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A drug therapy currently used to treat non-Hodgkin’s lymphoma and rheumatoid arthritis had a significant effect in treating the most common form of multiple sclerosis in a small, short-term clinical trial, researchers at the University of California at San Francisco report. Because the drug targets the immune system’s B-cells, rather than the immune system’s traditionally targeted T-cells—long considered the primary culprit in MS—the finding provides a new insight into the cause of the disease. The study, published in the New England Journal of Medicine, showed that the drug, rituximab, dramatically reduced the number of inflammatory lesions that form along nerve fibers in patients’ brains—the hallmark of the disease. It also significantly decreased the clinical symptom of the disease: sporadic, temporary disruptions in certain neurological functions, such as mobility in a limb or vision in an eye. MS is thought to be an autoimmune disease, a condition in which one or more types of cells of the immune system turn against a tissue of the body. MS occurs when the immune system attacks myelin, the protective insulating sheath that surrounds nerve fibers in the central nervous system. Genentech and Biogen Idec, which market rituximab (Rituxan), sponsored the trial, co-designing the study and analyzing the data.  

 

Men with jobs that require them to be physically active may be getting benefits beyond salary and health insurance—they may be at a decreased risk of developing prostate cancer, according to a study at the University of California at Los Angeles’ Jonsson Cancer Center. Researchers studied more than 2,100 men who worked at the Rocketdyne facility in the San Fernando Valley, many of whom were exposed to radiation and chemicals that may have increased their risk for certain cancers. The men were separated into jobs with low, moderate, and high amounts of exertion. The study found that the men who developed prostate cancer were less likely to hold the more physically active jobs. Those that got cancer also were more likely than the control group to be highly exposed to the chemicals that were evaluated, including hydrazine, benzene, mineral oil, polycyclic aromatic hydrocarbons, and trichloroethylene, which are known or suspected carcinogens. The findings are supported by other studies that suggest continuous physical activity, but not intermittent activity, is required to lower the risk of prostate cancer. The biologic mechanisms by which physical activity lower prostate cancer risk have not been identified, although some experts have speculated that activity can alter hormone levels in some men.

 

CANCER: RESEARCHERS FIND POTENT NEW TREATMENT FROM TOXIC ALGAE
A team of researchers at the University of California at San Diego’s Cancer Center has identified a potent new anti-cancer drug isolated from a toxic blue-green algae found in the South Pacific. The properties of somocystinamide A are described in a paper published online in Proceedings of the National Academy of Science. The compound was found in the cyanobacteria L. Majuscula, also known as “mermaid’s hair,” gathered off the coast of Fiji in the South Pacific. The researchers found that the compound inhibits neovascularization, the formation of blood vessels that feed tumors, and also had a direct impact on tumor cell proliferation.

AUTISM: SOME CASES CAN BE TRACED TO MOTHER’S IMMUNE SYSTEM DURING PREGNANCY
Research from the M.I.N.D. Institute and the Center for Children’s Environmental Health at the University of California at Davis has found that antibodies in the blood of mothers of children with autism bind to fetal brain cells, potentially interrupting healthy brain development. The researchers also found that the reaction was most common in mothers of children with the regressive form of autism, which occurs when a period of typical development is followed by loss of social and/or language skills. The findings, to be published in the March 2008 issue of Neurotoxicology, raise the possibility that the transfer of maternal antibodies during pregnancy is a risk factor for autism, and that a prenatal test and treatment could be developed to prevent the disorder for some children. IgG antibodies are responsible for long-term immune system responses to infection, but they can also contribute to autoimmune diseases such as arthritis, multiple sclerosis, and lupus. IgG also crosses the placenta in order to provide key immune system protectants to a growing fetus and newborn child.

 

A research team at the Moores Cancer Center at University of California at San Diego reports that patients with chronic lymphocytic leukemia (CLL) who were treated with a gene therapy protocol began making antibodies that reacted against their own leukemia cells. The study, published in the online edition of the Proceedings of the National Academy of Science, reported that several patients not only began making antibodies that reacted against their own leukemia cells, but when tested in the lab, the antibodies also reacted with the leukemia cells of other patients with the disease. The researchers modified patient’s own leukemia cells outside of their body and gave them back as a vaccine. The researchers said the result raises hope that it may be possible to activate a patient’s immune system against their own cancer.

 

EPILEPSY: VALEANT SAYS DRUG EFFECTIVE IN LATE-STAGE TRIAL
Aliso Viejo, California-based Valeant Pharmaceuticals reported positive results for retigabine in the first of two late-stage pivotal trials. Retigabine, a first-in-class neuronal potassium channel opener, is being developed as an adjunctive treatment for adult epilepsy patients with refractory partial-onset seizures. The trial evaluated the 1,200-mg daily dose of retigabine (the highest dose in the program) versus a placebo in patients taking stable doses of one to three additional anti-epileptic drugs. Retigabine demonstrated statistically significant results on the primary efficacy endpoints important for regulatory review by both the U.S. Food and Drug Administration and the European Medicines Evaluation Agency, the company said.

 

Menlo Park, California-based Depomed reported positive efficacy results from a mid-stage clinical trial evaluating Gabapentin GR for the treatment of women with moderate-to-severe menopausal hot flashes. The 124-patient study showed that Gabapentin GR, an extended release formulation of gabapentin developed using Depomed’s AcuForm drug delivery technology, significantly reduced the frequency and severity of hot flashes from baseline to the end of treatment compared to a placebo. A decrease of at least 80 percent in the frequency of moderate to severe hot flashes was observed in 63 percent of patients in the 1,800-mg treatment arm, compared to 20 percent of placebo patients, a decrease that was statistically significant. Gabapentin GR was well tolerated in the study. 

 

Palo Alto, California-based Horizon Therapeutics said it is closing enrollment in two late-stage clinical trials for its lead product candidate HZT-501, an investigational prescription non-steroidal anti-inflammatory drug, or NSAID, designed to be "GI-friendly." HZT-501 is a proprietary fixed-dose combination of ibuprofen with a high dose of the stomach acid-inhibiting drug famotidine. The program is comprised of two trials involving a total of 1,500 patients with mild-to-moderate pain, including patients with osteoarthritis. The trials are evaluating the efficacy and safety of HZT-501 with a primary endpoint of reduction in the risk of development of ibuprofen-associated upper gastrointestinal (gastric and/or duodenal) ulcers in patients who require the use of ibuprofen. The company said its is targeting the widespread medication void in the mild-to-moderate pain market left by COX-2 inhibitors that have either been taken off the market or are being prescribed less frequently due to elevated cardiovascular risk. While NSAIDs are commonly prescribed to treat pain, they have been linked to serious gastrointestinal side effects in up to 25 percent of all chronic arthritis patients. NSAID-induced GI toxicity causes an estimated 16,000 deaths and more than 100,000 hospitalizations annually in the United States.

 

Researchers will present data at the International Neuropsychological Society's annual meeting showing that training on the Brain Fitness Program developed by the San Francisco-based Posit Science improves mental function in cancer patients with "chemobrain." Chemobrain is a condition associated with chemotherapy that results in decreased cognition. It affects quality of life by impairing concentration and the ability to make decisions and often limits patients' ability to deal with daily activities of life such as caring for children, working, and household duties. Nineteen breast cancer patients, all women, who underwent chemotherapy and reported having "chemobrain" participated in the study. Each used the Posit Science Brain Fitness Program. The program consists of a series of six specially designed exercises to improve memory and speed of processing in mature adults. Study results showed that participants had statistically significant improvements in cognitive function, stress levels, and health-related quality of life, suggesting that the benefits generalized into every day life, the company said.

 

San Francisco-based Presidio Pharmaceuticals said it entered into a collaboration with San Bruno, California-based Numerate to develop and commercialize new small-molecule compounds for the treatment of the Hepatitis C virus, or HCV. The companies did not disclose the terms of the collaboration and the specific HCV target. Numerate’s drug engineering process addresses the key design criteria in parallel with a focus on delivering advanced lead compounds quickly. The process accelerates the discovery and design of novel leads and reduces the time and cost needed to advance compounds into clinical trials, the companies said.