OmniComm Systems, Inc. (OTC Bulletin Board: OMCM), a leader in integrated electronic data capture (EDC) solutions for clinical trials, announced that it has been selected by a leading European based Contract Research Organization (CRO) to provide eClinical solutions for a pivotal Phase III study in rheumatoid arthritis (RA). Phase III clinical studies serve to establish the safety and efficacy of investigational new drugs, in large patient populations, and are the last step prior to review for approval by the regulatory authorities, such as FDA and the EMEA . This particular RA study is expected to last 48 months and enroll close to 300 patients in 20 sites located in Europe.
"We are very excited to be working again with this leading CRO on this pivotal study," commented Stephen Johnson, OmniComm's COO. "We appreciate their ongoing trust in us and will continue to deliver superior products and services to them. We are also very excited about our continued expansion into the European marketplace. We have recently opened up another office in the United Kingdom, OmniComm Ltd., which will allow us to broaden our service and support offering even further." OmniComm Systems also has international offices in Bonn, Germany and Tula, Russia.
About OmniComm
OmniComm Systems, Inc. provides customer-driven Internet solutions to pharmaceutical, biotechnology, research and medical device organizations that conduct life changing clinical trial research. OmniComm's growing base of satisfied customers is a direct result of the company's commitment to deliver products and services that ensure ease of use, faster study build, ease of integration and better performance. OmniComm's client intuitive pricing model allows companies that range from small, to mid-size to large scale institutions to safely and efficiently capitalize on their clinical research investments. OmniComm Systems, Inc has U.S. headquarters in Fort Lauderdale, FL and European headquarters in Bonn, Germany, with satellite offices in New Jersey, the United Kingdom, and Russia as well as sales offices throughout the U.S. and Europe.
Safe Harbor Disclaimer
Statements made by OmniComm included in this release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve a number of risks and uncertainties such as the Company's ability to obtain new contracts and accurately estimate net revenues due to uncertain regulatory guidance, variability in size, scope and duration of projects, and internal issues at the sponsoring client, integration of acquisitions, competitive factors, technological development, and market demand. As a result, actual results may differ materially from any financial outlooks stated herein. Further information on potential factors that could affect the Company's financial results can be found in the Company's Reports on Form 10-K and 10-Q filed with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Source: OmniComm Systems, Inc
суббота, 30 июля 2011 г.
среда, 27 июля 2011 г.
Multiple Regulatory Cell Types Can't Keep Self-destructive Immune Cells Under Control
Multiple sclerosis (MS) is an autoimmune disease that occurs when cells of the immune system attack nerves in the brain. Although it is not clear exactly why this self destruction is able to occur, it has been shown that other immune cells that normally keep the destructive ones in check (known as regulatory T cells) are impaired in individuals with MS. Previous studies have focused on a regulatory T cell subset known as the CD4+CD25high regulatory T cell subset, but in a study which appeared online on November 9, in advance of publication in the December print issue of the Journal of Clinical Investigation, researchers from Harvard University, now show that IL-10 producing regulatory T cells (Tr1 cells) are also impaired in individuals with MS.
David Hafler and colleagues showed that T cells from patients with MS produced substantially less IL-10 when stimulated ex vivo with antibodies specific for CD3 and CD46 than T cells from healthy individuals. This inability to induce a Tr1 cell phenotype was associated with altered expression of CD46 cytoplasmic isoforms upon activation. This study shows that a second regulatory T cell population (the Tr1 cells) is impaired in individuals with MS and the authors speculate that, as for the CD4+CD25high regulatory T cell subset, this defect is likely to be observed in patients with other autoimmune diseases, such as rheumatoid arthritis.
TITLE: Alterations in CD46-mediated Tr1 regulatory T cells in patients with multiple sclerosis
AUTHOR CONTACT:
David A. Hafler
Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Anne L. Astier
Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
JCI table of contents: November 9, 2006
Contact: Karen Honey
Journal of Clinical Investigation
David Hafler and colleagues showed that T cells from patients with MS produced substantially less IL-10 when stimulated ex vivo with antibodies specific for CD3 and CD46 than T cells from healthy individuals. This inability to induce a Tr1 cell phenotype was associated with altered expression of CD46 cytoplasmic isoforms upon activation. This study shows that a second regulatory T cell population (the Tr1 cells) is impaired in individuals with MS and the authors speculate that, as for the CD4+CD25high regulatory T cell subset, this defect is likely to be observed in patients with other autoimmune diseases, such as rheumatoid arthritis.
TITLE: Alterations in CD46-mediated Tr1 regulatory T cells in patients with multiple sclerosis
AUTHOR CONTACT:
David A. Hafler
Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Anne L. Astier
Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
JCI table of contents: November 9, 2006
Contact: Karen Honey
Journal of Clinical Investigation
воскресенье, 24 июля 2011 г.
Researchers Say Hip Replacement Is Cost-Effective With No Age Limit For Benefits To Patients
Seniors with osteoarthritis who undergo total hip replacement are twice as likely as those who do not to show improvements in physical functioning and increased ability to care for themselves, according to researchers at Duke University Medical Center.
The study, which is the largest of its kind conducted to date, found that there is no age limit on the benefits of hip replacement for patients.
Researchers found that total hip replacements provide a cost savings to the health care system because reimbursement for the procedure (averaging $4,000 - $6,000) proves less costly than the long-term cost of health care for the disabled.
In addition to improved quality of life, health economists estimate savings associated with a year of a disability-free life at approximately $50,000, including all related health-care costs incurred by disabled patients such as hospital stays, nursing homes and home health care.
"We found that total hip arthroplasty improves everyday life for patients and is as beneficial to people in their 80s or 90s as it is for someone in their 60s," said Linda George, Ph.D., professor of Sociology and associate director of the Duke Center for the Study of Aging.
"While the number of surgeries conducted in the U.S. has increased dramatically over the last decade, fewer than 25 percent of patients who could benefit from the procedure elect to receive it."
Osteoarthritis of the hip is a progressive type of arthritis closely associated with aging and obesity. It affects about 10 million Americans, causing pain, decreased mobility and increased risk of falls and fractures.
Generally, non-surgical treatment is first recommended to reduce joint pain and inflammation and improve joint function. Hip replacements are performed when less invasive forms of treatment - medications and physical therapy - have failed.
"Osteoarthritis of the hip has a devastating impact on a patient's quality and length of life. Our study aimed to understand how total hip replacements affect tasks people do in their everyday lives, such as bathing, dressing, walking a few blocks, shopping and preparing meals," George said.
Patients who were disabled at the time of surgery had transitioned out of disability within one year of the procedure. Total hip replacement is an invasive treatment with a long rehabilitation period. According to Dr. George, this may help explain why physicians are less likely to present surgery as an option to those patients 85 years of age and older, and why there may be some reluctance among patients to choose the procedure.
"Physicians are less likely to present this option to the very old," George said, "but they should feel confident in recommending this procedure to those who are eligible for it."
"We know that hip replacements are relatively safe and reports have shown a very high rate of patient satisfaction due to reduced pain and increased range of motion," she added.
The study, published in the June issue of the Journal of the American Geriatrics Society, examined data from the Medicare Current Beneficiary Survey - a randomly selected group of Medicare beneficiaries who represent 96 percent of the U.S. population aged 65 and older - from 1992 to 2003. Health data from 131 patients who received total hip replacement were compared to data from 257 patients who also had osteoarthritis of the hip but did not receive hip replacement surgery. Patients were interviewed three times each year for four years.
The research was supported by a grant from The Institute for Health Technology Studies (InHealth). The co-authors of this study are Frank Sloan, Ph.D. and David Ruiz, Jr., BS.
Source: Robyn Stein
InHealth: The Institute for Health Technology Studies
The study, which is the largest of its kind conducted to date, found that there is no age limit on the benefits of hip replacement for patients.
Researchers found that total hip replacements provide a cost savings to the health care system because reimbursement for the procedure (averaging $4,000 - $6,000) proves less costly than the long-term cost of health care for the disabled.
In addition to improved quality of life, health economists estimate savings associated with a year of a disability-free life at approximately $50,000, including all related health-care costs incurred by disabled patients such as hospital stays, nursing homes and home health care.
"We found that total hip arthroplasty improves everyday life for patients and is as beneficial to people in their 80s or 90s as it is for someone in their 60s," said Linda George, Ph.D., professor of Sociology and associate director of the Duke Center for the Study of Aging.
"While the number of surgeries conducted in the U.S. has increased dramatically over the last decade, fewer than 25 percent of patients who could benefit from the procedure elect to receive it."
Osteoarthritis of the hip is a progressive type of arthritis closely associated with aging and obesity. It affects about 10 million Americans, causing pain, decreased mobility and increased risk of falls and fractures.
Generally, non-surgical treatment is first recommended to reduce joint pain and inflammation and improve joint function. Hip replacements are performed when less invasive forms of treatment - medications and physical therapy - have failed.
"Osteoarthritis of the hip has a devastating impact on a patient's quality and length of life. Our study aimed to understand how total hip replacements affect tasks people do in their everyday lives, such as bathing, dressing, walking a few blocks, shopping and preparing meals," George said.
Patients who were disabled at the time of surgery had transitioned out of disability within one year of the procedure. Total hip replacement is an invasive treatment with a long rehabilitation period. According to Dr. George, this may help explain why physicians are less likely to present surgery as an option to those patients 85 years of age and older, and why there may be some reluctance among patients to choose the procedure.
"Physicians are less likely to present this option to the very old," George said, "but they should feel confident in recommending this procedure to those who are eligible for it."
"We know that hip replacements are relatively safe and reports have shown a very high rate of patient satisfaction due to reduced pain and increased range of motion," she added.
The study, published in the June issue of the Journal of the American Geriatrics Society, examined data from the Medicare Current Beneficiary Survey - a randomly selected group of Medicare beneficiaries who represent 96 percent of the U.S. population aged 65 and older - from 1992 to 2003. Health data from 131 patients who received total hip replacement were compared to data from 257 patients who also had osteoarthritis of the hip but did not receive hip replacement surgery. Patients were interviewed three times each year for four years.
The research was supported by a grant from The Institute for Health Technology Studies (InHealth). The co-authors of this study are Frank Sloan, Ph.D. and David Ruiz, Jr., BS.
Source: Robyn Stein
InHealth: The Institute for Health Technology Studies
четверг, 21 июля 2011 г.
Rituximab Combined With A TNF Inhibitor And Methotrexate Shows No Safety Signal In RA Treatment
A recent trial of rituximab in combination with a tumor necrosis factor (TNF) inhibitor and methotrexate (MTX) in patients with active rheumatoid arthritis (RA) found the safety profile to be consistent with other RA trials with TNF inhibitors. While the trial reported no new safety risks, clear evidence of an efficacy advantage in RA patients receiving the combination therapy was not observed in this study sample. Results of the trial are published in the March issue of Arthritis & Rheumatism, a peer-reviewed journal of the American College of Rheumatology.
The National Arthritis Data Workgroup estimates that 1.3 million U.S. adults have RA which is characterized by systemic joint inflammation that often leads to joint damage, functional impairment and significant disability. While MTX is successfully used to treat many RA patients, the severity of the disease in some patient populations requires the use of additional disease-modifying antirheumatic drugs (DMARDs). A specific group of biologic DMARDs, called tumor necrosis factor (TNF) inhibitors and includes such therapies as etanercept and adalimumab, block the immune system response, and have been shown to be safe and effective in clinical trials.
Prior studies, however, have found that up to 40% of RA patients exhibit an inadequate response, intolerance, or inadequate slowing of the rate of joint damage with biologic therapies, and require additional treatment options. "Our objective was to assess the safety of the biologic DMARD, rituximab, in combination with a TNF inhibitor and MTX in patients with active RA," said lead study author Maria Greenwald, M.D., from Desert Medical Advances in California. This was a small exploratory study to evaluate safety with this combination due to the prolonged effect of rituximab, and the fact that RA patients may switch to an alternate biologic such as a TNF inhibitor before the effects of rituximab may have resolved.
The controlled trial enrolled 51 patients with active RA (more than 5 swollen and tender joints) who were receiving a stable dose of MTX (10-25 mg/week) and either etanercept or adalimumab for more than 12 weeks. Participants were randomized 2:1 to receive one course of rituximab or placebo (two 500-mg doses intravenously or placebo). The primary study end point was the proportion of patients developing more than one serious infection through week 24.
Researchers reported one serious infection (pneumonia) in the rituximab group compared with none in the placebo group (TNF only) at week 24. Nonserious infections were reported in 18 patients (55%) and 11 patients (61%) in the rituximab and placebo groups, respectively. Infections requiring intravenous antibiotics occurred in three patients administered rituximab and in none of the patients receiving placebo. No life-threatening, opportunistic, fungal or tuberculosis infections were observed. Dr. Greenwald noted, "The incidence of serious infections was low."
During the 24-week trial period the overall proportion of patients in the placebo and rituximab cohorts who experience an adverse event (AE) was 83% and 94%, respectively. The most common AEs reported in the rituximab group included nausea, pruritus (itching sensation), and fatigue. In the placebo group the common AEs included upper respiratory tract infections, sinusitis, headache, and exacerbation of RA. Two serious adverse effects (SAEs) pneumonia and coronary artery occlusion were observed in two rituximab-treated patients; no SAEs were reported in patients receiving placebo.
The research team also determined the percentage of patients achieving an ACR201 improvement response at week 24 was 30% in the rituximab group compared with 17% in the placebo group. ACR50 responses achieved in the rituximab and placebo groups were 12% and 6%, respectively. "The safety of rituximab in combination with a TNF inhibitor and MTX was consistent with other RA trials of rituximab and MTX that did not include TNF inhibitors," concluded Dr. Greenwald. The authors noted that a larger study examining efficacy of treatment of RA using multiple biologic DMARDs is underway.
1 The American College of Rheumatology provides a set of criteria to use in clinical trials for rheumatoid arthritis that report the percentage of study participants who achieve improvement in tender or swollen joint counts. Therefore, the ACR20 indicates a 20 percent in tender or swollen joint counts was achieved; ACR50 represents a 50 percent improvement in tender or swollen joint counts.
Sources: Wiley - Blackwell, AlphaGalileo Foundation.
The National Arthritis Data Workgroup estimates that 1.3 million U.S. adults have RA which is characterized by systemic joint inflammation that often leads to joint damage, functional impairment and significant disability. While MTX is successfully used to treat many RA patients, the severity of the disease in some patient populations requires the use of additional disease-modifying antirheumatic drugs (DMARDs). A specific group of biologic DMARDs, called tumor necrosis factor (TNF) inhibitors and includes such therapies as etanercept and adalimumab, block the immune system response, and have been shown to be safe and effective in clinical trials.
Prior studies, however, have found that up to 40% of RA patients exhibit an inadequate response, intolerance, or inadequate slowing of the rate of joint damage with biologic therapies, and require additional treatment options. "Our objective was to assess the safety of the biologic DMARD, rituximab, in combination with a TNF inhibitor and MTX in patients with active RA," said lead study author Maria Greenwald, M.D., from Desert Medical Advances in California. This was a small exploratory study to evaluate safety with this combination due to the prolonged effect of rituximab, and the fact that RA patients may switch to an alternate biologic such as a TNF inhibitor before the effects of rituximab may have resolved.
The controlled trial enrolled 51 patients with active RA (more than 5 swollen and tender joints) who were receiving a stable dose of MTX (10-25 mg/week) and either etanercept or adalimumab for more than 12 weeks. Participants were randomized 2:1 to receive one course of rituximab or placebo (two 500-mg doses intravenously or placebo). The primary study end point was the proportion of patients developing more than one serious infection through week 24.
Researchers reported one serious infection (pneumonia) in the rituximab group compared with none in the placebo group (TNF only) at week 24. Nonserious infections were reported in 18 patients (55%) and 11 patients (61%) in the rituximab and placebo groups, respectively. Infections requiring intravenous antibiotics occurred in three patients administered rituximab and in none of the patients receiving placebo. No life-threatening, opportunistic, fungal or tuberculosis infections were observed. Dr. Greenwald noted, "The incidence of serious infections was low."
During the 24-week trial period the overall proportion of patients in the placebo and rituximab cohorts who experience an adverse event (AE) was 83% and 94%, respectively. The most common AEs reported in the rituximab group included nausea, pruritus (itching sensation), and fatigue. In the placebo group the common AEs included upper respiratory tract infections, sinusitis, headache, and exacerbation of RA. Two serious adverse effects (SAEs) pneumonia and coronary artery occlusion were observed in two rituximab-treated patients; no SAEs were reported in patients receiving placebo.
The research team also determined the percentage of patients achieving an ACR201 improvement response at week 24 was 30% in the rituximab group compared with 17% in the placebo group. ACR50 responses achieved in the rituximab and placebo groups were 12% and 6%, respectively. "The safety of rituximab in combination with a TNF inhibitor and MTX was consistent with other RA trials of rituximab and MTX that did not include TNF inhibitors," concluded Dr. Greenwald. The authors noted that a larger study examining efficacy of treatment of RA using multiple biologic DMARDs is underway.
1 The American College of Rheumatology provides a set of criteria to use in clinical trials for rheumatoid arthritis that report the percentage of study participants who achieve improvement in tender or swollen joint counts. Therefore, the ACR20 indicates a 20 percent in tender or swollen joint counts was achieved; ACR50 represents a 50 percent improvement in tender or swollen joint counts.
Sources: Wiley - Blackwell, AlphaGalileo Foundation.
понедельник, 18 июля 2011 г.
Quigley Pharma Compound QR-443 Effective In Preventing Cachexia (Muscle Wasting)
Quigley Pharma, a
wholly-owned subsidiary of The Quigley Corporation (Nasdaq: QGLY),
announced today that it has obtained positive results for its QR-443
compound for the treatment of Cachexia, a debilitating and life threatening
muscle wasting condition. The results of an animal study found a 75%
efficacy rate in the treatment of mice with this condition.
The results of the study clearly indicated that 75% of the tested mice
injected with 5 mg of QR-433 were protected from Cachexia and did not
exhibit any significant weight loss compared to untreated control animals
which exhibited a 15-25 percent weight loss at the end of the experiment.
Cachexia, an extremely debilitating and life threatening condition, is
a loss of weight, muscle wasting, fatigue, weakness and decrease of
appetite which occurs in wasting diseases such as cancer, AIDs, chronic
renal failure, advanced aging and rheumatoid arthritis. Increases in the
blood levels of the cytokines IL-6, TNF-a and INF-y have been thought to
play a major role in Cachexia.
QR-443 is an all natural broad spectrum anti-inflammatory compound that
is being concurrently studied as a drug for Rheumatoid Arthritis (under the
designation QR-440) in humans and dogs. QR-443 has been shown in previous
pre-clinical studies to inhibit the production of TNFa and IFN gamma, and
reducing other inflammatory cytokines associated with Cachexia. This is a
significant and extremely positive development as systemic inflammation has
also been associated with poor prognosis in patients with cancer.
The QR-443 study was undertaken by Professor Yacov Ron of the
Department of Molecular Genetics and Microbiology at the Robert Wood
Johnson Medical School, University of Medicine and Dentistry of New Jersey.
Dr. Richard Rosenbloom, Chief Operating Officer, Quigley Pharma,
stated, "The significant findings of the study are sufficient to continue
to the next stage of the drug development process. We plan to investigate
the possibility of Fast Track Status with the FDA. Alternatively, due to
the importance of these findings, the Company may consider launching this
product as a neutraceutical."
The Quigley Corporation makes no representation that the US Food and
Drug Administration or any other regulatory agency will grant an
Investigational New Drug ("IND") or take any other action to allow its
formulations to be studied or/and for any Investigational New Drug to be
marketed. Furthermore, no claim is made that potential medicine discussed
herein is safe, effective, or approved by the Food and Drug Administration.
Additionally, data that demonstrates activity or effectiveness in animals
or in vitro tests do not necessarily mean the formula test compound,
referenced herein will be effective in humans. Safety and effectiveness in
humans will have to be demonstrated by means of adequate and well
controlled clinical studies before the clinical significance of the formula
test compound is known. Readers should carefully review the risk factors
described in filings the Company files from time to time with the
Securities and Exchange Commission.
About The Quigley Corporation
The Quigley Corporation (Nasdaq: QGLY, QuigleyPharma) is a
diversified natural health medical science company. Its Cold Remedy segment
is a leading marketer and manufacturer of the COLD-EEZE(R) family of
lozenges, gums and sugar free tablets clinically proven to cut the common
cold nearly in half. COLD-EEZE customers include leading national
wholesalers and distributors, as well as independent and chain food, drug
and mass merchandise stores and pharmacies. The Quigley Corporation has
several wholly owned subsidiaries. Darius International markets health and
wellness products through its wholly owned subsidiary, InnerLight Inc.
Quigley Manufacturing Inc. consists of two FDA approved facilities to
manufacture COLD-EEZE(R) lozenges as well as fulfill other contract
manufacturing opportunities. Quigley Pharma Inc.
(QuigleyPharma) conducts research in order to develop and
commercialize a pipeline of patented botanical and naturally derived
prescription drugs.
Forward-Looking Statements
Certain statements in this press release are "forward-looking
statements" within the meaning of the Private Securities Litigation Reform
Act of 1995 and involve known and unknown risk, uncertainties and other
factors that may cause the Company's actual performance or achievements to
be materially different from the results, performance or achievements
expressed or implied by the forward-looking statement. Factors that impact
such forward-looking statements include, among others, changes in worldwide
general economic conditions, changes in interest rates, government
regulations, and worldwide competition.
QuigleyPharma
wholly-owned subsidiary of The Quigley Corporation (Nasdaq: QGLY),
announced today that it has obtained positive results for its QR-443
compound for the treatment of Cachexia, a debilitating and life threatening
muscle wasting condition. The results of an animal study found a 75%
efficacy rate in the treatment of mice with this condition.
The results of the study clearly indicated that 75% of the tested mice
injected with 5 mg of QR-433 were protected from Cachexia and did not
exhibit any significant weight loss compared to untreated control animals
which exhibited a 15-25 percent weight loss at the end of the experiment.
Cachexia, an extremely debilitating and life threatening condition, is
a loss of weight, muscle wasting, fatigue, weakness and decrease of
appetite which occurs in wasting diseases such as cancer, AIDs, chronic
renal failure, advanced aging and rheumatoid arthritis. Increases in the
blood levels of the cytokines IL-6, TNF-a and INF-y have been thought to
play a major role in Cachexia.
QR-443 is an all natural broad spectrum anti-inflammatory compound that
is being concurrently studied as a drug for Rheumatoid Arthritis (under the
designation QR-440) in humans and dogs. QR-443 has been shown in previous
pre-clinical studies to inhibit the production of TNFa and IFN gamma, and
reducing other inflammatory cytokines associated with Cachexia. This is a
significant and extremely positive development as systemic inflammation has
also been associated with poor prognosis in patients with cancer.
The QR-443 study was undertaken by Professor Yacov Ron of the
Department of Molecular Genetics and Microbiology at the Robert Wood
Johnson Medical School, University of Medicine and Dentistry of New Jersey.
Dr. Richard Rosenbloom, Chief Operating Officer, Quigley Pharma,
stated, "The significant findings of the study are sufficient to continue
to the next stage of the drug development process. We plan to investigate
the possibility of Fast Track Status with the FDA. Alternatively, due to
the importance of these findings, the Company may consider launching this
product as a neutraceutical."
The Quigley Corporation makes no representation that the US Food and
Drug Administration or any other regulatory agency will grant an
Investigational New Drug ("IND") or take any other action to allow its
formulations to be studied or/and for any Investigational New Drug to be
marketed. Furthermore, no claim is made that potential medicine discussed
herein is safe, effective, or approved by the Food and Drug Administration.
Additionally, data that demonstrates activity or effectiveness in animals
or in vitro tests do not necessarily mean the formula test compound,
referenced herein will be effective in humans. Safety and effectiveness in
humans will have to be demonstrated by means of adequate and well
controlled clinical studies before the clinical significance of the formula
test compound is known. Readers should carefully review the risk factors
described in filings the Company files from time to time with the
Securities and Exchange Commission.
About The Quigley Corporation
The Quigley Corporation (Nasdaq: QGLY, QuigleyPharma) is a
diversified natural health medical science company. Its Cold Remedy segment
is a leading marketer and manufacturer of the COLD-EEZE(R) family of
lozenges, gums and sugar free tablets clinically proven to cut the common
cold nearly in half. COLD-EEZE customers include leading national
wholesalers and distributors, as well as independent and chain food, drug
and mass merchandise stores and pharmacies. The Quigley Corporation has
several wholly owned subsidiaries. Darius International markets health and
wellness products through its wholly owned subsidiary, InnerLight Inc.
Quigley Manufacturing Inc. consists of two FDA approved facilities to
manufacture COLD-EEZE(R) lozenges as well as fulfill other contract
manufacturing opportunities. Quigley Pharma Inc.
(QuigleyPharma) conducts research in order to develop and
commercialize a pipeline of patented botanical and naturally derived
prescription drugs.
Forward-Looking Statements
Certain statements in this press release are "forward-looking
statements" within the meaning of the Private Securities Litigation Reform
Act of 1995 and involve known and unknown risk, uncertainties and other
factors that may cause the Company's actual performance or achievements to
be materially different from the results, performance or achievements
expressed or implied by the forward-looking statement. Factors that impact
such forward-looking statements include, among others, changes in worldwide
general economic conditions, changes in interest rates, government
regulations, and worldwide competition.
QuigleyPharma
пятница, 15 июля 2011 г.
New Treatment Hope For Systemic Sclerosis
Systemic sclerosis (SSc) is a chronic autoimmune disorder marked by early skin lesions and the progressive tissue fibrosis. More than skin deep, this thickening and hardening of connective tissue affects the blood capillaries, the gastrointestinal tract, the lungs, and the heart. In SSc patients, fibrosis frequently leads to organ dysfunction, serious illness, and death. Researchers have yet to determine the underlying cause of this disfiguring, debilitating condition or find an effective anti-fibrotic remedy.
Studies of SSc suggest the central role of two cytokines, transforming growth factor - (TGF') and platelet-derived growth factor (PDGF), in the development of fibrosis through stimulating the synthesis of extracellular matrix (ECM) proteins. On the strength of these findings, researchers at the University of Erlangen-Nuremberg, Germany and University Hospital Zurich, Switzerland, set out to test the therapeutic potential for SSc patients of a small growth factor inhibiting molecule widely used in the treatment of leukemia. Featured in the January 2007 issue of Arthritis & Rheumatism (interscience.wiley/journal/arthritis), their experiments indicate the promise of imatinib mesylate to prevent tissue fibrosis and bring meaningful advances to the treatment of SSc.
Through skin biopsies, researchers obtained fibroblast cultures from the lesions of five patients with SSc, and six healthy sex- and age-matched controls. All the specimens were stimulated with TGF' and PDGF and incubated with the inhibitory molecule, imatinib mesylate. Then, applying real-time polymerase chain reaction and various assays, researchers analyzed and compared the expression of EMC proteins in SSc and normal skin fibroblasts. In addition, they assessed the anti-fibrotic effects of imatinib mesylate on laboratory mice with bleomycin-induced dermal fibrosis compared with non-diseased controls.
On the experimental fibroblast cultures from SSc patients, imatinib mesylate strongly reduced the synthesis of EMC proteins, the number of myofibroblasts, and the thickness of skin, almost back to levels observed in the healthy control groups. Similarly, imatinib mesylate effectively suppressed the development of fibrosis in the infected mice. These results were achieved by induction of the inhibitory molecule at strengths between 50 and 150 mg/kg.
"The present study provides the molecular background for controlled clinical trials with imatinib mesylate for the treatment of SSc," assert the leading authors, J'rg Distler, MD and Oliver Distler, MD. As they note, the oral form of this molecule has not only proven effective in the treatment of leukemia and other tumors, but also remarkably well-tolerated by patients, with a low incidence of adverse side effects.
In a related editorial, Frank A. Wollheim, M.D., a researcher with Lund University Hospital in Sweden, notes the promise of these experiments, with cautionary caveats. In his contention, the level of the molecule's induction was far higher than the standard clinical dosage of 400 to 800 milligrams per day. "In addition, the experimental conditions enabled study of imatinib mesylate as a prevention, but not as a treatment," Dr. Wollheim stresses. "The results are exciting and promising, considering that there is at present no effective non-toxic therapy for pulmonary fibrosis. However, more extensive animal studies of imatinib mesylate, as well as studies assessing its efficacy as a treatment of existing fibrosis in addition to its efficacy as a preventative agent, are needed."
Article: "Imatinib Mesylate Reduces Production of Extracellular Matrix and Prevents Development of Experimental Dermal Fibrosis," J'rg H. W. Distler, Astrid J'ngel, Lars C. Huber, Ursula Schulze-Horsel, Jochen Zwerina, Renate F. Gay, Beat A. Michel, Thomas Hauser, Georg Schett, Steffen Gay, and Oliver Distler, Arthritis & Rheumatism, January 2007; (DOI: 10.1002/art.22314).
Editorial: "Treatment of Pulmonary Fibrosis in Systemic Sclerosis: Light at the End of the Tunnel?," Frank A. Wollheim, Arthritis & Rheumatism, January 2007; (DOI: 10.1002/art.22315).
Contact: Amy Molnar
John Wiley & Sons, Inc.
Studies of SSc suggest the central role of two cytokines, transforming growth factor - (TGF') and platelet-derived growth factor (PDGF), in the development of fibrosis through stimulating the synthesis of extracellular matrix (ECM) proteins. On the strength of these findings, researchers at the University of Erlangen-Nuremberg, Germany and University Hospital Zurich, Switzerland, set out to test the therapeutic potential for SSc patients of a small growth factor inhibiting molecule widely used in the treatment of leukemia. Featured in the January 2007 issue of Arthritis & Rheumatism (interscience.wiley/journal/arthritis), their experiments indicate the promise of imatinib mesylate to prevent tissue fibrosis and bring meaningful advances to the treatment of SSc.
Through skin biopsies, researchers obtained fibroblast cultures from the lesions of five patients with SSc, and six healthy sex- and age-matched controls. All the specimens were stimulated with TGF' and PDGF and incubated with the inhibitory molecule, imatinib mesylate. Then, applying real-time polymerase chain reaction and various assays, researchers analyzed and compared the expression of EMC proteins in SSc and normal skin fibroblasts. In addition, they assessed the anti-fibrotic effects of imatinib mesylate on laboratory mice with bleomycin-induced dermal fibrosis compared with non-diseased controls.
On the experimental fibroblast cultures from SSc patients, imatinib mesylate strongly reduced the synthesis of EMC proteins, the number of myofibroblasts, and the thickness of skin, almost back to levels observed in the healthy control groups. Similarly, imatinib mesylate effectively suppressed the development of fibrosis in the infected mice. These results were achieved by induction of the inhibitory molecule at strengths between 50 and 150 mg/kg.
"The present study provides the molecular background for controlled clinical trials with imatinib mesylate for the treatment of SSc," assert the leading authors, J'rg Distler, MD and Oliver Distler, MD. As they note, the oral form of this molecule has not only proven effective in the treatment of leukemia and other tumors, but also remarkably well-tolerated by patients, with a low incidence of adverse side effects.
In a related editorial, Frank A. Wollheim, M.D., a researcher with Lund University Hospital in Sweden, notes the promise of these experiments, with cautionary caveats. In his contention, the level of the molecule's induction was far higher than the standard clinical dosage of 400 to 800 milligrams per day. "In addition, the experimental conditions enabled study of imatinib mesylate as a prevention, but not as a treatment," Dr. Wollheim stresses. "The results are exciting and promising, considering that there is at present no effective non-toxic therapy for pulmonary fibrosis. However, more extensive animal studies of imatinib mesylate, as well as studies assessing its efficacy as a treatment of existing fibrosis in addition to its efficacy as a preventative agent, are needed."
Article: "Imatinib Mesylate Reduces Production of Extracellular Matrix and Prevents Development of Experimental Dermal Fibrosis," J'rg H. W. Distler, Astrid J'ngel, Lars C. Huber, Ursula Schulze-Horsel, Jochen Zwerina, Renate F. Gay, Beat A. Michel, Thomas Hauser, Georg Schett, Steffen Gay, and Oliver Distler, Arthritis & Rheumatism, January 2007; (DOI: 10.1002/art.22314).
Editorial: "Treatment of Pulmonary Fibrosis in Systemic Sclerosis: Light at the End of the Tunnel?," Frank A. Wollheim, Arthritis & Rheumatism, January 2007; (DOI: 10.1002/art.22315).
Contact: Amy Molnar
John Wiley & Sons, Inc.
вторник, 12 июля 2011 г.
Supplements No Better Than Placebo In Slowing Cartilage Loss In Knees Of Osteoarthritis Patients
In a two-year multicenter study led by University of Utah doctors, the dietary supplements glucosamine and chondroitin sulfate performed no better than placebo in slowing the rate of cartilage loss in the knees of osteoarthritis patients.
This was an ancillary study concurrently conducted on a subset of the patients who were enrolled in the prospective, randomized GAIT (Glucosamine/chondroitin Arthritis Intervention Trial). The primary objective of this ancillary study was to investigate whether these dietary supplements could diminish the structural damage of osteoarthritis. The results, published in the October issue of Arthritis & Rheumatism, show none of the agents had a clinically significant effect on slowing the rate of joint space width loss - the distance between the ends of joint bones as shown by X-ray.
However, in line with other recent studies, the researchers observed that all the study's participants had a slower rate of joint space width loss than expected, making it more difficult to detect the effects of the dietary supplements and other agents used in the study.
Rheumatologist Allen D. Sawitzke, M.D., associate professor of internal medicine at the University of Utah School of Medicine, was lead investigator. "At two years, no treatment achieved what was predefined to be a clinically important reduction in joint space width loss," Sawitzke said. "While we found a trend toward improvement among those with moderate osteoarthritis of the knee in those taking glucosamine, we were not able to draw any definitive conclusions."
More than 21 million Americans have osteoarthritis, with many taking glucosamine and chondroitin sulfate, separately or in combination, to relieve pain. The original GAIT, led by University of Utah rheumatologist Daniel O. Clegg, M.D., professor of internal medicine, was a multicenter, randomized, national clinical trial that studied whether these dietary supplements provided significant pain relief to people with osteoarthritis in the knees. GAIT found that the supplements produced no more pain relief than placebo (New England Journal of Medicine, February 2006), although a subset of the original GAIT participants with moderate to severe osteoarthritis knee pain appeared to receive significant pain relief when they took a combination of glucosamine and chondroitin sulfate.
In this ancillary study, GAIT patients were offered the opportunity to continue their original study treatment for an additional 18 months, for a total of two years. Participants remained on their originally assigned GAIT treatment: 500 mg of glucosamine three times a day; or 400 mg of chondroitin sulfate three times a day; or a combination of the two supplements; or 200 mg of celecoxib daily; or a placebo.
X-rays were obtained at study entry and again at one and two years. Joint space width was measured on 581 knees from 357 patients. None of the trial groups showed significant improvement. The group taking glucosamine had the least change in joint space width, followed by the groups taking chondroitin sulfate, celecoxib, placebo and the combination of both dietary supplements.
The total joint space width loss over two years for each group was:
0.013mm (glucosamine)
0.107mm (chondroitin sulfate)
0.111mm (celecoxib)
0.166mm (placebo)
0.194mm (glucosamine and chondroitin sulfate)
The interpretation of the results was problematic because the placebo group's joint space width loss was much less at two years than the 0.4mm the researchers' expected. Based on other large studies published in scientific journals, the researchers hypothesized that a loss of 0.2mm or less at two years would mean a slowed rate of cartilage loss. However, because the reduction in rate of joint space loss for all the groups was under the 0.2mm threshold, the researchers concluded none of the agents significantly slowed the loss of joint space width.
Josephine P. Briggs, M.D., director of the National Center for Complementary and Alternative Medicine, one of the study's funders, said although no definitive conclusions can be drawn about the two dietary supplements yet, "the results of the study provide important insights for future research."
Clegg said the trial shed light on osteoarthritis progression, techniques that can more reliably measure joint space width loss, possible effects of glucosamine and chondroitin sulfate, and on identifying patients who may respond best as further studies are pursued.
The other centers in the study were: The Arthritis Research and Clinical Centers, Wichita, Kan.; University of Arizona, Tucson; Case Western Reserve University, Cleveland; Cedars-Sinai Medical Center; Los Angeles; Indiana University, Indianapolis; University of California, Los Angeles; University of California, San Francisco; University of Pittsburgh.
The National Institute of Arthritis and Musculoskeletal and Skin Diseases also funded the study. Both it and the National Center for Complementary and Alternative Medicine are part of the National Institutes of Health.
Source: Phil Sahm
University of Utah Health Sciences
This was an ancillary study concurrently conducted on a subset of the patients who were enrolled in the prospective, randomized GAIT (Glucosamine/chondroitin Arthritis Intervention Trial). The primary objective of this ancillary study was to investigate whether these dietary supplements could diminish the structural damage of osteoarthritis. The results, published in the October issue of Arthritis & Rheumatism, show none of the agents had a clinically significant effect on slowing the rate of joint space width loss - the distance between the ends of joint bones as shown by X-ray.
However, in line with other recent studies, the researchers observed that all the study's participants had a slower rate of joint space width loss than expected, making it more difficult to detect the effects of the dietary supplements and other agents used in the study.
Rheumatologist Allen D. Sawitzke, M.D., associate professor of internal medicine at the University of Utah School of Medicine, was lead investigator. "At two years, no treatment achieved what was predefined to be a clinically important reduction in joint space width loss," Sawitzke said. "While we found a trend toward improvement among those with moderate osteoarthritis of the knee in those taking glucosamine, we were not able to draw any definitive conclusions."
More than 21 million Americans have osteoarthritis, with many taking glucosamine and chondroitin sulfate, separately or in combination, to relieve pain. The original GAIT, led by University of Utah rheumatologist Daniel O. Clegg, M.D., professor of internal medicine, was a multicenter, randomized, national clinical trial that studied whether these dietary supplements provided significant pain relief to people with osteoarthritis in the knees. GAIT found that the supplements produced no more pain relief than placebo (New England Journal of Medicine, February 2006), although a subset of the original GAIT participants with moderate to severe osteoarthritis knee pain appeared to receive significant pain relief when they took a combination of glucosamine and chondroitin sulfate.
In this ancillary study, GAIT patients were offered the opportunity to continue their original study treatment for an additional 18 months, for a total of two years. Participants remained on their originally assigned GAIT treatment: 500 mg of glucosamine three times a day; or 400 mg of chondroitin sulfate three times a day; or a combination of the two supplements; or 200 mg of celecoxib daily; or a placebo.
X-rays were obtained at study entry and again at one and two years. Joint space width was measured on 581 knees from 357 patients. None of the trial groups showed significant improvement. The group taking glucosamine had the least change in joint space width, followed by the groups taking chondroitin sulfate, celecoxib, placebo and the combination of both dietary supplements.
The total joint space width loss over two years for each group was:
0.013mm (glucosamine)
0.107mm (chondroitin sulfate)
0.111mm (celecoxib)
0.166mm (placebo)
0.194mm (glucosamine and chondroitin sulfate)
The interpretation of the results was problematic because the placebo group's joint space width loss was much less at two years than the 0.4mm the researchers' expected. Based on other large studies published in scientific journals, the researchers hypothesized that a loss of 0.2mm or less at two years would mean a slowed rate of cartilage loss. However, because the reduction in rate of joint space loss for all the groups was under the 0.2mm threshold, the researchers concluded none of the agents significantly slowed the loss of joint space width.
Josephine P. Briggs, M.D., director of the National Center for Complementary and Alternative Medicine, one of the study's funders, said although no definitive conclusions can be drawn about the two dietary supplements yet, "the results of the study provide important insights for future research."
Clegg said the trial shed light on osteoarthritis progression, techniques that can more reliably measure joint space width loss, possible effects of glucosamine and chondroitin sulfate, and on identifying patients who may respond best as further studies are pursued.
The other centers in the study were: The Arthritis Research and Clinical Centers, Wichita, Kan.; University of Arizona, Tucson; Case Western Reserve University, Cleveland; Cedars-Sinai Medical Center; Los Angeles; Indiana University, Indianapolis; University of California, Los Angeles; University of California, San Francisco; University of Pittsburgh.
The National Institute of Arthritis and Musculoskeletal and Skin Diseases also funded the study. Both it and the National Center for Complementary and Alternative Medicine are part of the National Institutes of Health.
Source: Phil Sahm
University of Utah Health Sciences
суббота, 9 июля 2011 г.
How Gold Salts Ease Pain Of Arthritis
Scientists at Duke University Medical Center may have solved the mystery surrounding the healing properties of gold -- a discovery they say may renew interest in gold salts as a treatment for rheumatoid arthritis and other inflammatory diseases.
Physicians first used injections of gold salts in the early 1900s to ease the pain and swelling associated with arthritis. But treatment came at a high cost: The shots took months to take effect and side effects included rashes, mouth sores, kidney damage and occasionally, problems with the bone marrow's ability to make new blood cells. Recently, new treatments like methotrexate and biologically engineered drugs have replaced gold as a preferred treatment, and gold salts, while remaining effective, are usually administered as a last resort.
But Dr. David Pisetsky, chief of the division of rheumatology and immunology in the department of medicine at Duke, says "we shouldn't dismiss gold salts so quickly. We scientists have really never understood why gold works. Now that we have a better handle on its action, we may be able to use that mechanism to create new and better gold-like drugs to treat arthritis."
Pisetsky had long been interested in a particular molecule, HMBG1, which provokes inflammation, the key process underlying the development of rheumatoid arthritis. HMBG1 is a dual-function molecule, which means that it behaves one way when it's inside the nucleus of a cell, and quite another way when it's released from the cell.
Pisetsky says that inside the nucleus, HMGB1 is a key player in transcription, the process that converts genetic information in DNA to its RNA equivalent. But when HMGB1 is released from the cell -- either through normal processes or cell death -- it becomes a stimulus to the immune system and enhances inflammation.
"Interestingly, HMGB1 is not produced evenly throughout the body," says Pisetsky.
"There is an unusually high amount of it in the synovial tissue and fluid around the joints -- where arthritis occurs."
Pisetsky, working with colleagues at the University of Pittsburgh and the Karolinska Institute in Sweden, stimulated mouse and human immune system cells to secrete HMGB1, then treated them with gold salts. They found that the gold blocked the release of HMGB1 from the nucleus. That, in turn, should lessen the amount available to provoke the body's immune system, weakening the inflammatory response.
"Basically, keeping HMGB1 corralled inside the nucleus is a good thing, when it comes to arthritis," says Pisetsky.
Pisetsky says gold inhibits the release of HMGB1 by interfering with the activity of two helper molecules that ease HMGB1's release from the cell, interferon beta and nitric oxide.
The study will appear in the January, 2008 issue of the Journal of Leukocyte Biology, but a preprint is already online at the journal's website at: tinyurl/3cd957.
"Now that we have identified at least one of the ways gold can help arthritis sufferers, perhaps we can use that knowledge to build new and safer-acting, gold-based treatments," says Pisetsky, a senior author of the study.
Pisetsky is encouraged by the results but says additional studies need to be done to find out if the same mechanism is active in animals and people and not just in laboratory studies.
Co-authors of the study include lead investigators Weiwen Jiang, from Duke University, and Cecilia Zetterstrom, from the Karolinska Institute; Heidi Wahamaa, Therese Ostberg, Ann-Charlotte Aveberger, Hanna Schierback and Ufl Anderson from the Karolinska Institute; Helena Erlandersson Harris, senior co-author, from the Medicine and Rheumatology Unit of the Karolinksa University Hospital and Michael Lotze, from the University of Pittsburgh.
Support for the study comes from the Karolinska Institute King Gustav V 80-year Foundation, the Freemason Lodge Barnhuset in Stockholm, the Foundation for Technical Support to Disabled, the Swedish Research Council, the Swedish Rheumatism Association, the Lupus Research Institute, the VA Medical Research Service and the National Institutes of Health.
Source: Michelle Gailiun
Duke University Medical Center
Physicians first used injections of gold salts in the early 1900s to ease the pain and swelling associated with arthritis. But treatment came at a high cost: The shots took months to take effect and side effects included rashes, mouth sores, kidney damage and occasionally, problems with the bone marrow's ability to make new blood cells. Recently, new treatments like methotrexate and biologically engineered drugs have replaced gold as a preferred treatment, and gold salts, while remaining effective, are usually administered as a last resort.
But Dr. David Pisetsky, chief of the division of rheumatology and immunology in the department of medicine at Duke, says "we shouldn't dismiss gold salts so quickly. We scientists have really never understood why gold works. Now that we have a better handle on its action, we may be able to use that mechanism to create new and better gold-like drugs to treat arthritis."
Pisetsky had long been interested in a particular molecule, HMBG1, which provokes inflammation, the key process underlying the development of rheumatoid arthritis. HMBG1 is a dual-function molecule, which means that it behaves one way when it's inside the nucleus of a cell, and quite another way when it's released from the cell.
Pisetsky says that inside the nucleus, HMGB1 is a key player in transcription, the process that converts genetic information in DNA to its RNA equivalent. But when HMGB1 is released from the cell -- either through normal processes or cell death -- it becomes a stimulus to the immune system and enhances inflammation.
"Interestingly, HMGB1 is not produced evenly throughout the body," says Pisetsky.
"There is an unusually high amount of it in the synovial tissue and fluid around the joints -- where arthritis occurs."
Pisetsky, working with colleagues at the University of Pittsburgh and the Karolinska Institute in Sweden, stimulated mouse and human immune system cells to secrete HMGB1, then treated them with gold salts. They found that the gold blocked the release of HMGB1 from the nucleus. That, in turn, should lessen the amount available to provoke the body's immune system, weakening the inflammatory response.
"Basically, keeping HMGB1 corralled inside the nucleus is a good thing, when it comes to arthritis," says Pisetsky.
Pisetsky says gold inhibits the release of HMGB1 by interfering with the activity of two helper molecules that ease HMGB1's release from the cell, interferon beta and nitric oxide.
The study will appear in the January, 2008 issue of the Journal of Leukocyte Biology, but a preprint is already online at the journal's website at: tinyurl/3cd957.
"Now that we have identified at least one of the ways gold can help arthritis sufferers, perhaps we can use that knowledge to build new and safer-acting, gold-based treatments," says Pisetsky, a senior author of the study.
Pisetsky is encouraged by the results but says additional studies need to be done to find out if the same mechanism is active in animals and people and not just in laboratory studies.
Co-authors of the study include lead investigators Weiwen Jiang, from Duke University, and Cecilia Zetterstrom, from the Karolinska Institute; Heidi Wahamaa, Therese Ostberg, Ann-Charlotte Aveberger, Hanna Schierback and Ufl Anderson from the Karolinska Institute; Helena Erlandersson Harris, senior co-author, from the Medicine and Rheumatology Unit of the Karolinksa University Hospital and Michael Lotze, from the University of Pittsburgh.
Support for the study comes from the Karolinska Institute King Gustav V 80-year Foundation, the Freemason Lodge Barnhuset in Stockholm, the Foundation for Technical Support to Disabled, the Swedish Research Council, the Swedish Rheumatism Association, the Lupus Research Institute, the VA Medical Research Service and the National Institutes of Health.
Source: Michelle Gailiun
Duke University Medical Center
среда, 6 июля 2011 г.
Lesser-Invasive Techniques Shrink Rehabilitation Period In Joint Replacement Surgery
An emphasis on innovative, lesser-invasive surgical techniques for knee and hip replacement and the use of technologically advanced prostheses defines Cedars-Sinai Medical Center as a pioneer in the field of joint replacement, says Andrew Spitzer, MD, associate director of the Institute for Joint Replacement. Patients whose surgery is performed at Cedars-Sinai using lesser-invasive surgical techniques are often discharged from the hospital within three days after surgery and are back to normal functioning within one to two months.
The goal of lesser-invasive, minimum-incision surgery for knee and hip replacements, says Spitzer, is to try to facilitate the patient's rehabilitation.
"Lesser invasive joint replacement is valuable to the extent that it shortens the window between when the surgeon finishes the operation and the time the patient is able to mobilize and get back into an active, productive lifestyle. Shrinking the rehabilitation period − from three to six months to one to two months − is a very enticing goal both from the healthcare industry's viewpoint of resource management and economics and from the patient's viewpoint of more quickly returning to the workplace and being able to remain active there for a longer period of time."
One of the lesser-invasive techniques Spitzer uses in hip replacement surgery is a short posterior incision which minimizes the dissection of muscle and reduces the damage to surrounding tissues.
"This approach has faclitated a more rapid recovery and discharge for our patients on an anecdotal basis. We haven't scientifically looked at the data yet but we feel that this smaller incision technique, combined with the greater attention to soft tissue and more careful surgical techniques, seems to result in a quicker rehabilitation period for the patient," Spitzer said.
He emphasizes that it's important to note that other changes have been made in the arena of lesser invasive joint surgery as well, such as more aggressive pain management programs and improved patient education. Nurses are helping patients to become mobile more quickly after surgery and patients are becoming empowered to take charge of their rehabilitation and become independent as quickly as possible.
"Ten years ago we had patients staying in the hospital for one to two weeks after their joint replacement surgery (both knee and hip) and now we've reduced that to one to three days in some cases," says Spitzer.
As the baby boomer generation ages, the number of hip replacement surgeries is expected to increase. In 2001, about 165,000 hip joints were replaced in U.S. hospitals according to the National Center for Health Statistics, and 326,000 knees were replaced. While the majority of joint replacement patients remain in the 60-plus year category, more people are deciding to have surgery one or two decades earlier, some − like rock star Eddie Van Halen − in their early 40s. A hip or knee replacement lasts at least 20 years in about 80 per cent of those who receive them, according to the U.S. Food and Drug Administration.
About 70 per cent of people seeking hip replacement surgery have severe osteoarthritis, a common chronic disease that damages cartilage, the tissue that acts as a protective cushion allowing for the smooth, low-friction movement of the joint. Osteoarthritis is the leading cause of long-term knee damage and the most common reason for knee replacement. By age 65, women are five times more likely than men to have this disease.
One of the newer hip prostheses Spitzer uses is a triple-tapered polished collarless stem replacement, a technology he helped to design. "This cemented prosthesis represents an interesting twist in the history of hip replacements. Its unique feature is that it is the only prosthesis in its particular variety that has been observed to actively create positive remodeling of the bone." Over time, he explains, prostheses tend to cause the bone around them to waste in such a way that the body doesn't load them properly. Eventually, the bone surrounding the replaced joint becomes weaker and thinner and can fail catastrophically. "There is some early evidence to indicate that this new type of prosthesis may be causing the bone to positively remodel or reinforce itself in a physical manner."
"Cemented stems, paradoxically, have been felt to be more applicable to an older population. This particular prosthesis may create an indication for use in younger patients, particularly in those who may otherwise be looking at multiple joint replacements during their lifetime."
Another technically advanced implant being used at Cedars-Sinai is mobile-bearing knee replacement prosthesis. "The mobile-bearing prosthesis is a different concept than the more traditional fixed-bearing knee replacement. The plastic that's between the two metal pieces actually moves in multiple planes. The benefit of this kind of prosthesis is that it changes the knee prosthesis from something closer to a hinge-type function to a more natural function. This allows for a reduction in the wear associated with knee replacements by as much as 95 per cent. Since the wearing surface has been one of the weaker links in the replacement process, we're looking at expanding the longevity and durability of these surgeries, thereby greatly reducing the need for revision surgery."
The first of seven hospitals in California whose nurses have been honored with the prestigious Magnet designation, Cedars-Sinai Medical Center is one of the largest nonprofit academic medical centers in the Western United States. For 18 consecutive years, it has been named Los Angeles' most preferred hospital for all health needs in an independent survey of area residents. Cedars-Sinai is internationally renowned for its diagnostic and treatment capabilities and its broad spectrum of programs and services, as well as breakthroughs in biomedical research and superlative medical education. It ranks among the top 10 non-university hospitals in the nation for its research activities and is fully accredited by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). Additional information is available at cedars-sinai.
Public Relations
8700 Beverly Blvd., Rm 2429A
Los Angeles, CA 90048
United States
cedars-sinai
The goal of lesser-invasive, minimum-incision surgery for knee and hip replacements, says Spitzer, is to try to facilitate the patient's rehabilitation.
"Lesser invasive joint replacement is valuable to the extent that it shortens the window between when the surgeon finishes the operation and the time the patient is able to mobilize and get back into an active, productive lifestyle. Shrinking the rehabilitation period − from three to six months to one to two months − is a very enticing goal both from the healthcare industry's viewpoint of resource management and economics and from the patient's viewpoint of more quickly returning to the workplace and being able to remain active there for a longer period of time."
One of the lesser-invasive techniques Spitzer uses in hip replacement surgery is a short posterior incision which minimizes the dissection of muscle and reduces the damage to surrounding tissues.
"This approach has faclitated a more rapid recovery and discharge for our patients on an anecdotal basis. We haven't scientifically looked at the data yet but we feel that this smaller incision technique, combined with the greater attention to soft tissue and more careful surgical techniques, seems to result in a quicker rehabilitation period for the patient," Spitzer said.
He emphasizes that it's important to note that other changes have been made in the arena of lesser invasive joint surgery as well, such as more aggressive pain management programs and improved patient education. Nurses are helping patients to become mobile more quickly after surgery and patients are becoming empowered to take charge of their rehabilitation and become independent as quickly as possible.
"Ten years ago we had patients staying in the hospital for one to two weeks after their joint replacement surgery (both knee and hip) and now we've reduced that to one to three days in some cases," says Spitzer.
As the baby boomer generation ages, the number of hip replacement surgeries is expected to increase. In 2001, about 165,000 hip joints were replaced in U.S. hospitals according to the National Center for Health Statistics, and 326,000 knees were replaced. While the majority of joint replacement patients remain in the 60-plus year category, more people are deciding to have surgery one or two decades earlier, some − like rock star Eddie Van Halen − in their early 40s. A hip or knee replacement lasts at least 20 years in about 80 per cent of those who receive them, according to the U.S. Food and Drug Administration.
About 70 per cent of people seeking hip replacement surgery have severe osteoarthritis, a common chronic disease that damages cartilage, the tissue that acts as a protective cushion allowing for the smooth, low-friction movement of the joint. Osteoarthritis is the leading cause of long-term knee damage and the most common reason for knee replacement. By age 65, women are five times more likely than men to have this disease.
One of the newer hip prostheses Spitzer uses is a triple-tapered polished collarless stem replacement, a technology he helped to design. "This cemented prosthesis represents an interesting twist in the history of hip replacements. Its unique feature is that it is the only prosthesis in its particular variety that has been observed to actively create positive remodeling of the bone." Over time, he explains, prostheses tend to cause the bone around them to waste in such a way that the body doesn't load them properly. Eventually, the bone surrounding the replaced joint becomes weaker and thinner and can fail catastrophically. "There is some early evidence to indicate that this new type of prosthesis may be causing the bone to positively remodel or reinforce itself in a physical manner."
"Cemented stems, paradoxically, have been felt to be more applicable to an older population. This particular prosthesis may create an indication for use in younger patients, particularly in those who may otherwise be looking at multiple joint replacements during their lifetime."
Another technically advanced implant being used at Cedars-Sinai is mobile-bearing knee replacement prosthesis. "The mobile-bearing prosthesis is a different concept than the more traditional fixed-bearing knee replacement. The plastic that's between the two metal pieces actually moves in multiple planes. The benefit of this kind of prosthesis is that it changes the knee prosthesis from something closer to a hinge-type function to a more natural function. This allows for a reduction in the wear associated with knee replacements by as much as 95 per cent. Since the wearing surface has been one of the weaker links in the replacement process, we're looking at expanding the longevity and durability of these surgeries, thereby greatly reducing the need for revision surgery."
The first of seven hospitals in California whose nurses have been honored with the prestigious Magnet designation, Cedars-Sinai Medical Center is one of the largest nonprofit academic medical centers in the Western United States. For 18 consecutive years, it has been named Los Angeles' most preferred hospital for all health needs in an independent survey of area residents. Cedars-Sinai is internationally renowned for its diagnostic and treatment capabilities and its broad spectrum of programs and services, as well as breakthroughs in biomedical research and superlative medical education. It ranks among the top 10 non-university hospitals in the nation for its research activities and is fully accredited by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). Additional information is available at cedars-sinai.
Public Relations
8700 Beverly Blvd., Rm 2429A
Los Angeles, CA 90048
United States
cedars-sinai
воскресенье, 3 июля 2011 г.
Comparing Lidoderm Patch And Celebrax In Treating Pain, 1st Head-To-Head Study
Study results suggest that lidoderm can alleviate the pain associated with osteoarthritis of the knee -
Today at the 24th Annual Scientific Meeting of the American Pain Society, Endo Pharmaceuticals Inc. released new clinical
trial data which found patients receiving either Lidoderm® (lidocaine patch 5%) or Celebrex® (celecoxib) 200 mg for pain
associated with osteoarthritis (OA) of the knee experienced improvement in average daily pain intensity. Lidoderm is a
topical analgesic patch approved by the U.S. Food and Drug Administration (FDA) in 1999 to treat the pain associated with
post-herpetic neuralgia (PHN), a chronic condition resulting from nerve damage caused by shingles.
"The results of this exploratory study examining Lidoderm and Celebrex suggest that Lidoderm can alleviate the pain
associated with osteoarthritis of the knee," said Alan Kivitz, M.D., of Altoona (Pa.) Center for Clinical Research. "I am
encouraged by these findings since there is a critical need for new approaches to managing this type of pain."
OA affects more than 20 million Americans annually and generates more than seven million physician visits per year. If left
untreated, chronic pain conditions such as OA can have significant physical, psychological and financial consequences by
affecting daily functioning and quality of life.
Due to safety concerns regarding the entire COX-II inhibitor class in the fall of 2004, the sponsor of the study, Endo
Pharmaceuticals Inc., voluntarily elected to prematurely halt the study prior to reaching the original enrollment target.
However an analysis of data after six weeks of treatment showed that of the patients treated in the Lidoderm group (N=56),
54% experienced a 30% or greater improvement in average daily pain intensity; (studies have reported that 30% or greater
reductions in pain intensity are clinically meaningful to pain patients). In the Celebrex group (N=63), 62% experienced a 30%
or greater improvement in average daily pain intensity. In addition, clinically meaningful reductions in pain were noted in
both treatment groups at week 12.
"Although these results need to be confirmed with further randomized controlled trials, the potential of Lidoderm to treat
osteoarthritis knee pain is promising," added Dr. Kivitz. "Lidoderm has been used since 1999 to treat the pain of
post-herpetic neuralgia and, because it is a non-systemic patch, has demonstrated a minimal risk of side effects or
drug-to-drug interaction. Our hope is to see similar results in further Lidoderm osteoarthritis knee pain studies."
About the Study
The randomized, open-label, active-control, parallel-group study, which was intended to enroll 200 patients, contained data
for 143 patients experiencing OA pain of either one or both knees and evaluated efficacy and safety of treatment. After a 7-
to 14-day wash-out period during which all analgesic medications, chondroitin, and glucosamine were discontinued, patients
with an average daily pain intensity score of =5 on a scale of 0 to 10 for three of five consecutive days and an OA severity
score of =7 on a scale of 0 to 24 prior to the baseline visit were randomized to 12 weeks of treatment with either one full
Lidoderm patch on the front of the knee and one-third of a patch on the back of each affected knee (69 patients) once daily
for 24 hours or Celebrex 200 mg once daily (74 patients). Efficacy measures included the Western Ontario and McMaster
Universities OA Index, Brief Pain Index (BPI), Pain Quality Assessment Scale and global assessments of change in OA pain and
treatment satisfaction.
In the study, both treatments were well tolerated, with adverse events reported in eight patients in each group. The most
common adverse events were itchiness or redness at the patch site. Additionally, three patients in the Lidoderm group
discontinued the study due to adverse events. There were no discontinuations due to treatment-related adverse events in the
Celebrex group.
About Lidoderm
Lidoderm (lidocaine patch 5%) is FDA-approved for the relief of pain associated with post herpetic neuralgia (PHN). Lidoderm
produces an analgesic effect by the penetration of lidocaine from the patch into the epidermal and dermal layers of the skin,
without loss of sensation or numbness. The Lidoderm patch should only be applied to intact skin. The most frequently reported
adverse events with the Lidoderm patch are application site reactions, including erythema, edema, discoloration, burning
sensation, pruritus or abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a
few minutes to hours.
The FDA-approved dosing for Lidoderm is up to three patches applied for up to 12 hours within a 24-hour period. Lidoderm has
not been approved by the FDA for any indications other than for the relief of pain associated with PHN, and its safety and
efficacy in other indications have not been established.
About Endo
A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (Nasdaq: ENDP), Endo Pharmaceuticals is a fully integrated
specialty pharmaceutical company with market leadership in pain management products. The company researches, develops,
produces and markets a broad product offering of branded and generic pharmaceuticals, meeting the needs of healthcare
professionals and consumers alike. More information, including this and past press releases of Endo Pharmaceuticals Holdings
Inc., is available online at endo.
Celebrex® is a registered trademark of Pfizer Inc.
Forward-Looking Statements
This press release contains forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934, as amended, that are based on management's beliefs and assumptions,
current expectations, estimates and projections. Statements that are not historical facts, including statements which are
preceded by, followed by, or that include, the words "believes," "anticipates," "plans," "expects" or similar expressions and
statements are forward-looking statements. Endo's estimated or anticipated future results, product performance or other
non-historical facts are forward-looking and reflect Endo's current perspective on existing trends and information. Many of
the factors that will determine the Company's future results are beyond the ability of the Company to control or predict.
These statements are subject to risks and uncertainties and, therefore, actual results may differ materially from those
expressed or implied by these forward-looking statements. The reader should not rely on any forward-looking statement. The
Company undertakes no obligation to update any forward-looking statements whether as a result of new information, future
events or otherwise. Several important factors, in addition to the specific factors discussed in connection with these
forward-looking statements individually, could affect the future results of Endo and could cause those results to differ
materially from those expressed in the forward-looking statements contained in this press release. Important factors that may
affect future results include, but are not limited to: market acceptance of the Company's products and the impact of
competitive products and pricing; dependence on sole source suppliers; the success of the Company's product development
activities and the timeliness with which regulatory authorizations and product launches may be achieved; successful
compliance with extensive, costly, complex and evolving governmental regulations and restrictions; the availability on
commercially reasonable terms of raw materials and other third party manufactured products; exposure to product liability and
other lawsuits and contingencies; dependence on third party suppliers, distributors and collaboration partners; the ability
to timely and cost effectively integrate acquisitions; uncertainty associated with pre-clinical studies and clinical trials
and regulatory approval; uncertainty of market acceptance of new products; the difficulty of predicting FDA approvals; risks
with respect to technology and product development; the effect of competing products and prices; uncertainties regarding
intellectual property protection; uncertainties as to the outcome of litigation; changes in operating results; impact of
competitive products and pricing; product development; changes in laws and regulations; customer demand; possible future
litigation; availability of future financing and reimbursement policies of government and private health insurers and others;
and other risks and uncertainties detailed in Endo's filings with the Securities and Exchange Commission, including its
Registration Statement on Form S-3 filed with the SEC on April 30, 2004, as amended. Readers should evaluate any statement in
light of these important factors.
Contact: Fiona Buraimoh
fiona_buraimohnyc.cohnwolfe
212-798-9512
Cohn & Wolfe
cohnwolfe/home.asp
View drug information on Lidoderm Patch.
Today at the 24th Annual Scientific Meeting of the American Pain Society, Endo Pharmaceuticals Inc. released new clinical
trial data which found patients receiving either Lidoderm® (lidocaine patch 5%) or Celebrex® (celecoxib) 200 mg for pain
associated with osteoarthritis (OA) of the knee experienced improvement in average daily pain intensity. Lidoderm is a
topical analgesic patch approved by the U.S. Food and Drug Administration (FDA) in 1999 to treat the pain associated with
post-herpetic neuralgia (PHN), a chronic condition resulting from nerve damage caused by shingles.
"The results of this exploratory study examining Lidoderm and Celebrex suggest that Lidoderm can alleviate the pain
associated with osteoarthritis of the knee," said Alan Kivitz, M.D., of Altoona (Pa.) Center for Clinical Research. "I am
encouraged by these findings since there is a critical need for new approaches to managing this type of pain."
OA affects more than 20 million Americans annually and generates more than seven million physician visits per year. If left
untreated, chronic pain conditions such as OA can have significant physical, psychological and financial consequences by
affecting daily functioning and quality of life.
Due to safety concerns regarding the entire COX-II inhibitor class in the fall of 2004, the sponsor of the study, Endo
Pharmaceuticals Inc., voluntarily elected to prematurely halt the study prior to reaching the original enrollment target.
However an analysis of data after six weeks of treatment showed that of the patients treated in the Lidoderm group (N=56),
54% experienced a 30% or greater improvement in average daily pain intensity; (studies have reported that 30% or greater
reductions in pain intensity are clinically meaningful to pain patients). In the Celebrex group (N=63), 62% experienced a 30%
or greater improvement in average daily pain intensity. In addition, clinically meaningful reductions in pain were noted in
both treatment groups at week 12.
"Although these results need to be confirmed with further randomized controlled trials, the potential of Lidoderm to treat
osteoarthritis knee pain is promising," added Dr. Kivitz. "Lidoderm has been used since 1999 to treat the pain of
post-herpetic neuralgia and, because it is a non-systemic patch, has demonstrated a minimal risk of side effects or
drug-to-drug interaction. Our hope is to see similar results in further Lidoderm osteoarthritis knee pain studies."
About the Study
The randomized, open-label, active-control, parallel-group study, which was intended to enroll 200 patients, contained data
for 143 patients experiencing OA pain of either one or both knees and evaluated efficacy and safety of treatment. After a 7-
to 14-day wash-out period during which all analgesic medications, chondroitin, and glucosamine were discontinued, patients
with an average daily pain intensity score of =5 on a scale of 0 to 10 for three of five consecutive days and an OA severity
score of =7 on a scale of 0 to 24 prior to the baseline visit were randomized to 12 weeks of treatment with either one full
Lidoderm patch on the front of the knee and one-third of a patch on the back of each affected knee (69 patients) once daily
for 24 hours or Celebrex 200 mg once daily (74 patients). Efficacy measures included the Western Ontario and McMaster
Universities OA Index, Brief Pain Index (BPI), Pain Quality Assessment Scale and global assessments of change in OA pain and
treatment satisfaction.
In the study, both treatments were well tolerated, with adverse events reported in eight patients in each group. The most
common adverse events were itchiness or redness at the patch site. Additionally, three patients in the Lidoderm group
discontinued the study due to adverse events. There were no discontinuations due to treatment-related adverse events in the
Celebrex group.
About Lidoderm
Lidoderm (lidocaine patch 5%) is FDA-approved for the relief of pain associated with post herpetic neuralgia (PHN). Lidoderm
produces an analgesic effect by the penetration of lidocaine from the patch into the epidermal and dermal layers of the skin,
without loss of sensation or numbness. The Lidoderm patch should only be applied to intact skin. The most frequently reported
adverse events with the Lidoderm patch are application site reactions, including erythema, edema, discoloration, burning
sensation, pruritus or abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a
few minutes to hours.
The FDA-approved dosing for Lidoderm is up to three patches applied for up to 12 hours within a 24-hour period. Lidoderm has
not been approved by the FDA for any indications other than for the relief of pain associated with PHN, and its safety and
efficacy in other indications have not been established.
About Endo
A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (Nasdaq: ENDP), Endo Pharmaceuticals is a fully integrated
specialty pharmaceutical company with market leadership in pain management products. The company researches, develops,
produces and markets a broad product offering of branded and generic pharmaceuticals, meeting the needs of healthcare
professionals and consumers alike. More information, including this and past press releases of Endo Pharmaceuticals Holdings
Inc., is available online at endo.
Celebrex® is a registered trademark of Pfizer Inc.
Forward-Looking Statements
This press release contains forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934, as amended, that are based on management's beliefs and assumptions,
current expectations, estimates and projections. Statements that are not historical facts, including statements which are
preceded by, followed by, or that include, the words "believes," "anticipates," "plans," "expects" or similar expressions and
statements are forward-looking statements. Endo's estimated or anticipated future results, product performance or other
non-historical facts are forward-looking and reflect Endo's current perspective on existing trends and information. Many of
the factors that will determine the Company's future results are beyond the ability of the Company to control or predict.
These statements are subject to risks and uncertainties and, therefore, actual results may differ materially from those
expressed or implied by these forward-looking statements. The reader should not rely on any forward-looking statement. The
Company undertakes no obligation to update any forward-looking statements whether as a result of new information, future
events or otherwise. Several important factors, in addition to the specific factors discussed in connection with these
forward-looking statements individually, could affect the future results of Endo and could cause those results to differ
materially from those expressed in the forward-looking statements contained in this press release. Important factors that may
affect future results include, but are not limited to: market acceptance of the Company's products and the impact of
competitive products and pricing; dependence on sole source suppliers; the success of the Company's product development
activities and the timeliness with which regulatory authorizations and product launches may be achieved; successful
compliance with extensive, costly, complex and evolving governmental regulations and restrictions; the availability on
commercially reasonable terms of raw materials and other third party manufactured products; exposure to product liability and
other lawsuits and contingencies; dependence on third party suppliers, distributors and collaboration partners; the ability
to timely and cost effectively integrate acquisitions; uncertainty associated with pre-clinical studies and clinical trials
and regulatory approval; uncertainty of market acceptance of new products; the difficulty of predicting FDA approvals; risks
with respect to technology and product development; the effect of competing products and prices; uncertainties regarding
intellectual property protection; uncertainties as to the outcome of litigation; changes in operating results; impact of
competitive products and pricing; product development; changes in laws and regulations; customer demand; possible future
litigation; availability of future financing and reimbursement policies of government and private health insurers and others;
and other risks and uncertainties detailed in Endo's filings with the Securities and Exchange Commission, including its
Registration Statement on Form S-3 filed with the SEC on April 30, 2004, as amended. Readers should evaluate any statement in
light of these important factors.
Contact: Fiona Buraimoh
fiona_buraimohnyc.cohnwolfe
212-798-9512
Cohn & Wolfe
cohnwolfe/home.asp
View drug information on Lidoderm Patch.
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