
More information about VGX International can be found at vgxi.
About VGX Pharmaceuticals
More information about VGX can be found at vgxp.
VGX Pharmaceuticals
воскресенье, 31 июля 2011 г.
четверг, 28 июля 2011 г.
Knee injury in women soccer players linked to early osteoarthritis
One of the fastest growing team sports in America, particularly on college campuses, is women's soccer. Of the more than 17 million players participating in organized soccer nationwide, 7 million are female. While offering an equal opportunity playing field for student athletes, soccer has one unfortunate gender bias: women are more susceptible to knee injury. One of the most common is tearing of the anterior cruciate ligament (ACL)--the ligament in the center of the knee that provides stability. In Sweden, where soccer is wildly popular and women have a shot at playing in a professional league, the risk of ACL injury is 3 to 4 times higher per game hour for young female players than for their male counterparts.
As too many soccer players know, tearing this pivotal ligament brings immediate pain and swelling, followed by a nagging fear of the knee suddenly giving-way. A recent study, published in the October 2004 issue of Arthritis & Rheumatism (interscience.wiley/journal/arthritis), provides compelling evidence of serious risk of knee osteoarthritis (OA) and potentially crippling long-term consequences of a torn ACL for young female athletes. Conducted by a team of researchers at Lund University Hospital, and supported, in part, by the Swedish Soccer Federation, this study focused on 103 female soccer players, between the ages of 26 and 40, who had each suffered an ACL injury 12 years earlier, when they were between the ages of 14 and 28.
Each woman consented to knee radiographs, as well as answered questionnaires about her knee-related quality of life. More than half of the women were assessed as having OA of the knee, accompanied by persistent pain and functional limitations. What's more, 60 percent of the players had undergone reconstructive surgery of the torn ligament soon after sustaining their injury. Using various analyses, the researchers found that surgical reconstruction had no significant effect on knee pain or disabling symptoms. The surgical techniques used today for this injury might be more effective in preventing OA, but this has not yet been proven in scientific studies.
The study's leading researcher, L. S. Lohmander, M.D., Ph.D., describes the very high prevalence of pronounced OA among these young ACL-injured women as "alarming," with serious implications for their future. "For many of these women, the OA disease process can be expected to progress over time and the need for an osteotomy or knee arthroplasty may arise well before the age of 50 years in many of these subjects," Dr. Lohmander speculates. "Although joint replacement may be an efficient treatment for knee OA, the risk of aseptic implant loosening and revision is more than 3-fold higher in the patients operated on while younger than age 65 years, than if older than 75 years."
The first long-term study of the risk and complications of OA linked to this common and serious knee injury specifically among women soccer players, its findings emphasize the need for improved efforts at prevention and treatment of this torn ligament. "Randomized, controlled trials are needed in which different surgical techniques and rehabilitation protocols are compared directly with the best nonsurgical treatment," Dr. Lohmander concludes.
Article: "High Prevalence of Knee Osteoarthritis, Pain, and Functional Limitations in Female Soccer Players Twelve Years after Anterior Cruciate Ligament Injury," L. S. Lohmander, A. Ostenberg, M. Englund, and H. Roos, Arthritis & Rheumatism, October 2004; 50:10; pp. 3145-3152.
Contact: Amy Molnar
amolnarwiley
John Wiley & Sons, Inc.
As too many soccer players know, tearing this pivotal ligament brings immediate pain and swelling, followed by a nagging fear of the knee suddenly giving-way. A recent study, published in the October 2004 issue of Arthritis & Rheumatism (interscience.wiley/journal/arthritis), provides compelling evidence of serious risk of knee osteoarthritis (OA) and potentially crippling long-term consequences of a torn ACL for young female athletes. Conducted by a team of researchers at Lund University Hospital, and supported, in part, by the Swedish Soccer Federation, this study focused on 103 female soccer players, between the ages of 26 and 40, who had each suffered an ACL injury 12 years earlier, when they were between the ages of 14 and 28.
Each woman consented to knee radiographs, as well as answered questionnaires about her knee-related quality of life. More than half of the women were assessed as having OA of the knee, accompanied by persistent pain and functional limitations. What's more, 60 percent of the players had undergone reconstructive surgery of the torn ligament soon after sustaining their injury. Using various analyses, the researchers found that surgical reconstruction had no significant effect on knee pain or disabling symptoms. The surgical techniques used today for this injury might be more effective in preventing OA, but this has not yet been proven in scientific studies.
The study's leading researcher, L. S. Lohmander, M.D., Ph.D., describes the very high prevalence of pronounced OA among these young ACL-injured women as "alarming," with serious implications for their future. "For many of these women, the OA disease process can be expected to progress over time and the need for an osteotomy or knee arthroplasty may arise well before the age of 50 years in many of these subjects," Dr. Lohmander speculates. "Although joint replacement may be an efficient treatment for knee OA, the risk of aseptic implant loosening and revision is more than 3-fold higher in the patients operated on while younger than age 65 years, than if older than 75 years."
The first long-term study of the risk and complications of OA linked to this common and serious knee injury specifically among women soccer players, its findings emphasize the need for improved efforts at prevention and treatment of this torn ligament. "Randomized, controlled trials are needed in which different surgical techniques and rehabilitation protocols are compared directly with the best nonsurgical treatment," Dr. Lohmander concludes.
Article: "High Prevalence of Knee Osteoarthritis, Pain, and Functional Limitations in Female Soccer Players Twelve Years after Anterior Cruciate Ligament Injury," L. S. Lohmander, A. Ostenberg, M. Englund, and H. Roos, Arthritis & Rheumatism, October 2004; 50:10; pp. 3145-3152.
Contact: Amy Molnar
amolnarwiley
John Wiley & Sons, Inc.
понедельник, 25 июля 2011 г.
Actemra(R), A Humanized Anti-Human IL-6 Receptor Monoclonal Antibody, Filed For Rheumatoid Arthritis In Japan
Chugai Pharmaceutical Co., Ltd. and F. Hoffmann-La Roche Ltd. announced today that the humanized anti-human IL-6 (interleukin-6) receptor monoclonal antibody, Actemra(R) [ generic name: tocilizumab (genetical recombination) ] was filed for the additional indication of rheumatoid arthritis and systemic-onset juvenile idiopathic arthritis, to the Japanese Ministry of Health, Labour and Welfare.
Rheumatoid arthritis is a systemic inflammatory disease in which the cause is unknown. The main symptoms are multiple joint inflammation and progressive joint damage. In Japan, it is estimated that approximately 330 thousand patients are undergoing treatment. Since the majority of patients are females in their 40s and 50s, the disease is causing serious psychological and social problems not only for the patients but also for their families, and a measure to counter the disease is seriously needed. Systemic-onset juvenile idiopathic arthritis is one form of rheumatoid arthritis in children, and it is estimated that there are approximately 1,700 patients in Japan*. The main symptoms are joint involvement, remittent fever and rheumatoid rash. Patients are often forced to spend a long time fighting against the disease, causing various difficulties in school life and continuing into adulthood for employment.
Actemra(R), created by Chugai in collaboration with Osaka University, utilizes genetic recombinant technology to produce monoclonal antibody from mouse anti-IL-6 receptor monoclonal antibody. It works by inhibiting IL-6 biological activity through competitively blocking the binding of IL-6 to its receptor. Chugai filed the application with the two phase III studies conducted in Japan to gather data on efficacy and safety.
Actemra(R) was launched in June 2005 in Japan as a therapy for Castleman's disease**, following approval in April, and is now in preparation for filing the additional indication of rheumatoid arthritis. Outside of Japan, phase III clinical trials in rheumatoid arthritis are going on in 41 countries worldwide including co-development between Chugai and Roche, and Roche is planning to file the application in Europe and in the US in 2007.
* Estimated by using the incidence and prevalence rate derived from a field survey on "Medical Care of Juvenile Idiopathic Arthritis and Improvement of Quality of Life, 2001," combining with the population statistics of 2003 (Ministry of Health, Labour and Welfare).
** The approved indication is "improvement of various symptoms (e.g. general malaise) and laboratory findings (e.g. increased C-reactive protein, fibrinogen, and erythrocyte sedimentation rate, decreased haemoglobin and albumin) associated with Castleman's disease."
chugai-pharm.co.jp
Rheumatoid arthritis is a systemic inflammatory disease in which the cause is unknown. The main symptoms are multiple joint inflammation and progressive joint damage. In Japan, it is estimated that approximately 330 thousand patients are undergoing treatment. Since the majority of patients are females in their 40s and 50s, the disease is causing serious psychological and social problems not only for the patients but also for their families, and a measure to counter the disease is seriously needed. Systemic-onset juvenile idiopathic arthritis is one form of rheumatoid arthritis in children, and it is estimated that there are approximately 1,700 patients in Japan*. The main symptoms are joint involvement, remittent fever and rheumatoid rash. Patients are often forced to spend a long time fighting against the disease, causing various difficulties in school life and continuing into adulthood for employment.
Actemra(R), created by Chugai in collaboration with Osaka University, utilizes genetic recombinant technology to produce monoclonal antibody from mouse anti-IL-6 receptor monoclonal antibody. It works by inhibiting IL-6 biological activity through competitively blocking the binding of IL-6 to its receptor. Chugai filed the application with the two phase III studies conducted in Japan to gather data on efficacy and safety.
Actemra(R) was launched in June 2005 in Japan as a therapy for Castleman's disease**, following approval in April, and is now in preparation for filing the additional indication of rheumatoid arthritis. Outside of Japan, phase III clinical trials in rheumatoid arthritis are going on in 41 countries worldwide including co-development between Chugai and Roche, and Roche is planning to file the application in Europe and in the US in 2007.
* Estimated by using the incidence and prevalence rate derived from a field survey on "Medical Care of Juvenile Idiopathic Arthritis and Improvement of Quality of Life, 2001," combining with the population statistics of 2003 (Ministry of Health, Labour and Welfare).
** The approved indication is "improvement of various symptoms (e.g. general malaise) and laboratory findings (e.g. increased C-reactive protein, fibrinogen, and erythrocyte sedimentation rate, decreased haemoglobin and albumin) associated with Castleman's disease."
chugai-pharm.co.jp
пятница, 22 июля 2011 г.
People With Rheumatoid Arthritis And Lupus Often Skip Their Medications
People with rheumatic diseases don't take their medication on a regular basis, and this leads to poor outcomes in their disease treatment, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta.
Treatment adherence (consistently and correctly following the treatment plan outlined by a health care professional) is a crucial part of successfully managing rheumatic diseases such as rheumatoid arthritis and lupus. Although there are multiple ways health care professionals can monitor if their patients are taking medications as prescribed, electronic monitoring is considered one of the most accurate.
Recently researchers conducted two studies to look at adherence rates among people with RA and lupus to determine how well they follow their prescribed treatment plans. Throughout the course of the studies, researchers followed 110 participants with RA and 74 patients with lupus. The participants with RA were predominately Hispanic (67 percent) females (86 percent) with an average age of 49 years and who had suffered from RA for roughly seven years. The participants with lupus were predominately Black (49 percent) females (89 percent) with an average age of 36 years and who had suffered from lupus for roughly six years.
Both studies were two years long and recruited participants from two publicly-funded hospitals. With the permission of the participants, researchers monitored adherence using MEMS® caps, which are medicine bottle caps with a microchip that records the time and date of bottle openings. Each time a participant refilled a prescription, the researchers downloaded MEMS cap information. They calculated adherence to daily medications (such as disease modifying anti-rheumatic drugs and steroids) by determining the percentage of days with the correct dosage taken, and they calculated the adherence to weekly methotrexate by determining the percentage of doses taken within a week's time. Finally, researchers used MEMS cap data to estimate the percentage of prescribed doses taken by each participant.
"MEMS caps are the closest approach to a 'gold standard' to measure adherence, other than direct observation of the patients taking their medications which in this context and with our study duration is not feasible, and which is also thought to bias patients by increasing compliance when observed directly," explains Christian A. Waimann, MD and Maria F. Marengo, MD who are both at MD Anderson Cancer Center in Houston and who are the lead authors in the studies. Drs. Waimann and Marengo go on to explain that the MEMS caps system assumes that each opening of the bottle truly indicates the taking of the pill in the correct dose as prescribed by the physician.
The researchers noted the types of medications each participant was taking and evaluated each participant for physical pain and inflammation as well as social support and mental health at intervals of three, six, 12, 18 and 24 months.
Ninety-one percent of the participants with RA, and 81 percent of the participants with lupus completed the full course of their study. For those who didn't complete their study, researchers used what data they had to draw their conclusions.
Overall, the adherence rates in both study groups were low. The adherence rate for doses taken on schedule each day and/or week was 59 percent for participants in the RA study taking DMARDS and 64 percent for participants in the lupus study taking prednisone. Overall, only 61 percent of the participants in the RA study correctly took their medications, and the number ranged from 46 to 62 percent in the lupus study.
Additionally, researchers found that only one in five participants in both studies had an average adherence rate of 80 percent or higher. Although a small group, these participants reported better disease activity.
In the RA study, more participants were successful at taking the correct dosage of their medications than were successful at taking their medications on time each day and week (this was especially true with methotrexate). Participants in this study who had worse overall health and better mental health were found to be more adherent to their treatment plans. Finally, researchers noted that participants who lived alone, and those who were separated or were widowed showed less adherence, and those with social support might actually show more adherence.
In the lupus study, depression was associated with lower adherence, and better mental health increased the likelihood that participants would follow treatment plans. Also, researchers noted lower levels of disease activity among those participants who adhered to the correct dosages of their medication.
These results led researchers to conclude that there is poor treatment adherence among people with RA and lupus, at least in the populations studied, and that this lower adherence can affect those people's health in negative ways.
"It is important to ascertain if patients are taking their prescribed therapy as indicated before determining that a treatment is ineffective," explains Drs. Waimann and Marengo. "Physicians need to understand why patients may not take their medications as prescribed, and explain to patients the importance of taking medications as prescribed in order to reach treatment goals."
Source: American College of Rheumatology (ACR)
Treatment adherence (consistently and correctly following the treatment plan outlined by a health care professional) is a crucial part of successfully managing rheumatic diseases such as rheumatoid arthritis and lupus. Although there are multiple ways health care professionals can monitor if their patients are taking medications as prescribed, electronic monitoring is considered one of the most accurate.
Recently researchers conducted two studies to look at adherence rates among people with RA and lupus to determine how well they follow their prescribed treatment plans. Throughout the course of the studies, researchers followed 110 participants with RA and 74 patients with lupus. The participants with RA were predominately Hispanic (67 percent) females (86 percent) with an average age of 49 years and who had suffered from RA for roughly seven years. The participants with lupus were predominately Black (49 percent) females (89 percent) with an average age of 36 years and who had suffered from lupus for roughly six years.
Both studies were two years long and recruited participants from two publicly-funded hospitals. With the permission of the participants, researchers monitored adherence using MEMS® caps, which are medicine bottle caps with a microchip that records the time and date of bottle openings. Each time a participant refilled a prescription, the researchers downloaded MEMS cap information. They calculated adherence to daily medications (such as disease modifying anti-rheumatic drugs and steroids) by determining the percentage of days with the correct dosage taken, and they calculated the adherence to weekly methotrexate by determining the percentage of doses taken within a week's time. Finally, researchers used MEMS cap data to estimate the percentage of prescribed doses taken by each participant.
"MEMS caps are the closest approach to a 'gold standard' to measure adherence, other than direct observation of the patients taking their medications which in this context and with our study duration is not feasible, and which is also thought to bias patients by increasing compliance when observed directly," explains Christian A. Waimann, MD and Maria F. Marengo, MD who are both at MD Anderson Cancer Center in Houston and who are the lead authors in the studies. Drs. Waimann and Marengo go on to explain that the MEMS caps system assumes that each opening of the bottle truly indicates the taking of the pill in the correct dose as prescribed by the physician.
The researchers noted the types of medications each participant was taking and evaluated each participant for physical pain and inflammation as well as social support and mental health at intervals of three, six, 12, 18 and 24 months.
Ninety-one percent of the participants with RA, and 81 percent of the participants with lupus completed the full course of their study. For those who didn't complete their study, researchers used what data they had to draw their conclusions.
Overall, the adherence rates in both study groups were low. The adherence rate for doses taken on schedule each day and/or week was 59 percent for participants in the RA study taking DMARDS and 64 percent for participants in the lupus study taking prednisone. Overall, only 61 percent of the participants in the RA study correctly took their medications, and the number ranged from 46 to 62 percent in the lupus study.
Additionally, researchers found that only one in five participants in both studies had an average adherence rate of 80 percent or higher. Although a small group, these participants reported better disease activity.
In the RA study, more participants were successful at taking the correct dosage of their medications than were successful at taking their medications on time each day and week (this was especially true with methotrexate). Participants in this study who had worse overall health and better mental health were found to be more adherent to their treatment plans. Finally, researchers noted that participants who lived alone, and those who were separated or were widowed showed less adherence, and those with social support might actually show more adherence.
In the lupus study, depression was associated with lower adherence, and better mental health increased the likelihood that participants would follow treatment plans. Also, researchers noted lower levels of disease activity among those participants who adhered to the correct dosages of their medication.
These results led researchers to conclude that there is poor treatment adherence among people with RA and lupus, at least in the populations studied, and that this lower adherence can affect those people's health in negative ways.
"It is important to ascertain if patients are taking their prescribed therapy as indicated before determining that a treatment is ineffective," explains Drs. Waimann and Marengo. "Physicians need to understand why patients may not take their medications as prescribed, and explain to patients the importance of taking medications as prescribed in order to reach treatment goals."
Source: American College of Rheumatology (ACR)
вторник, 19 июля 2011 г.
Bone Medical Developing Potentially First Rheumatoid Arthritis Drug To Treat Both IL6 And TNF, Australia
New data from the Bone Medical Ltd (ASX: BNE) rheumatoid arthritis (RA) programme shows that its lead drug candidate BN006 is capable not only of down-regulating TNF secretion, but also of inhibiting secretion of IL6.
BN006 has been developed as an inhibitor of secretion of TNF, one of the cytokines involved in the inflammatory process that perpetuates RA. It has now been found that BN006 also inhibits IL6 secretion by macrophage type cells in culture with a clear dose-response relationship. This is significant as IL6 is becoming recognised as an important target alongside TNF in for new therapeutics in treatment of RA.
Although no such products have yet arrived on the market, one therapy targeting IL6 (Roche's Actemra) is in Phase III clinical trials. Roche recently reported the generation of positive data from its latest studies.
Professor Peter Brooks, Executive Dean of the Faculty of Health Sciences at the University of Queensland and a renowned world expert in arthritis, said "IL6 is one of the agents which is instrumental in creating the vicious cycle of inflammatory events in RA and could be as important in treatment of RA in the future as TNF is at present."
Both Actemra and the current anti-TNF treatments such as Remicade, Infliximab and Eternacept, are all monoclonal antibodies which need to be injected. Bone's candidate is a small molecule which could be orally available making the treatment much more patient friendly.
Dr Roger New, Chief Scientific Officer of Bone Medical, pointed out "the current monoclonal antibody treatments all target just one single component in the inflammatory process - either TNF or IL6. To have one molecule which affects both of these cytokines together could make it a much more powerful approach to treatment."
About Bone Medical Limited
Bone Medical Limited is an international biopharmaceutical development company positioned to exploit the growing market in the treatment of bone disease particularly in osteoporosis and arthritis. Bone has a portfolio of biopharmaceutical development projects for the treatment of bone disease including,
-- Osteoporosis
- Capsitonin™ oral calcitonin
- CaPTHymone™ oral parathyroid hormone
- bone cell regulators BN005 & BN008
-- Arthritis
- TNF regulators BN006
- joint protection & collagen tolerance BN007
Bone Medical Ltd
View drug information on Actemra; Remicade.
BN006 has been developed as an inhibitor of secretion of TNF, one of the cytokines involved in the inflammatory process that perpetuates RA. It has now been found that BN006 also inhibits IL6 secretion by macrophage type cells in culture with a clear dose-response relationship. This is significant as IL6 is becoming recognised as an important target alongside TNF in for new therapeutics in treatment of RA.
Although no such products have yet arrived on the market, one therapy targeting IL6 (Roche's Actemra) is in Phase III clinical trials. Roche recently reported the generation of positive data from its latest studies.
Professor Peter Brooks, Executive Dean of the Faculty of Health Sciences at the University of Queensland and a renowned world expert in arthritis, said "IL6 is one of the agents which is instrumental in creating the vicious cycle of inflammatory events in RA and could be as important in treatment of RA in the future as TNF is at present."
Both Actemra and the current anti-TNF treatments such as Remicade, Infliximab and Eternacept, are all monoclonal antibodies which need to be injected. Bone's candidate is a small molecule which could be orally available making the treatment much more patient friendly.
Dr Roger New, Chief Scientific Officer of Bone Medical, pointed out "the current monoclonal antibody treatments all target just one single component in the inflammatory process - either TNF or IL6. To have one molecule which affects both of these cytokines together could make it a much more powerful approach to treatment."
About Bone Medical Limited
Bone Medical Limited is an international biopharmaceutical development company positioned to exploit the growing market in the treatment of bone disease particularly in osteoporosis and arthritis. Bone has a portfolio of biopharmaceutical development projects for the treatment of bone disease including,
-- Osteoporosis
- Capsitonin™ oral calcitonin
- CaPTHymone™ oral parathyroid hormone
- bone cell regulators BN005 & BN008
-- Arthritis
- TNF regulators BN006
- joint protection & collagen tolerance BN007
Bone Medical Ltd
View drug information on Actemra; Remicade.
суббота, 16 июля 2011 г.
Chronic Hepatitis C Infection In A Patient With Bone Marrow Hypoplasia
HCV is acquired by intravenous drug abuse, sexually or via blood transfusion (rare nowadays due to the effective screening of blood products before transfusion). HCV is known to cause chronic infection in 80% - 90% of the patients becoming infected. Patients present with varying degrees of altered liver function ranging from mild cirrhosis to necrosis (liver cell death). Several factors namely male gender, older age at infection, excessive alcohol consumption and secondary hemochromatosis (excessive accumulation of iron in liver cells secondary to blood transfusion) enhance the fibrotic process. Furthermore, progression to cirrhosis is more rapid in patients with compromised immunity, hepatic steatosis, obesity and diabetes. Interestingly, viral factors such as viral load and genotype (6 types for HCV) do not influence the fibrosis progression Presently, evidence is accumulating on the role of HCV in association with other diseases, such as cryoglobulinemia, rheumatoid arthritis, thyroiditis to mention a few.
An article published in the World Journal of Gastroenterology addresses this report. The research team led by Prof. Kavitha Chandrikakumari from Centre Hospitalier Universitaire de Liege presentd a case of chronic HCV infection which was acquired by blood transfusion during childhood for the patient's anaemia secondary to bone marrow hypoplasia. However, the despite long duration of illness and having high serum ferritin (biological marker of iron content in the body) and cryoglobulins in her blood, the liver function remained normal through out the follow up. Patient had arthralgias and paraesthesia. Nonetheless arthritis or neuropathy was not demonstrated objectively. The patient had a normal staging on fibrotest and fibroscan (painless and non-invasive alternative to liver biopsy for assessing liver fibrosis). Chronic HCV induced translocation of immunoglobulin genes between chromosomes 14 and 18 was also negative in the patient. This translocation is known to induce B-lymphocyte proliferation and which then may progress to lymphoma (malignancy of lymphoid cells).
Reports from earlier studies in children under immunosuppression (induced by chemotherapeutic agents for the treatment of leukaemia) acquiring HCV through blood transfusion stated that these patients might not develop an immune response that could cause chronic injury. Although, this postulate was abandoned due to several conflicting reports, it is supportd in view of the normal liver function and absent fibrosis in the patient with bone marrow hypoplasia.
Chronic HCV infection might present with serious extra-hepatic manifestation rather than as hepatic disease itself. Patients immunological status might influence the extend of liver injury. HCV could be responsible for the rheumatology problems like arthritis, fibromyalgia and vasculitis.
Reference: Bethlen S, Chandrikakumari K, de Leval L, Giot JB, Mukeba D, Leonard P, Frippiat F, Meuris C, Delwaide J, Moutschen M. Chronic hepatitis C infection in a patient with bone marrow hypoplasia. World J Gastroenterol 2008; 14(26): 4238-4240
wjgnet/1007-9327/14/4238.asp
Correspondence to: Kavitha Chandrikakumari, Dr, Department of Infectious Diseases and Internal Medicine, Centre Hospitalier Universitaire de Liege, Service des Maladies Infectieuses et Medecine Interne, C.H.U, B35, Domaine du Sart-Tilman 4000, Belgium.
About World Journal of Gastroenterology
World Journal of Gastroenterology (WJG), a leading international journal in gastroenterology and hepatology, has established a reputation for publishing first class research on esophageal cancer, gastric cancer, liver cancer, viral hepatitis, colorectal cancer, and H pylori infection. It provides a forum for both clinicians and scientists. WJG has been indexed and abstracted in Current Contents/Clinical Medicine, Science Citation Index Expanded (also known as SciSearch) and Journal Citation Reports/Science Edition, Index Medicus, MEDLINE and PubMed, Chemical Abstracts, EMBASE/Excerpta Medica, Abstracts Journals, Nature Clinical Practice Gastroenterology and Hepatology, CAB Abstracts and Global Health. ISI JCR 2003-2000 IF: 3.318, 2.532, 1.445 and 0.993. WJG is a weekly journal published by WJG Press. The publication dates are the 7th, 14th, 21st, and 28th of every month. The WJG is supported by The National Natural Science Foundation of China, No. 30224801 and No. 30424812, and was founded with the title China National Journal of New Gastroenterology on October 1, 1995, and renamed WJG on January 25, 1998.
About The WJG Press
The WJG Press mainly publishes World Journal of Gastroenterology.
Source: Lai-Fu Li
World Journal of Gastroenterology
An article published in the World Journal of Gastroenterology addresses this report. The research team led by Prof. Kavitha Chandrikakumari from Centre Hospitalier Universitaire de Liege presentd a case of chronic HCV infection which was acquired by blood transfusion during childhood for the patient's anaemia secondary to bone marrow hypoplasia. However, the despite long duration of illness and having high serum ferritin (biological marker of iron content in the body) and cryoglobulins in her blood, the liver function remained normal through out the follow up. Patient had arthralgias and paraesthesia. Nonetheless arthritis or neuropathy was not demonstrated objectively. The patient had a normal staging on fibrotest and fibroscan (painless and non-invasive alternative to liver biopsy for assessing liver fibrosis). Chronic HCV induced translocation of immunoglobulin genes between chromosomes 14 and 18 was also negative in the patient. This translocation is known to induce B-lymphocyte proliferation and which then may progress to lymphoma (malignancy of lymphoid cells).
Reports from earlier studies in children under immunosuppression (induced by chemotherapeutic agents for the treatment of leukaemia) acquiring HCV through blood transfusion stated that these patients might not develop an immune response that could cause chronic injury. Although, this postulate was abandoned due to several conflicting reports, it is supportd in view of the normal liver function and absent fibrosis in the patient with bone marrow hypoplasia.
Chronic HCV infection might present with serious extra-hepatic manifestation rather than as hepatic disease itself. Patients immunological status might influence the extend of liver injury. HCV could be responsible for the rheumatology problems like arthritis, fibromyalgia and vasculitis.
Reference: Bethlen S, Chandrikakumari K, de Leval L, Giot JB, Mukeba D, Leonard P, Frippiat F, Meuris C, Delwaide J, Moutschen M. Chronic hepatitis C infection in a patient with bone marrow hypoplasia. World J Gastroenterol 2008; 14(26): 4238-4240
wjgnet/1007-9327/14/4238.asp
Correspondence to: Kavitha Chandrikakumari, Dr, Department of Infectious Diseases and Internal Medicine, Centre Hospitalier Universitaire de Liege, Service des Maladies Infectieuses et Medecine Interne, C.H.U, B35, Domaine du Sart-Tilman 4000, Belgium.
About World Journal of Gastroenterology
World Journal of Gastroenterology (WJG), a leading international journal in gastroenterology and hepatology, has established a reputation for publishing first class research on esophageal cancer, gastric cancer, liver cancer, viral hepatitis, colorectal cancer, and H pylori infection. It provides a forum for both clinicians and scientists. WJG has been indexed and abstracted in Current Contents/Clinical Medicine, Science Citation Index Expanded (also known as SciSearch) and Journal Citation Reports/Science Edition, Index Medicus, MEDLINE and PubMed, Chemical Abstracts, EMBASE/Excerpta Medica, Abstracts Journals, Nature Clinical Practice Gastroenterology and Hepatology, CAB Abstracts and Global Health. ISI JCR 2003-2000 IF: 3.318, 2.532, 1.445 and 0.993. WJG is a weekly journal published by WJG Press. The publication dates are the 7th, 14th, 21st, and 28th of every month. The WJG is supported by The National Natural Science Foundation of China, No. 30224801 and No. 30424812, and was founded with the title China National Journal of New Gastroenterology on October 1, 1995, and renamed WJG on January 25, 1998.
About The WJG Press
The WJG Press mainly publishes World Journal of Gastroenterology.
Source: Lai-Fu Li
World Journal of Gastroenterology
среда, 13 июля 2011 г.
Merck Responds To Journal Of The American Medical Association Articles
Merck & Co., Inc. today said it is committed to
high standards of scientific integrity and ethics, and believes that many of the comments in a
Journal of the American Medical Association (JAMA) news release and in the April 16 issue of
JAMA1 related to VIOXX are false, misleading or lack context. The Company said it was not
given an opportunity to respond prior to publication. The articles are based on analyses of
documents conducted by consultants hired by trial lawyers as part of their work in the VIOXX
product liability litigation, and make allegations similar to those previously advanced by these
consultants and related attorneys at trial.
"We are disappointed that such false and misleading statements about Merck from trial
lawyers have made their way into a medical journal," said Dr. Peter S. Kim, president of Merck
Research Laboratories. The Company said a full, unbiased evaluation of the Merck documents
shows significant errors in the conclusions put forward by the authors of the JAMA articles.
Merck said it believes that scientific discussion and debate can only be achieved when
accurate, factual information is presented, and that is the foundation for its interactions with
regulatory agencies and the scientific community. "The allegation that Merck misrepresented
mortality data from our Alzheimer's studies is just plain wrong," said Dr. Kim. In fact, the
Company said it provided complete mortality data from the Alzheimer's studies to the U.S. Food
and Drug Administration, as well as the mortality data from its other studies.
Responding to the assertions about scientific authorship in the JAMA articles Dr. Kim
said, "We have explicit policies governing the authorship of papers related to Merck's medicines
and vaccines, and we take those policies very seriously. The outside authors of the papers
about Merck's clinical trials referenced in the JAMA article were intimately involved in the
studies."
The Company said its policies have evolved and become more specific over time, as
have the policies of others in the health care field, including those of medical journals. Merck's
publication policies are available on merck.
"Merck remains committed to bringing forward medicines and vaccines that save and
improve people's lives," said Dr. Kim. "And we look forward to continuing to engage in
constructive, transparent discussions with the broader scientific and medical community about
our innovations."
Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the
Private Securities Litigation Reform Act of 1995. These statements are based on
management's current expectations and involve risks and uncertainties, which may cause
results to differ materially from those set forth in the statements. The forward-looking
statements may include statements regarding product development, product potential or
financial performance. No forward-looking statement can be guaranteed and actual results may
differ materially from those projected. Merck undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information, future events, or otherwise.
Forward-looking statements in this press release should be evaluated together with the many
uncertainties that affect Merck's business, particularly those mentioned in the risk factors and
cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and
in any risk factors or cautionary statements contained in the Company's periodic reports on
Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.
1 Catherine D. DeAngelis; Phil B. Fontanarosa. Editorial: Impugning the Integrity of Medical
Science: The Adverse Effects of Industry Influence. JAMA. 2008;299(15):1833-1835.
Bruce M. Psaty; Richard A. Kronmal. Reporting Mortality Findings in Trials of Rofecoxib for
Alzheimer Disease or Cognitive Impairment: A Case Study Based on Documents From
Rofecoxib Litigation JAMA. 2008;299(15):1813-1817.
Joseph S. Ross; Kevin P. Hill; David S. Egilman; Harlan M. Krumholz. Guest Authorship and
Ghostwriting in Publications Related to Rofecoxib: A Case Study of Industry Documents From
Rofecoxib Litigation. JAMA. 2008;299(15):1800-1812.
View drug information on Vioxx.
high standards of scientific integrity and ethics, and believes that many of the comments in a
Journal of the American Medical Association (JAMA) news release and in the April 16 issue of
JAMA1 related to VIOXX are false, misleading or lack context. The Company said it was not
given an opportunity to respond prior to publication. The articles are based on analyses of
documents conducted by consultants hired by trial lawyers as part of their work in the VIOXX
product liability litigation, and make allegations similar to those previously advanced by these
consultants and related attorneys at trial.
"We are disappointed that such false and misleading statements about Merck from trial
lawyers have made their way into a medical journal," said Dr. Peter S. Kim, president of Merck
Research Laboratories. The Company said a full, unbiased evaluation of the Merck documents
shows significant errors in the conclusions put forward by the authors of the JAMA articles.
Merck said it believes that scientific discussion and debate can only be achieved when
accurate, factual information is presented, and that is the foundation for its interactions with
regulatory agencies and the scientific community. "The allegation that Merck misrepresented
mortality data from our Alzheimer's studies is just plain wrong," said Dr. Kim. In fact, the
Company said it provided complete mortality data from the Alzheimer's studies to the U.S. Food
and Drug Administration, as well as the mortality data from its other studies.
Responding to the assertions about scientific authorship in the JAMA articles Dr. Kim
said, "We have explicit policies governing the authorship of papers related to Merck's medicines
and vaccines, and we take those policies very seriously. The outside authors of the papers
about Merck's clinical trials referenced in the JAMA article were intimately involved in the
studies."
The Company said its policies have evolved and become more specific over time, as
have the policies of others in the health care field, including those of medical journals. Merck's
publication policies are available on merck.
"Merck remains committed to bringing forward medicines and vaccines that save and
improve people's lives," said Dr. Kim. "And we look forward to continuing to engage in
constructive, transparent discussions with the broader scientific and medical community about
our innovations."
Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the
Private Securities Litigation Reform Act of 1995. These statements are based on
management's current expectations and involve risks and uncertainties, which may cause
results to differ materially from those set forth in the statements. The forward-looking
statements may include statements regarding product development, product potential or
financial performance. No forward-looking statement can be guaranteed and actual results may
differ materially from those projected. Merck undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information, future events, or otherwise.
Forward-looking statements in this press release should be evaluated together with the many
uncertainties that affect Merck's business, particularly those mentioned in the risk factors and
cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and
in any risk factors or cautionary statements contained in the Company's periodic reports on
Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.
1 Catherine D. DeAngelis; Phil B. Fontanarosa. Editorial: Impugning the Integrity of Medical
Science: The Adverse Effects of Industry Influence. JAMA. 2008;299(15):1833-1835.
Bruce M. Psaty; Richard A. Kronmal. Reporting Mortality Findings in Trials of Rofecoxib for
Alzheimer Disease or Cognitive Impairment: A Case Study Based on Documents From
Rofecoxib Litigation JAMA. 2008;299(15):1813-1817.
Joseph S. Ross; Kevin P. Hill; David S. Egilman; Harlan M. Krumholz. Guest Authorship and
Ghostwriting in Publications Related to Rofecoxib: A Case Study of Industry Documents From
Rofecoxib Litigation. JAMA. 2008;299(15):1800-1812.
View drug information on Vioxx.
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