Gentium Announces Completion Of Enrollment For The Phase II/III European Pediatric Prevention Trial Of Defibrotide
Gentium S.p.A. (Nasdaq: GENT) announced the completion of patient enrollment in a Phase II/III European, multi-center, open label, randomized trial to evaluate the prophylactic use of Defibrotide in pediatric patients undergoing stem cell transplantation who are at high risk for hepatic veno-occlusive disease (VOD).
In the Phase II/III trial, patients are randomly assigned to one of two treatment arms. Those allocated to the Defibrotide prophylaxis arm receive 25mg/kg/day in four divided doses beginning at the time of conditioning and finishing 30 days after stem cell transplantation (SCT) or upon discharge from inpatient care. Patients allocated to the control arm do not receive VOD prophylactic measures. The primary efficacy endpoint for the trial is the incidence of VOD within 30 days after SCT. The secondary safety endpoints include the occurrence of multi-system organ failure and survival at 100 days after SCT. Additional information on this trial can be found at http://www.clinicaltrials.gov.
Gentium plans to release initial results of this trial at the Annual Meeting of the European Group for Blood and Marrow Transplantation, March 29 to April 1, 2009 in Göteborg, Sweden. As was previously announced, following discussions with the European Medicines Agency, Gentium has been notified of the potential for an accelerated review of Defibrotide in the pediatric prevention indication.
“We are excited to have completed enrollment in our European Phase II/III prophylaxis trial for Defibrotide in pediatric patients,” stated Dr. Laura Ferro, CEO of Gentium S.p.A. “Prior investigator sponsored trials for Defibrotide in the prevention setting have shown promising results, and we are hopeful that this trial will fall in line with what we have previously seen.”
About VOD
Veno-occlusive disease is a potentially life-threatening condition, which typically occurs as an important complication of stem cell transplantation. Certain high-dose chemo-radiation therapy regimens used as part of SCT can damage the lining cells of hepatic blood vessels and so result in VOD, a blockage of the small veins of the liver that leads to liver failure and can result in significant dysfunction in other organs such as the kidneys and lungs (so-called severe VOD). SCT is a frequently used treatment modality following high-dose chemotherapy and radiation therapy for hematologic cancers and other conditions in both adults and children. There is currently no approved agent for the treatment or prevention of VOD in the U.S. or the EU.
About Gentium
Gentium S.p.A. is a biopharmaceutical company focused on the research, discovery and development of drugs derived from DNA extracted from natural sources, and drugs that are synthetic derivatives, to treat and prevent a variety of vascular diseases and conditions related to cancer and cancer treatments. Defibrotide, the Company’s lead product candidate, is an investigational drug that has been granted Orphan Drug status by the U.S. Food and Drug Administration and EMEA to prevent and to treat VOD and Fast Track designation by the U.S. FDA for the treatment of severe VOD in recipients of stem cell transplants.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements.” In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential” or “continue,” the negative of these terms and other comparable terminology. These statements are not historical facts but instead represent the Company’s belief regarding future results, many of which, by their nature, are inherently uncertain and outside the Company’s control. It is possible that actual results, including clinical trial results and regulatory reviews, may differ materially from those anticipated in these forward-looking statements. For a discussion of some of the risks and important factors that could affect future results, see the discussion in our Form 20F filed with the Securities and Exchange Commission under the caption “Risk Factors.”
Gentium
ZEVALIN(R) Produced 83 Percent Complete Response Rate In Mucosa-Associated Lymphoid Tissue (MALT) Orbital Lymphoma Study
Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI) announced results of a study published by Esmaeli, et al. online on January 15, 2009 in the Annals of Oncology demonstrating that rituximab followed by single agent ZEVALIN® (ibritumomab tiuxetan) in a front-line setting for patients with MALT lymphoma and low-grade follicular lymphoma that primarily involved the conjunctiva or orbit, produced a complete response rate of 83 percent.
Ocular adnexal lymphoma (OAL), defined as lymphoma affecting the orbit, eyelid and conjunctiva, is the most frequent primary malignant tumor of the orbit in adults, accounting for approximately 55 percent of all orbital tumors. MALT lymphoma is the most common histologic subtype of OAL, followed by low-grade follicular lymphoma. External-beam radiotherapy (EBRT) has been the most frequently used modality and is considered the gold standard for treating OAL that present with local disease. However, EBRT does not address systemic sites of involvement in OAL in patients with multifocal disease and therefore, systemic targeted radioimmunotherapy with ZEVALIN might offer an alternative to treating OAL.
In the study, 9 patients with MALT lymphoma of conjunctiva or orbit and 3 patients with low grade follicular lymphoma of the orbit received rituximab and Indium-111 ZEVALIN and then approximately 1 week later received a second infusion of rituximab followed by single dose of Yttrium-90 ZEVALIN.
Results demonstrated an initial response rate for patients of 100 percent with 83 percent achieving a complete response. There were no cases of extraorbital relapse, with a median follow-up time of 20 months. All 12 patients experienced Grade 1 or 2 transient pancytopenia during the first 3 months. Two patients had platelet transfusions, and one patient had blood transfusions due to myelosuppression. There were no episodes of Grade 3 or 4 toxicity.
The authors concluded that ZEVALIN may represent a reasonable alternative for front-line treatment of early-stage extranodal OAL, producing response rates similar to those with EBRT with one-tenth the absorbed radiation dose.
ZEVALIN is currently marketed in the United States by RIT (Radioimmunotherapeutics) Oncology, LLC, a joint venture between Spectrum Pharmaceuticals, Inc. and Cell Therapeutics, Inc. A sNDA for ZEVALIN as front-line consolidation therapy in patients with advanced follicular NHL has been submitted to the FDA for review. A Prescription Drug User Fee Act (PDUFA) target date of April 2, 2009 has been established by the FDA for a decision regarding the ZEVALIN sBLA.
About ZEVALIN®
ZEVALIN® (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the ZEVALIN therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma, including patients with rituximab-refractory follicular NHL. ZEVALIN is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naïve, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.
Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab (Rituxan®) infusions. Yttrium-90 ZEVALIN administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the ZEVALIN therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to ZEVALIN therapy. Myelodysplasia or acute myelogenous leukemia was observed in 2 percent of patients (8 to 34 months after treatment). ZEVALIN should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.
For more information on ZEVALIN, patients and healthcare professionals can visit http://www.ZEVALIN.com.
About Non-Hodgkin’s Lymphoma
Non-Hodgkin’s lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and normally spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms – aggressive NHL, a rapidly spreading acute form of the disease, and indolent NHL, which progresses more slowly. According to the National Cancer Institute’s SEER database there were nearly 400,000 people in the U.S. with NHL in 2004. The American Cancer Society estimates that in the United States 66,120 people are expected to be diagnosed with NHL in 2008. Additionally, approximately 19,160 are expected to die from this disease in 2008.
About First-Line Consolidation Therapy
Consolidation therapy aims to rapidly improve the quality of the response achieved with initial remission induction treatment. Induction therapy is a treatment designed as a first step toward reducing the number of cancer cells.
About RIT (Radioimmunotherapeutics) Oncology, LLC
Spectrum Pharmaceuticals and Cell Therapeutics are the sole members of the LLC, whose sole purpose is to commercialize ZEVALIN in the United States. The LLC is governed by a Board of Managers comprised of an equal number of members from both companies. Both parties are to equally provide for the future capital requirements of the LLC and share equally in the profits and losses of the LLC.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.celltherapeutics.com.
About Spectrum Pharmaceuticals
Spectrum is a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus mainly on oncology and urology. Spectrum’s strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in developing drugs and commercialization in our areas of focus; and, leveraging the expertise of partners around the world to assist us in the execution of our strategy. For more information, please visit Spectrum’s website at http://www.spectrumpharm.com.
Forward-looking statements
This press release may contain forward- looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to Spectrum’s business and its future, the safety and effectiveness of ZEVALIN, that ZEVALIN may represent a reasonable alternative for front-line treatment of early-stage extranodal OAL, producing response rates similar to those with EBRT with one-tenth the absorbed radiation dose, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that Spectrum’s existing and new drug candidates, may not prove safe or effective, the possibility that its existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that its existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that its efforts to acquire or in-license and develop additional drug candidates may fail, its lack of revenues, its limited marketing experience, its dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in Spectrum’s reports filed with the Securities and Exchange Commission, including without limitation its Annual Report on Form 10-K for the year ended December 31, 2007 and its subsequent Quarterly Reports on Form 10-Q. All forward looking statements in this press release speak only as of the date hereof. Spectrum does not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc. TURNING INSIGHTS INTO HOPE(TM) and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
ZEVALIN® is a registered trademark of RIT Oncology, LLC, and RIT and RIT Oncology are trademarks owned by RIT Oncology, LLC.
© 2009 Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals
DHBs’ Decision To Reduce RMO Vacancy Numbers Short-Sighted
NZMA is very concerned by the proposal of the three Auckland DHBs to reduce the number of Resident Medical Officer (RMO) vacancies down to the number of positions they can currently fill.
“This is an extremely short-sighted move” says NZMA Chair Dr Peter Foley. “It has taken us many years to identify the actual shortage of RMOs and this proposal will undermine that work. This merely hides the problem. “
“Moreover the decision to resolve the shortage of doctors by task delegation to other members of the health care team and/or by creating new roles ignores the fact that as well as critical shortages in medical practitioner numbers, we also have a severe shortage of nurses and others who might take on such tasks”.
The DHBs, and the Government have had years to seriously address New Zealand’s health workforce problems. This move by the Auckland DHBs seems to acknowledge defeat, rather than work with the Medical Training Board, the SMO and RMO Commissions that are currently trying to address the DHB medical workforce issues.
This move by the Auckland DHBs is unacceptable.
NZ Medical Association
Glucose Precisely Detected By Nano-Tetherball Biosensor
Researchers have created a precise biosensor for detecting blood glucose and potentially many other biological molecules by using hollow structures called single-wall carbon nanotubes anchored to gold-coated “nanocubes.”
The device resembles a tiny cube-shaped tetherball. Each tetherball is a sensor and is anchored to electronic circuitry by a nanotube, which acts as both a tether and ultrathin wire to conduct electrical signals, said Timothy Fisher, a Purdue University professor of mechanical engineering.
The technology, which detects glucose more precisely than any biosensors in development, also might be used in medicine to detect other types of biological molecules and in future biosensors for scientific research, said Marshall Porterfield, an associate professor of agricultural and biological engineering at Purdue.
“It might be part of a catheter to continuously monitor blood glucose for diabetics,” Porterfield said. “And it might have many other applications, including basic scientific research to study diseases and biological processes.”
The tetherball design lends itself to sensing applications, Fisher said.
“That’s because the sensing portion of the system extends out pretty far from the rest of the device so that it can more easily come into contact with target molecules,” he said. “It doesn’t have to wait for those target molecules to diffuse down all the way to the surface and can move into other regions within the range of the tether for enhanced sensing. “
Findings are detailed in a paper appearing in the January issue of the American Chemical Society journal ACS Nano. The paper, which will be featured on the journal’s cover, was written by Jonathan Claussen, a doctoral student in agricultural and biological engineering; Aaron Franklin, a doctoral student in electrical and computer engineering; Aeraj ul Haque, a doctoral student in agricultural and biological engineering; Porterfield; and Fisher.
The research was conducted at the Birck Nanotechnology Center and the Bindley Bioscience Center in Purdue’s Discovery Park.
The nanotubes have a diameter of about two nanometers, or billionths of a meter, roughly 25,000 times thinner than a human hair.
“The new biosensor is more sensitive than others in two very important respects,” Fisher said.
Other sensors require at least five times more glucose to generate a signal, and the new sensor also can operate over a wider range of glucose concentration, which means it could be used for many purposes.
“Depending on where in the body you might want to sense glucose, you would need to detect different concentrations – for example, in the arteries or small intestines or muscles there are significantly different glucose concentrations,” Porterfield said.
Being able to sense small quantities while at the same time detecting a wide range of concentrations are two traits that are normally mutually exclusive.
“Other sensors only detect over narrow ranges of specific concentrations,” Porterfield said. “Because of the advanced characteristics, this system could be adapted as an all-purpose sensor platform.”
The single-wall nanotubes are especially suited for electronic sensors because electricity flows more efficiently through wires only a few nanometers in diameter than it does through ordinary wires.
The engineers have developed a technique to grow individual carbon nanotubes vertically on top of a silicon wafer, a step toward making advanced electronics, wireless devices and sensors using nanotubes. The nanotubes grow out of tiny holes in a “porous anodic alumina template.” (This method is described in a previous news release at http://www.purdue.edu/UNS/html4ever/2006/060801.Fisher.vertical.html)
The nanotubes extend out of the pores, and then palladium metal is deposited inside the pores, eventually forming cube-shaped caps at the top of each pore. This palladium nanocube is then coated with gold, which is compatible with biological molecules.
The researchers then attached a protein called streptavidin onto the gold-coated palladium nanocubes and attached another protein called biotin to the streptavidin. The biotin-streptavidin combination is commonly used in laboratory techniques to analyze biological samples.
“Biotin and streptavidin are like tiny Lego blocks that are designed to hook together,” Porterfield said.
The researchers used fluorescent-dyed streptavidin molecules to prove that the molecule attached specifically to the nanocube tetherballs and not broadly to all materials. After verifying the tetherball portion of the device could be used as a sensor, the researchers turned the device into a glucose sensor by replacing the biotin with an enzyme called glucose oxidase. The enzyme causes an electrochemical reaction in the presence of glucose and oxygen, generating an electrical signal.
The same system could be used in biosensors to detect other types of molecules for medicine and scientific research.
“If we can allow someone to monitor their disease and have a better quality of life, that’s great,” Porterfield said. “But what if we could develop a tool that would allow scientists to discover the cure for that disease?”
Attaching enzymes associated with neuronal signaling could be used to study the brain and nervous system. An enzyme associated with ethanol could be used in a blood-alcohol sensor. Another application might be to study stresses in plants for agricultural research.
The device is an example of a nano electromechanical system, or a NEMS, which contains nanoscopic mechanical parts.
“This is the first time researchers have assembled from the atomic to the biomolecular level all the components you need for a biosensor,” Porterfield said. “It’s like Tinker Toys at the biomolecular level.”
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Article adapted by Medical News Today from original press release.
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The researchers have filed a patent application for the system.
Writer: Emil Venere
ABSTRACT
Electrochemical Biosensor of Nanocube-Augmented Carbon Nanotube Networks
Jonathan C. Claussen, Aaron D. Franklin, Aeraj ul Haque,
D. Marshall Porterfield, and Timothy S. Fisher
Networks of single-walled carbon nanotubes (SWCNTs) decorated with Au-coated Pd (Au/Pd) nanocubes are employed as electrochemical biosensors that exhibit excellent sensitivity (2.6 mA mM1 cm2) and a low estimated detection limit (2.3 nM) at a signal-to-noise ratio of 3 (S/N[1]3) in the amperometric sensing of hydrogen peroxide. Biofunctionalization of the Au/Pd nanocube-SWCNT biosensor is demonstrated with the selective immobilization of fluorescently labeled streptavidin on the nanocube surfaces via thiol linking. Similarly, glucose oxidase (GOx) is linked to the surface of the nanocubes for amperometric glucose sensing. The exhibited glucose detection limit of 1.3 M (S/N[1]3) and linear range spanning from 10M to 50mM substantially surpass similar CNT-based biosensors. These results, combined with the structure™fs compatibility with a wide range of biofunctionalization procedures, would make the nanocube-SWCNT biosensor exceptionally useful for glucose detection in diabetic patients and well suited for a wide range of amperometric detection schemes for clinically important biomarkers.
Source: Emil Venere
Purdue University
Older Adults Affected By Hurricane Katrina Show A Decline In Health
In the year following Hurricane Katrina, the health of survivors 65 and over declined nearly 4 times that of a national sample of older adults not affected by the disaster, according to a study led by researchers at the Johns Hopkins Bloomberg School of Public Health. The August 2005 storm was one of the most powerful and deadliest hurricanes in U.S. history. Hurricane Katrina displaced thousands and severely disrupted access to health care. Researchers monitored enrollees of a New Orleans-area managed care organization and found morbidity rates increased 12.6 percent compared with 3.4 percent nationwide. The results are published in the January issue of The American Journal of Managed Care.
“In the year following Hurricane Katrina, morbidity rates increased substantially,” said Lynda Burton, ScD, lead author of the study and adjunct associate professor with the Bloomberg School’s Department of Health Policy and Management. “Morbidity rates among non-white Orleans residents were the highest when compared to other parishes and there was a significant increase in the prevalence of patients with cardiac diagnoses, congestive heart failure and sleep problems. Survivors displaced out-of-state experienced higher morbidity rates than those not displaced. In the month following the disaster, mortality spiked, but during the remainder of the year returned to a level consistent with the previous year.”
Researchers examined the managed care organization claims of 20,612 white and non-white residents of Orleans, Jefferson, St. Tammany and Plaquemines parishes who were over the age of 65 and enrolled in Peoples Health, a provider-owned managed care organization. Burton, along with colleagues from the Bloomberg School, Health Data Essentials, Inc. and the Johns Hopkins School of Medicine, conducted an observational study to compare mortality, morbidity and services used for one year before and after Hurricane Katrina. The researchers found that emergency department visits increased 100 percent in the month following Katrina, and by 21 percent over the next year compared to the pre-Katrina year. Hospitalization rates increased 66 percent in the first month after Katrina and maintained an increase of 23 percent over the ensuing year. Using a telephone survey, the study also examined the health of a random sample of enrollees after the hurricane. Researchers believe displacement played a major role in health outcomes. Sixty-nine percent reported moderate or severe damage to their home, or that their home was destroyed. At the end of the year, 28 percent reported their residence remained unlivable and another 28 percent reported a worse financial situation.
“The enormous health burden experienced by older individuals and the disruptions in service utilization reveal the long-term effects of Hurricane Katrina on this vulnerable population,” said Jonathan Weiner, DrPH, senior author of the study and director of the Bloomberg School’s PhD Program in Health Services Research and Policy. “Although quick rebuilding of the provider network may have attenuated more severe health outcomes for this managed care population, new policies must be introduced to deal with the health consequences of a major disaster.”
“Health of Medicare Advantage Plan Enrollees at 1 Year After Hurricane Katrina” was written by Lynda C. Burton, Elizabeth A. Skinner, Lori Uscher-Pines, Richard Lieberman, Bruce Leff, Rebecca Clark, Qilu Yu, Klaus Lemke, and Jonathan P. Weiner.
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Article adapted by Medical News Today from original press release.
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The research was funded by Peoples Health.
Source: Natalie Wood-Wright
Johns Hopkins University Bloomberg School of Public Health
College President Responds To New ONS Figures Showing A Rise In The Number Of People Drinking Above Recommended Levels, UK
Responding to today’s publication of ONS figures indicating a small rise in the numbers of people drinking above the daily recommended limits, Professor Ian Gilmore, President of the Royal College of Physicians said:
“On the basis of these figures it appears unlikely that we will stem the rising tide of alcohol-related health harms in the near future. While people’s awareness of the health risks associated with drinking above the recommended limits is surprisingly good, knowledge of those limits is still poor, despite ten years of concerted work to raise awareness levels. Consequently, it is vital that the government take the next step of introducing mandatory labelling on drinks so that people are in a better position to keep track of their own consumption levels, especially now, as more people socialise at home, rather than in pubs and bars in order to take advantage of the cheap deals offered in the large supermarkets.”
Royal College of Physicians
Growing Reliance On Microfluidics Technology: GEN Report
Biotechnology companies are building on what they have learned about microfluidics techniques over the past decade and are expected to drive this market toward $1.9 billion in three years, reports Genetic Engineering and Biotechnology News (GEN); (http://www.genengnews.com). The technology offers a number of advantages, including reducing reagent consumption, increasing speed and analytical performance, multiparameter testing, and user friendliness, according to the January 15 issue of GEN.
“The globalization of life science research and an increasing trend toward novel diagnostic development, particularly point of care, are providing a significant boost toward a greater acceptance of microfluidics methodologies,” says John Sterling, Editor in Chief of GEN.
Much of drug discovery focuses on finding inhibitors of enzyme targets such as kinases, phosphatases, and proteases. Caliper Life Sciences created its Mobility Shift Assay to interrogate druggable enzymes. It combines the advantages of capillary electrophoresis with microfluidics technology for the direct measurement of substrate and product.
Biosite has developed protein array technologies that contain microcapillaries for controlling the flow of fluids in immunoassay processes. The protein array format uses several different microcapillary designs to control the contact of sample with reagents and to direct the flow of fluid throughout the protein array. For example, after a blood sample is added to the array, a special internal filter separates cells from plasma. Next a capillary directs the sample into a chamber that contains dried immunoassay reagents. After an incubation time that is determined by another microcapillary element of the array, the sample next flows down a capillary path and interacts with an antibody array. The interactions are detected in the company’s Triage® Meters that scan the array device with a laser diode.
Other companies covered in the GEN article include ChipShop, Genefluidics, Paraytec, CellASIC, and DiscoveRx.
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Article adapted by Medical News Today from original press release.
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Genetic Engineering and Biotechnology News, which is published 21 times a year by Mary Ann Liebert, Inc., includes articles on Drug Discovery, Bioprocessing, OMICS, Biobusiness, and Clinical Research and Diagnostics.
The Mary Ann Liebert Companies 140 Huguenot St., New Rochelle, NY 10801-5215 http://www.liebertpub.com
Source: John Sterling
Mary Ann Liebert, Inc./Genetic Engineering News
Latent Tuberculosis: A Shorter Treatment With Fewer Side Effects
Patients who are infected with the latent form of tuberculosis (TB) show no symptoms and are not contagious, yet they pose the biggest challenge when it comes to controlling the disease. The latest study by Dr. Dick Menzies of the Research Institute of the McGill University Health Centre (MUHC) describes a new potential treatment for this particular form of TB. The paper based on this study was recently published in the Annals of Internal Medicine.
“Our results show that a four-month treatment with a drug called rifampin is better tolerated than the traditional nine-month treatment with a drug called isoniazid,” explained Dr. Menzies. “The side effects with rifampin are much less frequent, particularly liver toxicity – which is the most serious risk of the traditional therapy with isoniazid. In addition patients are much more likely to complete this treatment – another big drawback to the nine month standard therapy.”
Patients who currently receive a diagnosis of latent TB are treated for nine months with daily doses of isoniazid. Although effective, this treatment is very long and has major side effects on the liver. It is therefore common that patients do not complete treatment. Of course, this reduces the treatment’s efficacy.
The new therapeutic option studied by Dr. Menzies lasts only four months and causes a lot less liver damage. Patients therefore adhere better to their treatment regimens, which is a critical first step towards ensuring the efficacy of the medication. This study was conducted on 847 patients in Canada, Brazil and Saudi Arabia. The results can therefore be generalized to a very broad population.
Currently, rifampin is most often used to treat the active form of TB. More in-depth studies will be necessary to test the effectiveness of this medication against latent TB, but the study researchers consider this treatment option to be very promising.
This study was funded by the Canadian Institutes of Health Research (CIHR) and the Fonds de la recherche en santé du Québec (FRSQ).
Dr. Dick Menzies is the Director of Respiratory Medicine at the MUHC and a researcher in the Respiratory Health Axis and Health Outcomes Axis at the Research Institute of the MUHC. He is also a Professor in Medicine, Epidemiology and Biostatistics – in the Faculty of Medicine of McGill University.
The Research Institute of the McGill University Health Centre (RI MUHC) is a world-renowned biomedical and health-care hospital research centre. Located in Montreal, Quebec, the institute is the research arm of the MUHC, the university health center affiliated with the Faculty of Medicine at McGill University. The institute supports over 600 researchers, nearly 1200 graduate and post-doctoral students and operates more than 300 laboratories devoted to a broad spectrum of fundamental and clinical research. The Research Institute operates at the forefront of knowledge, innovation and technology and is inextricably linked to the clinical programs of the MUHC, ensuring that patients benefit directly from the latest research-based knowledge.
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Article adapted by Medical News Today from original press release.
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This release is available in French.
The Research Institute of the MUHC is supported in part by the Fonds de la recherche en santé du Québec. For further details visit: http://www.muhc.ca/research.
Find this press release, with the original article and a short audio document by following this link : http://www.muhc.ca/media/news/
Source: Isabelle Kling
McGill University Health Centre
How Antibodies Block The S1P Receptor On T Cells Has Potential To Stop Autoimmune Diseases And Transplant Rejection
After several years of battling recurring infections, the last thing a patient and her doctors ever expected was that the cause of her problems might actually help millions live longer, more active lives. Now, researchers have high hopes because Edward Goetzl and his colleagues from the University of California and The Ohio State University discovered that the patient made a unique antibody to her own T cells, the cells that mediate much of autoimmunity. Acting on the surface of T cells via a novel mechanism, the antibody reduced the number of T cells in her blood stream: a result that usually requires a host of “immunosuppressive” and possibly toxic drugs. Their research discovery, published online in The FASEB Journal, may lead to entirely new therapies for a wide range of autoimmune disorders, such as colitis, lupus, rheumatoid arthritis, inflammatory bowel disease, and multiple sclerosis, as well as new ways to prevent transplant rejection.
“The possibility that these antibodies can be used to treat diverse autoimmune diseases with minimal risk of infections represents a new horizon for reversing these disabling and often fatal conditions,” said Edward Goetzl, a senior researcher involved in the study.
In the research report, Goetzl and colleagues explain how they discovered that the antibodies produced by this patient blocked the sphingosine 1-phosphate (S1P) receptor on T cells. The S1P receptor is a cell-surface antenna that receives signals telling T cells to leave the lymph nodes and patrol the body. When this antenna was disabled, the T cells failed to leave the lymph nodes (chemotaxis), reducing their numbers in the bloodstream. Taking this discovery one step further, the researchers created more of the patient’s antibodies in the laboratory and gave them to mice with colitis (an autoimmune disorder). After receiving the antibodies, symptoms of colitis were reduced.
“This discovery is very good news for people with autoimmune disorders.” said Gerald Weissmann, M.D., Editor-in-Chief of The FASEB Journal “It also shows that when modern scientists work out exactly what is wrong with one patient they can come up with unexpected new ways to treat many thousands.
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Article adapted by Medical News Today from original press release.
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The FASEB Journal (http://www.fasebj.org) is published by the Federation of American Societies for Experimental Biology (FASEB) and is the most cited biology journal worldwide according to the Institute for Scientific Information. FASEB comprises 22 nonprofit societies with more than 80,000 members, making it the largest coalition of biomedical research associations in the United States. FASEB advances biological science through collaborative advocacy for research policies that promote scientific progress and education and lead to improvements in human health.
Source: Cody Mooneyhan
Federation of American Societies for Experimental Biology
Apple Juice Delays Onset Of Alzheimer’s Disease In Mouse Model
A growing body of evidence demonstrates that we can take steps to delay age-related cognitive decline, including in some cases that which accompanies Alzheimer’s disease, according to a study published in the January 2009 issue of the Journal of Alzheimer’s Disease.
Thomas B. Shea, PhD, of the Center for Cellular Neurobiology; Neurodegeneration Research University of Massachusetts, Lowell and his research team have carried out a number of laboratory studies demonstrating that drinking apple juice helped mice perform better than normal in maze trials, and prevented the decline in performance that was otherwise observed as these mice aged.
In the most recent study Shea and his team demonstrated that mice receiving the human equivalent of 2 glasses of apple juice per day for 1 month produced less of a small protein fragment, called “beta-amyloid” that is responsible for forming the “senile plaques” that are commonly found in brains of individuals suffering from Alzheimer’s disease.
Dr. Shea commented that “These findings provide further evidence linking nutritional and genetic risk factors for age-related neurodegeneration and suggest that regular consumption of apple juice can not only help to keep one’s mind functioning at its best, but may also be able to delay key aspects of Alzheimer’s disease and augment therapeutic approaches.”
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Article adapted by Medical News Today from original press release.
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The article is “Dietary Supplementation with Apple Juice Decreases Endogenous Amyloid-β Levels in Murine Brain” by Amy Chan and Thomas B. Shea. It is published in the Journal of Alzheimer’s Disease 16:1 (January 2009).
Source: Astrid Engelen
IOS Press
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