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BRAIN CANCER: GENENTECH’S AVASTIN SHOWS PROMISING RESULTS IN MID-STAGE TRIAL
Genentech said that both study arms of a mid-stage clinical study of its drug Avastin—administered alone or in combination with irinotecan chemotherapy—demonstrated encouraging six-month progression-free survival and objective response rate in patients with relapsed glioblastoma multiforme, the most common and aggressive type of brain cancer. The South San Francisco, California-based biotechnology company said the study showed 36 percent of the patients treated with Avastin alone, and 51 percent of patients treated with Avastin in combination with chemotherapy, lived without the disease advancing within six months. No new or unexpected safety events related to Avastin have been observed in the study. The data were presented at the 12th Annual Scientific Meeting of the Society for Neuro-Oncology. Historical estimates suggest that only 15 percent of patients with this aggressive type of brain cancer live without their cancer progressing within six months.

 

EXERCISE: USE OF PEDOMETER ASSOCIATED WITH INCREASED PHYSICAL ACITIVITY, LOWER BLOOD PRESSURE, AND REDUCED WEIGHT
The pedometer, a small, inexpensive device that counts the number of steps walked per day, could be key to ramping up a person's physical activity. Researchers at the Stanford University School of Medicine have found that the use of a pedometer is associated with significant increases in physical activity and weight loss and improvements in blood pressure. They report, a study of previous studies, was published in JAMA and showed that use of the devices increased physical activity, with users walking about 1 mile more per day. Overall, the use of pedometers increased physical activity by nearly 27 percent.

 

Mothers who reported sleeping five hours or less per day when their babies were six months old had a threefold higher risk for substantial weight retention (11 pounds or more) at their baby’s first birthday than moms who slept seven hours per day, according to a new study by Kaiser Permanente and Harvard Medical School / Harvard Pilgrim Health Care. The study, published in the American Journal of Epidemiology, is the first to look at the impact of sleep deprivation on postpartum weight retention. The researchers said that getting enough sleep may be as important as a healthy diet and exercise for new mothers to return to their pre-pregnancy weight.

 

Researchers at the Stanford University School of Medicine have taken a small but significant step, in mouse studies, toward the goal of transplanting adult stem cells to create a new immune system for people with autoimmune or genetic blood diseases.

The researchers found a way to transplant new blood-forming stem cells into the bone marrow of mice, effectively replacing their immune systems. The researchers said many aspects of the technique would need to be adapted before it can be tested in humans. The work was done on a particular group of mice that are a poor mimic for the human immune system. The study, published in Science, avoided the use of radiation or chemotherapy to destroy the blood-forming stem cells in the bone marrow before the transplant. Instead, the researchers injected the mice with molecules that latch onto specific proteins on the surface of the blood-forming stem cells, effectively destroying the cells. That technique eliminated the blood-forming stem cells without otherwise harming the mice.

LIVER CANCER: NEXAVAR WINS APPROVAL FOR EXPANDED USE

Bayer HealthCare Pharmaceuticals and Emeryville, California-based Onyx Pharmaceuticals said that the U.S. Food and Drug Administration approved a supplemental New Drug Application for Nexavar for the treatment of patients with unresectable hepatocellular carcinoma, or liver cancer. Nexavar, an oral anticancer drug, is the first approved systemic therapy for liver cancer and the only one shown to significantly improve overall survival in patients with the disease. In 2005 Nexavar became the first new treatment in more than a decade for advanced kidney cancer, and is currently approved in more than 60 countries for this indication.

 

ANGINA: FDA TO CONSIDER FIRST-LINE USE OF CV THERAPEUTICS DRUG
Palo Alto, California-based CV Therapeutics said the U.S. Food and Drug Administration has notified the company that its supplemental new drug application and new drug application for Ranexa have both been accepted for filing. The agency is expected to take action on both applications by July 27, 2008. The supplemental application seeks to expand the approved product label for Ranexa to include a first-line angina indication and to significantly reduce the cautionary language on the label. The FDA also accepted for filing a separate new drug application on behalf of the company to provide a clinical review of a potential labeling change for Renexa to add reduction of hemoglobin A1c in coronary artery disease patients with diabetes as a new indication for the drug. Hemoglobin A1c transports sugar in the bloodstream.