IN THIS ISSUE:

• Galvus Consistently Cuts Blood Sugar
   
• Antibiotic Resistance Blocked
   
• Selenium Supplements May Increase The Risk Of Type 2 Diabetes
   
• Modified Herpes Virus Keeps Arteries 'Free-Flowing' Following Procedures
   
• Researchers Find a New Target for Muscular Dystrophy Drug Therapy
   
• New Monoclonal Antibody Reduces Cell Proliferation and Induces Cell Death in Human Liver Cancer Cells
   
• Researchers Probe Risks, Benefits of Folic Acid Fortification

• Believe It Or Not

• News From MedWatch

• Research Update

• Recently Approved Drugs/Indications

• FDA Recalls and Safety Alerts in the Past 60 Days

• Drug Shortages

• Recommend Edmund's Newsletter

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Galvus Consistently Cuts Blood Sugar

New data shows that type 2 diabetics treated with Galvus (vildagliptin) experienced consistent and robust blood sugar reductions, Swiss drugmaker Novartis AG said on Monday.
The data, which were presented at the annual American Diabetes Association meeting in Chicago, showed that Galvus demonstrated efficacy and tolerability both as a monotherapy and when added to many commonly used diabetes medicines, Novartis said.
The results were shown in patients across the type 2 diabetes spectrum, including varied ethnic groups, the elderly, those with impaired glucose tolerance at high risk of developing diabetes and those with uncontrolled blood sugar levels.
U.S. regulators have asked for more data on Galvus including a further clinical study to show its safety and efficacy in patients with kidney impairment, delaying approval of the potential blockbuster.


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Antibiotic Resistance Blocked

US scientists believe they may have found a way to stop the growing problem of bacteria becoming resistant to current drug treatments.
They have found drugs called bisphosphonates block an enzyme used by bacteria to swap genes, and acquire or spread resistance to antibiotic drugs.
They also showed that interfering with the enzyme could destroy drug resistant bacteria cultured in the lab.
The study appears in Proceedings of the National Academy of Sciences.

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Selenium Supplements May Increase The Risk Of Type 2 Diabetes

Selenium, an antioxidant included in multivitamin tablets thought to have a possible protective effect against the development of type 2 diabetes, may actually increase the risk of developing the disease, an analysis by researchers at the University at Buffalo has shown.
Results of a randomized clinical trial using 200 micrograms of selenium alone showed that 55 percent more cases of type 2 diabetes developed among participants randomized to receive selenium than in those who received a placebo pill.
Results will appear in print in the August 2007 issue of Annals of Internal Medicine and were posted online on July 10.
Self-reported diagnosis of type 2 diabetes was a secondary endpoint in a clinical trial designed to test the benefit of selenium supplementation in prevention of non-melanoma skin cancer in areas in the Eastern U.S. where selenium levels are lower than the national average. Selenium is a trace mineral that is an essential component of proteins involved in antioxidant activity.
Saverio Stranges, M.D., Ph.D., first author on the diabetes prevention study, conducted the analysis while at UB, in cooperation with colleagues from Roswell Park Cancer Institute. He now is affiliated with the Clinical Sciences Research Institute, Warwick Medical School, Coventry, UK.

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Modified Herpes Virus Keeps Arteries 'Free-Flowing' Following Procedures

A genetically engineered herpes simplex virus, primarily known for causing cold sores, may help keep arteries "free-flowing" in the weeks following angioplasty or stent placement for patients, according to research published early in the online edition of PNAS (Proceedings of the National Academy of Sciences of the United States of America).
Christopher Skelly, MD, assistant professor of vascular surgery at the University of Chicago Medical Center, and the study's lead author says, "One of the drawbacks of balloon angioplasty to open blocked arteries and the use of stents to keep them open is that arteries sometimes experience aggravation from the procedure. The balloon angioplasty, in addition to opening the artery can lead to smooth muscle cell proliferation, similar to formation of scar tissue, known as neointimal hyperplasia. This scar tissue can restrict blood flow not long after the procedures, leading to a recurrence of symptoms. A significant number of these cases end up requiring further intervention to address this complication."
Researchers at the University of Chicago noted that in recent years, genetically engineered herpes simplex virus studied for its efficacy against malignant tumors of the central nervous system and the liver was blocking certain types of cell death and proliferation of surviving cells. They wanted to test this effect in arteries following angioplasty therapy.
The researchers studied a rabbit model that replicates the restenosis or renarrowing after angioplasty. Rabbits that underwent angioplasty alone experienced significant narrowing of the artery. Rabbits exposed to the herpes simplex virus during angioplasty had minimal changes in the arteries. The smooth muscle cell proliferation which causes the restenosis was very low in the group treated with herpes and remained high in the untreated group.

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Researchers Find a New Target for Muscular Dystrophy Drug Therapy

Researchers at the University of Pennsylvania School of Medicine report how the gene for utrophin, which codes for a protein very similar to dystrophin, the defective protein in Duchenne muscular dystrophy (DMD), puts the brakes on its own expression in muscle cells, thereby suggesting a new target for treatment. The findings were published online in Molecular Biology of the Cell, in advance of print publication.
The production of utrophin slows in fetal muscles soon after birth, after which dystrophin takes over as the primary muscle-associated protein. How this normal utrophin silencing occurs has been a mystery, until now. If the brakes on utrophin production could be removed by drug intervention, then increased utrophin expression could substitute for dystrophin as a possible therapy for DMD, which affects 1 in 3,500 males.
Utrophin is normally made at the junction where nerves meet muscles, an area called the neuromuscular junction or synapse. In the present study, the Penn team discovered that silencing is applied by a protein called Ets-2 repressor factor (ERF) sitting on a small piece of the utrophin gene called the N-box.
“We demonstrated that ERF significantly reduces or represses the activity of utrophin’s N-box in muscle cells of mice,” says senior author Tejvir S. Khurana, MD, PhD, Associate Professor of Physiology and Member of the Pennsylvania Muscle Institute. When the N-box was deleted from the utrophin gene, ERF had no effect on silencing the utrophin gene, as measured by an increase in utrophin gene-promoter activity. In another experiment in which ERF was repressed, the researchers found utrophin mRNA production increased.

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New Monoclonal Antibody Reduces Cell Proliferation and Induces Cell Death in Human Liver Cancer Cells

Researchers from the University of Pittsburgh School of Medicine report a significant new advance in the search for an effective treatment for human liver cancer in the July issue of Molecular Cancer Therapeutics. Using a newly available monoclonal antibody, they demonstrated significant reductions in tumor cell proliferation and survival in human and mouse hepatocellular cancer (HCC) cell lines. According to the researchers, this finding has significant implications not only for the treatment of liver cancer but for a number of different types of cancer.
Most cases of HCC are secondary to either a viral hepatitis infection or cirrhosis of the liver. Despite recent advances, it remains a disease of grim prognosis due to the poorly understood mechanism of how the disease originates and spreads. Most patients live only a short time after diagnosis.
Based on previous studies showing that some pathways that were previously thought to be active only during fetal liver development, particularly the class III receptor tyrosine kinase (RTK) family pathway, became highly active again in the liver of HCC patients, Satdarshan P. Singh Monga, M.D., associate professor, division of cellular and molecular pathology and colleagues at the University of Pittsburgh School of Medicine, obtained rat and human liver cancer cell lines and analyzed them for level of expression of an RTK protein known as platelet-derived growth factor receptor-alpha, or PDGFRa. The investigators also analyzed the cells for their level of activation of the PDGFRa gene.
At an early fetal stage of liver development in the mouse, the investigators found that the level of expression of PDGFRa was 37 times higher compared to later stages of development in the adult mouse liver. They also found significantly higher levels of PDGFRa in rat and human liver cancer cell lines as compared to normal cells in culture.

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Researchers Probe Risks, Benefits of Folic Acid Fortification

Since the institution of nationwide folic acid fortification of enriched grains in the mid 1990s, the number of infants born in the United States and Canada with neural tube defects has declined by 20 percent to 50 percent. Concurrent with the institution of fortification, however, the rate at which new cases of colorectal cancer were diagnosed in men and women increased, report researchers at the Jean Mayer USDA Human Nutrition Research Center on Aging (USDA HNRCA) at Tufts University. Joel Mason, MD, director of the USDA HNRCA’s Vitamins and Carcinogenesis Laboratory, and colleagues analyze the temporal association between folic acid fortification and the rise in colorectal cancer rates, and present their resulting hypothesis in an article in the July issue of Cancer Epidemiology Biomarkers & Prevention.
“Nationwide fortification of enriched grains is generally considered one of the greatest advances in public health policy,” says Mason, who is also an associate professor at the Friedman School of Nutrition Science and Policy at Tufts. “But since the time that the food supply in North America was fortified with folic acid, we have been experiencing four to six additional cases of colorectal cancer for every 100,000 individuals each year compared to the trends that existed before fortification.
“Our analysis suggests that this increase is not explained by chance or by increased cancer screening. Therefore, it is important to analyze risks and benefits of fortification, and encourage scientific debate in countries that are considering instituting or enhancing folic acid fortification.”
Mason and colleagues analyzed data from national cancer registries, one in the United States and another in Canada. The US data were derived from the nationwide Surveillance Epidemiology and End Results (SEER) registry that publishes cancer occurrence rates and survival data, covering approximately 26 percent of the population. The Canadian data were obtained from Canadian Cancer Statistics, an annual publication by the Canadian Cancer Society and the National Cancer Institute of Canada.

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Believe It Or Not

Sexual problems could lead to rhinos' extinction

Low sperm counts and other reproductive problems are preventing pregnancy among Malaysia's endangered rhinos, a worrying trend that wildlife experts say could hasten its extinction.
Experts meeting on Borneo island this week to discuss ways to save the Borneo rhino said a major threat -- besides poaching -- was the animal's inability to reproduce.
"Maybe because they live in fragmented locations deep in the jungles and because of that, they rarely get the opportunity to mate," the New Straits Times newspaper on Thursday quoted Sabah Wildlife Department deputy chief, Laurentius Ambu, as saying.
But scientists also found that male rhinos suffer from low sperm count while many of their female counterparts have cysts in their reproductive organs.
"It's a mystery," he said. "We are curious to learn more."
The authorities attempts to encourage captive breeding had failed, Ambu said. "We will try our best to allow the rhinos to breed naturally," he added.
Conservation group, SOS Rhino, said some female rhinos held in captivity had developed tumors in their uterus, thus preventing pregnancy.
"It's more of a psychological disease due to imbalances of hormones or stress," said its president Nan Schaffer.
"It certainly has interfered with the reproduction of the animals in captivity," Schaffer, who is an expert on reproductive psychology, said by telephone from Sabah.
The wildlife department says there are between 30 and 50 rhinos left in the dense jungles of Malaysia's Sabah state, on Borneo. The animals are so secretive that the first photograph of one was only taken last year.
In April, global conservation group WWF said it had filmed the animal for the first time.
Scientists consider the Borneo rhino to be a subspecies of the Sumatran rhino.
Rhino horns, made of hair-like keratin fibers, have reputed aphrodisiac qualities and are a prized ingredient of traditional Asian medicine.

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News From MedWatch

Keep up-to-date on all of the recent MedWatch reports that gives you timely safety information on the drugs and other medical products regulated by the U.S. Food and Drug Administration by CLICK HERE

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Recently Approved Drugs/Indications

Keep up-to-date on all of the recently approved drugs and/or approved new indications on already FDA approved drugs CLICK HERE

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FDA Recalls and Safety Alerts in the Past 60 Days:

To see a list of all FDA Recalls and product safety alerts for the last 60 days CLICK HERE

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Drug Shortages:

As many of you are aware, many drugs in the US are either unavailable or in short supply. To view a list of these drugs CLICK HERE

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Edmund M. Hayes, R.Ph., M.S., Pharm.D.
Departments of Pharmacy and Medicine
Stony Brook University Hospital
State University of New York at Stony Brook
Stony Brook, New York, 11794
631 444-2668

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