Studies

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.

More information

The American Brain Tumor Association has more about glioblastoma and other brain tumors.

SOURCE: Rhode Island Hospital, news release, Jan. 18, 2010

Childbirth May Slow Progression of Multiple Sclerosis

TUESDAY, Nov. 24 (HealthDay News) -- Having children may slow the progression of multiple sclerosis, new research suggests.

Belgian researchers followed 330 women who had experienced their first MS symptoms between the ages of 22 and 38.

Women who had given birth to at least one child were 34 percent less likely to have the disease progress to a stage in which they needed walking assistance, such as a cane or brace, than women without children.

While having a baby either before or after the onset of MS symptoms seemed to help, women who had a child after they began experiencing MS symptoms were even better off. During the study, women with MS symptoms who'd had a baby were 39 percent less likely to have their disease progress to the point of needing walking assistance. In the study, women had the disease for an average of 18 years.

"Women with MS who have children seem to have a more benign MS course than those who don't," said study author Marie D'hooghe, of the department of neurology at Nationaal MS Centrum in Melsbroek, Belgium.

The research appears in the Nov. 24 online issue of the Journal of Neurology, Neurosurgery & Psychiatry.

Multiple sclerosis is an autoimmune disease in which the body's own defense system attacks myelin, or the protective fatty substance that surrounds nerve fibers in the central nervous system, according to the National Multiple Sclerosis Society. The damage causes a disruption to nerve signals traveling to and from the brain, which causes the numbness, walking problems, blurry vision and fatigue.

About 85 percent of those with MS start with a relapsing-remitting course, in which attacks are followed by partial or total recovery, according to the study. More than half go on to develop a more progressive form of the disease, in which symptoms worsen over time and there are fewer, shorter periods without symptoms. Eventually, the disease can lead to loss of vision and paralysis.

Women are twice as likely to develop MS as men, though women tend to have less severe cases than men, according to the study.

About three-quarters of the women in the study had children. The researchers measured the time it took for women to reach level 6 on the Expanded Disability Status Scale (EDSS), a rating system used by doctors to describe symptoms, with level 1 being the least severe and 10 being death due to MS. Level 6 is defined as needing a cane, crutch or brace to walk.

Women who did not have children took an average of 13 to 15 years to progress to EDSS 6, while women who had children took an average of 22 to 23 years to reach that stage, the researchers found.

"Having one or more children does seem to be beneficial," said Patricia O'Looney, director of biomedical research for the National Multiple Sclerosis Society. "But we don't know enough about the patient demographics to really draw some major conclusions."

Among the unknowns are the treatments the women in the study were getting for MS or if perhaps the women who decided to have children were feeling better and having fewer symptoms.

Though much remains to be learned about the role of pregnancy in MS, a possible reason why it may help slow the progression of the disease is that during pregnancy, the immune system is "downregulated," in part to prevent the mother's body from rejecting the fetus, O'Looney explained. Suppressing the immune system may also help to control MS, O'Looney noted.

Treatments for MS, such as interferon beta-1a and -1b, work by suppressing the immune system.

A second possibility for why childbirth might help delay the progression of MS is that during pregnancy, estrogen levels rise. Previous research has suggested estrogen may help protect from MS by stimulating the cells that make myelin. The MS Society is currently funding a clinical trial in which women with MS are given estriol, a form of estrogen, along with standard MS treatments.

"The sex hormones do seem to have some neuroprotective role, though we are not quite sure how," O'Looney said.

Still, O'Looney stressed that women should not interpret the results as reason to have a baby to delay the progression of the disease, or blame themselves if they decided not to have children.

"We still don't know a lot about the great variability of MS -- why does one person become more progressive while another follows a more benign course," O'Looney said. "What's certain is that one should not conclude it's based on whether or not you have a child. There are so many other factors, including possibly genetic factors, that determine that."

More information

The National Multiple Sclerosis Society has more on pregnancy and MS.

SOURCES: Marie D'hooghe, department of neurology, Nationaal MS Centrum in Melsbroek, Belgium; Patricia O'Looney, Ph.D., director, biomedical research, National Multiple Sclerosis Society; Nov. 24, 2009, Journal of Neurology, Neurosurgery & Psychiatry, online

Epilepsy Drug Linked to Serious Birth Defects

WEDNESDAY, June 9 (HealthDay News) -- The offspring of women who took the epilepsy drug valproic acid during the first trimester of pregnancy are much more likely to have serious births defects affecting the brain, heart and limbs, a new study finds.

Babies whose mothers took valproic acid during the first trimester were 12.7 times more likely to have spina bifida, in which the spinal cord and backbone fail to develop or close properly, compared to babies whose mothers did not take the drug.

Babies whose mothers took valproic acid were also 2.5 times more likely to have an atrial septal defect (a heart defect); about five times as likely to have a cleft palate (a defect of the upper lip and roof of the mouth) or hypospadias (a penis abnormality); more than twice as likely to be born with an extra digit on the hand (polydactyly); and nearly seven times more likely to have craniosynostosis (premature fusion of the skull during fetal development that restricts skull and brain growth).

While valproic acid (brand names include Depakene and Depakote) was associated with a higher relative risk of the six birth defects, the absolute risk of having a baby with any of the defects remains small, the researchers noted. For example, the risk of having a baby with spina bifida was 0.6 percent, or six in 1,000, among women who took the drug compared to five in 1,000 of babies born to mothers who didn't take any epilepsy medication.

Yet given mounting evidence of the risks of valproic acid to fetuses, researchers urged women of childbearing age to try other drugs to control their seizures.

"These findings provide further evidence to avoid valproic acid, if possible, in pregnant women and [for doctors] to discuss with girls and women of childbearing potential the risk of the drug for the unborn child," said senior study author Lolkje T.W. de Jong-van den Berg, of the University of Groningen in the Netherlands.

Dr. Kimford Meador, a professor of neurology at Emory University in Atlanta, echoed that warning.

"This drug should not be used as a first-line drug for epilepsy in women of childbearing age," Meador said. "There are multiple types of malformations that can be associated with valproic acid."

The review is published in the June 10 issue of the New England Journal of Medicine.

In the review, researchers first looked at eight studies that included nearly 1,600 births and identified some 14 birth defects that seemed to be much more common among the children of women who took valproic acid early in pregnancy.

Researchers then took that information and analyzed data from a large European study that included nearly 4 million births and 98,000 birth defects. They found women who took valproic acid in early pregnancy had two to 12 times the risk of having a baby with one of six specific birth defects compared to women who took no epilepsy drugs. The findings were similar when birth defect rates among those taking valproic acid were compared to the rates for women who took other epilepsy drugs, leading researchers to conclude it was the valproic acid, not some other epilepsy drug, that was to blame.

Among those who took valproic acid during early pregnancy, the chances of having a baby with any of the defects was less than 1 percent -- cleft palate (0.3 percent), hypospadias (0.7 percent), polydactyly (0.2 percent), craniosynostosis (0.1 percent).

Previous research has also linked valproic acid to spina bifida, other birth defects and cognitive problems in children, Meador noted. In April 2009, Meador was the lead author of a study that appeared in the New England Journal of Medicine that linked exposure to valproic acid in the womb to lower IQ scores in children at age 3.

The American Academy of Neurology recommends avoiding the use of valproic acid in pregnant women, according to background information in the article. Yet since up to half of pregnancies are unplanned, according to the study, all women of childbearing age should be warned about the dangers, researchers said.

Despite such concerns, valproic acid is often still prescribed, Meador said. In 2006, valproic acid was the second most commonly prescribed epilepsy drug, he noted.

Valproic acid is also prescribed to prevent migraines and for bipolar disorder, he added.

Despite the risks, valproic acid can be a very effective drug and may be the best choice for some patients whose seizures are not well-controlled by other medications, Meador said.

More information

The National Institute of Neurological Disorders and Stroke has more on epilepsy.

SOURCES: Lolkje T.W. de Jong-van den Berg, Ph.D., department of pharmacoepidemiology and pharmacoeconomics, University of Groningen, Groningen, Netherlands; Kimford J. Meador, M.D., professor, neurology, Emory University, Atlanta; June 10, 2010, New England Journal of Medicine

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.

More information

The FDA has more about this approval.

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