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
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