A Phase III, Randomised, Parallel Group, Multi-Centre Study in Recurrent Glioblastoma Patients to Compare the Efficacy of Cediranib [RECENTIN™, AZD2171] Monotherapy and the Combination of Cediranib With Lomustine to the Efficacy of Lomustine Alone (D8480C00055)
The purpose of this study is to see how effective cediranib is in treating a brain tumour called recurrent glioblastoma. Two drugs are being tested in this study. Lomustine is an approved oral chemotherapy that belongs to the class of drugs called alkylating agents. Cediranib is a new drug that has not yet been approved for this disease. This study will compare the use of lomustine with cediranib, cediranib alone or lomustine with placebo ("inactive substance") to see whether the combination or cediranib alone will be more effective than the chemotherapy alone (lomustine) in preventing the growth of cancer cells.
Read more! Combo Therapy Shows Promise Against Brain Cancer1/22/2010 12:00:00 AM (MST)
Success in mice with glioblastoma may someday lead to treatment for people, researchers say
Hide Article Combo Therapy Shows Promise Against Brain Cancer1/22/2010 12:00:00 AM (MST)
Combo Therapy Shows Promise Against Brain Cancer
FRIDAY, Jan. 22 (HealthDay News) -- A synthetic form of a naturally occurring hormone combined with chemotherapy inhibited tumor growth and achieved a 25 percent cure rate in mice with a deadly brain cancer called glioblastoma, a new study reports.
Currently, people diagnosed with glioblastoma have a poor prognosis and relatively short life expectancy.
The mice in the study were treated with thymosin alpha 1 (Talpha1/thymalfasin), a synthetic form of the hormone thymosin, produced by the thymus gland.
"Our hypothesis was that the immune system basically needs a boost to kill the cancer cells," Dr. Suzanne de la Monte of Rhode Island Hospital, who led the research, said in a news release from the hospital. "We know that thymosin is currently being used in Europe to treat cancer, so we set out to see what effect this could have on glioblastomas."
When Talpha1 was used alone, the tumor continued to grow. But the researchers found that combining it with chemotherapy produced promising results in the mice.
"We looked at giving chemo plus Talpha1 as a sort of immune booster," de la Monte explained. "What we found is that when you give Talpha1 and the chemo agent together, not only do you have a slower rate of tumor growth with cells being killed, but there have also been cures. We achieved a 25 percent cure rate in these animal models."
The study was published online in the Journal of Oncology.
The researchers said they now want to test the combination treatment in people with glioblastoma.
SOURCE: Rhode Island Hospital, news release, Jan. 18, 2010
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Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing 2 Annual Cycles of IV 12 mg and 24 mg Alemtuzumab to 3x Weekly SC Interferon Beta-1a (Rebif®) in Relapsing-Remitting Multiple Sclerosis Patients Who Have Relapsed on Therapy (CAMMS32400507)
The purpose of this study is to establish the efficacy and safety of two different doses of alemtuzumab as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with Rebif (interferon beta-1a). The study will enroll patients who have received an adequate trial of disease-modifying therapies but continued to relapse while being treated, and who meet a minimum severity of disease as measured by MRI. Patients will have monthly laboratory tests and comprehensive testing every 3 months.
Read more! Cholesterol Drugs May Slow MS4/16/2010 12:00:00 AM (CST)
Fewer brain lesions developed in patients taking Lipitor than placebo, researchers say
Hide Article Cholesterol Drugs May Slow MS4/16/2010 12:00:00 AM (CST)
Cholesterol Drugs May Slow MS
FRIDAY, April 16 (HealthDay News) -- Cholesterol-lowering statin drugs may slow the progression of multiple sclerosis, according to a new study.
It included 81 patients with early-stage MS randomly selected to take either 80 milligrams a day of Lipitor (atorvastatin) or a placebo. After 12 months of treatment, 55.3 percent of patients taking the drug had developed no new brain lesions, compared with 27.6 percent of those who took the placebo.
The results of the phase II, multi-center trial were presented Wednesday at the annual scientific meeting of the American Academy of Neurology. Lipitor, placebo and additional support were provided by Pfizer, Inc., which makes Lipitor.
"Our data is preliminary, and we need a larger study to confirm the effects of the drug and their magnitude," study co-leader Dr. Emmanuelle Waubant, an associate professor of neurology at the MS Center at the University of California, San Francisco, said in a news release.
"It is important that we understand how statins impact the progression of multiple sclerosis in order to better inform physicians and patients of their effect since these drugs are so broadly used throughout the United States and the world, and to learn whether a relatively inexpensive oral therapy can slow the course of the disease," he added.
MS is an autoimmune disease in which immune cells attack the central nervous system and destroy the protective sheath (myelin) that surrounds nerves. This results in scars or lesions in demyelinated areas of the brain and spinal cord.
More information
The U.S. National Institute of Neurological Disorders and Stroke has more about multiple sclerosis.
SOURCE: University of California, San Francisco, news release, April 14, 2010
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A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects With Partial-onset Seizures (SP904)
This open-label extension trial will assess the long-term use of lacosamide monotherapy and safety of lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (SP902).
Read more! Children With Epilepsy Feel on Par With Healthy Siblings5/24/2010 12:00:00 AM (CST)
Parents disagree, may underestimate their quality of life, researchers say
Hide Article Children With Epilepsy Feel on Par With Healthy Siblings5/24/2010 12:00:00 AM (CST)
Children With Epilepsy Feel on Par With Healthy Siblings
MONDAY, May 24 (HealthDay News) --Children with epilepsy view their quality of life as being as good as that of their healthy siblings, a new study reveals.
The finding suggests that despite the numerous challenges they face in the form of seizures, cognitive and learning disadvantages, social stigma and the effects of medication, children with epilepsy have a far more positive take on their well-being than their parents have.
The study is the result of research conducted by scientists at the University of California, Los Angeles, and led by Dr. Christine Bower Baca, a clinical instructor in UCLA's department of neurology.
About 3 million Americans have epilepsy, the study authors wrote, and approximately 45,000 children below the age of 15 develop the condition each year. Causes for childhood epilepsy vary, and can include problems during delivery, quirks in prenatal brain development, head trauma, tumors, genetics, brain infection and prolonged seizures linked to fever.
To gain insight into how the children with epilepsy viewed themselves, the research team interviewed 143 children with epilepsy (matching each one to a sibling without epilepsy) and their parents.
Interviews were conducted eight to nine years following a diagnosis of epilepsy. Among the children with the condition who were assessed, the average age was 12.
In terms of ranking such quality of life variables as behavior, general health, self-esteem and physical function, Baca and her colleagues found that parents rated their child with epilepsy much lower than their healthy child.
Children with epilepsy, in contrast, felt they were on par with their healthy siblings.
"In this regard, parental perception of their epileptic child may be distorted because of their perception that they have a child that is 'sick,'" Baca said in a news release. "Such a distortion could lead to an underestimate of the child's quality of life."
Noting that children and parents may not always share the same concerns, Baca added that children and parents "may draw on different values and perspectives to evaluate quality of life" without realizing it. Getting a handle on these critical differences in perspectives, she said, could be helpful down the road when designing support services for children as they enter adulthood.
Baca and her team reported the findings online in Value in Health.
A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Efficacy Study of Add-on Cladribine Tablet Therapy With Interferon-beta (IFN-b) Treatment in Multiple Sclerosis Subjects With Active Disease (26593)
The goal of this study is to evaluate the safety, tolerability and effectiveness of oral cladribine when taken in combination with Interferon-beta therapy for the treatment of MS.This study will randomize 200 subjects from approximately 50 sites located world-wide, who have experienced at least one relapse while taking Interferon-beta therapy within 48 weeks prior to Screening, irrespective of disability progression. Secondary progressive multiple sclerosis (SPMS) patients, who are still experiencing relapses, and patients who have received disease modifying drugs (DMDs), other than Interferon-beta therapy, during their MS treatment history, but are currently on Interferon-beta therapy and have experienced active MS symptoms (at least 1 relapse) during the 48 weeks prior to Screening, may also be enrolled.Subjects will be randomised in a 2:1 fashion to receive up to 4 cycles of oral cladribine or matching placebo in combination with Interferon-beta therapy. Total subject participation is 104 weeks.
Read more! Brain Changes in MS May Spur Depression7/7/2010 12:00:00 AM (CST)
Scans showed shrinkage in areas related to mood, memory, researchers say
Hide Article Brain Changes in MS May Spur Depression7/7/2010 12:00:00 AM (CST)
Brain Changes in MS May Spur Depression
WEDNESDAY, July 7 (HealthDay News) -- Brain atrophy may be a major reason why the lifetime risk of depression in multiple sclerosis patients is as high as 50 percent, new research suggests.
This atrophy, marked by a shrinkage of brain mass, occurs in the hippocampus, a part of the brain involved in a number of functions, including mood and memory.
For this study, researchers at the University of California, Los Angeles used MRI scans to compare the brains of multiple sclerosis (MS) patients and healthy people. The scan results showed that three important sub-regions of the hippocampus were smaller in MS patients.
The research team also identified a link between this brain atrophy and hyperactivity of the hypothalamic-pituitary-adrenal (HPA) axis, a part of the neuroendocrine system that controls reactions to stress and regulates many physiological functions. Excessive activity of the HPA axis may be associated with both atrophy of the hippocampus and the development of depression, the researchers suggested.
The study was released online June 19 in advance of publication in an upcoming print issue of the journal Biological Psychiatry.
The connection between HPA hyperactivity and brain atrophy hasn't received much attention, "despite the fact that the most consistently reproduced findings in psychiatric patients with depression (but without MS) include hyperactivity of the HPA axis and smaller volumes of the hippocampus," senior study author Dr. Nancy Sicotte, an associate professor of neurology, said in a news release from the university.
"So the next step is to compare MS patients with depression to psychiatric patients with depression to see how this disease progresses in each," she added.
Along with being one of the most common symptoms in patients with multiple sclerosis, depression "impacts cognitive function, quality of life, work performance and treatment compliance. Worst of all, it's also one of the strongest predictors of suicide," noted lead author Stefan Gold, a postdoctoral fellow in the UCLA Multiple Sclerosis Program.
More information
The U.S. National Institute of Neurological Disorders and Stroke has more about multiple sclerosis.
SOURCE: University of California, Los Angeles, news release, July 1, 2010.
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Biobank For MS And Other Demyelinating Diseases (ACP-001)
To establish a large, longitudinal collection of high quality samples and data from subjects with MS, selected other demyelinating diseases (Transverse Myelitis (TM), Neuromyelitis Optica (NMO) or Devic's, Acute Disseminated Encephalomyelitis (ADEM), and Optic Neuritis (ON)), and related and unrelated unaffected controls. Samples and data will be available as a shared resource to scientists researching the causes, sub-types, and biomarkers of MS and related demyelinating diseases.
Read more! Ampyra Approved for Adults With MS1/22/2010 12:00:00 AM (MST)
Helps those who have trouble walking
Hide Article Ampyra Approved for Adults With MS1/22/2010 12:00:00 AM (MST)
Ampyra Approved for Adults With MS
FRIDAY, Jan. 22 (HealthDay News) -- Dalfampridine (Ampyra) extended-release tablets have been approved by the U.S. Food and Drug Administration to help adults with multiple sclerosis (MS) who have trouble walking.
In clinical testing, people who took Ampyra had faster walking speeds that those who took a placebo, the agency said in a news release.
MS is a chronic, often disabling disease affecting the brain, spinal cord and optic nerves. Some 400,000 people in the United States and 2.5 million globally have been diagnosed with the disease, the FDA said.
The drug, if given at doses higher than the recommended 10 milligrams twice daily, can cause seizures, the agency warned. The most common reported side effects include urinary tract infection, insomnia, dizziness, headache, nausea, weakness, back pain, nasal or throat swelling, irregularity, indigestion and burning or itchy skin.
People with moderate-to-severe kidney disease shouldn't take Ampyra, the FDA said.
The drug is marketed in the United States by Hawthorne, N.Y.-based Acorda Therapeutics.
